|Budget Amount *help
¥2,200,000 (Direct Cost : ¥2,200,000)
Fiscal Year 1997 : ¥800,000 (Direct Cost : ¥800,000)
Fiscal Year 1996 : ¥1,400,000 (Direct Cost : ¥1,400,000)
In order to harmonize the regulation of pharmaceutical products, the tests for physicochemical properties of pharmaceutical preparations are important. The physicochemical properties of expicients affect their bioavailability of the preparations through effects on the dissolution rate, disintegration time, tabelt hardness. Thus, the design of pharmaceutical preparations, specially the interaction between the pharmaceutical additives and bulk drug powders which are practically insoluble in water affects on the bioavailability of the preparations, and the stability during storage period. However, there is no evaluation method concerning the effect of pharamceutical additives on the preparations in Pharmacopoeia in countries throughout the world. Therefore, we investigate the relationship between the physicochemical properties of pharmaceutical products and the effect of additives during storage period.
1)Effect of solvents on polymorphic transformation of piretanide, etc during granulation process were investigated.
2)Effect of mixing mode on the coloration of compound isoniazid sodium methanesulfonate and pyridoxal calcium phospate was investigeted.
3)In order to improvement of the photostability (Vitamin K1) in model infusion fluids, Effect of addition of fat-soluble vitamine on the photodegradation of phytonadione was investigated by kinetics methods.
4)Effect of excipients on polymorphic transformation of carbamazepine during tabletting compression was investigated.