1- METHOD FOR PREPARING ORAL SOLID DOSAGE FORM COMPRISING SPHINGOSINE-1-PHOSPHATE RECEPTOR AGONIST BY WET GRANULATION

• Main Authors: YOO SEOK CHEOL, AHN JAE SOON, KIM SOOK HEE
• Format: Patent
• Language: English; Korean
• Published: 21.10.2022
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

The present invention relates to a method for preparing a sphingosine-1-phosphate receptor agonist-containing oral solid preparation by wet granulation, and more specifically, to a method for preparing an oral solid preparation, wherein the oral solid preparation is prepared by wet granulation by using, as an active ingredient, 1-[1-Chloro-6-(3-chloro-1-isopropyl-1H-indazol-5-ylmethoxy)-3,4-dihydro-naphthalen-2-ylmethyl]-piperidine-4-carboxylic acid of chemical formula 1, or a pharmaceutically acceptable salt thereof, together with sodium lauryl sulfate, as a solubilizing agent. The oral solid preparation has excellent storage stability. 본 발명은 습식과립법에 의한 스핑고신-1-인산 수용체 효능제를 포함하는 경구형 고형 제제의 제조 방법에 관한 것으로, 보다 상세하게는 유효성분으로 하기 화학식 1의 1-[1-클로로-6-(3-클로로-1-아이소프로필-1H-인다졸-5-일메톡시)-3,4-디하이드로-나프탈렌-2-일메틸]-피페리딘-4-카르복실산 또는 이의 약제학적으로 허용되는 염을, 가용화제로 라우릴황산나트륨과 함께 사용하여 습식과립법으로 제조하는 경구용 고형 제제의 제조 방법에 관한 것이다: [화학식 1] JPEGpat00007.jpg3894