Film-forming compositions and methods

#The present invention relates to film-forming compositions, particularly to compositions that include at least one active agent, preferably an antimicrobial agent such that the compositions are useful for tissue antisepsis, particularly skin antisepsis.

#It is a standard practice in the industrialized world to disinfect the skin prior to any invasive procedure such as surgery, catheterization, or needle puncture in or to reduce the risk of infection. These products are often referred to as skin preps or simply “preps.” It is particularly advantageous to customers to have a single product that can be used on both in-tact skin and mucosal tissue (e.g. vaginal, oral, nasal, and ocular tissue). Other sensitive tissues that antimicrobial products have been used on include acute and chronic wounds as well as bums. For all of these skin antiseptics it is desirable to achieve a very rapid microbial reduction so that the clinician can get on with the intended procedure.

#Recently, there have been several alcohol-based antiseptics on the market for both presurgical and precatherization antisepsis. These products, while good rapid acting antiseptics due to the high alcohol content (e.g., typically at least about 60 wt-%), are only suitable for use on in-tact skin and are not suitable for use on sensitive tissues such as mucosal tissue, wounds, or bum tissue.

#The objects, features, and advantages of the present invention illustrated in the following examples, which incorporate particular materials and amounts, should not be construed to unduly limit this invention. All materials are commercially available unless otherwise stated or apparent. All parts, percentages, ratios, etc., in the examples are by weight unless otherwise indicated. 3 GLOSSARY EHA 2-ethylhexyl acrylate BASF Corporation, Mt. Olive, NJ LMA lauryl methacrylate: SR313B Sartomer, Exton, PA SMA stearyl methacrylate Rohm and Haas, Philadelphia, PA BA butyl acrylate Hoechst Celanese, Dallas, TX and ICI, Wilmington, DE IBMA isobutyl methacrylate Monomer-Polymer & Dajac Lab. Inc., Feasterville, PA IBOA isobonyl acrylate Shin-Nakamura Chemicals, Wakayama City, Japan AA acrylic acid BASF Corporation ACM acrylamide Cytec Industries, Inc., West Paterson, NJ DMAEAMC or dimethylaminoethyl acrylate Ciba Specialty DMAEAM.Cl methyl chloride quaternary salt Chemicals, (AGAFLEX FA1Q80MC) Also Woodbridge, NJ referred to as trimethylaminoethylmethacrylate chloride salt; 80% aqueous solution DMAEAMS dimethylaminoethyl acrylate Ciba Specialty methyl sulfate Chemicals DMAEMA dimethylaminoethyl Ciba Specialty methacrylate Chemicals DMAEA dimethylaminoethyl acrylate Ciba Specialty (AGEFLEX FA1) Chemicals AM-90G methoxy(polyethylene oxide) Shin-Nakamura acrylate, EOA-9 (approximately Chemicals 450 MW) MA methyl acrylate ICI MMA methyl methacrylate ICI EtOH ethanol SDA-3A, anhydrous Eastman EtOH ethanol N-190 Worum Chemicals, Minneapolis, MN H2O2 hydrogen peroxide, 50% Sigma-Aldrich Fine aqueous solution Chemicals, Inc., St. Louis, MO VAZO 67 2,2′-azobis E. I. du Pont de (2-methylbutanenitrile) Nemours and Company, Wilmington, DE Ascorbic Acid ascorbic acid, vitamin C Amend Drug & Chemical Co. NaOH sodium hydroxide Sigma-Aldrich Fine Chemicals, Inc. D-C Additive Dow-Corning Additive 62 Dow-Corning, 62 defoamer Midland, MI TBHP t-butyl hydroperoxide, 70% in Arco Chemicals water SFS sodiumformaldehyde sulfoxylate Fluka hydrate PLURONIC PLURONIC block copolymer of BASF Corporation poly(ethylene oxide) and poly(propylene oxide) TBA tertiary buty alcohol Sigma-Aldrich Fine Chemicals PVP-I povidone-iodine USP BASF Corporation POLYSTEP ammonium laureth 12 sulfate Stepan Company, B22 Northfield, IL LA L lactic acid, High Pure 88, USP Purac America, Lincolnshire IL MLA DL malic acid Universal Preserv-a- Chem, Edison, NJ SILWET Silicone copolyol Witco Corporation, L-7614 Greenwich, CT DIAFORMER aminoxide side-chain group Clariant Corporation, Z711, Z712, acrylate Charlotte, NC Z731, Z751 CELVOL 103, 98-98.8% hydrolyzed polyvinyl Celanese Ltd., 305, 321 Dallas, TX alcohol CELVOL 502, 88% hydrolyzed polyvinyl Celanese Ltd. 523 alcohol MACKAM coco betaine McIntyre Group Ltd., CB-35 University Park, IL THF tetrahydrofuran Sigma-Aldrich Fine Chemicals DI water deionized water CA citric acid Universal Preserv-a- Chem, Edison, NJ MDA mandelic acid Sigma-Aldrich Fine Chemicals MMB MMB glycol CBC (America) Corp. New York, NY TL10 NIKKOL TL-10 Barnet Products Corp., Englewood Cliffs, NJ TWEEN 20 ICI BRIJ 700 ICI PLURAFAC ceteareth 55 BASF Corporation A39 SURFONIC nonylphenolethoxylate having an Huntsman Corp., N-150 HLB of 15 Austin TX

#Inherent Viscosity (IV)

#The inherent viscosity of a polymer is measured in accordance with the protocol described by Fred Billmeyer, Jr. at pages 84-85 of the textbook entitled “Textbook of Polymer Science,” Second Edition, published by Wiley-Interscience (1971). Briefly, solution viscosity is measured by comparing the efflux time (t) required for a specified volume of polymer solution to flow through a capillary tube with the corresponding efflux time (t0) for the solvent. The measured variables t, t0, and solute concentration (c) are then used to calculate inherent viscosity (also know as Logarithmic Viscosity) using the equation: