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Stability Assessment of Topical Amitriptyline Extemporaneously Compounded with Lipoderm Base, PLO Gel Mediflo 30, and Emollient Cream

Author(s):  Shakshuki Ayah, Agu Remigius U

Issue:  Jan/Feb 2019 - Volume 23, Number 1
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Abstract:  Extemporaneous topical compounds for neuropathic pain offers an alternative or adjunct approach to existing therapies for patients. Assigning evidence-based beyond-use dating prior to dispensing topical medications is a legal requirement by pharmacy governing bodies. The purpose of this study was to utilize a validated stability-indicating high-performance liquid chromatography assay to determine beyond-use dating of topical amitriptyline in three different bases (Lipoderm Base, PLO Gel Mediflo 30, Emollient Cream) at three different temperatures [room temperature (25°C), refrigeration (4°C), and high temperature (40°C)]. Amitriptyline was stable after 90 days at room temperature in both Lipoderm Base and PLO Gel Mediflo 30. However, it was not stable at 40°C in Emollient Cream, irrespective of storage conditions.

Related Keywords: Ayah Shakshuki, BSc (Pharmacy), MSc (Pharmaceutical Sciences), Remigius U. Agu, BPharm, MPharm (Pharmacology), MPharm (Pharmaceutics), PhD, amitriptyline, topical preparations, tricyclic antidepressant, neuropathic pain, analgesic, analgesia, stability, storage, packaging

Related Categories: EXCIPIENTS, MENTAL HEALTH, PAIN MANAGEMENT, PEER-REVIEWED, DOSAGE FORMS/DRUG CARRIERS, NEUROLOGY

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