STABILITY OF BENDROFLUAZIDE IN A LOW-DOSE EXTEMPORANEOUSLY PREPARED CAPSULE

The stability of bendrofluazide 1.25 mg in capsules was studied. The f ormulation is intended to provide a unit dose powder for administratio n by dispersing the contents in liquid. The capsules were prepared fro m ground bendrofluazide tablets 5 mg from two different manufacturers, diluted with lactose and packed manually by weight into hard gelatin capsule shells. The capsules were stored at ambient temperature expose d to light or 75% relative humidity, and at 45 or 60-degrees-C. The am bient temperature and 60-degrees-C conditions were studied for up to 1 year. Bendrofluazide was determined by a stability-indicating HPLC me thod. The capsule contents remained easy to disperse in liquid by the end of the study. The weight of contents which could be extracted from the capsules also remained satisfactory. A 7-month storage life at am bient temperature would be feasible, based on the lower 95% confidence limits of the time to 5% degradation.