Invention Grant
- Patent Title: Direct compression and dry granulation processes for preparing carglumic acid tablets having less impurities than those produced by wet granulation process
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Application No.: US14213000Application Date: 2014-03-14
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Publication No.: US10064826B2Publication Date: 2018-09-04
- Inventor: Sanjay Rangnathrao Kawale , Mahendra R. Patel
- Applicant: Sanjay Rangnathrao Kawale , Mahendra R. Patel
- Applicant Address: US NJ Ewing
- Assignee: Navinta, LLC
- Current Assignee: Navinta, LLC
- Current Assignee Address: US NJ Ewing
- Agency: St. Onge Steward Johnston & Reens LLC
- Main IPC: A61K9/20
- IPC: A61K9/20 ; A61K31/194 ; A61K31/198

Abstract:
The invention provides a process for preparing stable, high API content, solid pharmaceutical dosage forms by direct compression or dry granulation, characterized in that the pharmaceutical tablets rapidly disintegrate in water or other aqueous solutions to produce a clear or almost clear solution. Also provided is a pharmaceutical carglumic acid tablet, which has improved manufacturing, dissolution, and stability properties, and is less expensive to produce, compared to the equivalent commercial product.
Public/Granted literature
- US20140275260A1 Preparation Of Stable Pharmaceutical Dosage Forms Public/Granted day:2014-09-18
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