Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2007-10-09
2007-10-09
Tsang, Cecilia J. (Department: 1654)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S004300, C514S866000, C514S951000, C514S953000, C514S959000, C530S303000, C530S304000
Reexamination Certificate
active
11077604
ABSTRACT:
Drug formulations for systemic drug delivery with improved stability and rapid onset of action are described herein. The formulations may be administered via buccal administration, sublingual administration, pulmonary delivery, nasal administration, subcutaneous administration, rectal administration, vaginal administration, or ocular administration. In the preferred embodiments, the formulations are administered sublingually or via subcutaneous injection. The formulations contain an active agent and one or more excipients, selected to increase the rate of dissolution. In the preferred embodiment, the drug is insulin, and the excipients include a metal chelator such as EDTA and an acid such as citric acid. Following administration, these formulations are rapidly absorbed by the oral mucosa when administered sublingually and are rapidly absorbed into the blood stream when administered by subcutaneous injection. In one embodiment, the composition is in the form of a dry powder. In another embodiment, the composition is in the form of a film, wafer, lozenge, capsule, or tablet. In a third embodiment, a dry powdered insulin is mixed with a diluent containing a pharmaceutically acceptable carrier, such as water or saline, a metal chelator such as EDTA and an acid such as citric acid. Devices for storing and mixing these formulations are also described.
REFERENCES:
patent: 5514646 (1996-05-01), Chance et al.
patent: 5547929 (1996-08-01), Anderson et al.
patent: 5573396 (1996-11-01), Swanson
patent: 5763396 (1998-06-01), Weiner et al.
patent: 5785989 (1998-07-01), Stanley et al.
patent: 5807315 (1998-09-01), Van Antwerp et al.
patent: 5849322 (1998-12-01), Ebert et al.
patent: 5929027 (1999-07-01), Takama et al.
patent: 6395744 (2002-05-01), Adams et al.
patent: 6432383 (2002-08-01), Modi
patent: 6676931 (2004-01-01), Dugger, III.
patent: 6949258 (2005-09-01), Zhang
patent: 7030084 (2006-04-01), Ekwuribe et al.
patent: 2003/0064097 (2003-04-01), Patel et al.
patent: 2003/0068378 (2003-04-01), Chen et al.
patent: 2003/0194420 (2003-10-01), Holl et al.
patent: 2004/0151774 (2004-08-01), Pauletti et al.
patent: 2004/0247628 (2004-12-01), Lintz et al.
patent: WO 95/34294 (1995-12-01), None
patent: WO 97/49386 (1997-12-01), None
patent: WO 03/057170 (2003-07-01), None
patent: WO 03/086345 (2003-10-01), None
patent: WO 2004/056314 (2004-07-01), None
US 5,785,981, 07/1998, Stanley et al. (withdrawn)
Costello et al. Zinc Inhibition of Mitochondrial Aconitase and Its Importance in Citrate Metabolism of Protease Epithelial Cells, Nov. 14, 1997, The Journal of Biological Chemistry, vol. 272, No. 46, pp. 28875-28881.
Brange and Langkjoer, “Insulin structure and stability”,Pharm Biotechnol., 5:315-50 (1993).
Dunn, “Zinc-ligand interactions modulate assembly and stability of the insulin hexamer”,Biometals., 18(4):295-303 (2005).
Prabhu, et al., “A study of factors controlling dissolution kinetics of zinc complexed protein suspensions in various ionic species”,Int J Pharm., 217(1-2):71-8 (2001).
Pohl Roderike
Steiner Solomon S.
Biodel Inc.
Mohamed Abdel A
Pabst Patent Group LLP
Tsang Cecilia J.
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