PROCESS OF MANUFACTURING A STABLE, READY TO USE IN

专利名称：PROCESS OF MANUFACTURING A STABLE,

READY TO USE INFUSION BAG FOR ANOXIDATION SENSITIVE FORMULATION

发明人：PURI, NAVNEET,HINGORANI,

TUSHAR,SOPPIMATH, KUMARESH,NAYAK,REKHA,MALKAN, TUSHAR,PEJAVER, SATISH

申请号：EP14783203申请日：20140408公开号：EP29832A4公开日：20161019

摘要：A process for minimizing formation of a highest degradation product duringmoist heat sterilization of a drug solution of an oxidation susceptible active

pharmaceutical ingredient is provided. The oxidation susceptible active pharmaceuticalingredient is mixed with excipients and deoxygenated water to prepare a non-sterile drugsolution. The non-sterile drug solution is filled into a moist heat sterilizable flexibleinfusion bag. The flexible infusion bag with the non- sterile drug solution is terminallymoist heat sterilized at a preset air overpressure between about 0.2 bar to about 1.2 barto obtain a parenteral drug product. The highest degradation product in the parenteraldrug product is less than 0.5% by weight of a labeled amount of the oxidationsusceptible active pharmaceutical ingredient in the parenteral drug product.

申请人：INNOPHARMA LICENSING, LLC

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