12 A stable aqueous solution of EM 12

• Main Authors: KUGELMANN HEINRICH, GERMANN TIENO
• Format: Patent
• Language: English; Korean
• Published: 26.01.2001
• Edition: 7
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

PURPOSE: A method for preparing stable aqueous solution of thalidomide-derivative EM12 which is useful in treating inflammatory diseases and hemato-neoplastic diseases is provided by dissolving a thalidomide derivative EM12 in an isotonic glucose solution to bring the pH of the resulting solution to a specified level or lower. The aqueous solution thus obtained is usable in a parenterally administrable manner, in particular intravenously administrable manner, its dose being normally 0.1-1 mg/kg. CONSTITUTION: The aqueous solution of which pH is 5.5 or lower is obtained by dissolving a thalidomide derivative EM12 £3-(1-oxo-1,3-dihydroisoindol-2-yl)piperidine-2,6-dione of the formula| in an isotonic glucose solution, wherein the aqueous solution contain preferably over 0.2 mg/mL of the active ingredient. It is preferable to prepare this solution by adding EM12 to an isotonic glucose solution of pH 4 to 5 followed by shaking the mixture until the EM12 is completely dissolved in the solution followed by treating the resultant solution with ultrasonic wave and then carrying out a filtration under sterile conditions. 본원 발명에는 비경구 적용 형태, 특히 면역학적 및 혈액학적-종양 질환의 치료를 위한 EM 12의 정맥내 적용 형태로서 적합한 EM 12의 수용액, 및 상응하는 EM 12의 용액을 제조하는 방법이 기재되어 있다.