Preservative free insulin formulations
AssigneeAerami Therapeutics, Inc.
InventorsJohn S. Patton, Ryan S. Patton, Mei-chang Kuo, Yehuda Ivri
Life of this patent
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Abstract
One embodiment describes an insulin formulation that is specifically adapted for aerosolization. The formulation comprises a major amount of water and a minor amount of insulin. Further, the formulation is preservative free, without meta-cresol, cresol or phenol, to permit the formulation to be aerosolized using a vibrating aperture plate without substantial foaming of the insulin formulation.
Claims21
An insulin formulation specifically adapted for aerosolization, the formulation comprising:
- a major amount of water;
- a minor amount of insulin;
- and
- 2 to 4 Zn2+ per insulin hexamer,
- wherein the formulation is preservative free thereby facilitating aerosolization of the formulation as an aerosolized liquid spray;
- and wherein the liquid spray is produced-without substantial foaming of the insulin formulation.
A preservative-free insulin formulation comprising:
- 100 IU/ml to about 1200 IU/ml of human insulin;
- a minor amount of HCl and NaOH;
- and
- 2 to 4 Zn2+ per insulin hexamer,
- wherein the formulation does not comprise a preservative.
A method for manufacturing a preservative-free insulin formulation comprising:
- suspending human insulin powder in water, the human insulin powder comprising 2 to 4 Zn2+ per insulin hexamer;
- adding a minor amount of HCl to dissolve the human insulin and form an insulin solution;
- after the human insulin is dissolved, adding a minor amount of NaOH to titrate the insulin solution to a desired pH;
- and
- adding additional water to adjust the concentration of the insulin solution to 100 IU/ml to 1200 IU/ml human insulin;
- wherein the inulin solution is devoid of preservatives.
Dependencies are inferred from the claim text.