Pharmaceutical composition comprising solifenacin or its pharmaceutically acceptable salts

• Main Authors: PARK SHIN JUNG, LIM JONG LAE, KIM EUN YOUNG, CHO MIN KWAN
• Format: Patent
• Language: English; Korean
• Published: 23.09.2021
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

The present invention relates to a pharmaceutical composition including a core layer (1) and a drug layer (2) coated on the core layer (1), wherein the drug layer (2) includes solifenacin or a pharmaceutically acceptable salt thereof and a plasticizer. The present invention also relates to a pharmaceutical preparation, and particularly, to an orally disintegrated tablet, including the pharmaceutical composition. The pharmaceutical composition according to the present invention shields a bitter taste and minimizes generation of a lead-containing material, and thus shows an effect of ensuring the stability of the active ingredient. Further, the pharmaceutical preparation according to the present invention includes an orally disintegrated tablet, and can accomplish a pharmacological effect equivalent to the effect of the conventional preparation, while improving the administration compliance of an elderly patient significantly. 본 발명은 코어층(1) 및 상기 코어층(1) 위에 코팅된 약물층(2)을 포함하고, 상기 약물층(2)은 솔리페나신 또는 이의 약제학적으로 허용가능한 염 및 가소제를 함유하는 약제학적 조성물을 제공한다. 또한, 본 발명은 상기 약제학적 조성물을 포함하는 약제학적 제제, 특히 구강붕해정을 제공한다. 본 발명의 약제학적 조성물은 쓴맛을 차폐하고, 유연물질의 발생을 최소화하여 유효성분의 안정성을 확보할 수 있는 효과를 나타낸다. 또한, 본 발명의 약제학적 제제는 구강붕해정으로서 고령 환자의 복약순응도를 크게 개선하면서 기존 제제와 비교하여 동등한 약리효과를 달성할 수 있다.