BY

GROUP 2
NAMES AND MATRIC
NUMBER
NAMES MATRIC NO
— JOSEPH REJOICE HADIZA — BHU/21/01/05/0010
— MDODO NGUNAN MIRABEL — BHU/21/01/05/0019
— IGONO ENYO-OJO JOSHUA — BHU/21/01/05/0036
— AYANWALE JOY — BHU/21/01/05/0028
— OBIOKOYE PURITY — BHU/21/01/05/0081
— ADEBAYO FOLASHADE — BHU/21/01/05/0072
— ARINZE JULIANA — BHU/21/01/05/0080
— OSHODI SAMUEL — BHU/21/01/05./0070
— AGADA JOHN — BHU/22/01/05/0046
— OGUCHE JEMIMAH AMIRA — BHU/22/01/05/0047
— YALMA HYELNI RUTH — BHU/22/01.05/0059
— AWE JOSHUA — BHU/19/01/05/0082
OUTLINES
— DEFINITION OF COATED TABLETS.
— RAW MATERIALS FOR FORMULATION.
— PRODUCTION PROCESS
— PRODUCTION EQUIPMENTS .
— QUALITY CONTROL PARAMETERS.
— CONCLUSION.
— REFERENCES.
DEFINITION
A coated tablet is a type of medicinal tablet covered with a protective
outer layer to improve its effectiveness and ease of use. The coating serves
various purposes such as;
— masking unpleasant taste or odor,
— protecting the drug from moisture or stomach acid,
— making it easier to swallow,
— controlling the release of the medication in the body.
Depending on its purpose, the coating can be made of sugar, polymers, or
enteric materials that prevent dissolution in the stomach, ensuring the drug
is released in the intestines instead.
Coated tablets fall under the category of solid dosage forms in
pharmaceuticals. They are a type of modified-release dosage form when
the coating is designed to control the drug’s release, such as enteric-coated
or sustained-release tablets. Otherwise, they can also be classified as
immediate-release dosage forms if the coating is mainly for protection,
taste-masking, or appearance.
RAW MATERIALS USED IN
PRODUCTION
To produce a coated tablet, two main types of raw materials are required:
A. Core Tablet Ingredients (for the tablet itself)
— Active Pharmaceutical Ingredient (API): The main drug that provides the therapeutic effect.
— Fillers/Diluents: Such as lactose, microcrystalline cellulose, or starch, used to give the tablet
bulk.
— Binders: Like povidone or gelatin, which help hold the tablet together.
— Disintegrants: Such as croscarmellose sodium, which helps the tablet break apart in the body.
— Lubricants & Glidants: Like magnesium stearate or talc, which improve tablet manufacturing
and prevent sticking.
B. Coating Materials (for the outer layer)
— Polymers: Like hydroxypropyl methylcellulose (HPMC) for film coatings or cellulose acetate
phthalate for enteric coatings.
— Plasticizers: Such as polyethylene glycol (PEG) to make the coating flexible.
— Colorants & Opacifiers: Like titanium dioxide or iron oxides, used for appearance.
— Sweeteners & Flavors: Such as sucrose or vanillin, for sugar-coated tablets.
— Solvents: Like water or ethanol, used to dissolve the coating materials before application.
PRODUCTION PROCESS OF A
COATED TABLET
The manufacturing of coated tablets involves two main stages: tablet core production
and coating application.
1. Tablet Core Production
This stage involves preparing and compressing the tablet before applying the coating.
Step 1: Weighing and Mixing
The active pharmaceutical ingredient (API) and excipients (fillers, binders,
disintegrants, lubricants) are accurately weighed.
The ingredients are mixed to ensure uniform distribution of the drug.
Step 2: Granulation (If Needed)
If the powder mixture does not flow well, granulation (wet or dry) is done to form
granules.
Wet granulation involves adding a binder solution, while dry granulation involves
compacting the powder before breaking it into granules.
Step 3: Drying (For Wet Granulation Only)
The granules are dried using fluid bed drying or tray drying to remove moisture.
Step 4: Compression
The dried granules or powder mixture is compressed into tablets using a tablet press.
EQUIPMENTS REQUIRED FOR
COATED TABLET
PRODUCTION
The production of coated tablets requires specialized equipment for tablet formation and coating application.
Below are the key machines used in each stage:
1. Tablet Core Production Equipment
These machines are used to manufacture the tablet before coating.
a. Weighing & Mixing Equipment
— Weighing Balances – For accurate measurement of raw materials.
— High-Speed Mixer/Blender – Ensures uniform mixing of active ingredients and excipients.
b. Granulation Equipment (if granulation is needed)
— Wet Granulator – Used for wet granulation before drying.
— Fluid Bed Dryer or Tray Dryer – Removes moisture from granules.
— Milling Machine – Breaks down large granules into uniform sizes.
c. Tablet Compression Equipment
— Tablet Press Machine – Compresses granules or powder into tablets of uniform size and shape.
2. Coating Equipment
After tablet formation, coating is applied using specialized machines. There are 3 major methods.
— Standard coating pan.
— Perforated Pan System.
— Fluidized Bed Coater
CONT…
2. Coating Application
Once the tablets are formed, they are coated to achieve specific properties.
Step 5: Coating Process
Tablets are placed in a coating pan or fluidized bed coater.
The coating solution (which contains polymers, plasticizers, and other agents)
is sprayed onto the rotating tablets.
Warm air is used to dry the coating and ensure even application.
3. Final Processing
Step 6: Inspection & Quality Control
Tablets are checked for uniformity, weight, thickness, and coating quality.
Step 7: Packaging
The coated tablets are packed into blister packs, bottles, or strip packs to
protect them from moisture and contamination.
STANDARD COATING PAN
A standard coating pan is a fundamental piece of equipment
in pharmaceutical tablet coating processes. It consists of a
circular metal pan, typically ranging from 15 to 200 centimeters
in diameter, mounted at an angle on a stand. An electric motor
rotates the pan, causing the tablets inside to tumble, ensuring
uniform exposure to the coating solution. The coating solution
is applied via a spray system, and warm air is introduced to
facilitate drying.
PERFORATED
PAN SYSTEM
A perforated pan system is an
advanced tablet coating machine that
features a drum with perforations
(small holes) to improve air
circulation during the coating process.
The tablets rotate inside the
perforated drum while a coating
solution is sprayed onto them, and
warm air passes through the
perforations to dry the coating
quickly and evenly.
FLUIDIZED BED
COATER
A fluidized bed coater is a device used
to apply a uniform coating to particles,
granules, or tablets by suspending them
in an upward flow of air, creating a
fluidized state. In this state, the particles
behave like a fluid, allowing for even
application of the coating material.
Air Inlet: Allows entry of air, which is
heated and used to fluidize the particles.
Air Distribution Plate: Ensures even
distribution of the incoming air to
uniformly fluidize the particles.
Coating Solution Spray Nozzle: Sprays
the coating solution onto the fluidized
particles.
Expansion Chamber: Provides space
for particles to move freely and prevents
them from escaping the system.
Exhaust Air Outlet: Removes excess air
and volatile components, maintaining the
desired environment within the coater.
QUALITY CONTROL
PARAMETERS
Quality control parameters are specific
tests and standards used to ensure that a
pharmaceutical product, such as a coated
tablet, meets the required quality, safety,
and effectiveness. These parameters help
confirm that the tablet is uniform,
properly coated, and performs as expected
in the body.
CONT….
1. Physical Appearance
— Color, Shape, and Size: The coating should be uniform, smooth, and free from cracks or defects.
— Gloss and Texture: Ensures that the coating provides the intended appearance and finish.
2. Weight Variation
— The tablet's weight must be consistent across a batch to ensure uniformity of the active ingredient.
3. Thickness and Hardness
— Thickness: Should be uniform to avoid dosage variation.
— Hardness: Ensures the tablet is strong enough to withstand handling but not too hard to affect drug release.
4. Friability Test
— Measures how easily the tablet breaks or crumbles under mechanical stress. A coated tablet should have low friability to
prevent damage.
5. Disintegration Time
— Checks how long the coated tablet takes to break down in a liquid medium.
— Enteric-coated tablets should not disintegrate in stomach acid but should break down in the intestines.
6. Dissolution Test
— Measures the rate and extent to which the active drug is released from the coated tablet into a solution.
7. Uniformity of Coating
— Ensures that the coating is evenly applied for consistent drug release and protection.
8. Moisture Content
— Prevents degradation by ensuring the tablet does not absorb excess moisture.
9. Stability Testing
— Tests how well the coated tablet maintains its quality under different conditions (e.g., temperature, humidity, and light
exposure).
CONCLUSION
Coated tablets play a vital role in pharmaceuticals by enhancing
drug stability, patient compliance, and controlled release.
The coating process involves specialized equipment like
coating pans and fluidized bed coaters, ensuring uniform
application. Strict quality control parameters—such as
appearance, weight uniformity, hardness, disintegration,
and dissolution—guarantee their safety and effectiveness.
With advancements in coating technology, coated tablets
continue to improve drug delivery, protection, and
therapeutic efficiency in modern medicine.
REFERENCES
— Lachman L., Lieberman H.A., & Kanig J.L. – The Theory
and Practice of Industrial Pharmacy (Pharmaceutical coating
techniques and quality control)
— Aulton M.E. – Aulton’s Pharmaceutics: The Design and
Manufacture of Medicines (Covers tablet coating, formulation,
and evaluation)
— Remington: The Science and Practice of Pharmacy
(Comprehensive pharmaceutical manufacturing reference).
— United States Pharmacopeia (USP) – Standards for coated
tablet testing and quality control.
— British Pharmacopeia (BP) – Official pharmaceutical
standards for coated tablet formulation.