Development of sustained release formulation by using crystal transition of active ingredient.

2016 Fiscal Year Final Research Report

• Project/Area Number: 26460039
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Physical pharmacy
• Research Institution: University of Shizuoka
• Principal Investigator: Itai Shigeru 静岡県立大学, 薬学部, 教授 (80453059)
• Project Period (FY): 2014-04-01 – 2017-03-31
• Keywords: sustained release / gastro-floating / Clarithromycin / polymorphism

Outline of Final Research Achievements

Clarithromycin(CAM) has 2 crystal forms at ambient temperature and meta-stable crystal(FormⅠ) transforms to stable crystal(FormⅡ) and hydrate(FormⅣ) immediately by contact with water. By using this property, we succeeded in development of highly --loaded CAM sustained release formulation with 0-order manner and gastro-floating formulation. FormⅡ can be obtained by dispersion in water-filtration-drying processes or heat treatment(150℃). Since these treatment lead to increase API cost, we tried and establish the transformation of FormⅠto FromⅡ during the manufacturing process of CAM formulation.

Free Research Field

製剤設計、ＤＤＳ