Haslam J L, Egodage K L, Chen Y, Rajewski R A, Stella V
Center for Drug Delivery Research, University of Kansas, Lawrence 66047, USA.
Am J Health Syst Pharm. 1999 Feb 15;56(4):333-6. doi: 10.1093/ajhp/56.4.333.
The stability of rifabutin 20 mg/mL in two oral liquids was studied. Powder from 100 150-mg rifabutin capsules was placed in a glass mortar. Cherry syrup (pH 2.9) or a 1:1 mixture of Ora-Sweet and Ora-Plus (Paddock Laboratories) was added to produce 750 mL of each formulation, which was then stored in 2-oz plastic prescription bottles. Three bottles of each formulation were stored at 4, 25, 30, and 40 degrees C. At 0, 1, 2, 4, 8, and 12 weeks, the bottles were collected and allowed to remain at room temperature for one hour; samples of about 1 mL were collected from each bottle, weighed, and assayed for rifabutin content by high-performance liquid chromatography. The rifabutin liquids prepared with cherry syrup and stored at 4, 25, and 30 degrees C lost a mean of < 8% of the initial drug concentration during the 12-week study; at 40 degrees C, the liquids lost > 10% of the initial drug concentration by 12 weeks. There was a mean loss of < 5% of the initial rifabutin concentration in all the liquids prepared with Ora-Sweet and Ora-Plus. The liquid prepared with cherry syrup, upon standing, showed a tendency for some of the ingredients to float. The suspension prepared with Ora-Sweet and Ora-Plus had a tendency to retain bubbles after it was shaken, but the ingredients did not settle upon standing. Rifabutin 20 mg/mL in two extemporaneously compounded oral liquids prepared from capsules and sweetened vehicles was stable for at least 12 weeks at 4, 25, 30, and 40 degrees C with the exception of rifabutin in cherry syrup, which was stable for only 8 weeks at 40 degrees C.
研究了利福布汀20 mg/mL在两种口服液体制剂中的稳定性。将100粒150 mg利福布汀胶囊中的粉末置于玻璃研钵中。加入樱桃糖浆（pH 2.9）或Ora-Sweet与Ora-Plus（帕多克实验室）的1:1混合物，制成每种制剂750 mL，然后储存在2盎司塑料处方瓶中。每种制剂的三瓶分别储存在4、25、30和40℃。在0、1、2、4、8和12周时，收集瓶子并在室温下放置1小时；从每个瓶子中收集约1 mL样品，称重，并通过高效液相色谱法测定利福布汀含量。用樱桃糖浆制备并储存在4、25和30℃的利福布汀液体在12周的研究期间平均损失的初始药物浓度<8%；在40℃时，到12周时液体损失的初始药物浓度>10%。用Ora-Sweet和Ora-Plus制备的所有液体中，初始利福布汀浓度平均损失<5%。用樱桃糖浆制备的液体静置后，一些成分有漂浮的趋势。用Ora-Sweet和Ora-Plus制备的混悬液振荡后有保留气泡的趋势，但成分静置后不会沉降。由胶囊和甜味赋形剂临时配制的两种口服液体制剂中的利福布汀20 mg/mL在4、25、30和40℃下至少稳定12周，但樱桃糖浆中的利福布汀在40℃下仅稳定8周。
