INSULIN PREMIX FORMULATION AND PRODUCT, METHODS OF PREPARING SAME, AND METHODS OF USING SAME

• Main Authors: Lee, Sarah Elizabeth, Wong, Joseph Chung Tak
• Format: Patent
• Language: English
• Published: 25.02.2021
• Subjects: BABY COMFORTERS; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, ORSURGICAL ARTICLES; CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICALPURPOSES; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; DEVICES FOR RECEIVING SPITTLE; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGINGPHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL ORADMINISTERING FORMS; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; HUMAN NECESSITIES; HYGIENE; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICALARTICLES; MEDICAL OR VETERINARY SCIENCE; METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS INGENERAL; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

A pharmaceutically acceptable insulin premix formulation contains about 0.1-10.0 Unit/mL of insulin for intravenous administration and preferably further contains a tonicity adjuster. The methods for making and using such formulation are also provided. The pharmaceutically acceptable insulin premix formulation may be aseptically filled into a flexible container assembly to form a pharmaceutical insulin premix product. The insulin premix product can be a sterile and ready-to-use aqueous solution for glycemic control in an individual with metabolic disorders through intravenous infusion. The insulin premix product is unexpectedly stable when freshly prepared and also during its shelf-life of storage at refrigeration temperatures of 2° C. to 5° C. for 24 months followed by additional 30 days at room temperatures of 23° C. to 27° C., even without any added preservative, any added zinc, any added surfactant or any other added stabilizing excipient.