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Formulate What?
p
Formulate Tablets
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| Basic
formulation information on formulating, developing,testing and
manufacturing OTC or Rx pharmaceutical or nutritional tablets.
If you have a specific question regarding tablets, please email us |
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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 of excipients, ingredients, instruments or equipment
used to formulate, develop, test or manufacture nutritional
or pharmaceutical tablets ? 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
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| 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
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| 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.
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| 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).
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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%
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| 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)
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Are
you a manufacturer or supplier of pharmaceutical grade, USP grade
or food grade ingredients, chemicals, equipment, instruments or
packaging materials used to formulate, develop or manufacture pharmaceutical
or nutritional tablets? If so , email us at pformulate@pformulate.com
to find out how to have your products listed in our pharmaceutical
and nutritional tablet directories.
Pformulate/01/02/2003
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| Excipient's
Express |
| Need
to find a supplier to formulate a film coating, softgel, tablet,
gluten-free or gum based pharmaceutical or nutraceutical ? Simply
submit in Excipients
Express Requests ! |
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