C - Chemistry – Metallurgy – 07 – C
Patent
C - Chemistry, Metallurgy
07
C
C07C 227/42 (2006.01) C07C 229/28 (2006.01)
Patent
CA 2368476
A process for the preparation of gabapentin starting from gabapentin hydrochloride, which comprises the following steps: preparing a gabapentin hydrochloride aqueous solution; adjusting the pH of said solution to or about to gabapentin isoelectric point by addition of a basic compound comprising a monovalent anion; diafiltering said solution through a membrane highly selective for organic compounds with molecular weight higher than 150 and poorly selective for inorganic monovalent ions, to separate said solution into an aqueous permeate containing chloride ions and a retentate containing unsalified gabapentin substantially free from chloride ions; concentrating said retentate by increasing the pressure exerted on said membrane to obtain a concentration of unsalified gabapentin in the retentate not lower than 5 %; evaporating the retentate under reduced pressure and at T° < 35°; precipitating gabapentin by addition of an alcohol.
L'invention concerne un procédé de préparation de gabapentine en partant du chlorhydrate de gabapentine qui consiste à: préparer d'une part une solution aqueuse de chlorhydrate de gabapentine, ajuster d'autre part le pH de cette solution au point isoélectrique de gabapentine ou aux alentours de ce point en ajoutant un composé basique contenant un anion monovalent, diafiltrer ladite solution à travers un membrane hautement sélective de composés organiques dont le poids moléculaire est supérieur à 150, et peu sélective d'ions monovalents organiques afin de séparer ladite solution en un perméat aqueux contenant des ions chlorures Cl- et un retentat contenant de la gabapentine non salée pratiquement exempte d'ions chlorures, concentrer ce retentat en augmentant la pression exercée sur la membrane pour obtenir une concentration de la gabapentine non salée d'au moins 5% dans le retentat, faire évaporer le retentat sous une pression réduite et à une température inférieure à 35 DEG , et enfin précipiter la gabapentine en ajoutant un alcool.
Caraccia Nicola
Giordani Cristiana
Tenconi Franco
Bioindustria Laboratorio Italiano Medicinali S.p.a.
Kirby Eades Gale Baker
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