Insulin formulations and methods of using same in preterm infants
AssigneeElgan Pharma Ltd
InventorsMichal Olshansky, Elena Ostrovsky, Stav Zeldis
Life of this patent
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Abstract
An insulin formulation and a method of preparing and using same. The insulin preparation includes insulin, oligosaccharide and sodium chloride at a ratio of 1:A:B (w:w:w respectively) with ranges of A and B are 1000-5000 and 10-50, respectively.
Claims9
A composition-of-matter comprising an amorphous insulin powder soluble in water, said amorphous insulin powder including insulin attached to dextrin particles at a gram/gram (g/g) insulin-to-dextrin ratio from 1:2500 to 1:10000, wherein 1 gram of said amorphous insulin powder includes from 10 IU to 40 IU of insulin, and further wherein when reconstituted in deionized water at a concentration of 0.03 g of amorphous insulin powder per 1 ml water, a pH of a formed solution is 6.0-7.6.
A method of preparing an amorphous insulin powder soluble in water comprising:
- (a) solubilizing insulin in hydrochloric acid to obtain solubilized insulin;
- (b) diluting said solubilized insulin with water and adjusting a pH to 6.9-8.0.
- (c) dissolving dextrin in water and adjusting pH to 7.0-7.5
- (d) adding insulin solution (b) to dextrin solution (c) to thereby sequester said insulin in cavities of said dextrin molecules;
- (e) adjusting pH of solution (d) to 6.9-8.0;
- and
- (f) freeze drying the solution of (e) to obtain the amorphous insulin powder.
Dependencies are inferred from the claim text.