Drug – bio-affecting and body treating compositions – Solid synthetic organic polymer as designated organic active... – Ion exchange resin
Patent
1998-10-02
2000-05-16
Kulkosky, Peter F.
Drug, bio-affecting and body treating compositions
Solid synthetic organic polymer as designated organic active...
Ion exchange resin
424 781, 514866, A61K 3828, A61K 4732
Patent
active
060633700
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to macromolecular drug complexes and to the administration of the macromolecular drug complexes to individuals. More particularly, the present invention relates to a new drug delivery system comprising a macromolecular drug complex containing a therapeutic agent that is noncovalently bound, i.e., is complexed, to a polymer having a plurality of acid moieties. The complex is prepared by interacting the polymer and a therapeutic agent, such as insulin, in an aqueous medium. Depending on the physicochemical properties of the polymer and therapeutic agent, the resulting macromolecular drug complex either is water soluble or separates from the aqueous medium as a solid precipitate. The solid macromolecular complex can be incorporated into a variety of drug compositions, including solid phase drug compositions for oral administration of the therapeutic agent.
BACKGROUND OF THE INVENTION
It is well known that modern day drugs are very efficacious with respect to treating acute and chronic diseases. However, several diseases, and especially chronic diseases, are associated with complications that are not treated by administration of the drug.
For example, the standard treatment for diabetes is administration of insulin. An individual suffering from diabetes does not produce sufficient insulin, and hence the individual cannot burn and store glucose. Diabetes cannot be cured, but diabetes can be treated by periodic injections of insulin. FIG. 1 shows that serum insulin levels rise from a low fasting value to a peak after about 30 to 60 minutes, then fall back to a low value after about 120 minutes. In mild diabetics, the rise in serum insulin is lower compared to normal individuals. In severe diabetics, no insulin is produced, and the rise in serum insulin levels is negligible. As a result, excess glucose accumulates in the blood of a diabetic, which can result, for example, in a loss of weight and loss of strength.
However, insulin injections to treat diabetes do not treat, or alleviate, the serious vascular complications associated with diabetes, including nephropathy, retinopathy, neuropathy, heart disease, and reduced blood circulation in the limbs, i.e., "diabetic foot", that can lead to gangrene. Another disadvantage with respect to the present therapeutic compositions used to treat diabetes is that insulin must be injected. Insulin cannot be administered orally because insulin is destroyed by the strong acid conditions of the stomach.
Therefore, it would be advantageous to develop a method of both treating a disease, and preventing or reversing complications associated with the disease. It also would be advantageous to develop easier methods of administering a drug to treat the disease. As set forth in detail hereafter, the present invention is directed to novel macromolecular drug complexes, and to use of the complexes to reduce, eliminate, or reverse complications associated with a disease. The present invention is further directed to improved drug delivery systems for administering difficult to administer drugs, like insulin.
With respect to diabetes, glycosaminoglycans (GAGs) are a class of negatively charged, endogenous polysaccharides composed of repeating sugar residues (uranic acids and hexosamines). GAGs have been shown to bind a variety of biological macromolecules, including connective tissue macromolecules, plasma proteins, lysosomal enzymes, and lipoproteins. In addition, exogenous GAGs have been shown to bind to the cell surfaces of a variety of different cell types, including liver cells (hepatocytes), fibroblasts, and importantly, endothelial cells. Exogenous GAGs therefore can be internalized. Furthermore, GAGs have been implicated in the regulation of cell proliferation and in cell-cell communication, shown to interact with cell-surface receptors (cell adhesion molecules), and shown to modify the behavior of cells in culture. In addition, GAGs were shown to be highly potent, selective inhibitors of HIV replication and giant cell format
REFERENCES:
patent: 4489065 (1984-12-01), Walton et al.
patent: 4834965 (1989-05-01), Martani et al.
patent: 5443505 (1995-08-01), Wong et al.
patent: 5478575 (1995-12-01), Miyazaki et al.
patent: 5665700 (1997-09-01), Cho et al.
Kulkosky Peter F.
The Board of Trustees of the University of Illinois
LandOfFree
Macromolecular complexes for drug delivery does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Macromolecular complexes for drug delivery, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Macromolecular complexes for drug delivery will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-256247