Premium
Stability of bendrofluazide in a low‐dose extemporaneously prepared capsule
Author(s) -
Barnes A. R.,
Nash S.
Publication year - 1994
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/j.1365-2710.1994.tb01117.x
Subject(s) - capsule , relative humidity , chromatography , lactose , chemistry , gelatin , humidity , food science , geology , biochemistry , paleontology , physics , thermodynamics
SUMMARY The stability of bendrofluazide 1.25 mg in capsules was studied. The formulation is intended to provide a unit dose powder for administration by dispersing the contents in liquid. The capsules were prepared from 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 exposed to light or 75% relative humidity, and at 45 or 60d̀C. The ambient temperature and 60d̀C conditions were studied for up to 1 year. Bendrofluazide was determined by a stability‐indicating HPLC method. 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 ambient temperature would be feasible, based on the lower 95% confidence limits of the time to 5% degradation.