Stability of Extemporaneously Prepared Amitriptyline Hydrochloride Topical Preparations for the Treatment of Neuropathic Pain

Objective: The aim of this study was to investigate the physicochemical and microbiological stability extemporaneous amitriptyline hydrochloride (AMH) topical preparations for treatment neuropathic pain. Materials Methods: AMH tablets were triturated produce fine powders with a mortar pestle. These levigated separately incorporated into four compounding bases: hydrophilic petrolatum USP, anionic cream, cold cream pluronic lecithin organogel (PLO) having concentration 2%w/w AMH. Results: In in vitro release study, most significant amount released from PLO, followed by petrolatum, respectively; therefore, compounded PLO selected evaluation permeation product stability. across human epidermal membrane significantly greater than that cream.Product characterized as no remarkable change color or texture remaining range 90–110% initial quantified high-performance liquid chromatography. Compounded stable at 2–8 °C 30 60 days, 40 whereas 14 days. There visible microbial growth any samples. Conclusion: Taken together studies, present suggests could be prepared used beyond-use date days when kept °C.