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Preparation Method and Stability of a Temozolomide Suspension: A Pilot Study
Author(s) -
Ambados Fotios,
Crea Joe,
Chin May,
Lee SuGil
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.tb00145.x
Subject(s) - suspension (topology) , compounding , medicine , chromatography , polypropylene , human decontamination , temozolomide , materials science , composite material , surgery , chemistry , pharmacology , mathematics , homotopy , pure mathematics , pathology , chemotherapy
Aim To investigate a compounding process for temozolomide 10 mg/mL suspension from capsules without using a mortar and pestle; and the stability of the suspension under refrigeration (2 to 8 °C) and at room temperature (22 to 23 °C). Method Temozolomide 10 mg/mL suspension was prepared using a modified formulation and method to contain the product in the final container and limit operator exposure to cytotoxic powder or residue. Decontamination was undertaken of work and finished product surfaces. Samples were stored at room temperature and under refrigeration. Both samples were protected from light and stored in identical polypropylene containers. High‐pressure liquid chromatography was used to assay the potency of the suspension. Results The sample refrigerated and protected from light exhibited little or no chemical degradation for 22 days. At room temperature, the concentration fell below the acceptable concentration after 8 days. An acceptable product was produced which re‐suspended evenly when shaken. Conclusion Preliminary results indicate that temozolomide 10 mg/mL suspension prepared via this method, refrigerated, protected from light and stored in polypropylene containers may be stable for up to 22 days.