Injectable formulation comprising isooxazoline derivatives and preparation method thereof

• Main Authors: BAEK JAE UK, YOON JUNG WOON, KIM SUNG WON
• Format: Patent
• Language: English; Korean
• Published: 30.08.2023
• 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 an isoxazoline derivative useful as a caspase inhibitor or a pharmaceutically acceptable salt thereof as an active pharmaceutical ingredient (API). The injectable formulation according to the present invention includes a first agent consisting of a high dose of API, and a second agent containing a reconstitution solution, and can be manufactured by mixing the first agent and the second agent immediately before administration to the patient. Since the injectable formulation contains a stable API, there is the advantage that effective drug efficacy can be expected when administered to patients. 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.