Stability of rifabutin in two extemporaneously compounded oral liquids

Abstract

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 on 2-oz plastic prescription bottles. Three bottles of each formulation were stored at 4, 25, 30, and 40 °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 °C lost a mean of <8% of the initial drug concentration during the 12-week study; at 40 °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 °C with the exception of rifabutin in cherry syrup, which was stable for only 8 weeks at 40 °C.