DETAILED DESCRIPTION OF THE INVENTION The invention described herein is directed to pharmaceutical compositions that provide for the controlled release of an active ingredient in the gastrointestinal cavity of a patient.
Such compositions provide for the delivery of polyleptide material to the lower intestine and comprise an effective amount of a polypeptide selected from the group consisting of: (a) tumor necrosis factor receptor (TNFR), (b) interleukin- 1 receptor (IL-1R), (c) interleukin-1 receptor antagonist (IL-1ra) and (d) a monoclonal antibody that is immunoreactive against TNF, IL-6 or IL- 1; and a salt of an alginic acid.
As used herein, "TNFR" refers to a genus of plasma membrane polypeptides, or fragments thereof, that bind independently with TNF.
Two forms of TNFRs are known in the art and encompassed by this invention, a first TNFR is a 80 kD mature protein described by Smith, et al.
, Science, 248:1019-1022 (1990), incorporated herein by reference.
A second TNFR is a 55-60 kD mature protein and is described in EP-A-0308,378; Schall, et al.
, Cell, 61:361-370 (1990); and Loeicscher, et al.
, Cell, 61:351-359 (1990), each of which is incorporated herein by reference.
The term TNFR as used herein also contemplates the soluble portions or fragments of these two forms, which soluble portions predominantly include the extracellular domain of the proteins, maintain binding activity and which are capable of being secreted by a cell.
Fusion proteins that include a TNFR are also contemplated by this invention.
For example, dimeric fusions of two extracellular domains of the 80 kD TNFR with the constant domain of a human IgG 1 are well known (p80 TNFR:Fc) and is described by Mohler et al.
, J.
Immun.
, 151(3):1548-1561 (1993), incorporated herein by reference.
Similar fusions using the extracellular regions of the 55 kD TNFR with the constant domain of a human IgG 1 are included in this definition, and is described by Peppel, et al.
, J.
Exp.
Med.
, 174:1483-1489 (1991), incorporated herein by reference
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