PHARMACEUTICAL COMPOSITION OF FULVESTRANT HAVING IMPROVED SOLUBILITY, AND METHOD FOR PREPARING SAME

• Main Authors: LEE, Jae Young, WON, Woong Roeck, CHO, Joong Woong, PARK, Sang Yeob
• Format: Patent
• Language: English; French; Korean
• Published: 29.06.2023
• 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 a pharmaceutical composition comprising fulvestrant and a method for preparing same and, more particularly, to a pharmaceutical composition and a method for preparing same, wherein the pharmaceutical composition comprises a combination of a specific nonionic surfactant, lecithin, castor oil, and a specific alcohol along with fulvestrant, a drug having poor solubility, thereby improving the solubility of the drug and increasing the concentration of the drug in a formulation, such that use of the pharmaceutical composition can reduce the number of administrations of the drug while showing equivalent pharmacological therapeutic effects compared to existing fulvestrant formulations, thereby reducing the inconvenience of existing formulations and increasing the convenience of patients and providers. La présente invention concerne une composition pharmaceutique comprenant du fulvestrant et son procédé de préparation et, plus particulièrement, une composition pharmaceutique et son procédé de préparation, la composition pharmaceutique comprenant une combinaison d'un tensioactif non ionique spécifique, de lécithine, d'huile de ricin et d'un alcool spécifique conjointement avec du fulvestrant, un médicament ayant une faible solubilité, ce qui permet d'améliorer la solubilité du médicament et d'augmenter la concentration du médicament dans une formulation, de telle sorte que l'utilisation de la composition pharmaceutique peut réduire le nombre d'administrations du médicament tout en présentant des effets thérapeutiques pharmacologiques équivalents par rapport aux formulations de fulvestrant existantes, ce qui permet de réduire l'inconvénient des formulations existantes et d'augmenter la commodité des patients et des fournisseurs. 본 발명은 풀베스트란트를 포함하는 약학 조성물 및 그 제조 방법에 관한 것으로, 보다 상세하게는, 난용성 약물인 풀베스트란트와 함께 특정 비이온성 계면활성제, 레시틴, 캐스터 오일 및 특정 알코올을 조합하여 포함함으로써 약물의 용해도가 향상되어 제제 내의 약물 농도를 증가시킬 수 있기 때문에, 기존의 풀베스트란트 제제 대비 동등한 약리학적 치료 효과를 보이면서도 투여 횟수를 줄일 수 있어 기존 제제의 불편을 개선하고 환자와 제공자의 편의성을 증대시킬 수 있는 약학 조성물 및 그 제조 방법에 관한 것이다.