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
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Quotation for National Phase entry

Country StagesTotal
China Filing3443
EPO Filing, Examination53110
Japan Filing530
South Korea Filing575
USA Filing, Examination18035
MasterCard Visa

Total: 75693

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.
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