Dijkers Eli, Nanhekhan Valerie, Thorissen Astrid, Marro Diego, Uriel Marta
Fagron, Rotterdam, The Netherlands.
Universidad San Jorge, Villanueva de Gállego Zaragoza, Spain.
Hosp Pharm. 2017 Jun;52(6):428-432. doi: 10.1177/0018578717717393. Epub 2017 Jul 13.
The objective of this study was to identify whether compounding oral suspensions with SyrSpend SF based on tablets or capsules is a suitable alternative for using raw pharmaceutical materials. Suspensions based on 5 different tablets and capsules were studied in SyrSpend SF. The summary of product characteristics of these different tablets and capsules were obtained from the manufacturer. Our hypothesis was that, if the maximum beyond-use date of the study was reached, the excipient did not seem to have an influence on the stability of the active pharmaceutical ingredient (API) within the studied time frame. All excipients used in flecainide acetate, labetalol HCl, and tiagabine HCl tablets as well as in celecoxib and oseltamivir capsules did not seem to influence the beyond-use date of the overall suspension based on SyrSpend SF. Although using raw materials as API sources is preferred, oral suspensions with SyrSpend SF prepared from crushed tablets or opened capsules could be a possible alternative. Based on this study, a wide range of different excipients does not seem to impact the beyond-use date of different APIs compounded in SyrSpend SF.
本研究的目的是确定基于片剂或胶囊用SyrSpend SF配制口服混悬液是否是使用原料药的合适替代方法。在SyrSpend SF中研究了基于5种不同片剂和胶囊的混悬液。这些不同片剂和胶囊的产品特性总结来自制造商。我们的假设是,如果达到研究的最长使用期限,在所研究的时间范围内辅料似乎对活性药物成分(API)的稳定性没有影响。用于醋酸氟卡尼、盐酸拉贝洛尔和盐酸替加宾片剂以及塞来昔布和奥司他韦胶囊中的所有辅料似乎都不会影响基于SyrSpend SF的整体混悬液的使用期限。虽然首选使用原料药作为API来源,但由压碎的片剂或打开的胶囊制备的含SyrSpend SF的口服混悬液可能是一种替代方法。基于本研究,多种不同的辅料似乎不会影响在SyrSpend SF中配制的不同API的使用期限。