EP0804208A1 - Polivinylpyrrolydon-jod ebthaltende brausemischung und ihre verwendung zur desinfektion - Google Patents

Polivinylpyrrolydon-jod ebthaltende brausemischung und ihre verwendung zur desinfektion

Info

Publication number
EP0804208A1
EP0804208A1 EP96902310A EP96902310A EP0804208A1 EP 0804208 A1 EP0804208 A1 EP 0804208A1 EP 96902310 A EP96902310 A EP 96902310A EP 96902310 A EP96902310 A EP 96902310A EP 0804208 A1 EP0804208 A1 EP 0804208A1
Authority
EP
European Patent Office
Prior art keywords
composition according
pvpi
composition
effervescent
polyvinylpyrrolidone
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP96902310A
Other languages
English (en)
French (fr)
Inventor
Jérome Besse
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Galenix Developpement
Original Assignee
Mission SC
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 Mission SC filed Critical Mission SC
Publication of EP0804208A1 publication Critical patent/EP0804208A1/de
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/74Synthetic polymeric materials
    • A61K31/785Polymers containing nitrogen
    • A61K31/787Polymers containing nitrogen containing heterocyclic rings having nitrogen as a ring hetero atom
    • A61K31/79Polymers of vinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A01AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01NPRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N59/00Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
    • A01N59/12Iodine, e.g. iodophors; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/56Medicinal 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
    • A61K47/58Medicinal 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007Effervescent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders

Definitions

  • Effervescent composition based on iodized polyvinylpyrrolidone and use for disinfection
  • the present invention relates to an effervescent composition based on iodized polyvinylpyrrolidone.
  • Iodine has long been used in various pharmaceutical forms (solution, tincture) for the fine disinfection of small wounds. Despite the good effectiveness of the product, its application is limited because it has a number of side effects.
  • PVPI Iodized polyvinylpyrrolidone
  • PVP polyvinylpyrrolidone
  • iodine contained in the complex is released slowly and gradually.
  • PVPI is characterized by a wide range of applications. The main areas of use are in the field of prophylaxis: - hand disinfection, in particular in surgery,
  • This compound is a broad spectrum antiseptic: - bactericide on all bacteria including chlamydiae and mycoplasmas,
  • PVPI polyvinylpyrrolidone
  • PVPI tablets have already been described, but specifically for mucoadhesive and local use.
  • PVPI tablets have the significant drawback of dissolving very slowly in aqueous media.
  • compositions containing in particular an iodine carrier which can be polyvinylpyrrolidone, an iodide or an iodine compound, an oxidizing agent, an acid and a base in the form of powders. These last two compounds form an effervescent couple.
  • this composition does not include iodized polyvinylpyrrolidone, which is a complex which it is necessary to form before integrating it into a composition.
  • this composition does not contain a disintegrating agent, and therefore is not susceptible to be used to make PVPI solutions extemporaneously, but only to form foams, as indicated in these abstracts.
  • Patent GB-A-2,108,386 (AUCHINCLOSS) describes compositions in dry form containing an iodine source, such as a polyvinylpyrrolidone and iodine complex, a non-reducing acid and a surfactant capable of combine with iodine to form an iodophore.
  • an iodine source such as a polyvinylpyrrolidone and iodine complex
  • a non-reducing acid such as sodium bicarbonate
  • a surfactant capable of combine with iodine to form an iodophore.
  • PCT / GB 90 01 423 discloses a composition comprising an inorganic water-soluble halide, a strong oxidizing agent, which will react with the halide in order to generate hypohalogenic ions, sulfamic acid, and a water-soluble carbonate or bicarbonate in order to produce, in reaction with the acid, an effervescent effect.
  • a disintegrating agent is not mentioned in this application, which preferably relates to chlorine-based tablets.
  • compositions containing PVPI While allowing extemporaneous, reproducible preparation, and easy to use solutions of PVPI.
  • the present invention therefore relates to an effervescent composition for the extemporaneous preparation of PVPI solutions comprising in synergistic amounts:
  • compositions object of the present invention have the advantage of dissolving in less than 10 minutes, and generally in three to five minutes, which allows an extemporaneous preparation of PVPI solution unlike the compositions described in the state of the art. which do not contain a disintegrating agent. They also make it possible to obtain reproducible levels of iodine in solution.
  • effervescent agent and disintegrating agent are meant substances meeting the definitions given by Le Hir in "Pharmacy Abstract Galenic "(Masson Editions; 5th edition).
  • Such a composition advantageously comprises by weight, from 0.1 to 99%, preferably from 10% to 90%, and even more preferably from 20% to 60% of PVPI relative to the total weight of the composition.
  • Said effervescent agent is advantageously a pair comprising on the one hand citric acid and on the other hand carbonic acid, or their derivatives. It can nevertheless be any combination of organic acid / carbonate substances, making it possible to obtain an effervescence.
  • the citric acid derivatives which can be used in such a couple are in particular monosodium citrate, or citric acid monohydrate or anhydrous.
  • a derivative of carbonic acid can be monosodium carbonate.
  • the citric acid and carbonic acid, or their derivatives are advantageously contained in substantially identical amounts.
  • the disintegrating agent may be a substance having a structural similarity to PVPI, in particular a crosslinked polyvinylpyrrolidone (PVP), or a crosslinked carboxymethylcellulose. It can nevertheless be any other substance or mixture of substances having a disintegrating effect as defined above.
  • a composition according to the present invention comprises by weight from 40 to 60% of effervescent agent and from 2 to 10%, preferably from 4 to 6% of disintegrating agent.
  • the composition is in the form of powder, granules, or tablets.
  • the present invention may also contain, without being essential, a system buffer at a pH close to 6, in order to limit the degradation of PVPI.
  • a buffering effect is produced by salts such as KH 9 PO4 or by sodium hydroxide.
  • a water-repellent substance can also be contained in the composition, in order to prevent it from being degraded by moisture.
  • Such a water-repellent substance may for example be colloidal silica.
  • the composition according to the invention can also contain one or more surfactants.
  • composition is in the form of granules formed:
  • the present invention also relates to the use of a composition as described above for the disinfection of the skin and mucous membranes.
  • compositions also have the advantage of having an industrial cost price much lower than the cost price of the PVPI. It has been estimated that their cost price is at least 30% lower than that of the solutions.
  • the tablets according to the present invention can be obtained by a process in which the PVPI and the effervescent agent are mixed, then the disintegrating agent and the other constituents of the tablet are introduced.
  • the tablet is then shaped using a tablet press. The whole process must be carried out in a dry place.
  • Granules according to the present invention can be obtained by a process similar to that of tablets, the step of compressing the tablets being replaced by a step of compaction then of granulation, for example on an ERWEKA AR 400 machine.
  • Granules with internal and external phases according to the invention can be obtained by a wet granulation process in which:
  • the internal phase consists of PVPI with possibly a surfactant and an effervescent couple
  • step (3) Add to the mixture of step (2) the previously sieved colloidal silica plus the disintegrant.
  • Humidity 3 g of water per m 3 of dry air, i.e. 20% relative humidity at 20 * C.
  • PVPI PVPI (PVP iodine) 30/06 46.70
  • anhydrous citric acid is replaced, for equivalent weight, by citric acid monohydrate.
  • wetting solution (1) In a suitable container pour the surfactant.
  • step (3) Pour the grain from step (3) in a thin layer on an oven tray.
  • step (5) Granulate the grain of step (5) using an oscillating granulator type ERWEKA AR 400 or equivalent on a grid with a diameter of 800 ⁇ m.
  • step (8) Calibrate the grain obtained in step (7) on an 800 ⁇ m sieve.
  • step (11) Mix 5 minutes at 50 RPM. (12) Introduce the lubricant previously sieved to the mixture of step (11) and mix for 3 minutes.
  • Nonoxymol can be replaced by Cremophor, Tween 80 or any other equivalent surfactant.
  • lactose can be added to the components of this layer.
  • compositions Two types of compositions, one containing a disintegrating agent, crosslinked PVP (polyplasdone XL), and the other devoid of this agent, called respectively GAL 01.16 and GAL 01.17 were produced by direct compression as described in Example 1 .
  • PVP polyplasdone XL

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Wood Science & Technology (AREA)
  • Pest Control & Pesticides (AREA)
  • Zoology (AREA)
  • Plant Pathology (AREA)
  • Inorganic Chemistry (AREA)
  • Dentistry (AREA)
  • Agronomy & Crop Science (AREA)
  • Environmental Sciences (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP96902310A 1995-01-30 1996-01-30 Polivinylpyrrolydon-jod ebthaltende brausemischung und ihre verwendung zur desinfektion Withdrawn EP0804208A1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR9501047 1995-01-30
FR9501047A FR2729858B1 (fr) 1995-01-30 1995-01-30 Composition effervescente a base de polyvinylpyrrolidone iodee et utilisation pour la desinfection
PCT/FR1996/000157 WO1996023510A1 (fr) 1995-01-30 1996-01-30 Composition effervescente a base de polyvinylpyrrolidone iodee et utilisation pour la desinfection

Publications (1)

Publication Number Publication Date
EP0804208A1 true EP0804208A1 (de) 1997-11-05

Family

ID=9475639

Family Applications (1)

Application Number Title Priority Date Filing Date
EP96902310A Withdrawn EP0804208A1 (de) 1995-01-30 1996-01-30 Polivinylpyrrolydon-jod ebthaltende brausemischung und ihre verwendung zur desinfektion

Country Status (7)

Country Link
US (1) US5846564A (de)
EP (1) EP0804208A1 (de)
JP (1) JPH10513170A (de)
AU (1) AU4667396A (de)
CA (1) CA2211586A1 (de)
FR (1) FR2729858B1 (de)
WO (1) WO1996023510A1 (de)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0872544A1 (de) * 1997-04-14 1998-10-21 The Procter & Gamble Company Trockene Brausegranulate und dessen Verwendung in granulierten Zusammensetzungen
US6974590B2 (en) 1998-03-27 2005-12-13 Cima Labs Inc. Sublingual buccal effervescent
US20030091629A1 (en) 1998-03-27 2003-05-15 Cima Labs Inc. Sublingual buccal effervescent
RU2145860C1 (ru) * 1999-08-16 2000-02-27 Хозяйственное общество с ограниченной ответственностью Намус Способ получения йодовидона
US7147873B2 (en) * 2002-01-16 2006-12-12 3M Innovative Properties Company Antiseptic compositions and methods
US7858121B2 (en) 2003-12-31 2010-12-28 Cima Labs, Inc. Effervescent oral fentanyl dosage form and methods of administering fentanyl
CA2549642C (en) 2003-12-31 2012-10-30 Cima Labs Inc. Effervescent oral opiate dosage forms and methods of administering opiates
DE602004031462D1 (de) 2003-12-31 2011-03-31 Cima Labs Inc Allgemein lineare brauseform von fentanyl zur oralen anwendung und verfahren zur verabreichung
US20060246027A1 (en) * 2005-05-02 2006-11-02 Tanner Paul R Personal care composition
FR2900795B1 (fr) * 2006-05-15 2011-04-29 Solutio Lab Formulation detergente et desinfectante sous forme solide divisee contenant a titre de principe actif une association pvp iodee/iodure de potassium
WO2011089584A1 (en) * 2010-01-25 2011-07-28 Modi-Mundipharma Pvt. Ltd Process for the preparation of a granular oral composition
WO2016015691A1 (en) 2014-07-30 2016-02-04 Albert SARKESSYAN A pharmaceutical composition having antibacterial and virucidal effects
JP6955784B2 (ja) * 2017-07-04 2021-10-27 フルケム リミテッドFluchem Ltd 水溶解性が向上されたヨード剤及び塩化ナトリウムを含む固体組成物及びその水溶液を含む目、口腔用、鼻腔用又は吸入用抗ウイルス及び抗菌組成物
IT202100003764A1 (it) * 2021-02-18 2022-08-18 Diego Zito Detergente biocida

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3136692A (en) * 1961-06-30 1964-06-09 Strong Cobb Arner Inc Effervescent composition containing polyvinylpyrrolidone
GB2108386B (en) * 1981-10-26 1985-11-27 Auchincloss Thomas R Iodine-containing disinfectant compositions
JPS63225308A (ja) * 1986-04-03 1988-09-20 Sanyo Chem Ind Ltd 固形ヨ−ドホ−ル組成物
US5089606A (en) * 1989-01-24 1992-02-18 Minnesota Mining And Manufacturing Company Water-insoluble polysaccharide hydrogel foam for medical applications
GB8920973D0 (en) * 1989-09-15 1989-11-01 Auchincloss Thomas R Effervescent tablets

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9623510A1 *

Also Published As

Publication number Publication date
AU4667396A (en) 1996-08-21
JPH10513170A (ja) 1998-12-15
FR2729858A1 (fr) 1996-08-02
WO1996023510A1 (fr) 1996-08-08
US5846564A (en) 1998-12-08
FR2729858B1 (fr) 1997-04-18
CA2211586A1 (fr) 1996-08-08

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