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Tablet Validation for Pharma Experts

Coated tablets are solid dosage forms containing active ingredients and excipients prepared by molding or compression. Validation of the coated tablet process is key to ensuring quality, and involves prospective, concurrent, or retrospective validation of parameters like mixing, granulation, drying, milling, lubrication, compression, and coating. Main parameters that need validation include equipment, materials, process conditions, and in-process and finished product tests.

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Pankaj Jaat
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474 views9 pages

Tablet Validation for Pharma Experts

Coated tablets are solid dosage forms containing active ingredients and excipients prepared by molding or compression. Validation of the coated tablet process is key to ensuring quality, and involves prospective, concurrent, or retrospective validation of parameters like mixing, granulation, drying, milling, lubrication, compression, and coating. Main parameters that need validation include equipment, materials, process conditions, and in-process and finished product tests.

Uploaded by

Pankaj Jaat
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

ANSWER 1

Coated tablets may be defined as the solid unit dosage form of medicament or


medicaments with suitable excipients and prepared either by molding or by
compression. It comprises a mixture of active substances and excipients, usually in
powder form, pressed or compacted from a powder into a solid dose .

Validation of coated tablet:-


Process validation of tablet is the key element to assure the
identity, strength, purity, safety, efficacy and maintaining the quality of final coated
tablet .

Need of validation of tablet:-

1. Assurance of Quality Cost reduction.


2. Process validation is necessary if failure needs to be reduced.
3. Productivity to be increased
Main types of methods for tablet validation are: -

1. Prospective validation
2. Concurrent validation
3. Retrospective validation
4. Revalidation

Main parameters in different process which needs to be validated :-

Mixing or Blending

1. Mixing or blending technique


2. Mixing or blending speed
3. Mixing or blending time:
4. Drug uniformity
5. Excipient uniformity
6. Equipment capacity/load
Wet Granulation

1. Binder addition
2. Binder concentration
3. Amount of binder solution/granulating solvent
4. Binder solution/granulating solvent addition
5. Mixing time
6. Granulation end point

Wet Milling

1. Equipment size and capacity


2. Screen size
3. Mill speed
4. Feed rate
Drying

Factors to be considered are


1. Inlet/outlet temperature
2. Airflow
3. Moisture uniformity
4. Equipment capability/capacity
Milling
 The milling operation will reduce the particle size of the dried granulation.
 The resultant particle size distribution will affect such material properties as flow,
compressibility, disintegration, and dissolution.

Factors to consider in milling are:

1. Mill type
2. Screen size
3. Mill speed
4. Feed rate
Lubrication
Lubricants are added to reduce the friction during tablet ejection between the
walls of the tablet and die cavity in which the tablet was formed. Factors like amount of
lubricant added, grade of lubricant used, compatibility with other ingredients and mixing
time must be considered.

Tablet Compression
Factors to consider during compression are as follows:
1. Tooling
2. Compression speed
3. Compression/ejection force

The following in-process tests should be examined during the compression stage:

1.Appearance
2.Hardness
3.Tablet weight
4.Friability
5.Disintegration
6.Weight uniformity
Tablet Coating

Tablet properties
1. Equipment type
2. Coater load
3. Pan speed
4. Spray guns:
5. Tablet flow
6. Inlet/outlet temperature and airflow
7. Coating solution
8. Coating weight
Residual solvent level

In-process tests
1. Moisture content of “dried granulation”
2. Granulation particle size distribution
3. Blend uniformity
4. Individual tablet weight
5. Tablet hardness
6. Tablet thickness
7. Disintegration
8. Impurity profile

Finished product tests


1. Appearance
2. Assay
3. Content uniformity
4. Tablet hardness
5. Tablet friability
6. Impurity profile

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