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.