COMPOSITION FOR STABILIZING RADIOCHEMICAL PURITY OF [18F]FLUORO-DOPA AND METHOD FOR PREPARING SAME

• Main Authors: LEE, Jong Jin, KIM, Jae Seung, LEE, Sang Ju, OH, Seung Jun, RYU, Jin Sook, MOON, Dae Hyuk
• Format: Patent
• Language: English; French; Korean
• Published: 16.03.2017
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

The present invention relates to a composition for stabilizing the radiochemical purity of [18F]fluoro-dopa by inhibiting the formation of impurities during a predetermined time period, and a method for preparing the same. The composition according to the present invention comprises: [18F]fluoro-dopa; ethanol at a concentration of 5% to 30%(v/v) relative to the total composition; and a buffer having a pKa value of 6 to 8.1 at 25°C, wherein the composition stabilizes the radiochemical purity of [18F]fluoro-dopa by inhibiting the formation of impurities during a predetermined time period. La présente invention concerne une composition pour stabiliser la pureté radiochimique de [18F]fluoro-dopa par l'inhibition de la formation d'impuretés pendant une période de temps prédéterminée, et un procédé de préparation de ceux-ci. La composition de la présente invention comprend : [18F]fluoro-dopa; de l'éthanol à une concentration de 5 % à 30 % (v/v) par rapport à la composition totale; et un tampon ayant une valeur de pKa de 6 à 8,1 à 25 °C, la composition stabilisant la pureté radiochimique de [18F]fluoro-dopa par l'inhibition de la formation d'impuretés pendant une période de temps prédéterminée. 본 발명은 소정 시간 동안 불순물 생성을 억제함으로써 [18F]플루오로-도파의 방사화학적 순도를 안정화시키는 조성물 및 이의 제조방법에 대한 것으로서, 본 발명에 따른 조성물은, [18F]플루오로-도파와; 전체 조성물 대비 5% 내지 30%(V/V) 농도의 에탄올과; 25℃에서 pKa 6 내지 8.1의 값을 갖는 버퍼를 포함하여, 소정 시간동안 불순물 생성을 억제하여 상기 [18F]플루오로-도파의 방사화학적 순도를 안정화시키는 조성물이다.