Invention Grant
- Patent Title: Parenteral unit dosage form of dihydroergotamine
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Application No.: US16285495Application Date: 2019-02-26
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Publication No.: US10532049B1Publication Date: 2020-01-14
- Inventor: Alpesh Goyani , Deepak Singodia , Bhaskar Pallerla , Sudeep Kumar Agrawal , Subhas Balaram Bhowmick , Rajamannar Thennati
- Applicant: SUN PHARMACEUTICAL INDUSTRIES LIMITED
- Applicant Address: IN Mumbai
- Assignee: Pharmaceutical Industries Limited
- Current Assignee: Pharmaceutical Industries Limited
- Current Assignee Address: IN Mumbai
- Agency: Liang & Hennessey LLP
- Agent Stanley D. Liang, Esq.
- Priority: IN201821031934 20180827
- Main IPC: A61K31/48
- IPC: A61K31/48 ; A61K9/08 ; A61K31/4985 ; A61K9/00

Abstract:
A parenteral unit dosage form comprising an aqueous solution of dihydroergotamine or pharmaceutically acceptable salt thereof as a sole active ingredient, one or more pH adjusting agents, and optionally one or more co-solvents, wherein the pH of the aqueous solution is such that it contains substantially lower amount of impurity of Formula I and impurity of Formula II as compared to aqueous solution having a pH of 4.0 or less, when the parenteral unit dosage form is stored at 25° C. and 60% relative humidity for at least three months.
Information query
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