Pharmaceutical Technology

Q. What do you mean by Pharmaceutical Technology?

Answer:
Pharmaceutical Technology is the part or branch of pharmacy that focused on the
formulation of medicine and drug delivery for the best quality of the treatment and
management of disease.

Pharmaceutical Technology is the application of scientific knowledge or technology

to pharmacy, pharmacology, and the pharmaceutical industry. It includes methods,
techniques, and instrumentation in the manufacture, preparation, compounding,
dispensing, packaging, and storing of drugs and other preparations used in diagnostic
and determinative procedures and in the treatment of patients.

Q. Define tablet, capsule, gelatin and collagen.

Answer:
Tablet: a compressed solid substance, typically a measured amount of a medicine or drug.
Capsule: a solid dosage forms made from gelatin or other suitable material which
is filled with medicines to produce a unit dose.
Gelatin: a substance of natural origin that prepared by the hydrolysis of collagen.
Collagen: the main protein constituents of connective tissue (Main source of
animal skin, bone, connective tissue).

Q. Mention the capsule size for humans and animals.

For humans:
Size - Body volume (ml)
0 - 0.67
1 - 0.48
2 - 0.37
3 - 0.28
4 - 0.20
5 - 0.10

For animals:
Size - Body volume (ml)
000 - 1.37
00 - 1.02

Page 1 of 56
Q. Define dryer. Mention different types of dryer.

Answer:
Dryer: is an equipment that is used for drying wet materials.
Different types of dryer:
Static bed dryers [no relative movement among the solid particles being dried]
Moving bed dryer [flow over each other]
Fluidized bed dryer [solid particles are partially suspended in an upward moving gas stream]
Special drying methods [ Freeze dryer, Microwave drying]

Q. What is the importance of drying?

Answer:
Preparation of bulk drugs
Preservation of drug products
Improved characteristics
Improved handling

Q. What is the principle of Fluidized Bed Dryer?

Answer:
Systems in which the solid particles are partially suspended in an upward moving gas
stream. In this dryer hot air (gas) is passed at high pressure through a perforated bottom
of the container containing granules to be dried. The granules are suspended in the
stream of air. This condition is called fluidized state.

Q. What do you mean by freeze drying? Mention the steps of freeze drying process.

Answer:
Freeze drying: is a conduction drying method that is operated under vacuum followed
by heat transfer in the dryers.

Freeze drying process:

Freezing
↓
Vacuum
↓
Primary drying / Sublimation phase
↓
Secondary drying / Ordinary vacuum drying
↓
Packaging
↓
Storage
↓

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 Reconstitution phase

Q. Mention the steps of tablet formulation.

Answer:
Dispensing of Raw materials
Granulation
Compression

Q. Mention the parts of tablet compression machine.

Answer:
1.Hopper (for holding and feeding granulation)
2.Dies (to define the size and shape of the tablet)
3.Punch - (upper and lower punches
compress the granules)
4. Feeder housing
5.Feed paddles (for moving granules)
6.Cam track (for guiding the movement of the punches)
7.Compression roller
8.Discharge chute
9.Ejection cam

Q What do you mean by mill? What are the actions & uses of Cutter, Revolving,
Hammer, Rolar, Attrition & Fluid energy mills?

Answer:
Mill: Equipment used to reduce the particle size of solids. Solid particles present
in semisolids and suspensions can be reduced by using specially designed
machine (Mills).

Characteristics of various types of mills are given below:

1. Cutter
Action: cutting
Used for: Fibrous, crude animal and vegetable drugs.
2. Revolving
Action: Attrition and impact
Used for: Fine grinding of abrasive material

3. Hammer
Action: Impact
Used for: Almost all drugs

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4. Rolar
Action: Pressure
Used for: Soft materials

5. Attrition
Action: Attrition
Used for: Soft and fibrous material

6. Fluid-energy
Action: Attrition and impact
Used for: Moderately hard and friable material.

Q. Describe compression machine tooling.

Answer:
'B' tooling (Maximum tablet size 16 mm)
'D' tooling (Maximum tablet size 25 mm)
'BB' tooling (Maximum tablet size 13 mm) .
'DB' tooling (Maximum tablet size 19 mm)

Q. What are the process equipments of coating?

Answer:
Most coating processes use one of three general types of equipment:

1.The standard coating pan

2.The perforated coating pan
3.The fluidized bed coater

Q. Define microcapsulation. Mention the application of microcapsulation.

Answer:
Microcapsulation: is a process by which solids, liquids, or even gases may be
enclosed in microscopic particles by formation of thin coatings of wall material
around the substance. A capsule with a size range about 200µ is termed as
microcapsule.

Applications:
Encapsulation is a fairly standard practice in the food, consumer product, and
cosmetics industries because this process can protect and enhance stability as in the
foods and vitamins.

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Q. Mention the process of microencapsulation.

Answer:
Air suspension: consists of the dispersing of solid, particulate core materials in a
supporting air steam and the spray-coating of the air suspended particles.
Pan coating: with respect to microencapsulation, solid particles greater than 600
micrometer in size are generally considered essential for effective coating, and the
process has been extensively employed for the preparation of controlled-release
beds.
Spray drying and spray congealing: are similar in that both involve dispersing the
core material in a liquefied coating substance and spraying or introducing the core-
coating mixture into some environmental condition.
Solvent evaporation: the microcapsule coating is dissolved in volatile solvent.
The mixture is then heated to evaporate the solvent for the polymer.

Q. Define clearly: Solution, Suspension, Emulsion, Multi-emulsion, Micro-emulsion, Tinctures,

Syrups, and Elixir.

Answer:

Solution: is a homogenous mixture prepared by dissolving a solid, liquid or gas in another liquid.
(Molecule in size)
Suspension: may be defined as a biphasic system comprising of a solid phase
uniformly dispersed in a liquid phase. (Larger than 10,000 Angstroms)
Emulsion: may be defined as a biphasic system comprising of two immiscible
liquids usually water and oil, one of which is finely subdivided and uniformly
dispersed as droplets throughout the other.
Multi-emulsion: in which oil in water or water in oil emulsion are dispersed in
another liquid medium.
Micro-emulsion: contains globules having diameters of less than 0.1 micrometer.
Tinctures: are alcoholic or hydro alcoholic solutions of chemicals or soluble
constituent of crude drugs.
Syrups: are viscous sweet concentration solutions of sugar such as sucrose in
water. Syrup BP is 66.7% solution of sucrose.
Elixir: Clear, sweetened, hydro alcoholic liquid intended for oral use.

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Q. What do you mean by semi-solid preparation? Define: Ointment, Cream, Lotion,
Liniment, Paste, Gels, Gullies and Poultices.

Answer:

Semi-solids: are neither solid nor liquid. They are in between the two. They
should be smooth, uniform mixture, easily washable, non irritant and not be
sticky.
Ointments: are hydrophobic type of preparation and are mainly composed of
hydrocarbons, mineral oils or petrolatum.
Creams: are semisolid preparations. They are used externally and contain one or
more medicinal agents dissolved or dispersed in either a w/o or o/w emulsion base
or in a water washable base. Lotions: are similar to solution but are thicker and tend
to be emollient in nature than solution. They are usually oil mixed with water.
Liniment: is a medicated topical preparation for application to the skin.
Pastes: are dilute preparations. Where insoluble solids are dispersed in the
continuous phase in large extent. These are less viscous, less sticky and slurry type.
Gels: are at least two component mixtures where one component is constrained
within a three dimensional polymeric matrix of the other which is in general is the
vehicle.
Gullies: are transparent or translucent non greasy semisolid gel.
Poultices: are the ready-made home made preparations that are still in use today.

Q. What is aerosol? Mention the components of aerosol.

Answer:
Aerosol: Aero means air, Sol means solution. Aerosol is a solution of air. It can be
defined as the system that depends on the power of compressed to expel the content
from the container.
Aerosol have site specific (local) action.
It has less side effects.
Rapid onset of action.

Components of Aerosol:
Active ingredient
Propellant
Container
Valve and Actuator
Product concentrate

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Propellant: regarded as the heart of the aerosol package. Because propellant is
responsible for developing the proper pressure within the container.

Q. What do you mean by DPI? Describe the formulation of DPI?

Answer:
DPI: is a device that delivers medication to the lungs in the form of a dry powder. DPIs
are commonly used to treat respiratory diseases such as asthma, bronchitis, emphysema
and COPD.
Formulation design:
Low aerodynamic diameters.
Low inter-particulate forces.
Dry powder particles of suitable size range, generally considered between 1
and 6 micrometer.

Q. What do you mean by MDI? Write down the uses of MDI.

Answer:
MDI: A metered-dose inhaler (MDI) is a device that delivers a specific amount of
medication to the lungs, in the form of a short burst of aerosolized medicine.

Uses: It is the most commonly used delivery system for treating asthma, COPD and
other respiratory diseases.

Q. What is parenteral product? Which factors must be considered for the

preparation of parenteral products?

Answer:
Parenteral products: are sterile solutions or suspensions of drugs in aqueous or oily
vehicles that are injected through the skin or mucous membrane into internal body
compartment. They may produce immediate responses.

The following factors must be considered for the preparation of parenteral products:
Volume of injection
Adjustment of pH
Stabilizer
Preservatives
Adjustment of specific gravity
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 Adjustment of isotonicity
Vehicles

Q. Mention the aqueous vehicles that are used for the preparations of parenteral products.

Answer:
Water for injection U.S.P
This water is purified by distillation or reverse osmosis or diamination.
It is well tolerated by the body.
It is not required to be sterile but must be pyrogen free.

Sterile water for Injections U.S.P

This water has been sterilized and packaged in single-
dose containers of not more than 1 liter size.
It must be pyrogens free.

Bacteriostatic Water for Injections U.S.P

This water is sterilized water for injection containing one or more suitable
anti-microbial agents.
It is packaged in vials containing not more than 30 ml of the water.

Sodium Chloride (NaCl) Injections U.S.P

It is sterile and isotonic solution of NaCl in water for injections.

Q. Classify parenteral product according to the volume.

Answer:
Parenteral product can be divides into two general classes according to the volume:
1.Small volume parenteral (usually 100 ml or less)
2.Large volume parenteral (more than 100 ml)

Q.What is opthalmic product? Mention the different types of opthalmic preparation.

Answer:
Opthalmic preparations: are the solid, semi-solid or liquid specialized dosage form designed to be
installed onto the external surface of the eye.

Types of opthalmic preparation:

Eye drops
Eye lotions
Eye ointments
Contact lenses solutions
Opthalmic inserts
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Q. What do you mean by blood? Write down the name of blood product.

Answer:
Blood: is a red, thick and slightly alkaline (pH 7.46-7.48) fluid connective tissue. In
blood cell components (RBC, WBC, Platelets) are suspended in liquid substance
(plasma). An adult human contains about five liters of blood. The composition of blood
is - Cell compound (45%) & Plasma (55%).

Types of blood products:

Blood
Blood plasma
Plasma fraction
Artificially synthesized blood products
Q. What do you mean by implant & Suppository?

Answer:
Implants: are drug bearing polymeric device which are implanted subcutaneously or in various body
cavities.
Examples include: Insulin for diabetes, Contraceptive steroids, and Narcotic antagonists.

There are four types of implantable devices based on the site of implantation:
Subcutaneous devices
Intravaginal devices
Intrauterine devices
Intraocular devices

Suppository: is a solid dosage forms intended for insertion into body orifices where
they melt, softer or dissolve and exert localized or systemic effects. Suppositories are
commonly used in -
Rectally
Vaginally
Occasionally Urethrally

Page 9 of 56
Q. Write down the chemical name of the followings.

Answer:
Name of the material [Chemical name]
Iso-propyl alcohol [Propan 2-ol]
Alcohol [Ethanol]
Acetone [2-Propanone]
Calcium carbonate [Carbonic acid]
Dextrose [D-(+)-Glucose monohydrate]
Fructose [D-Fructose]
Glycerin [Propane 1,2,3 -triol]
Methyl paraben [Methyl 4 -hydroxy benzoate]
Propyl paraben [Propyl 4 -hydroxy benzoate]
Kaolin [Hydrate aluminum silicate]
Sorbitol [D-Glucitol]
HPMC [Cellulose hydroxy propyl methyl ether]
Propylene glycol [1,2 -Dihydroxypropane]
Stearic acid [Octadecanoic acid]
Sucrose [B-D-fructosefuranosyl-a-D-glucopyranoside]

Q. Define preformulation? What are the purpose of

preformulation. Answer:
Preformulation: Before the formulation of a new drug substance into a dosage
form, it is essential to ascertain certain fundamental physical and chemical
properties of the drug powder.

Purpose of the preformulation studies

To study the physicochemical properties of the drug.
To provide a rationale for formulation design.
To support the need for molecular modification.

Q. What do you mean by warehouse? What are the functions of warehouse?

Answer:
Warehouse is the departments where the raw and packaging materials are store
which comes from the supplier, dispensed in the production area and finished
products are deliver through this area.

Functions of ware house

1.Storage of raw & packaging materials.

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 2.Temporary storage of finished product before going central depot.
3.Storage of rejected materials before disposals.
4 . Maintain proper quality during the storage of material.

Q. What do you mean by packaging?

Answer:
Packaging: is the process by which the pharmaceuticals are suitably packed so that
they should retain their therapeutic effectiveness from the time of their packaging till
they are consumed.

Packaging materials
Container (Glass, Plastic, Metals)
Closure (Glass, Plastic, Rubber, Cork)
Carton
Box

Aim of packaging
Protection
Identification
Presentation

Q. What do you mean by container? Classify Container.

Answer:
Container: may be defined as a device in which the drug is enclosed and is in direct contact with the
drug.

Classification:

Well closed container

Air-tight container
Hermetically-sealed container
Light resistant container
Single dose container
Multi-dose container
Aerosol container

Q. Describe different glass compounds.

Answer:
Glass compounds: is the first preferred materials of container for parenteral products.
Glass is composed principally of the silicon-dioxide (SiO2) tetrahedron.

Classification:
1.Type I glass (Borosilicate glass)
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 2.Type II glass (Treated soda lime glass)
Blister pack: consists of a base layer, which contains cavities containing pharmaceutical products and
a lid that is sealed by heat, pressure or both. Composition: Aluminum, PVC/PVDC, Polypropylene.

Q. What are the responsibilities of Production Executive?

Answer:
Management of day to day production activity.
Organize the daily or periodic production program as per monthly production plan.Maintain
Good Manufacturing Practice (GMP),
cGMP in all operations of the section.Maintain BMR and BPR.

Q. Differentiate between ointment & cream, jallies and pastes, Elixir and Syrups.

Answer:
Cream
Creams are viscous semisolid preparation Due to presence of water soluble base creams are easily
removable.
Multiphase preparation
Ointment
 Ointment are semisolid preparation but not viscous.
 Ointment are not easily removable
 Monophase preparation
 Jellies are transparent or translucent & non-greasy
 Pastes are not transparent and less-greasy

Elixir: are clear, pleasantly flavoured, sweetened hydroalcoholic liquid

preparations for oral administration. The main ingredients of elixir are ethanol
and water.
Syrups: are sweet, viscous, concentrated aqueous solutions, usually contain
water and other aqueous vehicle.

Page 12 of 56
 Pharmaceutics

Q. What do you mean by Pharmaceutics? What are the branches of Pharmaceutics?

Answer:
Pharmaceutics: is the discipline of pharmacy that deals with the process of turning a new chemical
entity into a medication to be used safely and effectively by patients. It is also called the science of
dosage form design.

Branches of pharmaceutics include:

1.Pharmaceutical formulation
2.Pharmaceutical manufacturing
3.Dispensing pharmacy
4. Physical pharmacy

Q. What is granulation? What are the reasons for granulation?

Answer:
Granulation: is the process in which powder particles are made to adhere to form larger particles
called granules. Pharmaceutical granules typically have a size range between 0.2mm to 4 .0mm
depending on their subsequent use.

Reasons for granulation:

To prevents segregation of constituents in powder mix.
To improve flow properties of mixture.
To improve compression characteristics of the mixture.

Q. What is particle bonding mechanism in granulation?

Answer:
To form granules particle bonds must be formed between powder particles so that they adhere and
these bonds must be sufficiently strong to prevent breakdown of the granules to powder in
subsequent handling operations.

There are five primary bonding mechanisms between particles:

1.Adhesion and cohesion forces in the immobile liquid films between individual primary particles.
2.Interfacial forces in mobile liquid films within the granules.
3.The formation of solid bridges after solvent evaporation.
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 4. Attractive forces between solid particles.
5.Mechanical interlocking.

Q. Describe the stage for pan granulation in the mechanism of granule formation.

Answer:

Nucleation: Particle contact and adhesion due to liquid bridges forms an intact mass which
acts as nuclei for further granule growth.
Transition: Nuclei can grow by two possible mechanisms; either single particle can be added
to the nuclei by pendular bridges or two or more nuclei may combine.
Ball growth: Further granule growth produces large, spherical granules and mean particle size
of the granulating system will increase with time.

Q. What do you mean by Carr's Index and Hausner Ratio?

Answer:
Carr's Index: [(Trapped density - Poured density) ÷Trapped density] ×100%

Carr's Index (%) [Type of powder flow]

5-15 [Excellent]
12-16 [Good]
18-21 [Fair to passable]
23-35 [Poor]
33-38 [Very Poor]
>40 [Extremely Poor]

Hausner Ratio:
Hausner Ratio = Trapped density ÷ Poured density
Values less than 1.25 indicates good flow.
Values greater than 1.25 indicates poor flow.

Q. Define angle of repose and angle of spatula.

Answer:
Angle of repose: Maximum angle that can be obtained between a freestanding heap of powder and
the horizontal plane. It is an indication of the resistance to flow of the powder.

Angle of repose (degrees) [Type of flow]

<25 [Excellent]
25-30 [Good]
30-40 [Passable]
>40 [Very Poor]

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Angle of Spatula: is the angle that the triangular section of a powder heap on a spatula forms with
the horizontal, when a quantity of powder is picked up on it.

Q. What is wet granulation? What are the steps of wet granulation?

Answer:
The agitation resulting in the system along with the wetting of the components within the formulation
results in the aggregation of the primary powder particles to produce wet granules.

Requisition of raw materials

↓
Weighing / Dispensing
↓
Crushing & sieving of all ingredients
↓
Dry mixing
↓
Addition of binder solution or granulating solvent
↓
Wet mixing
↓
Co-Milling
↓
Drying in the FBD
↓
Dry-Milling / Size reduction
↓
Lubrication/Blending
↓
Compression of tablet

Q. What is dry granulation? What are the steps of dry granulation?

Answer:
Granulation is a process in which powder particles are made to adhere to each other, resulting in
larger, multi-particle entities, so called granules. If such a process is performed without adding liquids,
this is called dry granulation.

Requisition of raw materials

↓
Weighing / Dispensing
↓
Compression into slugs or roll compaction
↓
Milling and screening of slugs
↓
Page 15 of 56
 Lubrication / Blending
↓
Compression of tablet

Q. What are the steps of direct compression?

Answer:
Requisition of raw materials
↓
Weighing / dispensing
↓
Lubrication/Blending
↓
Compression of tablet

Q. Differences between dry granulation & wet granulation:

Dry granulation
No solvent is used
Production cost is less
Very simple process
Little chance of contamination

Wet granulation
Suitable solvent is used
Production cost is high
It is complex process
As water is used, contamination may be occurred.
Meets all the qualities required for a good tablet.

Q. Granulation equipments:

Wet granulators
Shear granulators
High speed mixers
Fluidized bed dryer (FBD)
Spray dryers
Spheronizers
Sluggers
Roller compactors

Q. Define solution? Mention the types of solutions?

Answer:
Solution is a homogenous mixture composed of two or more substances. In Solution,
solute is a substance that dissolved in another substances, called the solvent.

Solutions are mainly two types:

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1. Aqueous solution: Solutions that are soluble in water are called aqueous solution. Ex-
Solution of water & sugar
2. Non-aqueous solution: Solutions that are not soluble in water are called non-aqueous solution.

Q. What is Aromatic water?

Answer:
According to USP - Aromatic water or medicated water is a clear saturated aqueous
solution of volatile oils or the aromatic or volatile substances.

Q. Define emulsion? Mention the types of emulsion?

Answer:
Emulsion: An emulsion is a system consisting of two immiscible liquid phases, one
of which is dispersed throughout the other in the form of fine droplets. Emulsifying
agent is used to stabilize the emulsion.

Emulsions are mainly 2 types:

Oil-in-water (o/w): Emulsions in which the oil phase is dispersed in water phase is
called oil in water emulsion.
Water in oil emulsion: Emulsions in which the water phase is dispersed in oil phase is
called water in oil emulsion.

Others- Multiple emulsions in which more than two phases are involved. These are-
a) Water in oil in water emulsion and
b) Oil in water in oil emulsion.

Q. What is emulsifier? What are the problems in emulsion formulation/ factors

affecting stability of emulsions?

Answer:
Emulsifier or emulsifying agents are the substances that are used to stabilize the emulsion.

Problems of emulsion formulation are –

Cracking or breaking
Flocculation
Phase inversion
Creaming

Page 17 of 56
Q. Define suspension? Mention the types of suspension?

Answer:
A suspension is a two phase system composed of a solid material dispersed in a liquid.
The liquid can be oily or aqueous. However, most suspensions of pharmaceutical
interest are aqueous. Mainly classified into 2 types-

1.Flocculated suspension
2.Deflocculated suspension

In flocculated system, particles aggregate themselves by physical bridging. These

flocks are light, fluffy conglomerate which are held together by weak van der Waal’s
forces of attraction.

In Deflocculated system, solids are present as individual particles.

Q. Define Tablet. Mention the types of tablet.

Answer:
Tablet: Tablets are solid dosage forms each containing a single dose of one or more
active ingredients and obtained by compressing uniform volumes of raw materials or
excipients and API.

Mainly (according to BP) Tablets are classified into following categories:

1. Coated Tablet
2. Uncoated Tablet
3. Effervescent Tablet
4. Soluble Tablet
5. Dispersible Tablet
6. Gastro-resistant Tablet
7. Modified Release Tablet

According to USP:
Immediate release tablet
Disintegrating tablet
Chewable tablet
Sublingual tablet
Buccal tablet
Effervescent table
Page 18 of 56
2. Modified release tablet
Extended release tablet
Delayed release tablet

Q. What is Coating? Mention the types of tablet coating.

Answer:
Coating is a process by which an essentially dry outer layer of coating material is
applied to the surface of the dosage form in order to confer specific benefits of
modifying drug release from the dosage form and primary protection of the dosage
form.

Generally three methods are used for tablet coating-

1.Sugar coating
2.Film coating
3.Enteric coating

Q. Mention the important properties of a tablet.

Answer:
1. Must be uniform in weight and in drug content
2. Should have sufficient strength to withstand mechanical shock during
dispensing , production, packaging and shipping.
3. Should have physical and chemical stability to maintain its physical attributes over time.
4. Must be able to release medicaments in the body in a predictable and reproducible
manner. Should be elegant and free from coating problem or other contamination

Q. What are the steps of compression?

Answer:
1.Transitional repacking
2.Deformations at point of contact
3.Fragmentation
4. Bonding
5.Deformation of the solid body
6.Decompression
7.Ejection

Page 19 of 56
Q. What type of ingredients is used in tableting?

Answer:
In addition to active ingredients, tablet contains a number of inert materials known as additives or
excipients.

Different excipients are:

Diluents [are fillers used to make required bulk of the tablet]
Binders and adhesives [are used to form granules]
Disintegrants [facilitate breaking or disintegration of tablet when it contact in
water in the GIT] Super-disintegrants [swells up to ten fold within 30 seconds
when contact in water]
Lubricant and Glidants [intended to prevent adhesion of the tablet materials to the
surface of dies and punches, promote flow of granules or powder material by
reducing the friction between the particles]
Coloring agent [to identify a product, to make a more elegant product]
Flavoring agents [to mask a bad odor, for chewable tablet]
Sweetening agents [to reduce bitter taste, for chewable tablet]

Q. Give the examples of Diluent, Binder and adhesive, Disintegrants, Lubricants,

Glidants, Colouring agents, Flavoring agents, Sweetening agents.

Answer:
Diluent:
Starch, Lactose, Mannitol, Sorbitol, Dextrose.

Binder and Adhesive:

Acacia, Tragacanth, Cellulose, Gelatin, Sodium alginate.

Disintegrants:
Starch (5-20% of tablet weight), Cellulose derivatives, PVP (Polyvinylpyrrolidone).

Super disintegrants:
Cross linked cellulose, Cross linked povidone.
Lubricant and Glidant:
Stearic acid, Magnesium stearate, Talc, PEG (Polyethylene glycols)

Glidants:
Talc -5%, Silica derivatives, Aerosil.

Colouring agent:
Erythrosine (E127), Indigo carmine (E132), Iron oxide (E172), Titanium oxide (E171).
Page 20 of 56
Sweetening agents:
Saccharine, Aspartame.

Q. Mention the problems of tableting.

Answer:
Capping : is the partial or complete separation of the top or bottom crowns of a
tablet from the main body of the tablet.
Lamination: is the separation of tablet into two or more distinct layer.
Chipping: is defined as the breaking of tablet leaves during the subsequent
handling and coating operation.
Cracking: small fine cracks observed on the upper & lower central surface of
tablets, or very rarely on the side wall.
Sticking: the tablet material adheres to the die wall and thereby the lower punch
cannot move freely.
Picking: a small surface of the tablet material is removed by the punches, therefore
the resulting in this problem tablet show a pitted surface instead of smooth surface.
Binding: when the tablets adhere, seize or tear in the die. With excessive binding,
the tablet sides are cracked and it may crumble apart.
Mottling: unequal distribution of colour on a tablet.
Double impression: involves only those punches, which have a monogram or other
engraving on them.
Weight variation

Q. What is tablet coating? Mention the types of tablet coating.

Answer:
Tablet coating: is the application of a coating material to the exterior of a tablet
with the intention of conferring benefits.

Purpose of tablet coating:

To give the tablet ingredients protection from environment.
To mask unpleasant taste.
To make different appearance.
To improve pharmaceutical elegance.
To protect the drug from gastric environment.
Types of tablet coating:
1.Film coating (Non enteric film coating & Enteric film coating)
2.Sugar coating

Page 21 of 56
Q. Define Film Coating and Sugar Coating.

Answer:
Film coating: which involves the deposition of a membrane, consisting of polymer,
plasticizer, colorant and possibly other additives on to the surface of a pharmaceutical
dosage form (tablet or granule).

There are two types of film coating available:

1.Non-enteric film coating
2.Enteric film coating

Non-enteric film coating: is like sugar coating but film coating agents are used. It is
used to overcome the disadvantage of sugar coating.

Non-enteric agents:
Methylcellulose (MC)
Hydroxypropyl methylcellulose (HPMC)
Polyvinyl phthalate (PVP)
Polyethylene glycol (PEG)

Enteric film coating: is a special type of coating, which intended to make the tablet
to pass through the stomach intact to disintegrate and release their drug content for
absorption along the intestines.

Enteric film coating agents:

Cellulose acetate phthalate (CAP)
Acrylate polymers
Hydroxypropyl methylcellulose phthalate (HPMCP)
Polyvinyl acetate phthalate (PVAP)

Sugar Coating: is the traditional method of coating tablets. Coating with sucrose
and other sugars over tablets or granules.

Stages involved in the production of sugar coated tablets:

Sealing of the tablet cores
Sub coating
Smoothing
Coloring
Polishing
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Printing

Page 23 of 56
Q. Mention the problems of film coating and sugar coating.

Answer:
Film coating problems:
Bridging (Films pulls out of intagliation forming bridge across the edge of the mark a blister.)
Blushing (Whitish specks or haziness in film.)
Blistering (Film becomes detached from substrate forming a blister.)
Blooming (Coating become dull immediately or after a prolong storage and
film become detached from substrate.)
Chipping (Film become chipped and dented, usually at the edges of the tablet.)
Cracking (Films cracks or splits.)
Orange peel/Roughness (Surface appearance similar to that of an orange or lemon.)
Wrinkling (Film has a wrinkled appearance.)

Sugar coating problems:

Chipping
Cracking
Non drying coating
Twinning (build up of multiples)
Uneven color
Blooming & Sweating
Marbling

Q. What are the differences between sugar coating and film coating ?

Answer:
Sugar coating
Appearance: High degree of polishness.
Weight increase: 30-50%
Logo/ break lines: Not possible
Process stages: Multi-stage process
Film coating:
Appearance: usually not as shiny as sugar coat types
Weight increase: 2-3%
Logo/ break lines: Possible
Process stages: Usually single stage
Q. Define capsule. Mention the types of capsule.

Answer:
Capsule: In pharmacy, the word capsule is used to describe the solid dosage form of
medicament in which the drug is enclosed in a practically tasteless, hard or soft soluble
container or shell made up of a suitable form of gelatin.

Types of capsule:
1.Hard gelatin capsule
2.Soft gelatin capsule

Q. State a process flow chart of capsule preparation.

Answer:
Take the gelatin capsule shell
↓
Fill the capsule with powder medicament/granules with the disintegrants,
diluents, etc., using capsule filling
Machine
↓
Sealing
↓
Polishing
↓
Transfer to blister packing

Q. Define Gelatin. What are the differences between hard gelatin & soft gelatin capsule?

Answer:
Gelatin: is a heterogeneous product obtained by the partial irreversible hydrolysis of
collagen derived from the skin, connective tissue & bones of animals.

Hard Gelatin
Firm & rigid
Only solid
Volatile substance not suitable
High bloom Strength gelatin

Soft gelatin
Flexible & Soft
Solid, semi solid & liquid
Volatile substances are suitable
Low bloom Strength gelatin

Suspending agents
Methyl cellulose
Carboxymethyl cellulose
Emulsifying agents
Acacia
Tragacanth
Gelatin
Methyl cellulose

Wetting agents
Alcohol

Flocculating agents
Sodium lauryl sulphate
Sodium dioctyl sulphosuccinate

Quality Control
Q. What do you mean by quality?

Answer: Quality is a standard of how good something is as measured against other

similar things. According to American Society, quality can be defined in following
ways:

1.Based on customers perceptions of product

2.The ability of a product
3.Achieved by conforming to established requirements within an
organization

Q. What are the criteria of quality?

Answer:
The criteria of quality are safety, potency, efficacy, stability, purity, Identify.

Q. What is quality control?

Answer:
The term quality control refers to the sum of all procedures undertaken to ensure the
identity and purity of a particular pharmaceutical. Such procedures may range from the
performance of simple chemical experiments which determine the identity and screening
for the presence of particular pharmaceutical substance to more complicated
requirements of pharmacopoeial monographs.

Q. What are the basic requirements of quality control?

Answer:
The basic requirements of quality control are:

1.The finished product container must comply with specification

2. Approved procedure
3.Trained personnel
4. Correct sampling methods
5.Validation testing methods
6.Sufficient retain sample of starting materials, packaging materials and
finished materials
7.All batches are reviewed and released by a qualified person to approved
procedures
8.Records are kept of all sampling , inspecting and testing procedures
9.Product label check

Q. What are the responsibilities of QC department?

Answer:
The responsibilities for QC are as follows:

*Approve or reject all procedures, specifications, methods, and results.

*Approve or reject all raw materials, packaging materials, labeling and finished products.
*Review all production records for accuracy and completeness before approving for
distribution.
*Establish procedures for revising procedures, formulas, etc.
*Approve changes to procedures, formulas, etc.
*Ensure that the latest revision is being used at all times.
*Perform all the required tests to ensure identity, purity, potency and composition, and
to ensure that products are not contaminated or adulterated
*Control of laboratory reagents and equipments
*Ensure precision and accuracy of all testing methods

Q. What is sample?

Answer: Sample is the unit that provides the experimental observations, such as tablet
sampled for potency and defects.

Q. What is sampling?

Answer: The process of taking a small portion from a batch for test and analysis.

8. What is reference sample?

Answer: A sample of a batch of starting material, packaging material or finished product

which is stored for the purpose of being analyzed should the need arise during the shelf
life of the batch concerned.

Q. What is retention sample?

Answer:
A sample of a fully packaged unit from a batch of finished product. It is stored for
identification purposes. For example, presentation, packaging, labeling, patient
information leaflet, batch number, expiry date should the need arise during the shelf life
of the batch concerned.

Q. What are the major QC instruments?

HPLC
GC
 AAS
FTIR
UV-visible spectroscopy
Incubator
Polarimeter
Balance
Autoclave
PH meter
Vortex mixer
Moisture analyzer
Dissolution tester
Disintegration tester
Centrifuge machine
Conductivity meter
Friability tester
Hardness tester
Electronic heating mantle
Total organic carbon analyzer
Tadpad density meter

Q. What is chromatography?

Answer:
Chromatography is a technique to separate mixtures of substances into their components
on the basis of their molecular structure and molecular composition. This involves a
stationary phase (a solid, or a liquid supported on a solid) and a mobile phase (a liquid or
a gas). The mobile phase flows through the stationary phase and carries the components
of the mixture with it.

Q. What is HPLC? Write down the types of HPLC.

Answer:
High Performance Liquid Chromatography (HPLC) is a form of column
chromatography that pumps a sample mixture or analyte in a solvent (known as the
mobile phase) at high pressure through a column with chromatographic packing material
(stationary phase).

There are following types of HPLC, depending upon the phase system (stationary) in the process:

Normal Phase HPLC:

This method separates analytes on the basis of polarity.

Reverse Phase HPLC:

It works on the principle of hydrophobic interactions hence the more non-polar the
material is, the longer it will be retained.
Size-exclusion HPLC:
The column is filled with material having precisely controlled pore sizes, and the
particles are separated according to it’s their molecular size.

Ion-Exchange HPLC:
The stationary phase has an ionically charged surface of opposite charge to the sample
ions. This technique is used almost exclusively with ionic or ionizable samples.

Q. Write down the principle of HPLC.

Answer:
HPLC is a technique in analytic chemistry used to separate the components in a mixture,
to identify each component and to quantify each component. It relies on pumps to pass a
pressurized liquid solvent containing the sample mixture through a column filled with a
solid adsorbent material. Each component in the sample interacts slightly different with
the adsorbent material causing different flow rates for the different components and
leading to the separation of the components as they flow out the column.

Q. What are the instrumentation of HPLC?

i. Solvent reservoir
ii. Pump
iii. Sample injector
iv. Columns
v. Detector
vi. Data collection devices

Q. Write down the pharmaceutical applications and advantages of HPLC?

Answer:
The pharmaceutical applications of HPLC are -
i. To control drug stability.
ii. Tablet dissolution study of pharmaceutical dosages form.
iii. Pharmaceutical quality control.

The advantages of HPLC are:

i. The separation becomes faster
ii. Very small amount can be detected
iii. Sensitive selective detectors
iv. Better resolution of compound from the column

Q. What is Spectrophotometry? What is the basic principle of UV spectrophotometer?

Answer:
Spectrophotometry is the quantitative measurement of the reflection or
transmission properties of a material as a function of wavelength. It deals with visible
light, near-ultraviolet, and near-infrared, but does not cover time-resolved spectroscopic
techniques.

Principle of UV spectrophotometer:
Absorption molecules containing π electrons or non bonding electrons can
absorb the energy in the form of ultraviolet or visible light to excite these electrons to
higher anti bonding molecular orbital’s. The more easily excited the electrons, the longer
the wavelength of light it can absorb.

Q. What are the instrumentation of UV spectrophotometer?

Answer:
i. Light source
ii. Lens
iii. Monochromator
iv. Wavelength selector
v. Sample solution
vi. Detector
vii. Digital display

Q. What is the wavelength of ultraviolet and visible light?

Answer:
The wavelength of ultraviolet light is 185 - 400 nm and visible light is 400 - 700
nm.

Q. What is the Lamberts law?

Answer:

When a monochromatic radiation or light passes through a homogenous transparent

medium the rate of decrease of intensity of radiation with the thickness of the absorbing
medium is directly proportional to the intensity of the incident light.

Q. What is Beers law?

Answer:

When a monochromatic radiation or light passes through a homogenous transparent

medium the rate of decrease of intensity of radiation with the concentration of the solute
in that system is directly proportional to the intensity of the incident light.

Q. What do you mean by Beer-Lamberts s law? Write down the limitations of Beer-Lamberts s law.

Answer:
The Beer Lamberts law states that the absorbance of a solution is directly proportional to
the concentration of the absorbing species in the solution and the path length. Thus, for a
fixed path length, UV/Vis spectroscopy can be used to determine the concentration of
the absorber in a solution. It is necessary to know how the absorbance changes with
concentration.

Limitations of Beer-Lamberts s law:

i. Deviations in absorptivity coefficients at high concentrations (>0.01 M)
ii. Interaction with solvent
iii. Changes in refractive index
iv. Shifts in chemical equilibrium
v. Scattering of light due to particulates in the sample

Q. What is IR spectroscopy?

Answer:
Infrared spectroscopy is the spectroscopy that deals with the infrared region of the
electromagnetic spectrum that is light with a longer wavelength and lower frequency
than visible light. It covers a range of techniques, mostly based on absorption
spectroscopy. It uses light over the infrared range 700 - 15000 nm.

Q. Write down the theory of IR spectroscopy.

Answer:
IR radiation does not have enough energy to induce electronic transitions as seen with
UV. Absorption of IR is restricted to compounds with small energy differences in the
possible vibrational and rotational states.

For a molecule to absorb IR, the vibrations or rotations within a molecule must cause a
net change in the dipole moment of the molecule. The alternating electrical field of the
radiation interacts with fluctuations in the dipole moment of the molecule. If the
frequency of the radiation matches the vibrational frequency of the molecule then
radiation will be absorbed, causing a change in the amplitude of molecular vibration.

Q. What do you mean by FTIR?

Answer:

Fourier Transform Infrared (FTIR) spectroscopy is a measurement technique that allows

one to record infrared spectra. Infrared light is guided through an interferometer and
then through the sample.

Q. What are the instrumentations of FTIR?

Answer:

i. IR source
ii. Half silvered mirror
iii. Fixed mirror
iv. Moving mirror
 v. Sample cell
vi. IR sensor

Q. What is NMR?

Answer.
Nuclear Magnetic Resonance (NMR) is a process in which nuclei absorb magnetic
resonance and re emit electromagnetic radiation. This energy is at a specific resonance
frequency which depends on the strength of the magnetic field and the magnetic
properties of the isotope of the atoms.

Q. Write down the basic principle of NMR.

Answer.
The principle of NMR usually involves two sequential steps:

The alignment (polarization) of the magnetic nuclear spins in an applied, constant

magnetic field B0.

The perturbation of this alignment of the nuclear spins by employing an electro-

magnetic, usually radio frequency (RF) pulse. The required perturbing frequency is
dependent upon the static magnetic field (H0) and the nuclei of observation.

The two fields are usually chosen to be perpendicular to each other as this maximizes
the NMR signal strength. The resulting response by the total magnetization (M) of the
nuclear spins is the phenomenon that is exploited in NMR spectroscopy and magnetic
resonance imaging. Both use intense applied magnetic fields (H0) in order to achieve
dispersion and very high stability to deliver spectral resolution, the details of which are
described by chemical shifts, the Zeeman effect, and Knight shifts (in metals).

NMR phenomena are also utilized in low-field NMR, NMR spectroscopy and MRI in
the Earth's magnetic field.

Q. What is AAS? What is the basic principle of AAS?

Answer.
Atomic absorption spectroscopy (AAS) is a spectroanalytical procedure for the
quantitative determination of chemical elements using the absorption of optical radiation
(light) by free atoms in the gaseous state. In analytical chemistry the technique is used

for determining the concentration of a particular element (the analytes) in a sample to be

analyzed.

Principle of AAS:
The technique makes use of absorption spectrometry to assess the concentration
of an analyte in a sample. It requires standards with known analyte content to establish
the relation between the measured absorbance and the analyte concentration and relies
therefore on the Beer-Lambert Law.

In short, the electrons of the atoms in the atomizer can be promoted to higher orbitals
(excited state) for a short period of time (nanoseconds) by absorbing a defined quantity
of energy (radiation of a given wavelength). This amount of energy, i.e., wavelength, is
specific to a particular electron transition in a particular element. In general, each
wavelength corresponds to only one element, and the width of an absorption line is only
of the order of a few picometers (pm), which gives the technique its elemental
selectivity. The radiation flux without a sample and with a sample in the atomizer is
measured using a detector, and the ratio between the two values (the absorbance) is
converted to analyte concentration or mass using the Beer-Lambert Law.

Q. What is TOC?

Answer.
Total organic carbon (TOC) is the amount of carbon found in an organic compound and
is often used as a non-specific indicator of water quality or cleanliness of
pharmaceutical manufacturing equipment.

Q. What is Karl Fischer titration?

Answer.
Karl Fischer titration is a classic titration method in analytical chemistry that uses
coulometric or volumetric titration to determine trace amounts of water in a sample. It
was invented in 1935 by the German chemist Karl Fischer.
31. What is chromatography? Write down the types of chromatography.

Answer.
Chromatography is an analytical method by which the compounds are physically
separated prior to measurement.

There are four main types of chromatography. These are:

Liquid chromatography
Gas chromatography
Thinlayer chromatography and
Paper chromatography

Q. What is liquid chromatography?

Answer.
Liquid chromatography is used in the world to test water samples to look for pollution in
lakes and rivers. It is used to analyze metal ions and organic compounds in solutions.
Q. What is gas chromatography? Write down the principal of gas chromatography.

Answer:
Gas chromatography (GC) is a common type of chromatography used in analytical
chemistry for separating and analyzing compounds that can be vaporized without
decomposition. Typical uses of GC include testing the purity of a particular substance,
or separating the different components of a mixture.

Principle of GC:
Gas chromatography is in principle similar to column chromatography but has several
notable differences. First, the process of separating the compounds in a mixture is
carried out between a liquid stationary phase and a gas mobile phase, whereas in column
chromatography the stationary phase is a solid and the mobile phase is a liquid. Second,
the column through which the gas phase passes is located in an oven where the
temperature of the gas can be controlled, whereas column chromatography (typically)
has no such temperature control. Finally, the concentration of a compound in the gas
phase is solely a function of the vapor pressure of the gas.

Q. What is thin layer chromatography?

Answer:
Thin-layer chromatography (TLC) is a chromatography technique used to separate non-volatile
mixtures. It is performed on a sheet of glass, plastic, or aluminium foil, which is coated with a thin
layer of adsorbent material, usually silica gel, aluminium oxide (alumina), or cellulose. This layer of
adsorbent is known as the stationary phase.

After the sample has been applied on the plate, a solvent or solvent mixture is drawn up
the plate via capillary action. Because different analytes ascend the TLC plate at
different rates, separation is achieved.

Q. What is Rf value?

Answer: RF value (in chromatography) is the distance travelled by a given component

divided by the distance travelled by the solvent front. For a given system at a known
temperature, it is a characteristic of the component and can be used to identify
components.

Q. What is paper chromatography?

Answer: Paper chromatography is an analytical method that is used to separate coloured

chemicals or substances. This can also be used in secondary or primary colours in ink
experiments. This method has been largely replaced by thin layer chromatography, but is
still a powerful teaching tool.

Q. What is tablet hardness testing?

Answer:
Tablet hardness testing, is a laboratory technique used by the pharmaceutical industry to
test the breaking point and structural integrity of a tablet under conditions of storage,
transportation and handling before usage. The breaking point of a tablet is based on its
shape. It is similar to friability testing but they are not the same thing.

38. What is friability of tablet and what is the percentage of friability?

Answer:
Friability is the tendency for a tablet to chip, crumble or break following compression. This tendency
is normally confined to uncoated tablets and surfaces during handling or subsequent storage.
Percentage of friability =(W1 – W2/W1) × 100
W1 = weight of tablets before testing
W2 = weight of tablets after testing

Q. What is friability limit for tablet?

Answer:
According to B.P. percentage of friability should not be more than 0.8%
According to U.S.P. percentage of friability should not be more than 1%

40. Write down the weight variation tolerance for uncoated tablets according to B.P.

Answer:
Average weight of Maximum percentage difference
tablets(mg) allowed

80 or less 10%
80-250 7.5%
More than 250 5%

Q. Write down the weight variation tolerance for uncoated tablets according to U.S.P.

Answer:
Average weight of Maximum percentage difference
tablets(mg) allowed

130 or less 10%

130-324 7.5%
More than 324 5%
Q. What is disintegration?

Answer:
The process by which a solid oral dosage form breaks up in water measured in a standard apparatus.

Q. What is dissolution?

Answer:
Dissolution is the process by which a solid drug substance becomes dissolved in a solvent.

Q. What do you mean by moisture content?

Answer:
Moisture content = (weight of water in a sample/weight of dry sample) × 100%

Q. What do you mean by LOD?

Answer:
LOD= (weight of water in a sample/total weight of wet sample) × 100%

Q. What is calibration?

Answer:
Calibration may be defined as a particular measuring device produce a result within a
specified limits by comparison with a reference standard device over an appropriate
range of measurements. It is a system of performance checking.

Q. What is validation?

Answer:
Validation is a detailed process of conforming that the instrument is installed correctly,
that it is operating effectively and that is performing without error. It is a tool to ensure
that the analytical method is working well.

Q. What is solubility?

Answer:
Solubility is the indicative of maximum concentration that can be dissolved in the
solvent to form a saturated solution.

Pharmacology
Q. What is pharmacology? Briefly explain the branches of pharmacology.

Answer: Pharmacology can be defined as the subject that deals with the knowledge
of drugs and their interactions with living systems.

Branches of Pharmacology
Pharmacokinetics: that deals with the absorption, distribution, metabolism and
excretion of drugs and their relationship with the onset, duration and intensity of the
drug effect.
Pharmacodynamics: deals with the mechanism of action of drug and the relation
between the drug concentration and its effect.
Therapeutics: deals with the art and science of treatment of disease.
Chemotherapy: that deals with the treatment of diseases by chemicals that kill the
cells, especially those of microorganisms and nanoplastic cells.
Toxicology: that deals with the symptoms, mechanisms, treatment and detection
of poisoning caused by different chemical substances.
Clinical Pharmacology: that deals with the scientific study of drugs in man. It
includes pharmacokinetic and Pharmacodynamics investigations in healthy or
diseased individuals.
Pharmacognosy: that deals with the identification of drugs by just seeing or
smelling them. Basically it deals with the drugs in crude or unprepared form and
study of properties of drugs from natural sources.
Pharmacoeconomics: deals with the cost of drugs.
Pharmacogenetics: that deals with the genetic variations that cause difference in
drug response among individuals or population.
Pharmacogenomics: that deals with the broader application of genomic
technologies to new drug discovery.
Pharmacoepidemiology: that deals with the effects of drugs on a large poulation.

Q. What is Pharmacopoeia?

Answer: Pharmacopoeia is a book published by authority of recognized body which

contains a list of drugs, their formulas, and methods for making medicinal preparations.
USP (United States Pharmacopoeia)
BP (British Pharmacopoeia)
JP (Japanese Pharmacopoeia)

Q. Define Drug, Medicine and Prodrug.

Answer:
Drug: is any substance that acts on the living body to alter the physiological
process and are used for prevention, diagnosis, control and treatment of disease.
Medicine: is the formulated form of drug having definite dose, dosages form,
leveling and packaging.
Prodrug: The drugs which do not produce any pharmacological effect until they
are chemically altered within the body are called prodrug.

Q. What are the sources of drug?

Answer:
Natural sources:
Plant sources: Atropine, Morphine, Digoxin.
Animal sources: Serum, Insulin, Thyroxin, Heparin.
Micro-organism: Penicillin, Streptomycin.

Minerals: MgSO4. 7H2O, Liquid paraffin.

Synthetic sources: Aspirin, Procaine, Sulfonamides.
Semi-synthetic sources: Ampicillin, Tetracycline.

Q. Why prodrug is used? Write down some examples of prodrug.

Answer:
Prodrug is used:
To avoid toxicity.
To increase bio-availability.

Prodrug -- Active drug

Aspirin -- Salicylic acid
Diazepam -- Oxazepam
Codein -- Morphine

Q. Define - Agonist, Antagonist, Drug-Receptor, Drug-Dose, Dosage and Placebo.

Answer:
Agonist: Drug that binds with receptor and activates them to produce a
pharmacological response is called agonist. (Sulbutamol is B2 receptor
agonist)
Antagonist: Drug that binds with receptor and no activating effect but block or
oppose agonist response is called antagonist. (Ranitidine H2 receptor antagonist)
Drug-receptors: are macro-molecules, lipoprotein in nature, situated on the cell
membrane or inside the cell and have chemo-recognition properties for specific
drug with which drugs bind reversibly or irreversibly to produce pharmacological
effect.

Drug-Dose: is the amount of the drug which is required to produce certain

measurable biological response, either at once or after sometime of administration.
Dosage: the amount, frequency and number of doses of drug for a patient is called dosage.
Placebo: a harmless inert substance is given as medicine to satisfy the patients
desire for drug therapy is called placebo.
Q. What is enzyme? Describe cytochrome P-450 enzyme.
Answer:
Enzyme: Enzymes are large biological molecules responsible for the thousands of
chemical interconversions that sustain life. Enzymes accelerate or catalyze
chemical reactions. The molecules at the beginning of the process are called
substrates and the enzyme converts these into different molecules, called products.

Cytochrome P-450 (CYP): the cytochrome P-450 superfamily of monooxygenases is

a large and diverse group of enzymes that catalyze the oxidation of organic
substances. The substrates of CYP enzymes include metabolic intermediates such as
lipids and steroidal hormones, as well as xenobiotic substances such as drugs and
other toxic chemicals. Cytochrome P450 enzymes also function to metabolize
potentially toxic compounds, including drugs and products of endogenous
metabolism such as bilirubin, principally in the liver. The Human Genome Project
has identified 57 human genes coding for the various cytochrome P450 enzymes.

Q. Give examples of acidic and basic drug.

Answer:
Acidic Drug: Aspirin, Barbiturates, Cloxacillin, Diazepam.
Basic Drug: Digoxin, Isoprenalin, Penicillin, Atropine.

Q. What are the routes of drug administration?

Answer: The route of drug administration is determined primarily by the properties of

the drug and by the therapeutic objectives. There are two major routes of drug
administration:

Enternal
Oral
Sublingual
Rectal

Parental
Intravascular
Intramuscular
Subcutaneous

Other
Inhalation
Intranasal
Topical
Transdermal

Q. What do you mean by NSAID? What is the indication of NSAID?

Answer:
NSAID: Non-steroidal anti-inflammatory drugs, usually abbreviated to NSAIDs but
also referred to as non-steroidal anti-inflammatory agents (NSAIAs).

Medical uses: NSAIDs are usually indicated for the treatment of acute or chronic
conditions where pain and inflammation are present. NSAIDs are generally indicated
for the symptomatic relief of the following conditions:

Rheumatoid arthritis
Osteoarthritis
Headache and migraine
Postoperative pain
Mild to moderate pain due to inflammation and tissue injury
Muscle stiffness
Pyrexia

Q. What is the rational use of drugs?

Answer:
Diagnosis
Prevention
Suppression
Treatment

Q. Define biological drugs with examples. What are the conditions for biological drugs?

Answer:
Biological drugs: can be defined as the drugs which are obtained from living sources
mostly from animals, are called biological drugs.

Examples:
Hormones - Insulin, Thyroxine, Steroids.
Vitamins - Vit-'A' from cod fish
Toxins- Toxoids

Criteria:
Protein in nature.
Must be kept in 4˚C to prevent denaturation.
Can not be given orally.
They have date of life.
Obtained from living source.
Q. Define the following terms - Over The Counter Drug (OTC), Prescription Drugs,
Control Drugs, Official Drugs.

Answer:
Over The Counter Drug (OTC): These drugs which are available without
prescription are called OTC drugs. [Paracetamol, Vitamin tablet, Iron Tablet]
Prescription drugs: which are available with prescription are called Prescription drugs.
Control drugs: This can never be dispensed without prescription.
Official drugs: are those drugs which are included in pharmacopoeia.

Q. Define Posology. What are the types of dose?

Answer:
Posology: is a branch of medical science which deals with the doses or quantity of
drugs which can be administered to produce the pharmacological effects.

Types of doses:
Therapeutic dose: which produces the optimum therapeutic effect.
Minimum effective dose: which produces just effect.
ED50 : which produces desired pharmacological effect in 50% of test population.
LD50 : which cause death of 50% of test population.
Booster dose: which is given after sometime of an initial doses to enhance the effect.
Adult dose: This is given between 20 and 60 years.
Test dose: the amount of drug given initially to see sensitivity/response of tissue to the drug.
Loading dose: is one or a series of doses that may be given at the onset of therapy
with the aim of achieving the target concentration rapidly.
Maintenance dose: dose required maintaining the desired effect that is achieved
by preceding dose.
Maintenance dose = Dosing rate×Dosing interval

Q. Classify NSAID with examples.

Answer:
NSAID can be classified based on their chemical structure or mechanism of action:

Salicylates: Aspirin (acetylsalicylic acid), Salsalate.

Propionic acid derivatives: Ibuprofen, Naproxen, Ketoprofen.
Acetic acid derivatives: Indomethacin, Ketorolac, Diclofenac.
Enolic acid (Oxicam) derivatives: Piroxicam, Tenoxicam, Isoxicam.
Fenamic acid derivatives: Meclofenamic acid, Flufenamic acid.
Selective COX-2 inhibitors: Celecoxib, Rofecoxib.
Sulphonalides

Q. What is adrenergic drug? Classify adrenergic drugs.

Answer:
Adrenergic drugs: Adrenergic blocking drugs, also called sympathomimetic
blocking drugs. It may divided into four groups:
Alpha adrenergic blocking drugs (that block alpha adrenergic receptors)
Beta adrenergic blocking drugs (that block beta adrenergic receptors)
Antiadrenergic drugs (that block adrenergic nerve fibers)
Alpha & Beta adrenergic blocking drugs (that block alpha and beta adrenergic receptors)

Q. What is sedatives and hypnotics drug? Classify with examples.

Answer:
Sedative: A sedative is a drug that produces a relaxing, calming effect. Sedatives are
usually given during daytime hours, and although they may make the patient drowsy,
they usually do not produce sleep.

Hypnotic: A hypnotic is a drug that induces sleep that is, it allows the patient to fall asleep and stay
asleep.
Hypnotics also may be called soporifics. Hypnotics are given at night or hour of sleep.

Classification:
Sedatives and hypnotics may be divided into two classes: barbiturates and
miscellaneous sedatives and hypnotics.

The barbiturates are divided into several groups, depending on their duration of action:
Ultrashort-acting (Thiopental)
Short-acting (Pentobarbital)
Intermediate-acting (Butabarbital)
Long-acting (Phenobarbital)

The miscellaneous sedatives and hypnotics consist of a group of nonrelated drugs and
second group called the benzodiazepines.

Q. What is CNS? Write down the name of CNS drug.

Answer:
The central nervous system (CNS) includes the brain and the spinal cord. The CNS
processes information to and from the peripheral nervous system and is the center of
coordination and control for the entire body.

CNS drug: Many drugs stimulate the CNS but only a few are used therapeutically.
Analeptics: Caffein, Modafinil (stimulate the respiratory center of the CNS)
 Amphetamines: Amphetamine sulfate, Methylphenidate HCl (produce euphoria)

Q. What is depression? Classify antidepressants with examples.

Answer:
Depression: is one of the most common psychiatric disorders. It is characterized by
feelings of intense sadness, helplessness, worthlessness and impaired functioning.

Antidepressants:
The four types of antidepressants are:
Tricyclic antidepressants (TCAs): Amitriptyline, Clomipramine, Doxepin, Amoxapine.
Monoamine oxidase inhibitors (MAOIs): Phenelzine, Tranylcypromine.
Selective serotonin reuptake inhibitors (SSRIs): Citalopram, Sertraline,
Fluvoxamine.
A group of miscellaneous, unrelated drugs: Bupropion HCl, Maprotilline,
Trazodone.
Q. What is anesthesia? Classify anesthesia with examples.
Answer:
Anesthesia: is a loss of feeling or sensation. There are two types of anesthesia:

Local anesthesia: is the provision of a pain free state in a specific area (or region). For
example: patient is fully awake but does not feel pain.
General anesthesia: is the provision of a pain-free state for the entire body. For
example: patient loses consciousness and feels no pain.

Q. What is histamine? Write down the examples of antihistamines.

Answer:
Histamine: is a substance present in various tissues of the body, such as the heart,
lungs, gastric mucosa and skin. Histamine is produced in response to injury.

Antihistamines: are drugs used to counteract the effects of histamine on body organs and structures.
Examples of antihistamines include diphenhydramine, loratadine, fexofenadine
and cetirizine.

Q. What do you mean by asthma? Classify the asthma.

Answer:
Asthma: is a reversible obstructive disease of the lower airway. With asthma there
is increasing airway obstruction caused by bronchospasm, bronchoconstriction,
inflammation, edema of the lining of the bronchioles and the production of thick
mucus that can plug the airway.
There are three types of asthma:
1. Extrinsic (allergic asthma and caused in response to an allergen, such as pollen,
dust and animal dander)
2. Intrinsic asthma (also called nonallergic asthma caused by chronic or recurrent
respiratory infections, emotional upset and exercise)
3. Mixed asthma (caused by both intrinsic and extrinsic factors)

Q. What is bronchodilator? Classify bronchodilator with suitable examples.

Answer:
Bronchodilator: is a drug used to relieve bronchospasm associated with respiratory
disorders, such as bronchial asthma, chronic bronchitis and emphysema.

Classification: The two major types of bronchodilators are the sympathomimetics

and the xanthine derivatives.
Sympathomimetics: Albuterol sulphate, Isoproterenol HCL.
Xanthine Derivatives: Aminophylline, Theophylline.

Q. What is anticoagulatant and thrombolytic agents. Give examples.

Answer:
Anticoagulant: is a substance that prevents coagulation of blood.

Examples of anticoagulant:
Warfarin
Clopidogrel
Prasugrel
Thrombolytic drugs: are used in medicine to dissolve blood clots in a procedure termed
thrombolysis. They limit the damage caused by the blockage or occlusion of a blood vessel. The
thrombolytic drugs include:

1. Ttissue plasminogen activator t-PA:

alteplase (Activase)
reteplase (Retavase)

tenecteplase (TNKase)
2. Anistreplase (Eminase)
3. Streptokinase
(Kabikinase, Streptase)
4 . Urokinase
(Abbokinase)

Q. What is anti-viral drug? Write down the examples of anti-viral drugs.

Answer:
 Anti-viral drugs: for the prophylaxis and treatment of viral diseases are known as anti-viral drugs.

Treatment of respiratory virus infections:

Amantadin
Ribavirin
Rimantadine

Treatment of herpes and cytomegalovirus infection:

Acyclovir
Trifluridine
Vidarabin
Famciclovir
Ganciclovir

Treatment of Human Immune Deficiency (HIV) infections:

Didanosine
Stavudine
Zalcitabine

Q. What is anti-fungal drug? Give some examples of anti-fungal drugs.

Answer:
Anti-fungal drug: which are used to kill or inhibit the growth of the fungus in the body are called
anti-fungal.
Examples: Ketoconazole, Miconazole, Fluconazole.

Q. Write down the examples of following drugs: Anti-hypertensive drug, Analgesic

& Antagonist, Anesthetics, Anti Parkinson's Drugs, Anti diabetic drug.

Answer:
Anti-hypertensive drugs
Atenolol
Metoprolol
Ramipril
Verapamil

Analgesic & Antagonist

Morphine
Acetaminophen
Codeine
Heroin
Methadone

Anesthetics
Thiopental

Anti Parkinson's Drugs

 Levodopa
Carbidopa

Anti diabetic Drug

Biguanides
Metformin
Buformin

First generation
Tolbutamide
Acetoheramide

Second generation
Glipizide
Gliclazide

Q. Define clearly Stroke, Ischemic Stroke, Hemorrhagic Stroke, Heart

Attack, Angina Pectoris, Congestive Heart Failure, Aneurysm and
Hypertension.

Answer:
Stroke: is an acute neurological injury whereby the blood supply to a part of the
brain is interrupted. Stroke can be classified into two major categories: ischemic
and hemorrhagic. About 80% of strokes are due to ischemia.

Ischemic stroke: In ischemic stroke, which occurs in approximately 85-90% of

strokes, a blood vessel becomes cloted and the blood supply to part of the brain is
totally or partially blocked. Hemorrhagic stroke: is a form of stroke that occurs
when a blood vessel in the brain ruptures or bleeds.
Heart attack: Acute myocardial infarction, commonly known as heart attack. A
heart attack occurs when the supply of blood and oxygen to an area of heart muscle
is blocked, usually by a clot in a coronary artery.

Angina pectoris: is chest pain due to ischemia (a lack of blood and hence oxygen
supply) of heart muscle. Generally due to obstruction or spasm of the coronary
arteries (the heart's blood vessels).

Congestive heart failure: is a condition that can result from any structural or
functional cardiac disorder that impairs the ability of the heart to fill with or pump
a sufficient amount of blood throughout the body.
Aneurysm: is a localized dilation or ballooning of a blood vessel by more than
50% of the diameter of the vessel and can lead to instant death at anytime.
Hypertension: is a medical condition wherein the blood pressure is chronically
elevated. Hypertension is defined by some authors as systolic pressure over 130
and diastolic over 85 mmHg.

Q. What is diabetes? Classify diabetes.

Answer:
Diabetes: describes a group of metabolic diseases in which the person has high blood
glucose (blood sugar), either because insulin production is inadequate, or because the
body's cells do not respond properly to insulin, or both.

There are three types of diabetes:

Type 1 diabetes: the body does not produce insulin. Some people may refer to this
type as insulin dependent diabetes or juvenile diabetes. People usually develop
type-1 diabetes before their 40th year, often in early adulthood or teenage years.
Type 2 diabetes: the cells in the body do not react to insulin (insulin resistance).
Approximately 90% of all cases of diabetes worldwide are of this type.
Gastational diabetes: this type affects female during pregnancy. When they have
very high levels of glucose in their blood and their bodies are unable to produce
enough insulin to transport.

Q. Mention the drugs for control of gastric acidity.

Answer:
Antacids:
Aluminium hydroxides
Magnesium hydroxides
Calcium carbonate
Sodium bicarbonate

Cytoprotectants
Sucralfate
Misoprostol
Bismuth compounds
H2 Receptor antagonists
Cimetidine
Ranitidine
Famotidine
Nizatidine

Proton pump inhibitor

Omeprazole
Esomeprazole
Pantoprazole
Lansoprazole
Rabeprazole
Q. What is insulin? Mention the mechanism of action of Insulin.

Answer:
Insulin: is a hormone. It makes our body's cells absorb glucose from the blood.

Mechanism of action:
Binding of insulin with a α-subunit of insulin receptor
↓
Auto phosphorylation of β-subunit
↓
Activation of β-subunit
↓
Activation of some enzymes in the cell & perform all activities of
insulin.

Q. Differentiate between H2 blocker and PPI.

Answer:
H2 blocker: Block H2 receptors of the gastric parietal cells and inhibit HCl
secretion. Relatively short duration of action.

PPI: Inhibit proton pump by inhibiting H+, K+, ATPase. Effective in H2 antagonist
resistance patients. Have a long lasting effect on acid secretion.

Q. What are the differences between side effect and toxic effect ?

Answer:
Side effect: It is normal pharmacological effect of drug. May occurs at normal
therapeutic dose. It is un-avoidable.

Toxic effect: It is noxious effect of a drug. Occurs due to overdose or repeated dose. It
can be avoided by careful and wise use of drug.

Q. Mention the Mechanism of action of NSAID.

Answer:
Membrane phospholipids
↓
Arachidonic acid
↓
Cyclo-oxygenase (COX-I & COX-II)
↓
Prostaglandin
↓
Pain, Inflammation & Fever
Most NSAIDs inhibit the activity of cyclooxygenase-1 (COX-1) and cyclooxygenase-
2 (COX-2), and thereby, the synthesis of prostaglandins and thromboxanes.
Q. Mention the mechanism of action of Tetracyclines.
Answer:
Tetracyclines
↓
Enters into the susceptible bacterial cell by two process (Energy dependent active
transport & Passive diffusion)
↓
Compete with bacterial tRNA to bind with 30S ribosome
↓
Inhibit bacterial protein synthesis.

Q. Mention the mechanism of action of Cephalosporin.

Answer:
Cephalosporin
↓
Binds with specific drug receptor on the bacteria
↓
Blocking the transpeptidation of peptidoglycan
↓
Inhibition the cell wall synthesis
↓
Activation of autolytic enzyme in the cell wall
↓
Bacteria Death

Q. Mention the mechanism of action of Penicillin.

Answer:
Penicillin Binds to PBPs (Penicillin Binding Protein)
↓
Inhibition of transpeptidation reaction
↓
Peptidoglycan synthesis is blocked
↓
Cell dies

Q. Mention the Mechanism of action of Ciprofloxacin.

Answer:
Ciprofloxacin
↓
Inhibit the DNA gyrase
↓
Interfere with the supercoiling of DNA
↓
Bacteria Death.

Q. Mention the mechanism of action of Benzodiazepam.

Answer:
Benzodazepam (Diazepam)
↓
Binds with GABA receptor
↓
Enhance of GABA activity
↓
Opening of Cl- Channels
↓
Hyperpolarization of cells
↓
Depression of CNS

Q. Mention the mechanism of action of H2 Blocker.

Answer:
H2 Blocker
↓
Competitively block the H2 receptor
↓
Decrease cAMP
↓
Reduction of HCl secretion
↓
Healing of Ulcer

Q. Mention the mechanism of action of Antacid.

Answer:
Antacid
↓
Acts with HCl and neutralizes it
↓
Raises of PH and pepsin become inactive
↓
Protect the gastric mucosa
↓
Healing Ulcer

Q. Mention the Mechanism of action of PPI.

Answer:
PPI
↓
Interfere in the final stage of gastric acid production by blocking ATPase enzyme
↓
Inhibition of gastric acid secretion

Q. Mention the mechanism of action of Propanolol.

Answer:
Propanolol
↓
Reduce myocardial contractility
↓
Slow the heart rate
↓
Reduce cardiac work
↓
Decrease cardiac oxygen consumption

Q. Mention the mechanism of action of Aspirin.

Answer:
Aspirin
↓
Inhibit platelets cyclo-oxygenase
↓
Decrease thromboxane-A2
↓
Inhibition of platelets aggregation
↓
Prevent thromboembolism

Q. What do you mean by antibiotic? Classify.

Answer:
Antibiotics: are the chemical substances obtained from certain micro-organism and
are used for killing or inhibiting the growth of other pathogenic micro-organism
without affecting the host tissue.

Classification
[According to chemical structure]
Sulfonamides and related drugs: Sulfacetamide, Sulfamethizole, Sulfadiazine
Diaminopyrimidine derivatives:2,4 -Diaminopyrimidine; 4,5-Diaminopyrimidine
Quinolone derivatives: Nalidixic acid, Ciprofloxacin, Gatifloxacin, Moxifloxacin
Beta lactam drugs: Amoxicillin, Ampicillin
Tetracyclines: Demeclocyclin, Doxycycline, Minocycline, Oxytetracycline
Nitrobenzene derivatives:
Aminoglycosides: Gentamicin, Neomycin
Macrolides: Azithromycin, Erythromycin
Nitrofuran derivatives:
Nitroimidazoles:
Nicotinic acid derivatives: Ethionamide
Azole derivatives: Ketoconazole, Triazole, Fluconazole

[According to mechanism of action]

Inhibit cell wall synthesis: Penicillin, Amoxicillin, Flucloxacillin, Oxacillin
Inhibit proein synthesis: Tetracyclines, Chloramphenicol
Inhibit DNA gyrase: Ciprofloxacin

Interfere with DNA function: Metronidazole, Rifampin

Interfere with DNA synthesis: Acyclovir
Cause leakage from cell membranes: Polymyxins, Bacitracin

[According to spectrum antibiotic]

Broad spectrum: Tetracycline, Chloramphenicol
Narrow spectrum: Penicillin G, Erythromycin

[According to mode of action]

Bacteriostatic: Sulfonamide, Tetracycline, Chloramphenicol
Bacteriocidal: Penicillin, Rifampin, Cephalosporines

Q. What do you mean by Cephalosporin? Classify cephalosporin with suitable examples.

Answer:
Cephalosporin: is a beta lactam antibiotic that inhibits the cell wal of bacteria.
Cephalosporin was first isolated from a fungus named as Cephalosporium
acremonium by Dr. Abraham in 1948.

Classification
First generation: Cephelexin, Cephradine
Second generation: Cefaclor, Cefuroxime, Cefonicid
Third generation: Cefixime, Cefotaxime
Fourth generation: Cefepime, Cefpirome
Fifth generation: Ceftobiprole
Q. What do you mean by pH? What is the pH of the followings?

Answer:
pH: is the negative logarithm of hydrogen ion.

Blood: 7.35-7.45
Saliva: 5.5-7.5
Gastric juice: 1.5-3.5
Bile: 6-8.5
Tear: 7.4
Skin: 5.5
HCl: 1.2-1.4
Urine: 4 .5-8.0

Q. What do you mean by vitamins? Classify vitamins with examples.

Answer:
Vitamins: are organic chemicals that are required for metabolic activities necessary
for tissue growth and healing.

Types of vitamins
1.Fat-soluble vitamins: Vitamin A, D, E & K.
2.Water-soluble vitamins: Vitamin B and C.

Q. Write down the chemical name of the following vitamins.

Answer:
Vitamin A - Retinol
Vitamin B1 - Thiamine
Vitamin B2 - Riboflavin
Vitamin B3 - Niacin
Vitamin B6 - Pyridoxine
Vitamin B7 - Biotin
Vitamin B9 - Folic acid
Vitamin B12 - Cyanocobalamin
Vitamin C - Ascorbic acid

Q. What is mineral? Which minerals are critical to maintain a healthy body?

Answer:
Minerals: are inorganic compounds that are required by the body for metabolism and
to form bones and teeth.

There are five minerals that are critical to maintain a healthy body:
Iron
Copper
Zinc
Chromium
Selenium

Pharmaceutical Abbreviations
1. APA: Aseptic Process Areas 19. LC: Liquid Chromatography
2. APR: Annual Product Review 20. MRP: Material Requirements Planning
3. AQL: Acceptable Quality Level 21. MS: Mass Spectroscopy
4. BLA: Biological License Application 22. MVP: Master Validation Plan
5. BMR: Batch Manufacturing Record 23. MSDS: Material Safety Data Sheet
6. CRM: Customer Relationship Management 24. NMR: Nuclear Magnetic Resonance
7. DPI: Dry Powder Inhaler 25. QMS: Quality Management System
8. DTL: Drug Testing Laboratory 26. OSD: Oral Solid Dosage
9. DVM: Digital Volt Meter 27. PCR: Polymerase Chain Reaction
10. ECSs: Environmental Control Systems 28. QRM: Quick Response Manufacturing
11. EM: Electron Microscope 29. R & D: Research and Development
12. EOP: End of Production 30. RO: Reverse Osmosis
13. FSC: Free Sales Certificate 31. RS: Reference Standard
14. GC: Gas Chromatography 32. RH: Relative Humidity
15. GLP: Good Laboratory Practice 33. UF: Ultra Filtration
16. IP: Indicative Price 34. AAPS: American Association of
17. IUPAC: International Union of Pure and Pharmaceutical Scientists
Applied Chemistry 35. ACPS: Advisory Committee for
18. LAF: Laminar Air Flow Pharmaceutical Science
36. BDNF: Bangladesh National Formulary 83. MHRA: Medicine and Healthcare Products
37. BP: British Pharmacopoeia Regulatory Agency
38. BNF: British National Formulary 84. MHW: Ministry of Health and Welfare
39. BSTI: Bangladesh Standard Testing 85. NSAID: Non Steroidal Anti-inflammatory
Institute Drug
40. CCU: Critical Care Unit 86. OTC: Over the Counter
41. COOP: Certificate of Pharmaceutical 87. PDR: Physician's Desk Reference
Product 88. PUD: Peptic Ulcer Diseases
42. COS: Certificate of Standard 89. Rx: Take Though
43. DHSS: Department of Health and Social 90. STD: Sexually Transmitted Disease
Security 91. WCB: Working Cell Banks
44. FDA: Food and Drug Administration 92. WFI: Water for Injection
45. FEFO: First Expired, First Out
46. FIFO: First in First Out
47. GAMP: Good Automated Manufacturing
Practice
48. GMP: Good Manufacturing Practice
49. GCP: Good Clinical Practice
50. GQS: Global Quality Standards
51. GRP: Good Regulatory Practice
52. IES: Institute of Environmental Sciences
53. IND: Investigation New Drug
54. INN: International Non Proprietarily Name
55. ISO: International Organisation for
Standardization.
56. ISPE: International Society for
Pharmaceutical Engineering
57. NDA: New Drug Application
58. NDC: National Drug Code
59. NF: National Formulary
60. NIST: National Institute of Standards and
Technology
61. NPD: New Product Development
62. PQS: Pharmaceutical Quality System
63. UNDP: United Nations Development
Program me
64. UNICEF: United Nations International
Children Emergency Fund
65. USP: United State Pharmacopoeia
66. VMP: Validation Master Plan
67. WHO: World Health Organization
68. ADE: Adverse Drug Event
69. ADR: Adverse Drug Reaction
70. API: Active Pharmaceutical Ingredient
71. BBB: Blood Brain Barrier
72. BET: Bacterial Endo toxin Test
73. BI: Biologic Indicator
74. CBC: Complete Blood Count
75. CCU: Critical Care Unit
76. CHD: Coronary Heart Disease
77. CHF: Congestive Heart Failure
78. CNS: Central Nervous System
79. HBV: Hepatitis B Virus
80. IBS: Irritable Bowel Syndrome
81. ICU: Intensive Care Unit
82. MCA: Medicine Control Agency