EP1519718A1 - Feuilles au moins partiellement degradables contenant un principe actif et procede de fabrication desdites feuilles - Google Patents

Feuilles au moins partiellement degradables contenant un principe actif et procede de fabrication desdites feuilles

Info

Publication number
EP1519718A1
EP1519718A1 EP03730175A EP03730175A EP1519718A1 EP 1519718 A1 EP1519718 A1 EP 1519718A1 EP 03730175 A EP03730175 A EP 03730175A EP 03730175 A EP03730175 A EP 03730175A EP 1519718 A1 EP1519718 A1 EP 1519718A1
Authority
EP
European Patent Office
Prior art keywords
film according
active ingredient
film
production
active
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Withdrawn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
EP03730175A
Other languages
German (de)
English (en)
Inventor
Günter Helling
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.)
AgfaPhoto GmbH
Original Assignee
AgfaPhoto GmbH
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 AgfaPhoto GmbH filed Critical AgfaPhoto GmbH
Publication of EP1519718A1 publication Critical patent/EP1519718A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Definitions

  • the invention relates to an agent containing at least one active ingredient, with which an exact, controlled and controllable release of the at least one active ingredient is possible.
  • Active substances are understood to mean low molecular weight, organic compounds which have a desired effect after their release from the agent, in particular a pharmacological or biocidal effect.
  • Active pharmaceutical ingredients are offered in a variety of dosage forms, which should make it possible for the active pharmaceutical ingredient to be able to develop its effect at the desired location in the organism at the desired time and in the desired dosage. These goals could not always be achieved with the known dosage forms.
  • This object is achieved according to the invention by a film containing the at least one active ingredient, which is at least partially degraded under the conditions of the site of action.
  • the film preferably consists of biological material, for example of an optionally partially degraded polypeptide, in particular of gelatin.
  • the biological material is preferably degraded enzymatically at the site of action and thus releases the at least one active ingredient stored in it.
  • the biological material of the film can be modified, for example by aqueous polymer latices or polymer dispersions, by water-soluble, optionally crosslinkable polymers or copolymers or protein derivatives. Examples of this are in Res. Discl. 38 957 (1996) on p. 598, Chapter II A and Chapter II C described, the z. B. contain a polyacrylamide, a polyacrylic acid derivative, a polyvinylpyrrolidone, a polyvinyl alcohol, a polyvinylimidazole, a polyethylene oxide, a polystyrene sulfonic acid or a cellulose derivative.
  • the biological material can be further hardened to different degrees, that is, cross-linked, e.g. B.
  • the films made of biological material, especially gelatin have many advantages: They can be any biological material, especially gelatin. They can be any biological material, especially gelatin.
  • the production takes place in particular in that the biological material on which the films are based is poured as an aqueous solution onto a carrier film by means of a suitable pouring device and is removed after drying. This is advantageously carried out continuously with a cascade or a curtain caster.
  • Suitable carrier films are, in particular, cellulose acetate film and paper coated on both sides with polyethylene, both of which are known as carrier materials for photographic materials. Films made of polyester (PET or PEN) and polycarbonate are also suitable.
  • the carrier films are not equipped with substrate or adhesive layers, which are known to bind the subsequent cast layers to the carrier film, since the cast layer is to be removed after production.
  • the active ingredients are added to the casting solutions and thus incorporated into the later films. An exact dosage is possible. Furthermore, the active ingredient z. B. distributed in a specific environment, for example in a solution in a high-boiling organic solvent, which is in the aqueous
  • Casting solution is emulsified.
  • the active ingredient can also be introduced in the form of a loaded latex.
  • a latex is impregnated or loaded with the water-soluble active ingredient. This insertion method is for photographic color couplers in Res. Discl. 38 957 (1996), p.
  • the film according to the invention can consist of several layers. This is advantageous if at least two active ingredients which are incompatible with one another are to be contained in a film, since they can be introduced in different layers. It is also possible to provide active substances in different concentrations in the different layers, in order to enable a targeted release of the active substance in different amounts during later use.
  • the film can be cut into small and very small parts and applied in this way, be it in one of these parts containing solid or liquid dosage form, for example in a tablet or in a juice.
  • the release occurs through degradation of the film substance, in the case of gelatin film through enzymatic degradation, in particular through an enzyme of the organism that is to be treated with the active ingredient, for example with trypsin.
  • Betaxolol and 90.0 g of olive oil are dissolved in 80 g of ethyl acetate and emulsified in an aqueous solution of 6.0 g of gelatin, 350 g of water and 0.5 g of dodecylbenzenesulfonate using an emulsifier at 40 ° C. within 12 minutes , The ethyl acetate is evaporated and an O / W emulsion is obtained, which is made up to 500 g with water.
  • emulsion 1 160 g of emulsion 1 are mixed at 40 ° C. with 66 g of 20% by weight gelatin, 90 g of water and 4.0 g of 10% by weight dioctyl sulfosuccinate, sodium salt solution (wetting agent) and water to 350 g filled up.
  • pouring solution 2 160 g of emulsion 1 are mixed at 40 ° C. with 66 g of 20% by weight gelatin, 90 g of water and 4.0 g of 10% by weight dioctyl sulfosuccinate, sodium salt solution (wetting agent) and water to 350 g filled up.
  • pouring solution 2 160 g of emulsion 1 are mixed at 40 ° C. with 66 g of 20% by weight gelatin, 90 g of water and 4.0 g of 10% by weight dioctyl sulfosuccinate, sodium salt solution (wetting agent) and water to 350 g filled up.
  • Pouring solution 2 160 g of e
  • 160 g of emulsion 2 are mixed at 40 ° C. with 70 g of 20% by weight gelatin, 90 g of water and 4.0 g of 10% by weight dioctyl sulfosuccinate, sodium salt solution (wetting agent) and water Replenished 350 g.
  • a cascade caster known from the manufacture of photographic materials is used to add a non-subbed polyethylene terephthalate film
  • the application is chosen so that after drying at 50 ° C a dressing of 3 layers with layer applications of
  • Sample 2 contains metipranolol and betaxolol
  • the test shows that the pieces of film selectively release the active substances one after the other by enzymatic degradation.

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Nouvelle forme d'administration de principes actifs, en particulier de principes actifs à action pharmacologique ou biocide, qui se présente sous forme d'une feuille contenant au moins un principe actif, ladite feuille étant au moins partiellement dégradée sous l'effet des conditions du site d'action.
EP03730175A 2002-05-24 2003-04-04 Feuilles au moins partiellement degradables contenant un principe actif et procede de fabrication desdites feuilles Withdrawn EP1519718A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10223435 2002-05-24
DE10223435 2002-05-24
PCT/EP2003/050092 WO2003099263A1 (fr) 2002-05-24 2003-04-04 Feuilles au moins partiellement degradables contenant un principe actif et procede de fabrication desdites feuilles

Publications (1)

Publication Number Publication Date
EP1519718A1 true EP1519718A1 (fr) 2005-04-06

Family

ID=29557316

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03730175A Withdrawn EP1519718A1 (fr) 2002-05-24 2003-04-04 Feuilles au moins partiellement degradables contenant un principe actif et procede de fabrication desdites feuilles

Country Status (6)

Country Link
US (1) US20060134184A1 (fr)
EP (1) EP1519718A1 (fr)
JP (1) JP2005531569A (fr)
CN (1) CN1655771A (fr)
AU (1) AU2003240762A1 (fr)
WO (1) WO2003099263A1 (fr)

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU528190B2 (en) * 1978-11-07 1983-04-21 Pfizer Inc. Device for oral administration of drugs to ruminant animals
JPS5647761A (en) * 1979-09-27 1981-04-30 Fuji Photo Film Co Ltd Laminated analyzing piece and immunity analyzing method using the same
EP0447719B1 (fr) * 1990-03-05 1993-11-03 Minnesota Mining And Manufacturing Company Dispositif de libération prolongée d'agents pharmacologiquement actifs dans l'oreille
GB2280850B (en) * 1993-07-28 1997-07-30 Johnson & Johnson Medical Absorbable composite materials for use in the treatment of periodontal disease
US5800832A (en) * 1996-10-18 1998-09-01 Virotex Corporation Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces
DE19646392A1 (de) * 1996-11-11 1998-05-14 Lohmann Therapie Syst Lts Zubereitung zur Anwendung in der Mundhöhle mit einer an der Schleimhaut haftklebenden, Pharmazeutika oder Kosmetika zur dosierten Abgabe enthaltenden Schicht
DE19960154A1 (de) * 1999-12-14 2001-07-12 Lohmann Therapie Syst Lts Flache Arzneizubereitung zur transmucosalen Verabreichung von Oxycodon oder einem vergleichbaren Wirkstoff in der Mundhöhle, für die Anwendung in der Schmerztherapie und Suchttherapie
WO2003020191A1 (fr) * 2001-09-04 2003-03-13 University Of Iowa Research Foundation Membranes a base de celluloses pour echafaudages biodegradables
US7204994B2 (en) * 2003-02-03 2007-04-17 Ashland Licensing And Intellectual Property Llc Juvenile hormone compositions and methods for making same

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO03099263A1 *

Also Published As

Publication number Publication date
US20060134184A1 (en) 2006-06-22
WO2003099263A1 (fr) 2003-12-04
CN1655771A (zh) 2005-08-17
AU2003240762A1 (en) 2003-12-12
JP2005531569A (ja) 2005-10-20

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