Compositions comprising PVP having an average molecular weight in the range of 3.000 to 14.000 daltons

• US 6,080,397 A
• Filed: 09/04/1998
• Issued: 06/27/2000
• Est. Priority Date: 01/10/1996
• Status: Expired due to Term

• Current Assignee: ED. Geistlich Soehne AG Fuer Chemische Industrie
• Original Assignee: ED. Geistlich Soehne AG Fuer Chemische Industrie
• Inventors: Pfirrmann, Rolf Wilhelm
• Primary Examiner(s): Kulkosky, Peter F.
• Application Number:
  US09/091,228
• Time in Patent Office: 662 Days
• Field of Search: 424/78.32, 424/78.08
• US Class Current: 424/78.08
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/549 having two or more nitrogen atoms in the same ring, e.g. hydrochlorothiazide
• CPC Class Codes: A61K 31/79 Polymers of vinyl pyrrolidone
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: A61P 7/08 Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock artificial tears A61P27/04

Abstract

The present invention relates to compositions for use in medicine, e.g. as infusion or surgical rinse solutions, and to processes for their preparation. The compositions of the invention comprise an aqueous solution of physiologically inert PVP having a weight average molecular weight in the range of from 3,000 to 14,000 daltons.

Claims

1. A composition suitable for use in medicine as an infusion solution, a haemodilation solution or a surgical rinse solution, comprising an aqueous colloidal solution of physiologically inert PVP having colloidal osmotic pressure and a weight average molecular weight in the range of from 7,000 to 12,000 Daltons, said solution being substantially free of chemical impurities with an amine content of less than about 10 ppm, a peroxide content of less than about 20 ppm, a solvent content of less than about 10 ppm wherein said solvent is isopropanol, t-butanol or acetone, and being substantially free from PVP having a molecular weight above 50,000 Daltons.

2. The composition of claim 1 having a monomer content of less than about 2 ppm.

3. The composition of claim 1 wherein said weight average molecular weight is in the range of from 7,000 to 11,000 Daltons.

4. The composition of claim 1 wherein said weight average molecular weight is in the range of from 10,000 to 11,000 Daltons.

5. The composition of claim 1 having a K-value of less than 17.

6. The composition of claim 5 having a K-value in the range of from 15 to 16.

7. The composition of claim 1 wherein the concentration of PVP is in the range of from 4 to 10% by weight.

8. The composition of claim 1 further comprising an effective concentration of taurolidine, tarultam or a combination thereof.

9. The composition of claim 8 comprising from 0.5 to 2% by weight taurolidine, from 1 to 10% by weight tarultam or a combination thereof.

15. The composition of claim 1 having a monomer content of less than about 2 ppm.

10. A process for the preparation of a composition suitable for use in medicine as an infusion solution, a haemodilation solution or a surgical rinse solution, comprising an aqueous colloidal solution of physiologically inert PVP having colloidal osmotic pressure and a weight average molecular weight in the range of from 7,000 to 12,000 Daltons, said solution being substantially free of chemical impurities with an amine content of less than about 10 ppm, a solvent content of less than about 10 ppm wherein said solvent is isopropanol, t-butanol or acetone, a peroxide content of less than about 20 ppm, and being substantially free from PVP having a molecular weight above 50,000 Daltons, said process comprising a step of passing a PVP solution over a cation exchange resin.

11. The process of claim 10 further comprising ultrafiltration of said PVP solution after passing said PVP solution over said cation exchange resin.

12. The process of claim 10 wherein said cation exchange resin is a strong acid cation exchanger.

13. The process of claim 11 wherein said ultrafiltration is carried out at a pressure of from 100 to 500 mm Hg.

14. A composition prepared according to the process of claim 10 said composition being suitable for use in medicine as an infusion solution, a haemodilation solution or a surgical rinse solution, said composition comprising an aqueous colloidal solution of physiologically inert PVP having colloidal osmotic pressure and a weight average molecular weight in the range of from 7,000 to 12,000 Daltons, said solution being substantially free of chemical impurities with an amine content of less than about 10 ppm, a solvent content of less than about 10 ppm wherein said solvent is isopropanol, t-butanol or acetone, a peroxide content of less than about 20 ppm, and being substantially free from PVP having a molecular weight above 50,000 Daltons.