WO2024176162 - STABLE PHARMACEUTICAL COMPOSITION OF HISTAMINE H2‐RECEPTOR ANTAGONIST
National phase entry is expected:
Publication Number
WO/2024/176162
Publication Date
29.08.2024
International Application No.
PCT/IB2024/051717
International Filing Date
22.02.2024
Title **
[English]
STABLE PHARMACEUTICAL COMPOSITION OF HISTAMINE H2‐RECEPTOR ANTAGONIST
[French]
COMPOSITION PHARMACEUTIQUE STABLE D'ANTAGONISTE DU RÉCEPTEUR H2 DE L'HISTAMINE
Applicants **
SUN PHARMACEUTICAL INDUSTRIES LIMITED
Inventors
TYAGI, Abhishek
SINGH, Sant
SRIVASTAVA, Abhishek
BEDI, Simrata
SINGH, Romi
Priority Data
202321013353
22.02.2023
IN
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
* |
| 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 | 2025 | |
| EPO | Filing, Examination, Granting | 8180 | |
| Japan | Filing, Examination, Granting | 2176 | |
| South Korea | Filing, Examination, Granting | 2051 | |
| USA | Filing, Examination, Granting | 4740 |
Total:
19,172
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 disclosure relates to a stable pharmaceutical composition comprising a Histamine H2-receptor antagonist or a pharmaceutically acceptable salt thereof and a stabilizing amount of at least one alkalizer. The composition provides effective control of the level of nitrosamine drug substance-related impurities (NDSRIs) such as NDMA in the drug product during shelf life of the product.[French]
La présente invention concerne une composition pharmaceutique stable comprenant un antagoniste du récepteur H2 de l'histamine ou un sel pharmaceutiquement acceptable de celui-ci et une quantité stabilisante d'au moins un alcaliseur. La composition permet une régulation efficace du niveau d'impuretés associées à une substance médicamenteuse à base de nitrosamine (NDSRI) telles que la NDMA dans le produit médicamenteux pendant la durée de conservation du produit.