دراسة تقويمية مقارنة لمعايير جودة الكريمات الموضعية المصنعة في سورية : الحاوية على ستيروئيدات خلال فترة العمر على الرف

Abstract EN

This research aims to make a comparative study for evaluation the quality parameters of topical creams locally produced containing steroids during shelf-life, and to ensure the compatibility of real shelf-life with labeled shelf-life through a set of quality tests which were applied to 47 samples of these creams.

Creams were evaluated through appearance, microscopic test, viscosity measurement, determination of pH value, electrical conductivity measurement, and the active substances have been assayed by using HPLC according to assay methods mentioned in USP 30.

The temperature cycling was applied also.

As a conclusion these creams have the quality parameters required by the Pharmacopoeia, and steroids used as an active substance still maintain their chemical stability in creams even after their labeled expiry period, but the problem observed in the physical stability of cream, in which demonstrate the importance of reconsider the physical stability studies during the development of these formulations, also to follow good practice in transporting, distribution and storage of these creams and to follow the conditions which ensure protection of products from degradation.