USPTO Patent Grant for API Crystalline Form Preparation
Summary
The USPTO has granted patent US12583860B2 to Apotex Inc. for processes to prepare multicomponent crystalline forms of active pharmaceutical ingredients using solvent vapour. The patent covers methods involving mixing a solid API with a liquid or solid pharmaceutically acceptable entity in the presence of solvent vapour, utilizing standard rotary apparatus.
What changed
The United States Patent and Trademark Office (USPTO) has issued patent US12583860B2 to Apotex Inc. This patent details novel processes for preparing specific crystalline forms of active pharmaceutical ingredients (APIs). The described methods involve mixing a solid API with a pharmaceutically acceptable high-boiling liquid or solid in the presence of solvent vapour, and specifically mentions the use of rotary apparatus like rotary cone dryers.
This patent grant represents a new intellectual property right for Apotex Inc. in the area of pharmaceutical manufacturing. Companies involved in the synthesis and formulation of APIs, particularly those seeking to control crystalline forms for improved stability, bioavailability, or manufacturing efficiency, should be aware of this granted patent. While this is a patent grant and not a regulatory rule imposing direct compliance obligations, it may impact freedom to operate for competitors in this specific area of chemical process development.
Source document (simplified)
Processes for the preparation of multicomponent crystalline forms of active pharmaceutical ingredients using solvent vapour
Grant US12583860B2 Kind: B2 Mar 24, 2026
Assignee
Apotex Inc.
Inventors
Alexander J. Stirk, Fabio E. S. Souza, Avedis Karadeolian, Allan W. Rey, Fatemeh Mohammadpourmir
Abstract
The present invention provides solvent-limited processes for the preparation of an existing crystalline solid form of an active pharmaceutical ingredient comprising mixing, in the presence of solvent vapour, of a solid active pharmaceutical ingredient and a pharmaceutically acceptable entity that is either a high-boiling liquid or a solid. Also provided is the use of a standard rotary apparatus, such as a rotary cone dryer, for application of the processes herein.
CPC Classifications
C07D 487/04 C07B 2200/13 A61K 31/10 A61K 31/4985 A61K 2300/00
Filing Date
2021-02-24
Application No.
17802203
Claims
14
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