Purpose
To lay down the procedure for the Subdivision of Tablets.
Reference
BP/Ph.Eur
Procedure
- Tablets may bear one or more break-marks such that the tablets may be subdivided into parts, either to ease the intake of the medicinal products or to comply with the Posology.
- In the later case, subdivision must be assessed and authorized by the competent authority.
- In order to ensure that the patient will receive the intended dose, the efficacy of break-marks must be assessed during the development of the product, in respect of the uniformity of mass of the subdivided parts.
- Each authorized dose must undergo the following test.
- Take 30 tablets at random, break them by hand along the break- marks, take one part from each tablet for the test, & discard the other the part(s).
- Weigh each of the 30 parts individually and calculate average mass.
- The tablets comply with the test if not more than one individual mass is outside the limits of 85% to 115% of the average mass.
- The tablets fail to comply with the test if more than one individual mass is outside these limits, or if one individual mass is outside the limits of 75% to 125% of the average mass.
Revision History
Nil
Tags
GTP
