WO2023175542 - STABILIZATION OF PHENOBARBITAL SODIUM FOR INJECTION
National phase entry is expected:
Publication Number
WO/2023/175542
Publication Date
21.09.2023
International Application No.
PCT/IB2023/052546
International Filing Date
15.03.2023
Title **
[English]
STABILIZATION OF PHENOBARBITAL SODIUM FOR INJECTION
[French]
STABILISATION DE PHÉNOBARBITAL SODIQUE POUR INJECTION
Applicants **
SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED
Inventors
SHAH, Malay
BOROLE, Bhushan
PATEL, Ravi
KHOPADE, Ajay Jaysingh
Priority Data
63/319,918
15.03.2022
US
17/715,491
07.04.2022
US
Application details
| Total Number of Claims/PCT | * |
| Number of Independent Claims | * |
| Number of Priorities | * |
| Number of Multi-Dependent Claims | * |
| Number of Drawings | * |
| Pages for Publication | * |
| Number of Pages with Drawings | * |
| Pages of Specification | * |
| * | |
| Number of Office Actions | * |
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International Searching Authority |
EPO
* |
| Recordal of a Change of the Applicant's Name/Address |
Change of Applicant's Name and Address
* |
| Type of Assignment |
The Standard Agent's Assignment
* |
| Applicant's Legal Status |
Legal Entity
* |
| * | |
| * | |
| * | |
| * | |
| * | |
| Entry into National Phase under |
Chapter I
* |
| Patent Delivery |
Send the Letters Patent by Courier
* |
| Translation |
|
* The data is based on automatic recognition. Please verify and amend if necessary.
** IP-Coster compiles data from publicly available sources. If this data includes your personal information, you can contact us to request its removal.
Quotation for National Phase entry
| Country | Stages | Total | |
|---|---|---|---|
| China | Filing, Examination, Granting | 2663 | |
| EPO | Filing, Examination, Granting | 11110 | |
| Japan | Filing, Examination, Granting | 2186 | |
| South Korea | Filing, Examination, Granting | 2160 | |
| USA | Filing, Examination, Granting | 5790 |
Total:
23,909
The term for entry into the National Phase has expired. This quotation is for informational purposes only
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Abstract[English]
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.[French]
La présente invention concerne une composition pharmaceutique lyophilisée de composés pharmaceutiques hydrolytiquement instables, tels que le phénobarbital ou les sels de celui-ci. La présente invention concerne également une solution aqueuse pour l'injection de phénobarbital ou de sels de celui-ci, qui est reconstitué à partir de la composition pharmaceutique lyophilisée. Les compositions pharmaceutiques de la présente divulgation ont une teneur en éthanol dans la plage d'environ 12 000 ppm à environ 25 000 ppm. La composition de la présente divulgation, dans certains modes de réalisation, est stable après 36 mois de stockage, les impuretés totales ne dépassant pas 0,2 %. Les compositions pharmaceutiques de la présente divulgation peuvent être utilisées pour le traitement de convulsions néonatales. La présente invention concerne en outre des procédés de préparation d'une composition lyophilisée de phénobarbital sodique et des compositions pharmaceutiques lyophilisées de phénobarbital sodique préparées à l'aide de celle-ci.