International journal of pharmaceutical compounding
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Cyclobenzaprine has been commonly compounded by pharmacists into topically applied dosage forms for the treatment of pain disorders. However, the efficacy and transdermal penetration of topically applied compounded cyclobenzaprine is currently unknown. In this study, the transdermal penetration of cyclobenzaprine was studied in Franz diffusion cells using porcine skin. ⋯ In addition, cyclobenzaprine was tested in an in vivo formalin pain model. Cyclobenzaprine 5% compounded into all three bases yielded significant transdermal penetration and results in modest levels of cyclobenzaprine being retained in the skin tissue. Systemically administered cyclobenzaprine (10 mcg/kg), but not topically administered cyclobenzaprine (1% and 5%), attenuated nociception in a rodent formalin pain model.
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The tragedy surrounding the New England Compounding Center and contaminated steroid syringe preparations clearly points out what can happen if quality-assurance and quality-control procedures are not strictly practiced in the compounding of sterile preparations. This article represents part 1 of a 2-part article on quality-assurance and quality-control procedures and serves as an introduction to the topic of finished preparation release checks and tests. Part 1 highlights what is required to comply with United States Pharmacopeia General Chapter <797>, and part 2 continues with a discussion on the requirements of <797> as well as what is required in chapter < 1163> with respect to quality assurance of compounded sterile preparations. Written procedures, good documentation practices, and specific details for clarity, sterility, and bacterial endotoxin (pyrogen) testing are presented in this article.
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This article discusses factors that affect the assurance of sterility of an aseptic process operation and balances what is required/practiced in the pharmaceutical industry via the U. S. Food and Drug Administration and European aseptic processing guidelines and what is required/practiced in compounding pharmacies via the United States Pharmacopeia (USP) General Chapter <797>.
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Progesterone has been compounded by pharmacists over the last decade using a variety of different dosage forms including, suppositories, troches, solutions, capsules, nasal sprays, creams, ointments, and gels. In particular, the topical/transdermal route has become very popular among physicians, compounders, and patients. There are a few studies in the medical literature that address the transdermal permeation of progesterone from topically applied dosageforms. ⋯ Our results indicate that only minute quantities of progesterone transdermally penetrated through the porcine skin. However, there was significant partitioning of progesterone in the skin tissues. Consequently, these results suggest that the lymphatic circulation that exists in the skin may potentially account for the systemic delivery of topically applied progesterone that is often observed clinically.
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Sterile dosage forms are unique pharmaceutical dosage forms with characteristics and requirements unlike any other dosage form. This article features and focuses on the seven unique characteristics of sterile dosage forms.