Tablets of the British pharmacopeia

Question 1

Content of active ingredient of tablets

Answer 1

The range for the content of active ingredient stated in the monograph is based on the requirement that 20 tablets, or such other number as may be indicated in the monograph, are used in the Assay. In circumstances where 20 tablets cannot be obtained, a smaller number, which must not be less than five, may be used, but to allow for sampling errors the tolerances are widened

Question 2

Several categories of tablets for oral use may be distinguished:

Answer 2

— uncoated tablets;
— coated tablets;
— gastro-resistant tablets;
— modified-release tablets;
— effervescent tablets;
— soluble tablets;
— dispersible tablets;
— orodispersible tablets;
— chewable tablets;
— oral lyophilisates.

Question 3

Tablet - testing

Answer 3

Uniformity of dosage units
Uniformity of content
Uniformity of mass
Dissolution
Disintegration

Question 4

Gastro-resistant tablets are

Answer 4

delayed-release tablets that are intended to resist the gastric fluid and to release their active substance(s) in the intestinal fluid. Usually they are prepared by covering tablets with a gastro-resistant coating or from granules or particles already covered with a gastro-resistant coating.

Tablets covered with a gastro-resistant coating conform to the definition of coated tablets.

Question 5

Modified-release tablets are

Answer 5

coated or uncoated tablets that contain special excipients or are prepared by special procedures, or both, designed to modify the rate, the place or the time at which the active substance(s) are released.

Modified-release tablets include prolonged-release tablets, delayed-release tablets and pulsatile-release tablets.

Question 6

Effervescent tablets are

Answer 6

uncoated tablets generally containing acid substances and carbonates or hydrogen carbonates, which react rapidly in the presence of water to release carbon dioxide. They are intended to be dissolved or dispersed in water before administration.

Question 7

Soluble tablets are

Answer 7

uncoated or film-coated tablets. They are intended to be dissolved in water before administration. The solution produced may be slightly opalescent due to the added excipients used in the manufacture of the tablets.

Question 8

Dispersible tablets are

Answer 8

uncoated or film-coated tablets intended to be dispersed in water before administration, giving a homogeneous dispersion

Question 9

Orodispersible tablets are

Answer 9

uncoated tablets intended to be placed in the mouth where they disperse rapidly before being swallowed

Question 10

Oral lyophilisates are

Answer 10

solid single-dose preparations made by freeze-drying of a liquid or semi-solid preparation. These fast-releasing preparations are intended to be placed in the mouth where their contents are released in saliva and swallowed or, alternatively, are intended to be dissolved or dispersed in water before oral administration.