Optimum Heat Treatment Conditions for Masking the Bitterness of the Clarithromycin Wax Matrix

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The effects of the contents of aminoalkyl methacrylate copolymer E (AMCE) in a wax matrix on the mechanism of polymorphic transformation of glyceryl monostearate (GM) were clarified by evaluating the enthalpy change defined as 1.51 (ΔH_1-ΔH_2)/ΔH_2, where ΔH_1 and ΔH_2 denote the enthalpies in the first and second thermal analyses, respectively. Using this value, K_1 the rate constant of transformation from α-form to β'-form, and K_2, the rate constant of transformation from β'-form to β-form, could be obtained. As the ratio of AMCE increased, K_2 increased, but a minimum point existed for K_1. K_1 was always larger than K_2, but gradually approached K_2 as the ratio of AMCE increased. The optimum temperature for the transformation of GM was 50℃, at which the enthalpy change was maximum. To prepare the wax matrix preparation of clarithromycin (CAM), we considered 40℃ the optimum treatment temperature for the transformation of GM in a CAM wax matrix compounded from CAM, GM and AMCE, since the matrices were mutually welded at above 45℃ during the spray congealing process. Although K_1 and K_2 were almost the same at 40℃, the rate of transformation was accelerated by tumbling. By applying the tumbling that accelerated the transformation of GM in a CAM wax matrix, almost all of the α-form disappeared, and the release of CAM from the wax matrix diminished when the enthalpy change was more than 0.8.
公益社団法人日本薬学会の論文
2003-11-01

Optimum Heat Treatment Conditions for Masking the Bitterness of the Clarithromycin Wax Matrix

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