Patent 5960792 Issued on October 5, 1999. Estimated Expiration Date: October 27, 2015. 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.
128/203.22, Means for supplying, or permitting inhalation of, separate streams of treating agent/respiratory gas mixture through nasal passages128/200.14, LIQUID MEDICAMENT ATOMIZER OR SPRAYER128/204.23Means for sensing condition of user's body
A method of treating human patients is provided by the intrapulmonary delivery of a pharmaceutically active peptide formulation. The formulation is automatically released in an aerosolized form from a hand-held, self-contained, portable device comprised of a means for automatically releasing a measured amount of drug into the inspiratory flow path of a patient in response to information obtained from a means for measuring the inspiratory flow rate and determining the inspiratory volume of a patient. Reproducible dosing is obtained by providing for automatic release at the same inspiratory flow rate and inspiratory volume each time drug is released. The device includes a timer to enable a patient to take a drug at the same time each day. Further, overadministration of hormone formulations is avoided by providing a pre-programmed microprocessor designed to avoid overdosing.
Other References
Newman, S.P. et al. "How Should a Pressurized ଲ-Adrenergic Bronchodilator Be Inhaled?", Eur. J. Respir. Dis., 62:3-21, 1981
Adjei, A. et al., "Pulmonary Delivery of Peptide Drugs: Effect of Particle Size on Bioavailability of Leuprolide Acetate in Healthy Male Volunteers", Pharmaceutical Research, 1990, 7:565-567
Adjei, A. et al., "Bioavailability of leuprolide following intratracheal administration to beagle dogs", 1990, International Journal of Pharmaceutics, 61:135-144
Barrowcliffe, M. et al., "Pulmonary clearance of vasoactive intestinal peptide", 1986, Thorax 41:88-93
Braquet, P., "Effect of endothelin-1 on blood pressure and bronchopulmonary system of the guinea pig", 1989, Journal of Cardiovascular Pharmacology, 13(Suppl. 5):S143-S146
Colthorpe, P. et al., "The Pharmacokinetics of Pulmonary-Delivered Insulin: A Comparison of Intratracheal and Aerosol Administration to the Rabbit", 1992, Pharmaceutical Research, 9:764-768
Debs, R. et al., "Lung-specific delivery of cytokines induces sustained pulmonary and systemic immunomodulation in rats", 1988, Journal of Immunology, 140:3482-3488
Gourlay, G.K., "Fentanyl Blood Concentration-Analgesic Response Relationship in the Treatment of Postoperative Pain", 1988, Anesth. 67:329-337
Harrison, T.R. et al., Harrison's Principles of Internal Medicine (10th edition), 1983, pp. 666-674
Hubbard, R.C. et al., "Anti-Neutrophil-Elastase Defenses of the Lower Respiratory Tract in a1-Antitrypsin Deficiency Directly Augmented with an Aerosol of a1-Antitrypsin", Annals of Internal Medicine, 111:206-212
Hubbard, R.C. et al., "Fate of aerosolized recombinant DNA-produced a1-antitrypsin:Use of the epithelial surface of the lower respiratory tract to adminster proteins of therapeutic importance", 1989, Proc. Natl. Acad. Sci. USA 86:680-684
Jaffe, A.B., et al., "Rats self-administer Sufentanil in Aerosol Form", 1989, Psychopharmacology, 99:289-293
Kohler, D., "Aerosols for Systemic Treatment", 1990, Lung, Suppl.:677-684
Laube, Beth L. et al., "Aerosolized Insulin Delivered Through The Lungs Is Effective In Normalizing Plasma Glucose Levels In Non-Insulin Dependent Diabetic Subjects", 1991, J. Aerosol Medicine, 4:286
Laube, Beth L., "Preliminary Study of the Efficacy of Insulin Aerosol Delivered by Oral Inhalation in Diabetic Patients", 1993, JAMA 269:2106-2109
Lee, V.H., "Changing Needs in Drug Delivery in the Era of Peptide and Protein Drugs", Marcel Dekker, N.Y., pp. 1-11
Lehman, K.A. et al., 1991, "Transdermal Fentanyl for the Treatment of Pain After Major Urological Operations", Eur. J. Clin. Phamacol. 41:17-21
Miller, R., "Anesthesia Second Edition", 1986, Churchill Livingstone, 1:762
Moses et al., Insulin Administered Intranasally as an Insulin-Bile Salt Aerosol--Effectiveness and Reproducibility in Normal and Diabetic Subjects, 1983, Diabetes 32:1040-1047
Newman, S.P. et al., "Deposition of pressurized suspension aerosols inhaled through extension devices", 1981, Am. Rev. Respir. Dis. 124:317-320
Newman, S.P. et al., "Deposition of Pressurized Aerosols in the Human Respiratory Tract", 1981, Thorax, 36:52-55
Newman, S.P., "Deposition and Effects of Inhalation Aerosols", 1983, (2nd ed.) Churchill Livingstone
Nieminen et al., "Aerosol Deposition in Automatic Dosimeter Nebulization" 1987, European Journal of Respiratory Diseases, 71:145-152
Patton, J.S. et al., "Routes of Delivery: Case Studies-Pulmonary delivery of peptides and proteins for systemic action", 1992, Advanced Drug Delivery Reviews, 8:179-196
Rapp, R.P. et al., Patient-controlled analgesia:a review of effectiveness of therapy and an evaluation of currently available devices, 1989, DICP, The Annals of Pharmacotherapy 23:899-904
Rosenberg, M., "Patient-Controlled Analgesia", 1992, J. Oral Maxillofac. Surg. 50:386-389
Rowbotham, D.J., "A disposable device for patient-controlled analgesia with fentanyl", 1989, Anaesthesia, 44:922-924
Ryder, E., "The history of patient-controlled analgesia", 1991, Journal of Intravenous Nursing, 14(6):372-381
Salzman, R., et al., Intranasal Aerosolized Insulin Mixed-Meal Studies and Long-Term Use in Type I Diabetes, 1985, New England Journal of Medicine, 213:1078-1084
Shade, P., "Patient-controlled Analgesia: Can Client Education Improve Outcomes?", 1992, Journal of Advanced Nursing, 17:408-413
Smith, Robert M., et al., "Pulmonary Deposition and Clearance of Aerosolized Alpha-1-Proteinase Inhibitor Administered to Dogs and to Sheep", 1989, J. Clin. Invest. 84:1145-1154
Smythe, M., "Patient-controlled Analgesia:A Review", 1992, Pharmacotherapy, 12:132-143
Wearley, Lorraine L., "Recent Progress in Protein and Peptide Delivery by Noninvasive Routes", 1991, Critical Reviews in Therapeutic Drug Carrier Systems, 8:331-392
Wigley, F.M. et al., "Insul in Across Respiratory Mucosae by Aerosol Delivery" 1971, Diabetes, 20:552-556
Yoshida et al., "Absorption of Insulin Delivered to Rabbit Trachea Using Aerosol Dosage Form" Journal of Pharmaceutical Sciences, 68(5):670-671 (1979
October 27, 2015. 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.
