International journal of pharmaceutical compounding
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Hard-capsule compounding plays an essential role in drug delivery for pharmaceutical application. Versatile and easy to use, capsules represent a popular dosage form for patients. Nevertheless, bioavailability of the drugs compounded in hard capsules is not always optimized and choosing the appropriate excipients is a key factor to improve the dissolution kinetics of active pharmaceutical ingredients. ⋯ Moreover, dissolution profile results for the aforementioned capsules depicted dissolution values meeting the Pharmacopeial criteria of acceptance. These results reinforce the fact that the Biopharmaceutical Classification System concept represents a valuable guideline for formulation chemists or pharmacists to assist them for capsule compounding. To ensure a high level of efficiency of compounded capsules, premixed excipient blends, carefully developed by taking into consideration the solubility and permeability of a drug, represent a significant formulation advantage to improve the dissolution of active pharmaceutical ingredients.
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This article is the first in a two-part series that breaks down quality planning into a systematic, stepwise process. Part 1 addresses the tangible aspects of compounding that directly influence the quality of compounded preparations. Part 2 will speak to less tangible but critically important mechanisms targeting continuous improvement. The author takes a holistic approach, which he describes as a comprehensive, systematic, and proactive approach to continuously improve everything that may, directly or indirectly, influence the quality of a preparation or service.
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Recent events have directed the U. S. Food and Drug Administration's attention to compounding pharmacies and have increased the frequency and vigorousness of pharmacy inspections. It is critical for compounding pharmacists to be prepared for such inspections and to understand their responsibilities after an inspection is over.