아시아인의 제2형 당뇨병 치료를 위한 친수성 고분자를 사용한 메트포르민 염산염-리나글립틴 방출제어형 정제 개발 = Development of Metformin Hydrochloride-Linagliptin Controlled Release Tablet Using Hydrophilic Polymers for Type 2 Diabetes in Asians

국문 초록 (Abstract)

제2형 당뇨병 치료제 메트포르민 염산염은 생물약제학적 분류체계 III에 속하는 약물로 물에 대한 용해도가높다. 따라서 초기 방출이 급격하게 일어나기 때문에 서구인에 비해 낮은 체중과 체지방을 가진 아시아인들에게는저혈당증이 발생한다. 이에 급격한 약물 혈중농도 증가에 의한 저혈당증 위험의 발생률을 낮출 수 있도록 친수성고분자를 사용하였고, 습식과립공정을 통하여 메트포르민 염산염과 리나글립틴 고정 용량 조합 삼중층 정제를 제조하였다. X-ray diffractometer(XRD)를 통해 약물의 결정성 및 포접을 평가했고, Fourier transform infrared spectroscopy(FTIR)을 통해 물리·화학적 변화를 확인하였다. 최종적으로, 본 연구의 서방정제와 트라젠타듀오정과의 비교용출 시험을 수행하여, 아시아인들에 적합한 제2형 당뇨병 치료제로 개발 가능함을 확인하였다.

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