Aurobindo Pharma has been granted a patent for a solid dispersion of Naloxegol oxalate and an improved process for its production. The process involves stereoselective reduction of 3-O-MEM naloxone, reaction with specific compounds, and conversion to Naloxegol. GlobalData’s report on Aurobindo Pharma gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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According to GlobalData’s company profile on Aurobindo Pharma, Nanoparticle drug conjugates was a key innovation area identified from patents. Aurobindo Pharma's grant share as of May 2024 was 72%. Grant share is based on the ratio of number of grants to total number of patents.
Solid dispersion of naloxegol oxalate
The patent (Publication Number: US11974996B2) discloses a process for the preparation of Naloxegol or its salt, involving several steps. The process includes the stereoselective reduction of 3-O-MEM naloxone using Lithium tri-tert-butoxy aluminium hydride (LTBA) and 2-Methoxyethanol as an additive to produce 3-O-MEM a-Naloxol. Subsequent reactions with specific compounds lead to the formation of 3-O-MEM Naloxegol, which is then purified using acid and base treatments before being converted to Naloxegol or its salt by acid treatment.
Furthermore, the patent also details a process for the purification of 3-O-MEM a-Naloxol, involving treatment with an acid to form an acid addition salt with less than 1% of ß-epimer, followed by isolation and treatment with a base to obtain the purified 3-O-MEM a-Naloxol. The purity of the final product is emphasized, with the acid addition salt being specified as 3-O-MEM a-Naloxol oxalate, which is described as crystalline. The process ensures a high purity level of about 99% or greater for the 3-O-MEM a-Naloxol, with the choice of acid and base being from organic and inorganic options, respectively.
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