MIXED SOLVENT COMPOSITION FOR IMPROVING STABILITY OF W/O/W EMULSION FOR MANUFACTURING SUSTAINED-RELEASE CARRIER

• Main Authors: CHOI, Sung Hak, JUNG, Ho Sup, CHANG, Pahn-Shick
• Format: Patent
• Language: English; French; Korean
• Published: 27.06.2024
• 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 is a method for producing a multi-particle sustained-release formulation using a mixed organic solvent that improves the stability of a W/O/W emulsion, the method comprising: (a) a step for preparing an immiscible first water phase component containing at least one biologically active material; (b) a step for preparing a first oil phase by dissolving a lipid component, containing at least one type of amphiphilic lipid and one type of neutral lipid, in at least two types of organic solvents; (c) a step for mixing the resultants of (a) and (b) to encapsulate the biologically active material and form a W/O emulsion; (d) a step for mixing the W/O emulsion with a second water phase to prepare a W/O/W emulsion; and (e) a step for removing the organic solvents from solvent globules by evaporation. La présente invention concerne un procédé de production d'une formulation à libération prolongée de particules multiples utilisant un solvant organique mixte qui améliore la stabilité d'une émulsion E/H/E, le procédé comprenant : (a) une étape de préparation d'un premier composant en phase aqueuse non miscible contenant au moins un matériau biologiquement actif ; (b) une étape de préparation d'une première phase huileuse par dissolution d'un composant lipidique, contenant au moins un type de lipide amphiphile et un type de lipide neutre, dans au moins deux types de solvants organiques ; (c) une étape de mélange des composants issus de (a) et (b) pour encapsuler le matériau biologiquement actif et former une émulsion E/H ; (d) une étape de mélange de l'émulsion E/H avec une seconde phase aqueuse pour préparer une émulsion E/H/E ; et (e) une étape d'élimination des solvants organiques des globules de solvant par évaporation. 본 발명은 W/O/W 에멀젼의 안정성을 향상시키는 혼합유기용매를 이용한 다중입자형태 서방형 제제의 제조방법으로, (a) 하나 이상의 생물학적 활성 물질을 함유하는 불혼화성 제 1 수상 성분을 준비하는 단계; (b) 2 종 이상의 유기 용매 중에 1 종 이상의 양극성 지질과 1 종의 중성지질을 함유하는 지질 성분을 용해시켜 제 1 오일상을 준비하는 단계; (c) (a)와 (b)의 산물을 혼합하여 상기 생물학적 활성물질을 캡슐화시켜 W/O 에멀젼을 형성시키는 단계; (d) 상기 W/O 에멀젼을 다시 제 2 수상에 혼합하여 W/O/W 에멀젼을 제조하는 단계; 및 (e) 증발에 의해서 용매 소구체로부터 유기용매를 제거시키는 단계를 포함한다.