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曲马多、氟西汀和多西环素临时口服混悬液在SyrSpend SF pH4中的稳定性

Stability of Extemporaneous Oral Tramadol, Fluoxetine, and Doxycycline Suspensions in SyrSpend SF pH4.

作者信息

Espana B, Joseph-Tornabène F, Jaquet Cécile, Perrot S, Prouillac C

机构信息

Université de Lyon, Vetagro Sup, Marcy l'Etoile, France.

France-Prep, Marseille, France.

出版信息

Int J Pharm Compd. 2020 Jul-Aug;24(4):327-336.

Abstract

Extemporaneous compounding in veterinary practice sometimes represents the only possibility for treating animals in the absence of appropriate commercial formulations, especially for particular species. This method involves manipulating pharmaceutical active ingredients to a suitable dosage and formulation for administration to humans or animals. However, veterinarians and pharmacists should focus on the risk of potential incompatibilities and instability of their preparations. To help practitioners in drug compounding, we investigated the stability of oral suspensions of tramadol, fluoxetine, and doxycycline in a commercial ready-to-use vehicle (SyrSpend). A validated high-performance liquid chromatography method was developed to assay these active pharmaceutical ingredients. The oral suspensions were prepared at two concentration ranges and were stored in amber glass bottles under refrigerated conditions and at room temperature. After 90 days, the average recovery rates were between 90% and 110% for tramadol (5 mg/mL to 30 mg/mL) and doxycycline  (2 mg/mL to 10 mg/mL) without organoleptic modification. For fluoxetine, only the formulation at 2 mg/mL was stable; at higher concentrations, the uniformity of the suspension was compromised.

摘要

在兽医临床实践中,当没有合适的市售制剂时,尤其是针对某些特定物种,临时配药有时是治疗动物的唯一选择。这种方法涉及将药物活性成分制成适合人类或动物给药的剂量和剂型。然而,兽医和药剂师应关注其制剂潜在的不相容性和不稳定性风险。为了帮助从业者进行药物配药,我们研究了曲马多、氟西汀和多西环素在市售即用型载体(SyrSpend)中的口服混悬液的稳定性。开发了一种经过验证的高效液相色谱法来测定这些活性药物成分。口服混悬液在两个浓度范围内制备,并储存在琥珀色玻璃瓶中,分别置于冷藏条件和室温下。90天后,曲马多(5mg/mL至30mg/mL)和多西环素(2mg/mL至10mg/mL)的平均回收率在90%至110%之间,且无感官变化。对于氟西汀,只有2mg/mL的制剂是稳定的;在较高浓度下,混悬液的均匀性受到影响。

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