WO1981000207A1 - Pharmaceutical preparation - Google Patents

Pharmaceutical preparation Download PDF

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Publication number
WO1981000207A1
WO1981000207A1 PCT/AU1980/000029 AU8000029W WO8100207A1 WO 1981000207 A1 WO1981000207 A1 WO 1981000207A1 AU 8000029 W AU8000029 W AU 8000029W WO 8100207 A1 WO8100207 A1 WO 8100207A1
Authority
WO
WIPO (PCT)
Prior art keywords
preparation
antiseptic
epidermis
disinfecting
absorbed
Prior art date
Application number
PCT/AU1980/000029
Other languages
French (fr)
Inventor
P Harrigan
Original Assignee
P Harrigan
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by P Harrigan filed Critical P Harrigan
Publication of WO1981000207A1 publication Critical patent/WO1981000207A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/18—Iodine; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/58—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. poly[meth]acrylate, polyacrylamide, polystyrene, polyvinylpyrrolidone, polyvinylalcohol or polystyrene sulfonic acid resin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions

Definitions

  • This invention concerns pharmaceu tical preparations for topical application to the skin in order to render the skin surface aseptic.
  • Bacteria and viruses are frequently tra nsm itted by one person to another by skin contact and especially by the transfer of facteria on the skin of the palms and fingers. This is an ever present risk in hospitals where doctors and nursing staff shoul d continually cleanse their hands when dealing with patients. However this frequent ly does not occur, whether for reasons of forgetfulness or pressure of time, and therefore the risk of transferring infection remains.
  • a preparation is therefore required which combines a microbicidal agent with the convenienve of lonh-actinh surface action, thereby affording the minimum number of applications over a period of time in order to overcome the human problems associated with the spresd of infection in this manner. It has been shown that mere surface cleansing of the epidermis is effective only for a short period because living organisms which inhabit the epidermal interstices are constantly rising to the surface thereof. Thus any surface application of surface active agents, bactericide s, fungicides and anti-viral drugs can only exert temporary action before necessary cleansing removes them.
  • This invention seeks to provide preparation for topical application wherein the presence of the active agents in the epidermis will be more difficult to dispel.
  • This invention provides a pharmaceutical preparation for topical application to the skin comprising a germicidally effective quantity of iodine. in a combined form and an agent for promoting the absorption and dispersal of the latter in the epidermis.
  • the iodine is elemental iodine in polyvinylpyrrolidone.
  • Sim ilarly polymeric suspensions of iodine are expected to be e qually effective.
  • This component of the preparation may be present as a 10-15% aqueous solution.
  • the reagent for promoting dispersal of the iodine and its absorption may be hyaluronidase or an organo -heparinoid. A quantity of lower than 7% of this enzyme suffices to give satisfactory penetrati on of the iodine.
  • An example of an organoheparinoid is a mucopolysaccaride polysulphuric acid ester.
  • a small quantity of a 0.5% solution of hyaluronidase is added to a 21 ⁇ 2% aqueous solution of Povidone-Iodine (Registered Trade Mark) which is a commonly available, form of iodine combined with polyninylpyrrolidone.
  • Povidone-Iodine Registered Trade Mark
  • This solution is dispersed in a standard hand cream fo rmulation, that is of the vanishing type.
  • the action of the cream softens the horny l ayer of the epidermis while the hyaluronidase promotes the penetration of the iodine , dissolving to a small extent the connective tissue which is directly beneath the horny layer.
  • This preparation therefore permits the use of element Iodine as a microbicide without harmful effects on the user, while the efficacy of its action is improved by its penetration below the skin's surface, both in terms of effec tiveness over time and by virtue of its action against sub-epithelial microbes.
  • This preparation caters for this problem by providing a method of perhaps once a day application of an antiseptic known to be effective against bacteria in general, funguses, yeasts, protozoa, viruses and veget ative organisms.
  • an antiseptic known to be effective against bacteria in general, funguses, yeasts, protozoa, viruses and veget ative organisms.
  • the minimisation of the number of times a preparation of this type is requrired to be applied, will cater for the failure to cleanse hands for any reason, and therefore reduce transfer of infection in this manner.

Abstract

A topical composition for rendering the skin aseptic, consisting of a combined form of iodine and an agent for promoting the absorption and dispersal of the composition in the epidermis.

Description

This invention concerns pharmaceu tical preparations for topical application to the skin in order to render the skin surface aseptic.
Bacteria and viruses are frequently tra nsm itted by one person to another by skin contact and especially by the transfer of facteria on the skin of the palms and fingers. This is an ever present risk in hospitals where doctors and nursing staff shoul d continually cleanse their hands when dealing with patients. However this frequent ly does not occur, whether for reasons of forgetfulness or pressure of time, and therefore the risk of transferring infection remains.
A preparation is therefore required which combines a microbicidal agent with the convenienve of lonh-actinh surface action, thereby affording the minimum number of applications over a period of time in order to overcome the human problems associated with the spresd of infection in this manner. It has been shown that mere surface cleansing of the epidermis is effective only for a short period because living organisms which inhabit the epidermal interstices are constantly rising to the surface thereof. Thus any surface application of surface active agents, bactericide s, fungicides and anti-viral drugs can only exert temporary action before necessary cleansing removes them. This invention seeks to provide preparation for topical application wherein the presence of the active agents in the epidermis will be more difficult to dispel.
"PHARMACEUTICAL PREPARATION"
The Invention is described in the following statement:- This invention provides a pharmaceutical preparation for topical application to the skin comprising a germicidally effective quantity of iodine. in a combined form and an agent for promoting the absorption and dispersal of the latter in the epidermis.
Preferably the iodine is elemental iodine in polyvinylpyrrolidone. Sim ilarly polymeric suspensions of iodine are expected to be e qually effective. This component of the preparation may be present as a 10-15% aqueous solution. The reagent for promoting dispersal of the iodine and its absorption may be hyaluronidase or an organo -heparinoid. A quantity of lower than 7% of this enzyme suffices to give satisfactory penetrati on of the iodine. An example of an organoheparinoid is a mucopolysaccaride polysulphuric acid ester. In addition there may be an agent to re duce the stai ning tendency of the iodine.
In one example of the invention a small quantity of a 0.5% solution of hyaluronidase is added to a 2½% aqueous solution of Povidone-Iodine (Registered Trade Mark) which is a commonly available, form of iodine combined with polyninylpyrrolidone.
This solution is dispersed in a standard hand cream fo rmulation, that is of the vanishing type. The action of the cream softens the horny l ayer of the epidermis while the hyaluronidase promotes the penetration of the iodine , dissolving to a small extent the connective tissue which is directly beneath the horny layer. This preparation therefore permits the use of element Iodine as a microbicide without harmful effects on the user, while the efficacy of its action is improved by its penetration below the skin's surface, both in terms of effec tiveness over time and by virtue of its action against sub-epithelial microbes.
Because of the failure of personnel dealing with infectious or infective material and environments to satisfac torily cleanse their hands, the problem of initiation and transfer of infection exists. This preparation caters for this problem by providing a method of perhaps once a day application of an antiseptic known to be effective against bacteria in general, funguses, yeasts, protozoa, viruses and veget ative organisms. The minimisation of the number of times a preparation of this type is requrired to be applied, will cater for the failure to cleanse hands for any reason, and therefore reduce transfer of infection in this manner.

Claims

The claims defining the invention are as follows: -
(1) Because of its formulation, namely the combination of the polyuinllpyrrolidone form of elemental iodine and a tissue dispersant agent, hyaluronidase or an organo-heparinoid, the preparation will be absorbed into the epidermis, a function not performed by any other avail able antiseptic or disinfecting preparation.
(2) Because it is absorbed into the epidermis the antiseptic and disinfecting action of the preparation is in effect prolonged over a period of time not presently possible by any other antiseptic or disinfecting agent.
(3) Because it is absorbed into the epidermis and possibly (to a lesser extent) into the dermis, the preparation will act against resident micro-organisms, which would otherwise rise tothe surface of the skin, thereby causing re-contamination. This sub-epithelial antiseptic and/or disinfecting action is not possible with presently available preparations.
PCT/AU1980/000029 1979-07-11 1980-07-03 Pharmaceutical preparation WO1981000207A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU9543/79 1979-07-11
AU954379 1979-07-11

Publications (1)

Publication Number Publication Date
WO1981000207A1 true WO1981000207A1 (en) 1981-02-05

Family

ID=3700291

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AU1980/000029 WO1981000207A1 (en) 1979-07-11 1980-07-03 Pharmaceutical preparation

Country Status (2)

Country Link
EP (1) EP0031827A1 (en)
WO (1) WO1981000207A1 (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0338589A2 (en) * 1988-04-22 1989-10-25 Fred Leroy Stoner Microbicidal cleanser/barrier kit for preventing the transmission of aids and other sexually transmitted diseases
US4996146A (en) * 1987-02-20 1991-02-26 Kessler Jack H Rapid sterilization enzymatic process with persistence

Citations (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2550622A (en) * 1947-07-11 1951-04-24 Benjamin Clayton Ointment base and iodine ointment
US2739922A (en) * 1952-03-13 1956-03-27 Herman A Shelanski Mixtures of polymeric n-vinyl pyrrolidone and halogens
US2776924A (en) * 1954-02-05 1957-01-08 Coty Inc Composition of matter containing polyvinylpyrrolidone and a fatty carrier
AU2077256A (en) * 1956-08-15 1957-02-21 General Aniline & Film Corporation Improvements in iodine complexes of copolymers of n-vinyl-2-pyrrolidones and nitrogen free vinyl and vinylidene compounds
US2976212A (en) * 1956-12-01 1961-03-21 Schenley Ind Inc Hyaluronidase with heparin or heparinoids in ointment compositions
US3152951A (en) * 1960-11-18 1964-10-13 Perlman Samuel Donald Germicidal composition of iodine and liquid lanolin
US3210248A (en) * 1963-09-04 1965-10-05 Merck & Co Inc Emollient gel comprising lanolin alcohol, microcrystalline wax and a liqquid fatty acid ester
US3472931A (en) * 1969-01-17 1969-10-14 Foster Milburn Co Percutaneous absorption with lower alkyl amides
US3728449A (en) * 1972-05-01 1973-04-17 West Laboratories Inc Germicidal iodine compositions for application to skin tissue including teats of milk animals
US3751562A (en) * 1972-09-22 1973-08-07 Princeton Biomedix Medicated gelled oils
FR2201881A1 (en) * 1972-06-28 1974-05-03 Manoil Jean Antiseptic creams for cows udders - contg. fat and halogen, protects against bacteria, weather and skin lesions and improves skin suppleness
GB1441364A (en) * 1974-02-19 1976-06-30 Diversey Ltd Iodophor compositions
CH582001A5 (en) * 1971-08-06 1976-11-30 Mundipharma Ag Solid iodine-contg germicidal detergents
US4012504A (en) * 1972-05-12 1977-03-15 Velvet Chemical Co. Iodine mineral oil solution for preventing bovine mastitis
FR2323393A1 (en) * 1975-09-12 1977-04-08 West Laboratories Inc Germicidal gels contg. iodine - in which the gelling agent is a block copolymer of ethylene and propylene oxides
US4017408A (en) * 1975-07-14 1977-04-12 Fults Elmer H Water soluble liquid iodine concentrate, aqueous iodine bacteriocidal solution and methods of making the same
DE2611701A1 (en) * 1976-03-18 1977-09-29 Josef Dipl Chem Dr Rer N Klosa Polyvinyl pyrrolidone and iodine adduct - used in deodorising space and cosmetic compsns.
CA1028242A (en) * 1975-02-20 1978-03-21 Diversey (Canada) Ltd. Iodophor compositions
GB1516653A (en) * 1974-08-09 1978-07-05 West Laboratories Inc Poloxamer-iodine gel
AU552439B2 (en) * 1981-12-14 1986-05-29 Lockheed Missiles & Space Company, Inc. Single stage high pressure centrifugal slurry pump

Patent Citations (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2550622A (en) * 1947-07-11 1951-04-24 Benjamin Clayton Ointment base and iodine ointment
US2739922A (en) * 1952-03-13 1956-03-27 Herman A Shelanski Mixtures of polymeric n-vinyl pyrrolidone and halogens
US2776924A (en) * 1954-02-05 1957-01-08 Coty Inc Composition of matter containing polyvinylpyrrolidone and a fatty carrier
AU2077256A (en) * 1956-08-15 1957-02-21 General Aniline & Film Corporation Improvements in iodine complexes of copolymers of n-vinyl-2-pyrrolidones and nitrogen free vinyl and vinylidene compounds
US2976212A (en) * 1956-12-01 1961-03-21 Schenley Ind Inc Hyaluronidase with heparin or heparinoids in ointment compositions
US3152951A (en) * 1960-11-18 1964-10-13 Perlman Samuel Donald Germicidal composition of iodine and liquid lanolin
US3210248A (en) * 1963-09-04 1965-10-05 Merck & Co Inc Emollient gel comprising lanolin alcohol, microcrystalline wax and a liqquid fatty acid ester
AU4939464A (en) * 1964-09-17 1966-03-17 Samuel Donald Perlman Germicidal composition
US3472931A (en) * 1969-01-17 1969-10-14 Foster Milburn Co Percutaneous absorption with lower alkyl amides
CH582001A5 (en) * 1971-08-06 1976-11-30 Mundipharma Ag Solid iodine-contg germicidal detergents
US3728449A (en) * 1972-05-01 1973-04-17 West Laboratories Inc Germicidal iodine compositions for application to skin tissue including teats of milk animals
US4012504A (en) * 1972-05-12 1977-03-15 Velvet Chemical Co. Iodine mineral oil solution for preventing bovine mastitis
FR2201881A1 (en) * 1972-06-28 1974-05-03 Manoil Jean Antiseptic creams for cows udders - contg. fat and halogen, protects against bacteria, weather and skin lesions and improves skin suppleness
US3751562A (en) * 1972-09-22 1973-08-07 Princeton Biomedix Medicated gelled oils
GB1441364A (en) * 1974-02-19 1976-06-30 Diversey Ltd Iodophor compositions
GB1516653A (en) * 1974-08-09 1978-07-05 West Laboratories Inc Poloxamer-iodine gel
CA1028242A (en) * 1975-02-20 1978-03-21 Diversey (Canada) Ltd. Iodophor compositions
US4017408A (en) * 1975-07-14 1977-04-12 Fults Elmer H Water soluble liquid iodine concentrate, aqueous iodine bacteriocidal solution and methods of making the same
FR2323393A1 (en) * 1975-09-12 1977-04-08 West Laboratories Inc Germicidal gels contg. iodine - in which the gelling agent is a block copolymer of ethylene and propylene oxides
DE2611701A1 (en) * 1976-03-18 1977-09-29 Josef Dipl Chem Dr Rer N Klosa Polyvinyl pyrrolidone and iodine adduct - used in deodorising space and cosmetic compsns.
AU552439B2 (en) * 1981-12-14 1986-05-29 Lockheed Missiles & Space Company, Inc. Single stage high pressure centrifugal slurry pump

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
Acta Dermatovzer (Stockholm), Supplement 73, issued 1973, TATSUYA OHKUBO and SHIGEHARU SANO, "Functional Aspects of Dermo-Epidermal Junction", pages 121 - 128. *
K. Meyer and M.M. Rapport, 'Advances in Enzymology' (Editor: F.F. Nord), Volume XIII, published 1952, by Interscience Publishers Inc. (New York), see pages 224 - 226. *
The American Journal of Surgery, Volume 132, issued 1976, July, G. Rodeheaver, V. Turnbull, M.T. Edgerton, L. Kurtz and R.F. Edlich, "Pharmacokinetics of New Skin Wound Cleanser", pages 67 - 74. *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4996146A (en) * 1987-02-20 1991-02-26 Kessler Jack H Rapid sterilization enzymatic process with persistence
EP0338589A2 (en) * 1988-04-22 1989-10-25 Fred Leroy Stoner Microbicidal cleanser/barrier kit for preventing the transmission of aids and other sexually transmitted diseases
EP0338589A3 (en) * 1988-04-22 1990-11-28 Fred Leroy Stoner Microbicidal cleanser/barrier kit for preventing the transmission of aids and other sexually transmitted diseases

Also Published As

Publication number Publication date
EP0031827A1 (en) 1981-07-15

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