Stability of the Powdered Dosage Form Prepared by Unsealing the Capsules. II. Investigation of Hygroscopicity and Discoloration of the Powdery Contents of Clorazepate Dipotassium Capsule.

Abstract

( Received October 15, 1999 Accepted March 10, 2000 ) The hygroscopicity of the contents of clorazepate dipotassium (Mendon(R)) capsule (CM) divided in packages made of polyethylene laminated glassine was investigated by storing the capsules at various relative humidities (RHs). The CM capsules were found to significantly absorb water vapor at an RH of more than 61.5%. The hygroscopicity of CM decreased after placing the CM capsules into air-tight containers, e.g., polyethylene laminated glassine. At the same time, a marked discoloration of CM was also observed during storage, in which the color changed from white to yellow. The discoloration of the CM capsules accelerated at high RH levels and after expose to fluorescent light. As a result, when Mendon(R) capsules must be prepared in a powdered dosage form, CM should be stored below an RH of 31.3% and be protected from light to avoid any adsorption of water vapor and/or discoloration.