Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing
Reexamination Certificate
2005-01-04
2005-01-04
Hartley, Michael G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Effervescent or pressurized fluid containing
C424S045000, C424S489000, C514S002600, C530S300000, C128S203150
Reexamination Certificate
active
06838075
ABSTRACT:
The present invention provides highly dispersible spray-dried powder compositions, and in particular, inhaleable dry powder compositions for aerosolized delivery to the lungs. The powders of the invention are produced by spray drying a 4 α-helix bundle protein under conditions which both (i) protect the protein from aggregation and (ii) provide particles suitable for inhalation (i.e., demonstrating superior aerosol performance).
REFERENCES:
patent: 4917685 (1990-04-01), Viswanathan et al.
patent: 5284678 (1994-02-01), Hirschfeld et al.
patent: 5300317 (1994-04-01), Ivarson
patent: 5482927 (1996-01-01), Maniar et al.
patent: 5507871 (1996-04-01), Morino et al.
patent: 5547696 (1996-08-01), Sorensen
patent: 5552385 (1996-09-01), Christensen et al.
patent: 5567677 (1996-10-01), Castensson et al.
patent: 5582643 (1996-12-01), Takei et al.
patent: 5589167 (1996-12-01), Cleland et al.
patent: 5612135 (1997-03-01), Matsui et al.
patent: 5612315 (1997-03-01), Pikal et al.
patent: 5631225 (1997-05-01), Sorensen
patent: 5641510 (1997-06-01), Clark et al.
patent: 5653996 (1997-08-01), Hsu
patent: 5654010 (1997-08-01), Johnson et al.
patent: 5654278 (1997-08-01), Sorensen
patent: 5667808 (1997-09-01), Johnson et al.
patent: 5705482 (1998-01-01), Christensen et al.
patent: 5753219 (1998-05-01), Cleland et al.
patent: 5763394 (1998-06-01), O'Conner et al.
patent: 5780599 (1998-07-01), Junker et al.
patent: 5804557 (1998-09-01), Cleland et al.
patent: 5834598 (1998-11-01), Lowman et al.
patent: 5849535 (1998-12-01), Cunningham et al.
patent: 5849700 (1998-12-01), Sorensen et al.
patent: 5849704 (1998-12-01), Sorensen et al.
patent: 5851992 (1998-12-01), Sorensen
patent: 5891478 (1999-04-01), Johnson et al.
patent: 5898030 (1999-04-01), Samaritani
patent: 5904951 (1999-05-01), Yamanaka et al.
patent: 5952008 (1999-09-01), Backstrom et al.
patent: 5977069 (1999-11-01), Sorensen
patent: 6004574 (1999-12-01), Backstrom et al.
patent: 6004583 (1999-12-01), Plate et al.
patent: 6022858 (2000-02-01), Sorensen et al.
patent: 6051256 (2000-04-01), Platz et al.
patent: 6099517 (2000-08-01), Daugherty
patent: 6191107 (2001-02-01), Yamagata et al.
patent: 6197369 (2001-03-01), Watano et al.
patent: 6372258 (2002-04-01), Platz et al.
patent: 20030158375 (2003-08-01), Nissen et al.
patent: 0177478 (1986-04-01), None
patent: 0216485 (1987-04-01), None
patent: 0303746 (1989-02-01), None
patent: WO 9200998 (1992-01-01), None
patent: WO 9217200 (1992-10-01), None
patent: WO 9312811 (1993-07-01), None
patent: WO 9312812 (1993-07-01), None
patent: WO 9313792 (1993-07-01), None
patent: WO 9319776 (1993-10-01), None
patent: WO 9611702 (1996-04-01), None
patent: WO 9611703 (1996-04-01), None
patent: WO 9611704 (1996-04-01), None
patent: WO 9619197 (1996-06-01), None
patent: WO 9621459 (1996-07-01), None
patent: WO 9621460 (1996-07-01), None
patent: WO 9621461 (1996-07-01), None
patent: WO 9639173 (1996-12-01), None
patent: WO 9702833 (1997-01-01), None
patent: WO 9703692 (1997-02-01), None
patent: WO 9739768 (1997-10-01), None
patent: WO 0000176 (2000-01-01), None
patent: WO 0010541 (2000-03-01), None
patent: WO 0132144 (2003-05-01), None
Adler M. et al., “Stability and Surface Activity of Lactate Dehydrogenase in Spray-Dried Trehalose,” J. Pharm. Sci., vol. 88 (2): pp. 199-208, 1999.
Bell, Leonard N. et al., “Thermally Induced Denaturation of Lyophilized Bovine Somatotropin and Lysozyme as Impacted by Moisture and Excipients,” J. of Pharm. Sci., vol. 84 (6): pp. 707-712, Jun. 1995.
Cleland, Jeffrey et al., “Stable Formulations of Recombinant Human Growth Hormone and Interferon-y for Microencapsulation in Biodegradable Microspheres,” Pharm. Res., vol. 13 (10): pp. 1464-1475, 1996.
Costantino, Henry R. et al., “Effect of Excipients on the Stability and Structure of Lyophilized Recombinant Human Growth Hormone,” J. of Pharm. Sci., vol. 87 (11): pp. 1412-1420, Nov. 1998.
IP, Anna Y. et al., “Stability of Recombinant Consensus Interferon to Air-Jet and Ultrasonic Nebulization,” J. of Pharm. Sci., vol. 84 (10): pp. 1210-1214, Oct. 1995.
HSU, C. C. et al., “Determining the Optimum Residual Moisture in Lyophilized Protein Pharmaceuticals,” Develop. Biol. Standard, vol. 74: pp. 255-271, 1990.
Johnson Olufunmi L. et al., “The Stabilization and Encapsulation of Human Growth Hormone into Biodegradable Microspheres,” Pharm. Res., vol. 14 (6): pp. 730-735, 1997.
Maa Yuh-Fun et al., “Spray-Drying of Air-Liquid Interface Sensitive Recombinant Human Growth Hormone,” J. Of Pharm. Sci., vol. 87 (2): pp. 152-159, Feb. 1998.
Mumenthaler, Marco et al., “Feasibility Study on Spray-Drying Protein Pharmaceuticals: Recombinant Human Growth Hormone and Tissue-Type Plasminogen Activator,” Plenum Publishing Corp., vol. 11 (1): pp. 12-20, 1994.
Niven, Ralph W. et al., “Protein Nebulization II. Stability of G-CSF to Air-Jet Nebulization and the Role of Protectants,” International J. of Pharmceutics, pp. 191-201, 1996.
Niven, Ralph W. et al., “Some Factors Associated with the Ultrasonic Nebulization of Proteins,” Pharm. res., vol. 12 (1): pp. 53-59, 1995.
O'Hagan, Derek T. et al., “Nasal Absorption Enhances for Biosynthetic Human Growth Hormone in Rats,” Pharm. Res., vol. 7 (7): pp. 772-776, 1990.
Tzannis, Stelios T. et al., “Irreversible Inactivation of Interleukin 2 in a Pump-Based Delivery Environment,” Proc. Natl. Acad. Sci., pp. 5460-5465, May 1996.
Zhang, Mei Z. et al., “The Effect of the Reconstitution Medium on Aggregation of Lyophilized Recombinant Interleukin-2 and Ribonuclease A,” Pharm. Res., vol. 13 (4): pp. 643-646, 1996.
Bennett David B.
Cabot Kirsten
Chiang Hi-Shi
Gong David
Hastedt Jayne E.
Evans Susan T.
Haghighatian Mina
Hartley Michael G.
Nektar Therapeutics
Wilson Mark A.
LandOfFree
Inhaleable spray dried 4-helix bundle protein powders having... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Inhaleable spray dried 4-helix bundle protein powders having..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Inhaleable spray dried 4-helix bundle protein powders having... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3404867