WO2024246776 - STABLE CYCLOSPORINE OPHTHALMIC FORMULATION AND MANUFACTURING PROCESS THEREOF
National phase entry is expected:
Publication Number
WO/2024/246776
Publication Date
05.12.2024
International Application No.
PCT/IB2024/055222
International Filing Date
29.05.2024
Title **
[English]
STABLE CYCLOSPORINE OPHTHALMIC FORMULATION AND MANUFACTURING PROCESS THEREOF
[French]
FORMULATION OPHTALMIQUE DE CYCLOSPORINE STABLE ET SON PROCÉDÉ DE FABRICATION
Applicants **
SUN PHARMACEUTICAL INDUSTRIES LIMITED
Sun House, Plot No. 201 B/1
Western Express Highway
Goregaon (E)
Mumbai, Maharashtra 400 063, IN
Inventors
KHOPADE, Ajay Jaysingh
Sun Pharmaceutical Industries Limited
Survey No. 127/1, Tandalja
Vadodara, Gujarat 390020, IN
HALDER, Arindam
Sun Pharmaceutical Industries Limited
Survey No. 127/1, Tandalja
Vadodara, Gujarat 390020, IN
Priority Data
202321036901
29.05.2023
IN
Application details
| Total Number of Claims/PCT | * |
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International Searching Authority |
EPO
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| Applicant's Legal Status |
Legal Entity
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| Entry into National Phase under |
Chapter I
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| Translation |
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Recalculate
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Quotation for National Phase entry
| Country | Stages | Total | |
|---|---|---|---|
| China | Filing | 3443 | |
| EPO | Filing, Examination | 53110 | |
| Japan | Filing | 530 | |
| South Korea | Filing | 575 | |
| USA | Filing, Examination | 18035 |
Total: 75693 USD
Abstract[English]
The present invention relates to a stable nanomicellar ophthalmic formulation comprising cyclosporine, hydrogenated 40 polyoxyl castor oil, octoxynol-40, and an aqueous vehicle, wherein the stable nanomicellar ophthalmic formulation is made by a method comprising: a) mixing the hydrogenated 40 polyoxyl castor oil and the octoxynol-40, wherein the mixing produces a Mixture A comprising a water content of less than 3%; b) adding the cyclosporine to the Mixture A to form a Mixture B; and c) mixing the Mixture B with the aqueous vehicle, thereby forming the stable nanomicellar ophthalmic formulation.[French]
La présente invention concerne une formulation ophtalmique nanomicellaire stable comprenant de la cyclosporine, de l'huile de ricin polyoxyl 40 hydrogénée, l'octoxynol-40 et un véhicule aqueux, la formulation ophtalmique nanomicellaire stable étant fabriquée par un procédé consistant à : a) mélanger l'huile de ricin polyoxyl hydrogénée et l'octoxynol-40, le mélange produisant un mélange A présentant une teneur en eau inférieure à 3 % ; b) ajouter la cyclosporine au mélange A pour former un mélange B ; et c) mélanger le mélange B avec le véhicule aqueux, ce qui permet ainsi de former la formulation ophtalmique nanométrique stable.