Stability of Acetazolamide, Baclofen, Dipyridamole, Mebeverine Hydrochloride, Propylthiouracil, Quinidine Sulfate, and Topiramate Oral Suspensions in SyrSpend SF PH4
Author(s): de Oliveira Ferreira Anderson, Polonini Hudson, Loures da Silva Sharlene, Buzinari Aglio Natália Cristina, Abreu Jordana, Fernandes Brandão Marcos Antônio
Issue: Jul/Aug 2017 - Volume 21, Number 4
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Page(s): 339-346
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Abstract: The objective of this study was to evaluate the stability of 7 commonly used active pharmaceutical ingredients compounded in oral suspensions using an internationally used suspending vehicle (SyrSpend SF PH4): acetazolamide 25.0 mg/mL, baclofen 10.0 mg/mL, dipyridamole 10.0 mg/mL, mebeverine hydrochloride 10.0 mg/mL, propylthiouracil 5.0 mg/mL, quinidine sulfate 10.0 mg/mL, and topiramate 5.0 mg/mL. All suspensions were stored both at controlled refrigerated (2°C to 8°C) and room temperature (20°C to 25°C). Stability was assessed by measuring the percentage recovery at varying time points throughout a 90-day period. Active pharmaceutical ingredient quantification was performed by ultraviolet (UV) high-performance liquid chromatography, via a stability-indicating method. Given the percentage of recovery of the active pharmaceutical ingredients within the suspensions, the beyond-use date of the final products (active pharmaceutical ingredient + vehicle) was at least 90 days for all suspensions with regards to both temperatures. This suggests that SyrSpend SF PH4 is suitable for compounding active pharmaceutical ingredients from different pharmacological classes.
Related Keywords: acetazolamide, carbonic anhydrase inhibitor, baclofen, skeletal muscle relaxant, dipyridamole, adenosine reuptake inhibitor, mebeverine hydrochloride, smooth muscle relaxant, propylthiouracil, thiourea antithyroid, quinidine sulfate, class I anti-arrhythmic agent, topiramate, sulfamate, migraine, storage, stability-indicating assay, compatibility studies, physical stability, chemical stability
Related Categories: EXCIPIENTS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES