KIM, CHANG JU,김창주,JUN, HUN,KIM, JU HEE,김주희,KIM, NAM HYUCK,김남혁
申请号:
KR1020120025195
公开号:
KR1020130104059A
申请日:
2012.03.12
申请国别(地区):
KR
年份:
2013
代理人:
摘要:
PURPOSE: A pharmaceutical composite formulation for oral administration for treating hyperlipidemia is provided to enhance the uniformity of a drug coating process because different drugs exist in a soft capsule inner layer and a drug-coated outer layer, respectively, not to contact each other by insertion of an intermediate layer of a soluble polymer.CONSTITUTION: A pharmaceutical composite formulation for oral administration for treating hyperlipidemia contains 500-1000 mg of omega-3 fatty acids and 5-40 mg of HMG-CoA reductase or a pharmaceutically acceptable salt thereof. An HMG-CoA reductase inhibitor is selected among lovastatin, simvastatin, pravastatin, atorvastatin, fluvastatin, and rosuvastatin. The pharmaceutical composite formulation comprises: an inner layer containing omega-3 fatty acids an intermediate layer containing a soluble polymer and an outer layer containing the HMG-CoA reductase inhibitor.COPYRIGHT KIPO 2013[Reference numerals] (AA) Elution rate % (BB) Example 1-1 (CC) Example 4-1 (DD) Example 4-2 (EE) Example 4-3 (FF) Example 4-4 (GG) Time (min)본 발명은 고지혈증 치료를 위한 경구투여용 약제학적 복합제제에 관한 것으로, 더 상세하게는 오메가-3 지방산 내층 수용성 중합체 중간층 및 HMG-CoA 환원효소 저해제 또는 이의 약제학적으로 허용 가능한 염의 외층으로 구성된 약물 안정성 및 균일성을 향상시킨 다층으로 형성된 고지혈증 치료를 위한 경구투여용 약제학적 복합제제에 관한 것이다.