Alexander K S, Haribhakti R P, Parker G A
Department of Pharmacy Practice, University of Toledo (UT), OH 43606.
Am J Hosp Pharm. 1991 Jun;48(6):1241-4.
The stability of acetazolamide in an extemporaneous suspension compounded from tablets was studied. Acetazolamide 25-mg/mL suspension was prepared by levigating the comminuted 250-mg tablets with 70% sorbitol solution. The mixture was incorporated into a suspension vehicle containing magnesium aluminum silicate and carboxymethylcellulose sodium. Appropriate sweeteners, flavoring agents, preservatives, humectants, and pH adjusters were then added. The suspension was stored in amber glass bottles at 5, 22, 30, 40, and 50 degrees C. Samples were analyzed for the concentration of acetazolamide by stability-indicating high-performance liquid chromatography on days 3, 7, 11, 18, 24, 32, 42, 54, and 79. For batches stored at 5, 22, and 30 degrees C, the initial acetazolamide concentration was maintained during the entire 79 days of the study. However, the concentrations in the batches stored at 40 and 50 degrees C were below 90% of the initial value after 79 and 32 days, respectively. The Arrhenius plot was used to predict a shelf life of the suspension at room temperature of 371 days. Acetazolamide oral suspension 25 mg/mL was stable for at least 79 days at 5, 22, and 30 degrees C. The formulation should be maintained at pH 4-5 and stored in amber glass bottles.
研究了由片剂配制的乙酰唑胺临时混悬液的稳定性。通过将粉碎的250mg片剂与70%山梨醇溶液研磨来制备25mg/mL的乙酰唑胺混悬液。将混合物加入含有硅酸镁铝和羧甲基纤维素钠的混悬剂载体中。然后加入适当的甜味剂、调味剂、防腐剂、保湿剂和pH调节剂。将混悬液储存在5、22、30、40和50℃的琥珀色玻璃瓶中。在第3、7、11、18、24、32、42、54和79天，通过稳定性指示高效液相色谱法分析样品中乙酰唑胺的浓度。对于储存在5、22和30℃的批次，在整个79天的研究期间，乙酰唑胺的初始浓度保持不变。然而，储存在40和50℃的批次中的浓度分别在79天和32天后低于初始值的90%。用阿仑尼乌斯图预测该混悬液在室温下的保质期为371天。25mg/mL的乙酰唑胺口服混悬液在5、22和30℃下至少稳定79天。该制剂的pH应保持在4-5，并储存在琥珀色玻璃瓶中。
