WO2023281441 - STABILIZATION OF PHENOBARBITAL SODIUM FOR INJECTION
National phase entry:
Publication Number
WO/2023/281441
Publication Date
12.01.2023
International Application No.
PCT/IB2022/056290
International Filing Date
07.07.2022
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
202121030559
07.07.2021
IN
63/319,918
15.03.2022
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 | * |
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| 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
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| Type of Assignment |
The Standard Agent's Assignment
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| Applicant's Legal Status |
Legal Entity
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| * | |
| * | |
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| Entry into National Phase under |
Chapter I
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| Patent Delivery |
Send the Letters Patent by Courier
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| Translation |
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* 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 | 8223 | |
| EPO | Filing, Examination, Granting | 270384 | |
| Japan | Filing, Examination, Granting | 5638 | |
| South Korea | Filing, Examination, Granting | 15225 | |
| USA | Filing, Examination, Granting | 59740 |
Total:
359,210
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 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.[French]
La présente invention concerne une composition pharmaceutique lyophilisée de composés pharmaceutiques hydrolytiquement instables, tels que le phénobarbital ou ses sels. 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 invention ont une teneur en éthanol dans la plage d'environ 5 000 ppm à environ 70000 ppm. La composition de la présente invention, dans certains modes de réalisation, est stable après deux années de stockage, les impuretés totales ne dépassant pas 0,5 %. Les compositions pharmaceutiques de la présente invention peuvent être utilisées pour le traitement de crises néonatales.