Delivery of alprazolam, estazolam midazolam or triazolam through an inhalation route
Patent 7018619 Issued on March 28, 2006. Estimated Expiration Date: December 12, 2023. 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.
424/45, Organic pressurized fluid424/46, Powder or dust containing424/489, Particulate form (e.g., powders, granules, beads, microcapsules, and pellets)424/499, Contains proteins or derivative or polysaccharides or derivative128/200.14, LIQUID MEDICAMENT ATOMIZER OR SPRAYER128/200.24, RESPIRATORY METHOD OR DEVICE128/203.15, Particulate treating agent carried by breathed gas514/958FOR SMOKING OR INHALING
The present invention relates to the delivery of alprazolam, estazolam, midazolam or triazolam through an inhalation route. Specifically, it relates to aerosols containing alprazolam, estazolam, midazolam or triazolam that are used in inhalation therapy. In a method aspect of the present invention, alprazolam, estazolam, midazolam or triazolam is administered to a patient through an inhalation route. The method comprises: a) heating a composition of alprazolam, estazolam, midazolam or triazolam, to form a vapor; and, b) allowing the vapor to cool, thereby forming a condensation aerosol comprising particles with less than 5% drug degradation products. In a kit aspect of the present invention, a kit for delivering alprazolam, estazolam, midazolam or triazolam through an inhalation route is provided which comprises: a) a thin coating of an alprazolam, estazolam, midazolam, or triazolam composition and b) a device for dispensing said thin coating as a condensation aerosol.
Other References
U.S. Appl. No. 10/633,876, filed Aug. 4, 2003, Hale et al.
U.S. Appl. No. 10/633,877, filed Aug. 4, 2003, Hale et al.
U.S. Appl. No. 10/749,537, filed Dec. 30, 2003, Rabinowitz et al.
U.S. Appl. No. 10/749,539, filed Dec. 30, 2003, Rabinowitz et al.
U.S. Appl. No. 10/766,149, filed Jan. 27, 2004, Rabinowitz et al.
U.S. Appl. No. 10/766,279, filed Jan. 27, 2004, Rabinowitz et al.
U.S. Appl. No. 10/766,566, filed Jan. 27, 2004, Rabinowitz et al.
U.S. Appl. No. 10/766,574, filed Jan. 27, 2004, Rabinowitz et al.
U.S. Appl. No. 10/766,634, filed Jan. 27, 2004, Rabinowitz et al.
U.S. Appl. No. 10/766,647, filed Jan. 27, 2004, Rabinowitz et al.
U.S. Appl. No. 10/767,115, filed Jan. 28, 2004, Rabinowitz et al.
U.S. Appl. No. 10/768,205, filed Jan. 29, 2004, Rabinowitz et al.
U.S. Appl. No. 10/768,220, filed Jan. 29, 2004, Rabinowitz et al.
U.S. Appl. No. 10/768,281, filed Jan. 29, 2004, Rabinowitz et al.
U.S. Appl. No. 10/768,293, filed Jan. 29, 2004, Rabinowitz et al.
U.S. Appl. No. 10/769,046, filed Jan. 30, 2004, Rabinowitz et al.
U.S. Appl. No. 10/769,051, filed Jan. 30, 2004, Rabinowitz et al.
U.S. Appl. No. 10/769,157, filed Jan. 29, 2004, Rabinowitz et al.
U.S. Appl. No. 10/769,197, filed Jan. 29, 2004, Rabinowitz et al.
U.S. Appl. No. 10/775,583, filed Feb. 9, 2004, Rabinowitz et al.
U.S. Appl. No. 10/775,586, filed Feb. 9, 2004, Rabinowitz et al.
U.S. Appl. No. 10/791,915, filed Mar. 3, 2004, Hale et al.
U.S. Appl. No. 10/792,001, filed Mar. 3, 2004, Rabinowitz et al.
U.S. Appl. No. 10/792,012, filed Mar. 3, 2004, Hale et al.
U.S. Appl. No. 10/792,013, filed Mar. 3, 2004, Rabinowitz et al.
U.S. Appl. No. 10/792,096, filed Mar. 3, 2004, Hale et al.
U.S. Appl. No. 10/792,239, filed Mar. 3, 2004, Hale et al.
U.S. Appl. No. 10/813,721, filed Mar. 31, 2004, Rabinowitz et al.
U.S. Appl. No. 10/813,722, filed Mar. 31, 2004, Rabinowitz et al.
U.S. Appl. No. 10/814,690, filed Mar. 31, 2004, Rabinowitz et al.
U.S. Appl. No. 10/814,998, filed Mar. 31, 2004, Rabinowitz et al.
U.S. Appl. No. 10/815,527, filed Apr. 1, 2004, Rabinowitz et al.
U.S. Appl. No. 10/816,407, filed Apr. 1, 2004, Rabinowitz et al.
U.S. Appl. No. 10/816,492, filed Apr. 1, 2004, Rabinowitz et al.
U.S. Appl. No. 10/816,567, filed Apr. 1, 2004, Rabinowitz et al.
U.S. Appl. No. 10/912,462, filed Aug. 4, 2004, Hale et al.
Bennett, R.L. et al. (1981). “Patient-Controlled Analgesia: A New Concept of Postoperative Pain Relief,” Annual Surg. 195(6):700-705.
Carroll, M.E. et al. (1990), “Cocaine-base smoking in rhesus monkeys: reinforcing and physiological effects,” Psychopharmacology (Berl). 102:443-450.
Clark, A. and Byron, P. (1986). “Dependence of Pulmonary Absorption Kinetics on Aerosol Particle Size,” Z. Erkrank. 166:13-24.
Darquenne, C. et al. (1997). “Aerosol Dispersion in Human Lung: Comparison Between Numerical Simulations and Experiments for Bolus Tests,” American Physiological Society. 966-974.
Davies, C.N. et al. (May 1972). “Breathing of Half-Micron Aerosols,” Journal of Applied Physiology. 32(5):591-600.
Dershwitz, M., M.D., et al. (Sep. 2000). “Pharmacokinetics and Pharmacodynamics of Inhaled versus Intravenous Morphine in Healthy Volunteers,” Anesthesiology. 93(3): 619-628.
Finlay, W.H. (2001). “The Mechanics of Inhaled Pharmaceutical Aerosols”, Academic Press: San Diego Formula 2.39. pp. 3-14 (Table of Contents). pp. v-viii.
Gonda,I. (1991). “Particle Deposition in the Human Respiratory Tract,” Chapter 176, The Lung: Scientific Foundations. Crystal R.G. and West, J.B. (eds.), Raven Publishers, New York. pp. 2289-2294.
Hatsukami D, et al. (May 1990) “A method for delivery of precise doses of smoked cocaine-base to humans.” Pharmacology Biochemistry & Behavior. 36(1):1-7.
Heyder,J. et al. (1986). “Deposition of Particles in the Human Respiratory Tract in the Size Range 0.005-15 μm,” J. Aerosol Sci. 17(5):811-822.
Huizer, H., “Analytical studies on illicit heron. V. Efficacy of volatilization during heroin smoking.” Pharmaceutisch Weekblad Scientific Edition (1987). 9(4):203-211.
Hurt, R.D., MD and Robertson, C.R., PhD, (Oct. 1998). “Prying Open the Door to the Tobacco Industry's Secrets About Nicotine: The Minnesota Tobacco Trial,” JAMA 280(13):1173-1181.
Lichtman, A.H. et al. (1996). “Inhalation Exposure to Volatilized Opioids Produces Antinociception in Mice,” Journal of Pharmacology and Experimental Therapeutics. 279(1):69-76.
Martin, B.R. and Lue, L.P. (May/Jun. 1989). “Pyrolysis and Volatilization of Cocaine,” Journal of Analytical Toxicology 13:158-162.
Mattox, A.J. and Carroll, M.E., (1996). “Smoked heroin self-administration in rhesus monkeys,” Psychopharmacology, 125:195-201.
McCormick, A.S.M., et al., “Bronchospasm During Inhalation of Nebulized Midazolam,” British Journal of Anaesthesia, vol. 80(4), Apr. 1988, pp. 564-565.
Meng, Y. et al. Inhalation Studies With Drugs of Abuse, NIDA Research Monograph, (1997) 173:201-224.
Meng, Y., et al. (1999). “Pharmacological effects of methamphetamine and other stimulants via inhalation exposure,” Drug and Alcohol Dependence. 53:111-120.
Office Action mailed Aug. 13, 2003 for U.S. Appl. No. 10/153,313, filed May 21, 2002 “Delivery of Benzodiazepines Through an Inhalation Route”.
Pankow, J.F. et al. (1997). “Conversion of Nicotine in Tobacco Smoke to Its Volatile and Available Free-Base Form Through the Action of Gaseous Ammonia,” Envron. Sci. Technol. 31:2428-2433.
Pankow, J. (Mar. 2000). ACS Conference-San Francisco-Mar. 26, 21000. Chemistry of Tobacco Smoke. pp. 1-8.
Seeman, J. et al. (1999). “The Form of Nicotine in Tobacco. Thermal Transfer of Nicotine and Nicotine Acid Salts to Nicotine in the Gas Phase,” J. Agric. Food Chem. 47(12):5133-5145.
Sekine, H. and Nakahara, Y. (1987). “Abuse of Smoking Methamphetamine Mixed with Tobacco: 1. Inhalation Efficiency and Pyrolysis Products of Methamphetamine,” Journal of Forensic Science 32(5):1271-1280.
Vapotronics, Inc. (1998) located at http://www.vapotronics.com.au/banner.htm., 11 pages, (visited on Jun. 5, 2000).
Ward, M.E. MD, et al. (Dec. 1997). “Morphine Pharmacokinetics after Pulmonary Administration from a Novel Aerosol Delivery System,” Clinical Pharmacology & Therapeutics 62(6):596-609.
Wood, R.W. et al. (1996). “Generation of Stable Test Atmospheres of Cocaine Base and Its Pyrolyzate, Methylecgonidine, and Demonstration of Their Biological Activity.” Pharmacology Biochemistry & Behavior. 55(2):237-248.
Office Action mailed Dec. 4, 2003 for U.S. Appl. No. 10/057,198, filed Oct. 26, 2001 “Method And Device For Delivering A Physiologically Active Compound”.
Office Action mailed Jan. 12, 2005 for U.S. Appl. No. 10/057,197, filed Oct. 26, 2001, “Aerosol Generating Device And Method”.
Office Action mailed Jun. 3, 2004 for U.S. Appl. No. 10/057,197, filed Oct. 26, 2001, “Aerosol Generating Device And Method”.
Office Action mailed Dec. 15, 2003 for U.S. Appl. No. 10/057,197, filed Oct. 26, 2001, “Aerosol Generating Device And Method”.
Office Action mailed Feb. 27, 2004 for U.S. Appl. No. 10/146,080, filed May 13, 2002, “Aerosol Forming Device For Use In Inhalation Therapy”.
U.S. Appl. No. 10/057,198, filed Oct. 26, 2001, Lloyd et al.
U.S. Appl. No. 10/302,614, filed Nov. 21, 2002, Lu.
U.S. Appl. No. 10/146,088, filed May 13, 2002, Hale et al.
U.S. Appl. No. 10/280,315, filed Oct. 25, 2002, Shen.
U.S. Appl. No. 10/322,227, filed Dec. 17, 2002, Novack et al.
U.S. Appl. No. 10/442,385, filed May 20, 2003, Cross et al.
U.S. Appl. No. 10/719,540, filed Nov. 20, 2003, Hale et al.
U.S. Appl. No. 10/850,895, filed May 20, 2004, Damani et al.
U.S. Appl. No. 10/851,429, filed May 20, 2004, Hale et al.
U.S. Appl. No. 10/851/883, filed May 20, 2004, Hale et al.
U.S. Appl. No. 10/851,432, filed May 20, 2004, Hale et al.
U.S. Appl. No. 10/861,554, filed Jun. 3, 2004, Cross et al.
U.S. Appl. No. 10/851,018, filed May 20, 2004, Hale et al.
U.S. Appl. No. 10/917,735, filed Aug. 12, 2004, Hale et al.
U.S. Appl. No. 10/917,720, filed Aug. 12, 2004, Hale et al.
U.S. Appl. No. 10/912,417, filed Aug. 4, 2004, Bennett et al.