WO2024127365 - STABLE PHARMACEUTICAL COMPOSITION OF AN AMINE DRUG
National phase entry:
Publication Number
WO/2024/127365
Publication Date
20.06.2024
International Application No.
PCT/IB2023/062817
International Filing Date
15.12.2023
Title **
[English]
STABLE PHARMACEUTICAL COMPOSITION OF AN AMINE DRUG
[French]
COMPOSITION PHARMACEUTIQUE STABLE D'UN MEDICAMENT AMINE
Applicants **
SUN PHARMACEUTICAL INDUSTRIES LIMITED
Inventors
AGNIHOTRI, Kapil
SINGH, Pawan Kumar
FANDA, Anuj Kumar
MADAN, Sumit
SINGH, Romi
WAGH, Avinash
PATEL, Daxesh
KURIL, Virendra Ramkrupal
Priority Data
202221073257
17.12.2022
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
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| Type of Assignment |
The Standard Agent's Assignment
* |
| Applicant's Legal Status |
Legal Entity
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| * | |
| * | |
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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 | 2897 | |
| EPO | Filing, Examination, Granting | 23504 | |
| Japan | Filing, Examination, Granting | 3118 | |
| South Korea | Filing, Examination, Granting | 3883 | |
| USA | Filing, Examination, Granting | 10940 |
Total:
44,342
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 multiparticulate composition comprising coated discrete units of an amine drug or a pharmaceutically acceptable salt thereof, with stabilizing amount of one or more nitrite quencher. The composition provides effective control of the level of nitrosamine drug substance-related impurities (NDSRIs) in the drug product during shelf life of the product.[French]
La présente invention concerne une composition multiparticulaire stable comprenant des unités discrètes enrobées d'un médicament amine ou d'un sel pharmaceutiquement acceptable de celui-ci, avec une quantité stabilisante d'un ou plusieurs extincteurs nitrités. La composition permet une régulation efficace du niveau d'impuretés nitroamines liées aux substances médicamenteuses (nDSRI) dans le produit médicamenteux pendant la durée de conservation du produit.