Aerosol formulations including proteins and peptides solubilized in reverse micelles and process for making the aerosol formulations

Patent 5230884 Issued on July 27, 1993. Estimated Expiration Date:

February 11, 2012. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.

Abstract Claims Description Full Text

Patent References

Drug-containing chlorofluorocarbon aerosol propellent formulations Patent #: 4814161
Issued on: 03/21/1989
Inventor: Jinks , et al.

Inventors

Assignee

University of Wales College of Cardiff

Application

No. 834111 filed on 02/11/1992

US Classes:

424/45, Organic pressurized fluid424/43, EFFERVESCENT OR PRESSURIZED FLUID CONTAINING424/450, Liposomes514/3, Insulin or derivative514/866, DIABETES514/937DISPERSION OR EMULSION

Examiners

Primary: Page, Thurman K.
Assistant: Bawa, Raj

Attorney, Agent or Firm

Whitham and Marhoefer

Foreign Patent References

0372777 GB. 11/13/1989

International Classes

A61K 009/12
A61K 009/127

Abstract

Highly purified and recombinantly produced polypeptides and proteins can be provided to a patient to treat systemic disorders using a metered dose inhaler (MDI). The polypeptides and proteins are solubilized in reverse micelles formed from the surfactant in the MDI propellant. By controlling the molar ratio of water to surfactant, the amount of polypeptide or protein solubilized in the reverse micelles can be controlled, thereby providing an accurate dosing mechanism. In addition, controlling the molar ratio of water to surfactant also can adjust the size and shape of the reverse micelles which will affect the degree and rate of penetration of the lung mucosa for delivery of the drugs to the patient's blood stream. Proteins which may particularly benefit from the solubilization and systemic delivery process include calcitonin, oxytocin, and insulin.

Other References

Singleterry et al., J. Am. Oil Chem. Soc., 32:446-452 (1955)
Byron, Ad. Drug Delivery Rev., 5:107-132 (1990)
Evans et al., J. Aerosol Sci. 20:1309 (1989)
Evans et al., J. Pharm. Pharmacol. 41:36 (1989)
Evans et al., J., Pharm. Pharmacol. 40:76 (1988)
Luisi et al., Biochimica Biophysica Acta., 947:209-246, (1988)
Appendix: Respiratory Drug Delivery, Peter Byron, Ed., CRC Press, Inc., 1990, pp. 249-25