Drug – bio-affecting and body treating compositions – Solid synthetic organic polymer as designated organic active...
Patent
1998-09-04
2000-06-27
Kulkosky, Peter F.
Drug, bio-affecting and body treating compositions
Solid synthetic organic polymer as designated organic active...
422 28, 514833, 210692, A61K 908, A61K 3179
Patent
active
060803975
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to polyvinylpyrrolidone (PVP) compositions for use in medicine, in particular as injection, infusion and surgical rinse solutions and as plasma expanders.
Infusion solutions, which are administered in relatively large volumes, commonly contain PVP to provide a colloid osmotic pressure similar to that of blood and to assist in stabilising relatively insoluble components in such solutions. In particular, infusion solutions containing the antibacterial compound taurolidine have been formulated with PVP to maintain a relatively high taurolidine concentration. Similarly, taurolidine solutions for injection have also been formulated with PVP.
Surgical rinse solutions are used either during or immediately after surgery to irrigate body tissues and generally contain a synthetic colloidal material to bind water and thus reduce the incidence of oedema.
Plasma expanders are used to replace or maintain blood volume. Except in the case of major blood loss when replacement of blood constituents is necessary, whole blood is not used for simple expansion of blood volume due to difficulties with availability and cross matching. A number of synthetic plasma substitutes, e.g. colloidal solutions of dextrans, gelatin and starch derivatives, are currently in use. Synthetic plasma substitutes have the additional advantages of lower viscosity which enables early improvement in microcirculation and erythrocyte aggregation. Synthetic plasma substitutes are particularly useful in the rheological therapy of peripheral and cerebral circulatory disturbances due to improved oxygen supply to the ischaemic tissue, and in the treatment of sepsis.
However, the colloidal materials currently in use are associated with hypersensitivity reactions, which limits their use. For example, infusions of dextrans, gelatin or hydroxy ethyl starch (HES) may produce hypersensitivity reactions such as itching, fever, joint pains and hypotension, as well as severe cases of anaphylactic reactions. HES is potentially nephrotoxic and can lead to acute kidney failure and the storage of HES in various body tissues can also lead to severe long term itching. In part, such effects are may be due to metabolic degradation of such colloids as well as any impurities present.
Polyvinylpyrrolidone (PVP), also commonly known as povidone or polyvidone, is a synthetic polymer consisting essentially of linear chains comprising repeating N-vinyl-2-pyrrolidone units, the degree of polymerisation resulting in polymers of various molecular weights according to a Gaussian distribution. Indicative of its molecular weight is its viscosity in aqueous solution, relative to that of water. This is expressed as a K-value which may range from 10 to 120.
An important property of PVP is its universal solubility which extends from hydrophilic solvents such as water to hydrophobic solvents such as butanol. This makes PVP particularly well suited to use as a blood replacement solution. However, the consequences of exposure of the human body to PVP solutions have been the subject of much study.
Although PVP solutions are, in general, well tolerated, it is now well established that high molecular weight PVP when administered in large amounts intravenously can be partly stored in the body. The extent of PVP uptake into tissues is dependent upon a number of factors, such as the molecular weight of the material and the amount of PVP administered, as well as the site and frequency of administration.
The various adverse effects associated with long term storage of PVP have been found to be related to the PVP fractions with relatively high molecular weight. It has been demonstrated that PVP molecules having a molecular weight up to about 30,000 daltons are excreted rapidly by glomerular filtration. Above this limit, e.g. up to about 70,000 daltons, excretion via the kidney is still possible but this is slower. Long term storage of high molecular weight PVP seems to be solely or mainly associated with uptake in the reticuloendothelial system (RES).
When administered over
REFERENCES:
patent: 4350156 (1982-09-01), Malchesky et al.
C.A. 94:71523 R.W. Pfirrmann et al DE 3017711 Nov. 1980.
C.A. 124:97697 D. Jones et al 1995 C.A. 94:202400.
Janik et al., "Prevention of Postoperative Peritoneal Adhesions, Efficacy of Povidone", Archives of Surgery, vol. 117, No. 10, pp. 1321-1324, 1982.
Dr. Herbert P. Fiedler, "Lexikon Der Hilfsstoffe Fur Pharmazie, Kosmetik Und Angrenzende Gebiette", Editor Cantor, pp. 695.
Ed. Geistlich Sohne AG fur chemische Industrie
Kulkosky Peter F.
LandOfFree
Compositions comprising PVP having an average molecular weight i does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Compositions comprising PVP having an average molecular weight i, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Compositions comprising PVP having an average molecular weight i will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-1781872