INJECTABLE FORMULATION COMPRISING ISOXAZOLINE DERIVATIVE AND METHOD FOR PREPARING SAME

• Main Authors: KIM, Sung Won, BAEK, Jaeuk, YOON, Jung Woon
• Format: Patent
• Language: English; French; Korean
• Published: 31.08.2023
• 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 an injectable formulation comprising, as an active pharmaceutical ingredient (API), an isoxazoline derivative or a pharmaceutically acceptable salt thereof, which are useful as caspase inhibitors. The injectable formulation according to the present invention can be prepared by mixing a first agent consisting of a high-dose API and a second agent including a reconstituted solution immediately before administered to a patient, and due to stably containing an active API, it is advantageous in that the injectable formulation can be expected to effectively exhibit efficacy when administered to a patient. La présente invention concerne une formulation injectable comprenant, comme principe pharmaceutique actif (API), un dérivé d'isoxazoline ou un sel pharmaceutiquement acceptable de celui-ci, qui sont utiles comme inhibiteurs de la caspase. La formulation injectable selon la présente invention peut être préparée en mélangeant un premier agent constitué d'un API à dose élevée et d'un second agent comprenant une solution reconstituée immédiatement avant l'administration à un patient, et du fait de la présence stable d'un API actif, la formulation injectable présente l'avantage d'avoir avoir une efficacité lorsqu'elle est administrée à un patient. 본 발명은 카스파제 저해제로서 유용한 이소옥사졸린 유도체 또는 이의 약학적으로 허용가능한 염을 활성 제약 성분(API)으로 포함하는 주사용 제제에 관한 것이다. 본 발명에 따른 주사용 제제는 고용량의 API로 구성된 제1제와 재구성 용액을 포함하는 제2제를 포함하여, 환자에게 투여 직전에 제1제와 제2제를 혼합하여 제조될 수 있고, 활성형 API를 안정적으로 포함하여 함유하고 있으므로, 환자에 투여하는 경우 효과적으로 약효를 기대할 수 있다는 장점이 있다.