Accelerated Stability Testing of Extemporaneous Suspensions and Reconstituted Powder for Suspensions of Acetazolamide and Furosemide
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Abstract
Introduction: This study investigated the physical and chemical stability of the extemporaneous suspensions and reconstituted powder for suspensions of 10 mg/mL acetazolamide (AM) and 2 mg/mL furosemide (FM) in order to verify their tentative shelf-life and appropriate storage conditions. Materials and Method: All preparations in terms of reconstituted powder for suspensions and suspensions were kept for 120 days at 4°C, 25°C/75% RH, 45°C/75% RH, and room temperature (30°C). The changes in physical characters such as color and pH of suspensions were determined. The remained drug contents were analyzed using HPLC technique at the beginning and the end of the testing period. Results: It was found that pH value and content remaining of AM reconstituted powder for suspensions was unchanged at all conditions while that of suspensions decreased when kept at 45 °C/75% RH for 120 days. For both dosage forms of FM, there was no change in pH value and % drug content remaining contents was more than 90% in all conditions keeping for 120 days. Conclusion: The extemporaneous preparation of AM should be prepared in the form of reconstituted powder for suspension and kept at less than 30°C. For the extemporaneous preparation of FM could be prepared in either reconstituted powder for suspension and suspension forms. The desirable storage conditions for either FM extemporaneous preparation was less than 30°C. The shelf life of AM and FM reconstituted powder for suspensions is at least 120 days regarding their physical and chemical stability. However the microbial stability and preservative effectiveness tests should have been included in this study in order to ensure the efficacy and safety of drug use.
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