By Sarfaraz K. Niazi
The fourth quantity within the six-volume guide of Pharmaceutical production Formulations, this ebook covers semi-solid medicinal drugs. It comprises ointments, creams, gels, and suppositories, from publicly to be had yet greatly dispersed details from FDA New Drug purposes (NDA), patent functions, and the BASF ebook of common formulations. every one access starts with an absolutely verified scaleable production formulation that comes with compendial specification requirement for every factor, in-process controls for production and unencumber of product, a precis of producing strategy, and information of packaging.
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Extra info for Handbook of Pharmaceutical Manufacturing Formulations Volume 4 of 6: Semisolids Products
If CRT storage is ultimately justified, it may be necessary to add to the product labeling a cautionary statement against prolonged exposure at or above 30°C. The long-term testing will be continued for a sufficient period of time beyond 12 months to cover shelf life at appropriate test periods. The further accumulated data should be submitted to the FDA during the assessment period of the drug application. [ICH Q1A] The first three production batches manufactured postapproval, if not submitted in the original application, should be placed on accelerated and long-term stability studies using the same stability protocol as in the approved drug application.
Cutting Cutting is particle size reduction by mechanical shearing. d. Compression Milling Particle size reduction by compression stress and shear between two surfaces is known as compression milling. e. Screening Particle size reduction by mechanically induced attrition through a screen (commonly referred to as milling or deagglomeration) is called screening. f. Tumble Milling Tumble milling is particle size reduction by attrition, using grinding media. 4. Compression Mills Although compression mills, also known as roller mills, can differ in whether one or both surfaces move, no compression mill subclasses have been identified.
Where a significant change occurs during 12 months of storage at 30°C/60% RH, it may not be appropriate to label the drug product for CRT storage with the proposed expiration dating period even if the stability data from the full long-term studies at 25°C/60%RH appear satisfactory. In such cases, alternate approaches, such as qualifying higher acceptance criteria for a degradant, shorter expiration dating period, refrigerator temperature storage, more protective container and closure, and modification to the formulation or manufacturing process, should be considered during drug development.