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Stability Study of a Thalidomide Suspension
Author(s) -
Hopkins Ashley M,
Sharley Nicholas A,
Tang Cuong D
Publication year - 2012
Publication title -
journal of pharmacy practice and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.222
H-Index - 22
eISSN - 2055-2335
pISSN - 1445-937X
DOI - 10.1002/j.2055-2335.2012.tb00146.x
Subject(s) - thalidomide , medicine , suspension (topology) , chromatography , high performance liquid chromatography , chemistry , multiple myeloma , mathematics , pure mathematics , homotopy
Background Thalidomide is being used increasingly for its immunomodulatory, anti‐inflammatory and anti‐angiogenic properties. Data on the stability of an oral liquid thalidomide formulation for use in patients with swallowing difficulties and enteral feeding tubes are lacking. Aim To determine the stability of a thalidomide 100 mg/10 mL suspension. Method Thalidomide 100 mg/10 mL suspension was formulated (in triplicate) using Thalomid capsules and stored at room temperature (22 ± 1 °C) for 31 days. Stability was assessed via high‐performance liquid chromatography (HPLC) on Days 7, 14, 21 and 31. Assay suitability was analysed via forced degradation products of thalidomide samples under acidic, basic and oxidative conditions. Results A validated thalidomide HPLC assay indicated that the original thalidomide content of the suspension remained within 5% throughout the 31‐day study period. After shaking, no visible changes in suspension consistency, colour or sedimentation were observed. Conclusion The formulated thalidomide 100 mg/10 mL suspension when protected from light and stored at room temperature was stable for up to 31 days.