DIRECTLY COMPRESSIBLE ADJUVANTS - A PHARMACEUTICAL APPROACH.
SALAM W. AHJEL, DUMITRU LUPULIASA
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Abstract:
The aim of this article is to review all information required to produce a stable, uniform and effective drug product. It is essential to know the properties of the active ingredient alone and in combination with all the other ingredients based on the requirements of the dosage form and processes applied. Excipients are usually produced by batch process; hence, there is a possibility of batch-to-batch variation for the same manufacturer. Excipients obtained from different sources may not have identical properties with respect to use in a specific formulation. To assure interchangeability in such circumstances, users may wish to ascertain equivalency in the final formulation or determine such characteristics before use. Such tests are thus related to the functionality, that the excipients impose to a specific formulation.
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