Flow chart:
Dispensing
Sizing
Milling
Blending
Coating
compress
Drying
Granulation
TABLET MANUFACTURING PROCESS
Dispensing: (the ingredients/ components) are gathered and each
component is weighed to the precise amount needed).
Sizing operation: (which grades the incoming API (active
pharmaceutical ingredient).
Milling operation: which aims to deliver the API with uniform particle
size.
Blending operation: which mixes the milled API with a number of
inactive ingredients with the goal of delivering a uniformly blended
material
Granulation: When the blending phase is completed, the product is
taken out of the blender and the granules are prepared in a granulator
or direct to compression.
Drying: the granules prepared are dried in a dryer
Compression operation: which aims to produce tablets with target
hardness characteristics.
Coating operation: that delivers the final producta coated tablet.
Packing: packaging in the final container or strip or blisters
METHODS FOR PREPARATION OF TABLETS
There are three (3) methods by which the tablets can be prepared
DRY BLENDING :
WEIGHING
SIZING
BLENDING
LUBRICATION
COMPRESSION
COATING
DRY
GRANULATION :
WEIGHING
SIZING
BLENDING
COMPACTION
MILLING
LUBRICATION
COMPRESSION
WET GRANULATION :
WEIGHING
SIZING
GRANULATION
DRYING
BLENDING
LUBRICATION
COMPRESSION
1.
Direct Compression
2.
Dry Granulation
3.
Wet Granulation
1. DRY GRANULATION
In dry granulation, the dry powder particles may be brought together
mechanically via compression to form slugs, or more frequently via
compaction by a roller compactor.
This method has been utilized when one of the constituents, either the drug or
the excipients has insufficient cohesive or flow properties to be directly
compressed into tablets.
Dry granulation is a valuable technique in situations where the effective dose
of drug is too high for direct compression and the drug is sensitive to heat,
moisture or both, which precludes wet granulation (Banaker, 1979; 1991).
WET GRANULATION
With wet granulation, extra process steps are necessary to produce a tablet
mass with sufficient tableting properties.
After dry blending the tablet mixture to uniformity, a binder solution is added
to the mixture to moisten the particles.
Introduction of the binder solution improves binding between the particles and
therefore can produce stronger tablets.
Mixing is continued until granules with a specific diameter are produced.
This wet mass is then screened to remove large lumps, and dried in oven to
remove granulation fluid.
Finally, the granules are sieved to remove the agglomerates that are formed
during drying followed by lubrication of the granules.
Direct Compression
The other technique for tablet production is direct compression
In direct compression, all the powder mixture is blended to form a uniform
mixture and is directly compressed into tablets without any modification of its
physical nature.
Lubrication step may be necessary to prevent the mixture from adhesing to
the die and punches during compression.
Tablets are compressed directly from powder blends of the active ingredient
and suitable excipients
No pretreatment of the powder blends by wet or dry granulation procedures is
necessary
Additives:
Diluents
Disintegrating agents
Organoleptic additives
Glidants, anti-adhesives, lubricants
PREPARATION OF SOFT CAPSULE
Soft capsules are generally prepared in two methods
1) Plate process,
2) Rotary die process
PLATE PROCESS
In the plate process a warmed sheet of plasticized gelatin is placed over a
plate having a number of depressions or moulds.
The sheet is drawn into these moulds by applying vacuum.
A measured quantity of liquid medicament is poured over it.
Then another sheet of gelatin is placed over it and the pressure is then
applied to the combined plates.
The capsules are then simultaneously shaped, filled, sealed and cut into
individual units.
ROTARY DIE PROCESS
In this process filled capsules are produced continuously and automatically.
Two continuous sheets of gelatin are supplied to the die rolls of the machine
which has a number of matching dies and rotate at the same speed and in the
opposite direction.
The pressure exerted by the material forces gelatin sheet to go in the cavities
of the die rolls to form two halves of the capsule and fill them.
The heat and pressure exerted by the die rolls seals and cuts out the
capsules.
The finished capsules are then passed through a series of naphtha baths to
remove lubricants and then dried.
These rotary die machines are produce 25000 to 30000 capsules per hour.
Figure: Rotary die machine for producing soft capsules
PQA
Pharmaceutical Quality Assurance may be defined as the responsibilities of
an organization to determine the system, facilitates & written procedures
are both adequate and followed in order to assure that products are controlled
& met in the final dosage forms all the applicable specifications.
Sum of all activities and responsibilities required to ensure that the medicine
that reaches the patient is safe, effective, and acceptable to the patient.
Quality assurance personnel must establish control or, check points to
monitor the quality of the product as it is processed & upon completion of
manufacture these begin with raw materials & component testing and
includes:
in-process,
packaging,
labeling, and
finished product testing
as well as batch auditing and stability monitoring.
The need for PQA
assuring the quality, safety, purity and effectiveness of the drug supply.
assures that at each stage of manufacturing the necessary test are made &
the product is not released until it has passed these tests.
To ensure the correct & most appropriate manufacturing & packaging
practices.
To assure that the testing results are in compliance with the standards or,
specifications
To check the maintain of the department premises & requirements,
MATERIAL MANAGEMENT
Material management is defined as an organizational concept, which
has the authority and responsibility of all activities, concerned with
the flow of materials in the organization.
It is concerned with planning, organizing and controlling the flow of
materials from their initial purchase through internal operations to
the service point through distribution.
Material management is a scientific technique, concerned with
Planning, Organizing & Control of flow of materials, from their initial
purchase to destination.
The aims of material management are following:
1. To get the right quality
2. To get right quantity of supplies
3. To get at the right time
4. To get at the right place
5. To get For the right cost
The purpose of material management are following:
1. To gain economy in purchasing
2. To satisfy the demand during period of replenishment
3. To carry reserve stock to avoid stock out
4. To stabilize fluctuations in consumption
5. To provide reasonable level of client services
RAW MATERIAL
RAW MATERIALS is basically the chemical ingredients of a process.
Basic raw materials are starting material, which is used in
production of final product.
Good raw material specifications must be written in precise
terminology, must be complete, must provide specific details of test
methods, type of instruments, and manner of sampling, and must
be properly identified.
CRITERIA FOR RAW MATERIAL ( FIND 2 MORE )
It must be noted that Pharmacopoeial standards are minimum.
Where no such standards are applicable to raw material, the
specifications should include at least requirements for identification,
limits for purity and potency and limits for impurities.
Where such standard exist for raw material, alternative test
methods may be used but there should be written evidence to show
that such method are at least as precise and specific as the official
methods.
QC
Quality control (Q.C) works from the raw materials up to
finished products which is assures that at each stage of
manufacturing the necessary test are made & the product is
not released until it has passed these tests.
It is that part of GMP concerned with sampling, specification
& testing, documentation & release procedures which ensure
that the necessary & relevant tests are performed & the
product is released for use only after ascertaining its quality.
Operational laboratory techniques and activities used to fulfill
the requirement of Quality
QC is lab based
It is the sum total of the organized arrangements with the
QA
objective of ensuring that products
will be of the quality
required for their intended use.
All those planned or systematic actions necessary to provide
adequate confidence that a product will satisfy requirements
for quality
QA is company based
