ABSTRACT
PURPOSE: Sodium valproate, which is commonly repacked to assist with adherence to ensure seizure control, is hygroscopic and therefore sensitive to moisture. The aim of this study was thus to determine the stability implications of removing the enteric coated tablets from their original packaging and repackaging into a Dose Administration Aid (DAA) with storage under various environmental conditions. METHODS: Physicochemical stability of enteric coated sodium valproate tablets repackaged into a DAA and stored at controlled room temperature, accelerated and refrigerated conditions was evaluated for 28 days. A validated high performance liquid chromatography method was used for the quantitation of the drug content. RESULTS: Although the chemical stability (sodium valproate between 95 and 105% of labelled content) was maintained for 28 days for all storage conditions, for those tablets stored under accelerated conditions the integrity of the enteric coat was compromised after only 8 days. CONCLUSIONS: Repackaging of enteric coated sodium valproate should be undertaken with caution and be informed by storage climate. This is particularly relevant for those patients living in hot, humid environments where they should be advised to store their DAA in a refrigerator.
Subject(s)
Anticonvulsants/administration & dosage , Drug Packaging , Seizures/drug therapy , Valproic Acid/administration & dosage , Anticonvulsants/chemistry , Chromatography, High Pressure Liquid , Drug Packaging/methods , Drug Packaging/standards , Drug Stability , Drug Storage/methods , Humans , Patient Compliance/psychology , Seizures/psychology , Tablets , Temperature , Valproic Acid/chemistryABSTRACT
A comprehensive profile on Butyl methoxy dibenzoylmethane, one of the most commonly used ultraviolet (UV) filters in topical sunscreen products, is prepared. This UV filter, often referred to as Avobenzone, has its main absorbance in the UVA I region of the spectrum and is susceptible to photodegradation. The profile contains the following sections: general information, use and mechanism of action, method of preparation, physical characteristics, methods of analysis, stability, and toxicity. The physical characteristics section includes the melting range, differential scanning calorimetry, partition coefficient, ionization constant, solubility, and UV, infrared, nuclear magnetic resonance ((1)H NMR and (13)C NMR) and mass spectrometry and X-ray powder diffractometry. The method of analysis section in addition to compendial identification and purity and assay methods includes thin-layer gas and high-performance liquid chromatography. The photostability and photostabilization of Butyl methoxy dibenzoylmethane, in addition to its toxicity, are also documented.
