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2004 Pformulate. All rights reserved.
Books
About Tabletting: Pharmaceutical
Powder Compaction Technology Tabletting
Specification Manual 5th Edition (January 2000) Pharmaceutical
Principles of Solid Dosage Forms Pharmaceutical
Technology: Tabletting Technology (Compression) |
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| 1. A tablet is a combination of ingredients that is compressed into a solid mass. The basic components of an immediate release pharmaceutical tablet are: |
Optional excipients include:
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glidant |
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anti-adherent |
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anti-static agent |
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colorant |
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flavor |
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sweetener |
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surfactant (wetting agent) |
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anti-oxidant |
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film-coating |
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Need a supplier?
Submit in Excipients
Express!!!
2. Types of Tablets:
| Tablets have the ability to be produced with many different properties including immediate, delayed or sustained release of active drug substance. They can be single or multiple compression (double or triple layered, tablet within a
tablet). They can also be coated with an active drug substance, film or sugar coating. |
3. Tablet Properties:
Physically Acceptable and Stable - tablet print or imprint must be legible, and tablets must be free from chips, cracks, contamination, uneven coloration, etc. Tablets must remain whole during manufacture, coating, packaging, transport and dispensing. In-process controls include:
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| PARAMETER |
VARIABLES |
| Tablet
Weight |
Limits on
tablet weight are generally set as 3 to 5% of a formulation specific
target weight
Some issues that may cause weight variation are powder flow problems,
improper die fill, and powder size distribution |
| Tablet
Hardness |
Expresses as
load required to crush a tablet on end. Measured using a tablet hardness
tester.
Generally, the larger the tablet, the higher the hardness. Smaller
tablets (1/4" round) usually have a hardness <5 kp. Larger
tablets usually have a hardness <20 kp.
Some issues that may cause variations in tablet hardness are
inconsistent tablet weight, particle size variations, poor powder
compressibility, insufficient binder level |
| Tablet
Thickness |
Uniform
compression force and volume of die fill, leads to uniform thickness |
| Disintegration
Time |
The time it
takes for the tablet to break up into individual granules or particles.
Poor disintegration can come from tablets which are compressed too
hard, insufficient disintegrant levels, or too much binder. |
| Friability |
Friability is
the tendency of a tablet to crumble, chip or break.
It is measured by tablet weight loss after rotation on a friabilator
(i.e. 100 revolutions or 4 minutes at 25 RPM). Typically % loss is
<0.5%, but can be up to 2% for very large tablets.
Friable tablets can be caused by low moisture content, insufficient
binder, tablet configuration (e.g. sharp versus beveled edges). |
Chemically
Acceptable and Stable - the amount of active drug substance
specified on the label must be present in the tablet at the time of
manufacture and beyond the expiration date. Tablets must have
acceptable drug content uniformity. Tablet must have acceptable drug release
characteristics (dissolution). Finished Product Testing
Includes:
| PARAMETER |
DESCRIPTION |
| Identification |
Used to
verifiy that active drug substance in the tablet is correct |
| Potency |
A measure of
the amount of active drug substance in the tablet (i.e. mg/tablet or %
label claim)
Typically in the range of 90 or 95% to 105 or 110% |
| Related
Substances |
Verifies the
quantities of other substances in the product. Limits should be set for
other known sustances. Unknown substances should fall within ICH
guidelines. |
| Content
Uniformity |
A measure of
the consistency of tablet potency, based on the individual analysis of
10 tablets. Typically 85-115% of label claim with a relative standard
deviation of <6%. |
| Dissolution |
A measure of
the rate and extent of active drug substance going into solution.
Dissolution specifications vary depending on the type of tablet made.
Typically performed using USP apparatus I (rotating basket) or II
(paddle), but may also be done with Apparatus III (Bio-dis) or IV (Flow
through cell) |
Suppliers of Tablet Presses:
DT Industries Stokes
Fette America,Inc.
Key International
Korsch
Suppliers of Tablet Tooling:
Elizabeth
Natoli
Contract Tabletting Services
Norwich Pharmaceuticals
Tablet Formulation Consulting Services
Emerson Resources
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Pformulate
01/02/03
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