Stabilization Of Phenobarbital Sodium For Injection

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 12000 ppm to about 25000 ppm. The composition of the present disclosure in certain embodiments is stable following 36 months of storage wherein the total impurities do not exceed 0.2%. The pharmaceutical compositions of the present disclosure may be used for the treatment of neonatal seizures. The present invention further relates to methods of preparing a lyophilized composition of phenobarbital sodium and to lyophilized pharmaceutical compositions of phenobarbital sodium prepared using the same.

Patent Information

Application #

Filing Date

16 September 2024

Publication Number

09/2025

Publication Type

INA

Invention Field

BIO-MEDICAL ENGINEERING

Status

Email

Parent Application

Applicants

SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED

17/B Mahal Industrial Estate Off Mahakali Caves Road Andheri (East) Mumbai Maharashtra 400093

Inventors

1. SHAH Malay

408 B1 Ashwamegh 3 Samrajya Extension Akota Vadodara Gujarat 390020

2. BOROLE Bhushan

45 Shriraj Hindu Housing Society Tapi nagar Bhusawal Dist. Jalgaon Maharashtra 425201

3. PATEL Ravi

11 Ashruti Tenaments Opp Akruti Nagar Jitodia Road Anand Gujarat 388001

4. KHOPADE Ajay Jaysingh

12 Bansuri Bungalows Pashabhai Park Race Course Vadodara Gujarat 390007

Specification

Documents

Application Documents

#	Name	Date
1	202427069784-STATEMENT OF UNDERTAKING (FORM 3) [16-09-2024(online)].pdf	2024-09-16
2	202427069784-PROOF OF RIGHT [16-09-2024(online)].pdf	2024-09-16
3	202427069784-POWER OF AUTHORITY [16-09-2024(online)].pdf	2024-09-16
4	202427069784-FORM 18 [16-09-2024(online)].pdf	2024-09-16
5	202427069784-FORM 1 [16-09-2024(online)].pdf	2024-09-16
6	202427069784-DRAWINGS [16-09-2024(online)].pdf	2024-09-16
7	202427069784-COMPLETE SPECIFICATION [16-09-2024(online)].pdf	2024-09-16
8	Abstract1.jpg	2024-10-21