Considerations for the Revision of General Requirements of Pharmaceutical Films in the General Chapter of the Chinese Pharmacopoeia
The pharmaceutical films are thin sheets formed by various methods such as casting or extrusion,which results in a dispersion of the active pharmaceutical ingredients through the film.They are subject to growing re-search and have received increasing interests recently due to their convenient administration and improved patient com-pliance.This review summarizes the marketed products of film dosage form,their quality standards,and storage requirements.Besides,the testing methods of quality inspection items including disintegration time and dissolution are discussed.Finally,brief explanations are provided for the revision of general requirements of pharmaceutical films in the general chapter of the Chinese Pharmacopoeia by comparing with the United States Pharmacopoeia,European Pharmacopoeia,and Japanese Pharmacopoeia.
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