The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.
The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.
Patent No.:
Date of Patent:
Aug. 31, 2021
Filed:
Nov. 20, 2017
Recordati Industria Chimica E Farmaceutica S.p.a., Milan, IT;
Fabio Berlati, Rho, IT;
Sergio Menegon, Milan, IT;
Pierluigi Farina, Milan, IT;
Diego Provvedini, Milan, IT;
Marco Barchielli, Milan, IT;
Alberto Mattei, Milan, IT;
Abstract
The present invention relates to a pharmaceutical formulation suitable for parenteral administration containing carglumic acid and a buffering agent having a pKfrom 5.5 to 9.0 at 25° C.; according to an embodiment, the buffering agent may have a pKfrom 7.5 to 8.5, preferably a pKof about 8.07, such as trometamol. The formulation may also contain at least one bulking agent, such as mannitol. The invention also includes a method for manufacturing a lyophilised sterile formulation by freeze-drying a water solution containing carglumic acid, a buffering agent having a pKfrom 5.5 to 9.0 at 25° C., preferably from 7.5 to 8.5, and optionally a bulking agent to obtain a freeze-dried powder.