Controlled-pH formulation for intravesicular instillation of TGF

Details Controlled-pH formulation for intravesicular instillation of TGF Controlled-pH formulation for intravesicular instillation of TGF

1996-06-27

1997-03-18

Schain, Howard E.

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Peptide containing doai

514 21, A61K 4748, A61K 3166, A61K 3342, C07K 14495

Patent

active

056123132

ABSTRACT:
A buffered intravesicular pharmaceutical dosage system for delivery of TGF.alpha.PE.sub.40 ab to a human bladder for bladder cancer chemotherapy, in which a buffer system of 100 mM phosphate at an initial pH of 7.8 maintains a pH range in the bladder of 6.5 to 7.8 that is sufficient to maximize interaction of TGF.alpha.PE.sub.40 ab with the EGF receptor expressed on the surface of bladder cancer cells and to prevent aggregation of the TGF.alpha.PE.sub.40 ab while in the bladder.

REFERENCES:
U.S. application No. 07/669,269, J. Ahern et al., filed Mar. 14, 1991.
U.S. application No. 08/224,422, Merck & Co., Inc., filed Apr. 11, 1994.
Sanyal, G., et al. "The pH-Dependent Conformational Changes of a TGF alpha-Pseudomonas Exotoxin Hybrid Protein," (1991), Biophysical Journal, 59, pp. 614a.
Haigler, H.T., et al., Dansylcadayerine Inhibits Internalization of 1251-Epidermal Growth Factor in BALB 3T3 Cells, (1980), Jour. of Biological Chem., 255, No. 4, pp. 1239-1241.
Sorkin, A.D. et al., "The Endocytosis of Epidermal Growth Factor in A431 Cells: a pH of Microenvironment and the Dynamics of Receptor Complex Dissociation," (1988), Experimental Cell Research, 1975, pp. 192-205.
Gueffroy, D.E., Buffers, "A guide for the preparation and use of buffers in biological systems" (1986), Hoechst Technical Manual, pp. 3-24.
Sanyal et al., Biophysical J. (59) p. 614a (1991).
Haigler et al., J. Biological Chemistry (255) No. 4, pp. 1239-1241 (1980).
Sorkin et al., Experimental Cell Research (175) pp. 192-205 (1988).
Gueffroy, D.E., Buffers, A guide for the preparation and use of buffers in biological systems, (1986), Hoechst Technical Manual, pp. 3-24.

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