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 product—a coated tablet.

– Packing: packaging in the final container or strip or blisters

Flow chart:

 

Dispensing Sizing Milling Blending

Coating compress Drying Granulation

Packing

METHODS FOR PREPARATION OF TABLETS

There are three (3) methods by which the tablets can be prepared

1. Direct Compression

2. Dry Granulation

3. Wet Granulation

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. 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 it’s quality.

Operational laboratory techniques and activities used to fulfill the

requirement of Quality

QC is lab based

QA

It is the sum total of the organized arrangements with the 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