Optimised formulation of tobramycin for aerosolization

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai

Reexamination Certificate

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C514S036000, C514S035000, C514S025000, C536S004100, C536S055300, C536S124000

Reexamination Certificate

active

07939502

ABSTRACT:
The invention provides a tobramycin formulation for delivery by aerosolization in the form of additive-free, isotonic solution whose pH has been optimised to ensure adequate shelf-life at room temperature. Said formulation can be advantageously used for the treatment and prophylaxis of acute and chronic endobronchial infections, in particular those caused by the bacteriumPseudomonas aeruginosaassociated to lung diseases such as cystic fibrosis.

REFERENCES:
patent: 3361306 (1968-01-01), Grim
patent: 3622053 (1971-11-01), Ryden
patent: 4185100 (1980-01-01), Rovee et al.
patent: 4499108 (1985-02-01), Sequeira et al.
patent: 4579854 (1986-04-01), Iwakuma et al.
patent: 4584320 (1986-04-01), Rubin et al.
patent: 4835145 (1989-05-01), MacDonald
patent: 5190029 (1993-03-01), Byron et al.
patent: 5192528 (1993-03-01), Radhakrishnan et al.
patent: 5415853 (1995-05-01), Hettche et al.
patent: 5435297 (1995-07-01), Klein
patent: 5508269 (1996-04-01), Smith et al.
patent: 5605674 (1997-02-01), Purewal et al.
patent: 5642728 (1997-07-01), Andersson et al.
patent: 5653961 (1997-08-01), McNally et al.
patent: 5676930 (1997-10-01), Jager et al.
patent: 5683677 (1997-11-01), Purewal et al.
patent: 5695743 (1997-12-01), Purewal et al.
patent: 5776433 (1998-07-01), Tzou et al.
patent: 5891419 (1999-04-01), Cutie
patent: 5954047 (1999-09-01), Armer et al.
patent: 5955058 (1999-09-01), Jager et al.
patent: 6004537 (1999-12-01), Blondino et al.
patent: 6006745 (1999-12-01), Marecki et al.
patent: 6026808 (2000-02-01), Armer et al.
patent: 6045778 (2000-04-01), Jager et al.
patent: 6045784 (2000-04-01), Ruebusch et al.
patent: 6131566 (2000-10-01), Ashurst
patent: 6143277 (2000-11-01), Ashurst et al.
patent: 6149892 (2000-11-01), Britto
patent: 6150418 (2000-11-01), Hochrainer et al.
patent: 6241969 (2001-06-01), Saidi et al.
patent: 6253762 (2001-07-01), Britto
patent: 6290930 (2001-09-01), Blondino et al.
patent: 6315985 (2001-11-01), Wu et al.
patent: 6413496 (2002-07-01), Goodman et al.
patent: 6451285 (2002-09-01), Blondino et al.
patent: 6461591 (2002-10-01), Keller et al.
patent: 6645466 (2003-11-01), Keller et al.
patent: 6713047 (2004-03-01), Lewis et al.
patent: 6716414 (2004-04-01), Lewis et al.
patent: 6987094 (2006-01-01), Malvolti et al.
patent: 2001/0031244 (2001-10-01), Lewis et al.
patent: 2003/0066525 (2003-04-01), Lewis et al.
patent: 2003/0077230 (2003-04-01), Blondino et al.
patent: 2003/0089369 (2003-05-01), Lewis et al.
patent: 2003/0157028 (2003-08-01), Lewis et al.
patent: 2003/0190287 (2003-10-01), Lewis et al.
patent: 2003/0190289 (2003-10-01), Lewis et al.
patent: 2003/0206870 (2003-11-01), Lewis et al.
patent: 2004/0047809 (2004-03-01), Lewis et al.
patent: 2004/0062720 (2004-04-01), Lewis et al.
patent: 2004/0096399 (2004-05-01), Lewis et al.
patent: 2004/0184993 (2004-09-01), Lewis et al.
patent: 2005/0129621 (2005-06-01), Davies et al.
patent: 2005/0142071 (2005-06-01), Lewis et al.
patent: 2005/0152846 (2005-07-01), Davies et al.
patent: 2006/0083693 (2006-04-01), Lewis et al.
patent: 2006/0120966 (2006-06-01), Church et al.
patent: 0 372 777 (1990-06-01), None
patent: 0 504 112 (1992-09-01), None
patent: 0 642 992 (1995-03-01), None
patent: 0 653 204 (1995-05-01), None
patent: 0734 249 (1996-10-01), None
patent: 0 911 048 (1999-04-01), None
patent: 1 157 689 (2001-11-01), None
patent: 1 525 181 (1978-09-01), None
patent: 2 326 334 (1998-12-01), None
patent: WO 91/11173 (1991-08-01), None
patent: WO 92/11236 (1992-07-01), None
patent: WO 92/20391 (1992-11-01), None
patent: WO 93/05765 (1993-04-01), None
patent: WO 93/11743 (1993-06-01), None
patent: WO 93/11747 (1993-06-01), None
patent: WO 93/18746 (1993-09-01), None
patent: WO 94/13262 (1994-06-01), None
patent: WO 94/14490 (1994-07-01), None
patent: WO 94/21228 (1994-09-01), None
patent: WO 94/21229 (1994-09-01), None
patent: WO 95/17195 (1995-06-01), None
patent: WO 96/12471 (1996-05-01), None
patent: WO 96/18384 (1996-06-01), None
patent: WO 96/19198 (1996-06-01), None
patent: WO 96/19968 (1996-07-01), None
patent: WO 96/19969 (1996-07-01), None
patent: WO 96/32099 (1996-10-01), None
patent: WO 96/32150 (1996-10-01), None
patent: WO 96/32151 (1996-10-01), None
patent: WO 96/32345 (1996-10-01), None
patent: WO 97/47286 (1997-12-01), None
patent: WO 98/01147 (1998-01-01), None
patent: WO 98/03533 (1998-01-01), None
patent: WO 98/05302 (1998-02-01), None
patent: WO 98/13031 (1998-04-01), None
patent: WO 98/24420 (1998-06-01), None
patent: WO 98/34595 (1998-08-01), None
patent: WO 98/34596 (1998-08-01), None
patent: WO 98/56349 (1998-12-01), None
patent: WO 99/12596 (1999-03-01), None
patent: WO 99/64014 (1999-12-01), None
patent: WO 99/65460 (1999-12-01), None
patent: WO 99/65464 (1999-12-01), None
patent: WO 00/06121 (2000-02-01), None
patent: WO 00/07567 (2000-02-01), None
patent: WO 00/23065 (2000-04-01), None
patent: WO 00/30608 (2000-06-01), None
patent: WO 00/35458 (2000-06-01), None
patent: WO 00/53157 (2000-09-01), None
patent: WO 00/78286 (2000-12-01), None
patent: WO 01/47493 (2001-07-01), None
patent: WO 01/89480 (2001-11-01), None
patent: WO 03/074023 (2003-09-01), None
Nikolaizik et al. (European Journal of Pediatrics, (Jul. 1996) vol. 155, No. 7, pp. 608-611).
Nikolaizik et al, Eur. J. Pediatr, (1996) 155: pp. 608-611.
McCallion et al, International Journal of Pharmaceutics (1996) 130, pp. 1-11.
Mann et al, British Medical Journal, Aug. 25, 1984, vol. 289, p. 469.
Newman et al, Thorax, 1988, 43, pp. 318-322.
The Lancet, Jul. 23, 1988, vol. II, p. 202.
Le Brun et al, International Journal of Pharmaceutics, Apr. 27, 1999, vol. 189, pp. 205-214.
Derbracher et al, Atemwegs und Lung, 1994, 20, pp. 381-382.
Machine translation of EP 0734249 Abstract Only, Jan. 15, 2000.
Le Brun PPH et al., “Inhalation of tobramycin in cystic fibrosis Part 2: Optimization of the tobramycin solution for a jet and an ultrasonic nebulizer.” International Journal of Pharmaceutics, vol. 189, No. 2, Nov. 5, 1999, pp. 215-225.
Brandl M and Gu L: “Degradation of tobramycin in aqueous solution,” Drug Development and Industrial Pharmacy, vol. 18, No. 13, 1992, pp. 1423-1436.
Alexander Chuchalin et al., “A Formulation of Aerosolized Tobramycin (Bramitob®) in the Treatment of Patients with Cystic Fibrosis andPseudomonas aeruginosaeInfection,” Pediatr. Drugs, 2007, vol. 9, pp. 21-31.
R.O. Williams III et al, “A study of an epoxy aerosol can lining exposed to hydrofluoroalkane propellants”,European Journal of Pharmaceutics and Biopharmaceutics, vol. 44, pp. 195-203, (1997).
ABPI Compendium of Data Sheets and Summaries of Product Characteristics, Datapharm Publications Limited, London, pp. 81-82, (1996-97).
Paul A. Sanders, Ph.D., “Homogeneous Systems and Their Properties”,Handbook of Aerosol Technology, Second Edition, Van Nostrand Reinhold Company, NY, p. 30, 1979.
G. Brambilla et al, “Modulation of Aerosol Clouds Produced by HFA Solution Inhalers”,Portable Inhalers, pp. 155-159, (Nov. 26 & 27, 1998).
B. Meakin, “Fine Particle Dose Control of Solution Based pMDIs”,Drug Delivery to the Lungs IX, The Aerosol Society, pp. 1-20, (Dec. 14 & 15, 1998).
S.S. Davis, “Physico-Chemical Studies on Aerosol Solutions for Drug Delievery I. Water-Propylene Glycol Systems”,International Journal of Pharmaceutics, 1, 1978, pp. 71-83.
L. Harrison et al, “Twenty-eight-day Double-blind Safety Study of an HFA-134a Inhalation Aerosol System in Healthy Subjects”,J. Pharm. Pharmacol., 1996, vol. 48, pp. 596-600.
P. Hoet et al, “Epidemic of liver disease caused by hydrochlorofluorocarbons used as ozone-sparing substitutes of chlorofluorocarbons”The Lancet, 1997, vol. 350, pp. 556-559.
J. Daly, Jr., “Properties and toxicology of CFC alternatives”Aerosol Age, Feb. 1990, pp. 26-27, 40, 56 and 57.
D. Strobach, “Alternatives to CFCs” Part II,Aerosol Age, Jul. 1988, pp. 32-33, 42 and 43.
Tsi-Zong Tzou et al, “Drug Form Selection in Albuterol-Containing Metered-Dose Inhaler Formulat

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