SUPPOSITORY DOSAGE FORM: REQUIREMENTS FOR QUALITY TESTS

DOI: https://doi.org/10.29296/25419218-2018-05-01
Issue: 
5
Year: 
2018

I.V. Gammel(1), N.V. Pyatigorskaya(2), I.P. Rudakova(2) 1-Volga Research Medical University; 10/1, Minin and Pozharsky Sq., Nizhny Novgorod 603950, Russian Federation 2-I.M. Sechenov First Moscow State Medical University; 4-2, Bolshaya Pirogovskaya St., Moscow 119991, Russian Federation

Due to the fact that the range of drugs as suppositories has been expanded, the importance of pharmacopoeial requirements for testing this formulation is being increasing, which serve as a guarantor of its quality, safety, and efficacy. The identity and content of the active ingredient in the suppositories are determined in compliance with the requirements of an individual pharmacopoeia article. However, in addition to the analytical indicators determining the quality of all drugs, the State Pharmacopoeia imposes specific requirements for testing the specific dosage forms, in particular suppositories. Analysis of the requirements of different (7th to 13th) editions the State Pharmacopoeia of the Russian Federation for tests of the suppository dosage form showed not only the evolution of the latter, but also the simultaneous update of the contents of pharmacopoeia requirements for suppository testing. The change in the requirements for testing the suppositories is due to the development of their pharmaceutical market segment and to the need to harmonize the requirements of Russian and leading foreign pharmacopoeias. The indicators of the evolution of pharmacopoeia requirements for dosage forms, which emphasize the important role of testing the assessment of their quality, is to identify separate Pharmacopoeia sections «General articles on dosage forms», «Pharmacotechnical tests and processes», «Dosage forms and methods for their analysis» with the subsection «Pharmaceutical technological dosage form testing».

Keywords: 
suppositories
pharmacopoeia requirements
quality tests

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