Sustained sustained release liposome gel composition having active ingredient of hypoglycemic action and method for producing the same

摘要

The present invention provides a slow and controlled released liposomal gel composition for subcutaneous administration comprises insulin or exenatide as active ingredient for reduction of blood sugar level and method of preparation thereof. Said controlled released composition has high bioavailability and is demonstrated to be able to sustain release therapeutically effective concentration of drug over a period of time and without rapid release of drug after initial administration. Method of preparing the controlled released composition of the present invention comprises the following steps: mixing insulin or exenatide, lipid and aqueous dispersion medium together; then mixing with poloxamer (e.g. F127 or P123) and/or gelatin and hyaluronic acid (HA) or the like gel solution so as to form a protective layer on surface of every lipid micro vesicles or nano-vesicles for use in intramuscular, abdominal and subcutaneous administration. A single administration of the present composition lasts 2 to 7 days to reduce side-effects, such as pain and irritation.