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.

Date of Patent:
Jan. 02, 2024

Filed:

Apr. 07, 2022
Applicant:

Sun Pharma Advanced Research Company Limited, Maharashtra, IN;

Inventors:

Malay Shah, Vadodara, IN;

Bhushan Borole, Jalgaon, IN;

Ravi Patel, Anand, IN;

Ajay Jaysingh Khopade, Vadodara, IN;

Attorney:
Primary Examiner:
Int. Cl.
CPC ...
A61K 9/19 (2006.01); A61P 25/08 (2006.01); A61K 9/08 (2006.01); A61K 31/515 (2006.01); A61K 47/10 (2017.01);
U.S. Cl.
CPC ...
A61K 9/19 (2013.01); A61K 9/08 (2013.01); A61K 31/515 (2013.01); A61K 47/10 (2013.01); A61P 25/08 (2018.01);
Abstract

The present invention relates to a lyophilized pharmaceutical composition of hydrolytically unstable pharmaceutical compounds, such as phenobarbital or salts thereof. The present invention also relates to an aqueous solution for injection of phenobarbital or salts thereof that is reconstituted from the lyophilized pharmaceutical composition. The pharmaceutical compositions of the present disclosure have an ethanol content in the range from about 5000 ppm to about 70000 ppm. The composition of the present disclosure, in certain embodiments, is stable following two years of storage, wherein the total impurities do not exceed 0.5%. The pharmaceutical compositions of the present disclosure may be used for the treatment of neonatal seizures.


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