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p Formulate Tablets


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
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:
active drug substance
diluent or filler (see compression aids)
binder
disintegrant
lubricant

Optional excipients include:

glidant
anti-adherent
anti-static agent
colorant
flavor
sweetener
surfactant (wetting agent)
anti-oxidant
film-coating

 

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:
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)

 

 

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 !

P formulate

527 NE 57th Street Miami, FL  33137

Phone: 305-756-6267

pformulate@pformulate.com

Owned and operated by Janice L. Cacace, Ph.D., 

a consultant to the pharmaceutical industry with over 20 years of pharmaceutical and nutraceutical research, development, formulation and manufacturing experience.