EP1959921A2 - Cachet alveolaire constitue de copolymere greffe d'alcool polyvinylique et de polyethyleneglycol - Google Patents

Cachet alveolaire constitue de copolymere greffe d'alcool polyvinylique et de polyethyleneglycol

Info

Publication number
EP1959921A2
EP1959921A2 EP06818972A EP06818972A EP1959921A2 EP 1959921 A2 EP1959921 A2 EP 1959921A2 EP 06818972 A EP06818972 A EP 06818972A EP 06818972 A EP06818972 A EP 06818972A EP 1959921 A2 EP1959921 A2 EP 1959921A2
Authority
EP
European Patent Office
Prior art keywords
dosage form
form according
gas
cavities
polyvinyl alcohol
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.)
Ceased
Application number
EP06818972A
Other languages
German (de)
English (en)
Inventor
Markus Krumme
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.)
LTS Lohmann Therapie Systeme AG
Original Assignee
LTS Lohmann Therapie Systeme AG
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 LTS Lohmann Therapie Systeme AG filed Critical LTS Lohmann Therapie Systeme AG
Publication of EP1959921A2 publication Critical patent/EP1959921A2/fr
Ceased 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • 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
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/465—Nicotine; Derivatives thereof
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A61K9/122—Foams; Dry foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/34—Tobacco-abuse
    • 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
    • A61K9/0031—Rectum, anus
    • 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
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • 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
    • A61K9/0043—Nose

Definitions

  • Buccal or sublingual tablets are usually used to administer active substances via the oral mucosa
  • Medication can be administered orally that the
  • the onset of action occurs quickly due to bypassing the gastrointestinal passage and that the active substance utilization is high.
  • wafers Dosage forms known, which are referred to as "wafers".
  • the device should have a thickness of 3 to 4.5 mm and its solubility should be adjustable so that it has dissolved within 5 to 60 seconds after administration.
  • This device should also be able to be in the form of a laminate which has cavities foamed with gas.
  • Gelatin polysaccharide carriers described can also be used in the form of wafers. Measures to
  • WO 98/26764 describes an active substance-containing and film-like dosage form which disintegrates rapidly on contact with liquid, in which a fat-soluble phase in the form of liquid droplets is distributed in an outer water-soluble phase.
  • Oral mucosa can adhere to release antixnikrobial substances and to reduce the number of undesirable microorganisms in the oral flora.
  • Substances are essential oils that are preferred as a lipophilic phase with pullulan
  • Matrix material are mixed in the aqueous phase.
  • US 2001/006677 discloses film-like, foaming and water-soluble or swellable dosage forms which easily adhere to the oral mucosa.
  • WO 02/02085 describes rapidly disintegrating dosage forms for releasing active substances in the mouth or other body openings, the dosage form having a matrix which contains at least one water-soluble polymer as the base substance and which is provided with cavities.
  • WO 2004/060298 describes rapidly dissolving films for the oral administration of pharmaceutical
  • Active ingredients comprising a polyvinyl alcohol-polyethylene glycol graft copolymer and an active ingredient.
  • WO 2005/009386 discloses rapidly dissolving films which are suitable for oral applications of cosmetic or
  • active pharmaceutical ingredients can be used. These films are based on a polyvinyl alcohol-polyethylene glycol graft copolymer.
  • the known wafers tend to adhere to the palate or other mucous membrane surfaces of the mouth
  • Oral mucosa creates an uncomfortable or disturbing sensation in the oral cavity in the person concerned, which is referred to as "mouthfeel"
  • WO 02/02085 To improve the sensations caused in the oral cavity, it was proposed with WO 02/02085 to provide spaces or cavities in a polymeric matrix of the dosage form in a sheet-like dosage form which rapidly disintegrates or dissolves in an aqueous environment, the contents of the spaces / cavities being different differs from that of the matrix in terms of its aggregate state.
  • studies have shown that the "mouthfeel" of a surface-shaped dosage form according to WO 02/02085 is still in need of improvement, and therefore also sensitive
  • the present invention was therefore based on the object of providing a dosage form in the form of a surface
  • the present invention was therefore also based on the object of a method for producing
  • sheet-like dosage forms present in the form of solidified foams and rapidly disintegrating or rapidly dissolving in an aqueous environment, for releasing active substances in body openings, which takes into account the disadvantages of the known production processes avoids or at least reduces energy costs and / or process times.
  • the objects are surprisingly achieved by providing a sheet-like sealing mold, in which the polymer matrix in the form of a solidified foam consists of polyvinyl alcohol-polyethylene glycol graft copolymer, or by providing a method in which a polyvinyl alcohol-polyethylene glycol graft copolymer is used to produce a solidified foam for the at least one active substance sheet-like
  • the dosage form according to the invention is a sheet-like dosage form which disintegrates or dissolves in an aqueous environment for releasing at least one active ingredient in a body opening or body cavity, comprising a matrix which is in the form of a solidified foam having spaces or cavities, and at least one pharmaceutical foam or cosmetic active ingredient.
  • a sheet-like dosage form which disintegrates or dissolves in an aqueous environment for releasing at least one active ingredient in a body opening or body cavity, comprising a matrix which is in the form of a solidified foam having spaces or cavities, and at least one pharmaceutical foam or cosmetic active ingredient.
  • the spaces or cavities of the foam are filled with a gas, a gas mixture, a liquid or a liquid mixture.
  • the dosage form according to the invention is characterized in that the polymer of the matrix is a polyvinyl alcohol-polyethylene glycol graft copolymer.
  • a preferred polyvinyl alcohol-polyethylene glycol graft copolymer is the polyvinyl alcohol-polyethylene glycol graft copolymer sold under the name Kollicoat® IR (BASF AG, Ludwigshafen), which consists of 75%
  • Kollicoat® IR is a water-soluble polymer that can be used as a coating for tablets or as a film former in sprays and transdermal therapeutic systems.
  • Dosage forms can each be present in isolation from one another in the polymer matrix, preferably in the form of
  • the spaces or cavities are connected to one another, preferably by forming a coherent channel system penetrating the matrix.
  • the spaces or cavities have a share of 5 to 98%, preferably 50 to 80%, based on the total volume of the dosage form.
  • the spaces or cavities are preferably filled with gas or a gas mixture, particularly preferably with air. But it can also be advantageous if the rooms or
  • Cavities contain other gases or gas mixtures.
  • Spaces / cavities are preferably filled with an inert gas, i.e. H. with a gas or gas mixture that does not react with other components of the dosage form.
  • an inert gas i.e. H. with a gas or gas mixture that does not react with other components of the dosage form.
  • Particularly preferred gases are nitrogen, carbon dioxide and helium, and a mixture of these gases or two of these gases.
  • the spaces or cavities are filled with a liquid or a liquid mixture (for example an oil), these liquids being immiscible with the matrix material and not dissolving the polymer structure of the matrix.
  • a liquid or a liquid mixture for example an oil
  • the liquid or the liquid mixture can also contain one or more pharmaceutical and / or cosmetic active ingredients.
  • the intended adhesion-reducing effect is brought about in the dosage form according to the invention without the active ingredient absorption capacity of the dosage form being restricted too much.
  • Another important parameter which influences the properties of the dosage forms according to the invention is the diameter of the cavities or bubbles.
  • the bubbles or cavities are preferably created using a
  • the diameter of the bubbles can be set in a wide range, almost arbitrarily.
  • the diameter of the bubbles or voids can range from 0.01 to 50 ⁇ m; bubbles / cavities with a diameter between 0.1 and 10 ⁇ m are preferred.
  • the cavities of the dosage forms according to the invention are free of active ingredient.
  • the spaces or cavities contain active ingredients, auxiliaries and / or additives in order to be able to achieve certain effects.
  • Particularly preferred substances that can be contained in the spaces / cavities are surfactants or gas-forming
  • the surfaces of the dosage form are uneven or irregularly shaped, preferably wavy or relief-like, or they are provided with a structured surface.
  • a Irregular surface structure can be caused, for example, by the bubble-shaped introduced into the polymer matrix
  • Cavities themselves are caused, and / or by a subsequent special drying treatment.
  • the dosage forms according to the invention are thin,
  • the thickness of the dosage form is preferably 0.1 to 5 mm, particularly preferably 0.5 to 1 mm.
  • the lower limit for the thickness of the dosage forms is approximately 50 ⁇ m.
  • Therapeutically active compounds can be used as active substances, without limitation. These can come from the following groups: agents for infection treatment;
  • Antivirals such as fentanyl, sufentanil,
  • Antihistamines Antidiarrheals; Anti-migraines, itching, nausea and nausea; Motion sickness such as scopolamine and ondansetron; Parkinson drugs;
  • Antipsychotics Antipyretics, antispasmodics,
  • Anticholinergics such as ranitidine,
  • Sympathomimetics Calcium channel blockers such as nifedipine; Beta blockers; Beta agonists such as dobutamine; Antiarrhythmics;
  • Antihypertensives such as atenolol; ACE inhibitors such as enalapril;
  • Benzodiazepine agonists such as flumazenil; coronary, peripheral and cerebral vasodilators; Stimulation for that
  • Nicotine can be pharmaceutical not only in the form of its free base, but also in the form of one or more of it
  • suitable salts of nicotine are, for example
  • Nicotine bitartrate nicotine hydrochloride
  • Nicotine dihydrochloride nicotine sulfate, nicotine zinc chloride double salt and nicotine salicylate. Nicotine polacrilin is also a potential source of nicotine.
  • the active substance content per dosage unit is up to 50 mg, preferably up to 30 mg, particularly preferably up to 20 mg.
  • Polishing agents such as titanium dioxide, silicon dioxide, etc .; Sodium fluoride, dicalcium phosphate;
  • essential oils such as anise oil, fennel oil, eucalyptus oil,
  • Thyme oil lemon oil, etc .
  • the dosage forms according to the invention are therefore also suitable for cosmetic purposes and for applications in the field of dental care, tooth cleaning, oral hygiene or dental hygiene.
  • Chocolate aroma can be contained in the dosage form, each individually or in combination.
  • One or more sweeteners may also be added, e.g. B. sucralose, aspartame, cyclamate, saccharin and acesulfame, and their salts.
  • the auxiliary ⁇ come, among others, to the expert
  • Chicken egg white, alginates, bridge or brij an emulsifier
  • isopropanol benzyl alcohol, ethyl acetate, ethyl citrate,
  • a sugar (or a mixture of sugars) or at least one other carbohydrate material can also be dissolved in the foam.
  • the sugar or carbohydrate increases the mass that the foam has after drying.
  • drying and crystallization of the sugar or other carbohydrates gives the dried foam additional strength and stability.
  • the sugar or other carbohydrates can cause a sweet taste sensation in the dried foam or otherwise improve the organoleptic properties of the foam. Examples of sugar in the
  • composition can be contained are maltose,
  • Lactose sucrose, dextrose (glucose) and trehalose.
  • Sugar alcohols such as mannitol, sorbitol, xylitol, maltitol and the like are also suitable. As examples for others
  • Carbohydrates include maltodextrins, corn syrup, soluble starches, and the like.
  • the dosage form according to the invention is intended in particular for oral administration, but is not restricted to the administration of active substances in the area of the oral cavity. Rather, the invention extends to dosage forms that are in other body cavities or
  • Body openings can be introduced to the in there release active ingredients contained in them.
  • the active ingredient released from the dosage form is either absorbed at the application site, e.g. B. via the oral mucosa, or it is transported and resorbed in another place (z. B. after swallowing the drug released in the oral cavity in the gastrointestinal tract).
  • the dosage form according to the invention is a preparation which rapidly disintegrates or dissolves in aqueous media.
  • Dosage forms according to the invention at the application site (eg mouth) or their disintegration time is preferably in the range from 1 s to 5 min, more preferably in the range from 5 s to 1 min, and most preferably in the range from 10 s to 30 s.
  • one or more acids can also be added in order to give the foam a pleasant acidic taste.
  • acids include citric acid, lactic acid, acetic acid, benzoic acid,
  • the dosage forms according to the invention are relatively insoluble under basic conditions, such as. B. ibuprofen, or active ingredients that are not stable under basic conditions. Furthermore, the dosage forms according to the invention
  • Humectants or humectants can be added to the To improve the aesthetic properties of the dried foam and to reduce the brittleness or brittleness of the dried foam.
  • examples of such agents are glycerol, propylene glycol and polyglycerol esters.
  • Substituted sorbitan derivatives are particularly suitable as examples of suitable surface-active substances, preferably those from the "Tween” series (ICI).
  • Foaming is usually at temperatures of 80-90 0 C and the partially saponified polyvinyl alcohol must be dissolved at this temperature for 2 to 3 hours with stirring. Before the resulting solution is foamed, it must be cooled by observing sustainable cooling times or by active cooling.
  • the aim of the present invention was therefore also to provide a process for producing sheet-like, rapidly disintegrating or dissolving in an aqueous environment
  • Dosage form according to the invention apart from drying the foamed solution at room temperature be performed. Dissolving the polyvinyl alcohol-polyethylene glycol graft copolymer in water
  • the process according to the invention is also advantageous with regard to the stability of the active substance, in particular if the active substance is added to the solvent before the polymer.
  • a solution or dispersion is first prepared which contains the polyvinyl alcohol-polyethylene glycol graft copolymer and at least one active ingredient.
  • This solution which can also be a concentrated solution or viscous mass, is then foamed by introducing a gas or gas mixture (for example air).
  • a gas or gas mixture for example air.
  • Inert gases such as nitrogen, carbon dioxide or helium or mixtures of inert gases are particularly suitable as gases.
  • a foam-stabilizing agent can be used before or during foam generation
  • Agents are added. Suitable means, e.g.
  • suitable base as a film or layer and then dried.
  • the foam solidifies into one during drying Airgel, whereby the voids are given a permanent structure.
  • Wafers or wafers with the desired area dimensions or geometric shapes are obtained by pouring the foamed coating material into appropriate shapes, or by making the individual wafers from a larger one
  • the drug forms obtained in this way have the properties and advantages according to the invention, i. H. they disintegrate quickly after oral application and without an unpleasant sensation on the oral mucosa
  • Cavities can be created using various
  • Influence process parameters e.g. through the
  • Nicotine can either be in the form of one of its pharmaceutically acceptable salts, for example as
  • Nicotine tartrate are introduced into the polymer solution.
  • the nicotine base can be added to the
  • Nicotine base would be at the
  • All fruit acids are suitable for the formation of the nicotine salt, but preference is given to using citric acid or a dicarboxylic acid, in particular malic acid,
  • Succinic acid fumaric acid and tartaric acid. Mixtures of suitable fruit acids can also be used.
  • An emulsion is created which contains the hydrophobic solvent in the form of finely divided droplets.
  • Foaming through gas evolution can occur either during the Production of the polymer mass or during the coating of this mass on the base, or only during the subsequent drying process.
  • Substances or mixtures of substances suitable for gas formation are known to the person skilled in the art.
  • the foaming can also be effected by expanding a previously dissolved gas.
  • An inert gas such as nitrogen, carbon dioxide or helium, or a mixture thereof, is preferably used as the gas.
  • a melt of the matrix polymer or polymer mixture can alternatively also be assumed.
  • the processing is basically similar to that of hot melt ("not melt") coating compositions known in the prior art.
  • melt is then spread onto a suitable base, extruded or poured into a mold in order to then cool or solidify.
  • Processing from the melt is out of the question if the intended active ingredient is unstable or volatile at the melting temperature of the polymer melt. If
  • auxiliary substances to lower the melting point can be added to the polymer melt.
  • the manufacturing process described first produces the polymer matrix in the form of a block. From this are subsequently, ie after drying or Solidification, the desired sheet-like dosage forms are separated by cutting.
  • the dosage forms according to the invention are advantageously suitable for the administration of medication in the oral cavity or for rectal, vaginal or intranasal administration. They can be used in human medicine as well as in veterinary medicine.
  • Kollicoat® IR was dissolved in water (30 min. With stirring, at room temperature) and the other additives were added. Air was introduced into the composition using a foam whipping machine, which was then applied to a base and dried at 80 ° C.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Dispersion Chemistry (AREA)
  • Physiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Addiction (AREA)
  • Nutrition Science (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Psychiatry (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)

Abstract

L'invention concerne une forme galénique de forme plane, se dissolvant ou se désintégrant en milieu aqueux, destinée à libérer au moins un principe actif dans un orifice ou une cavité du corps et présentant une matrice polymère sous la forme d'une mousse solidifée pourvue de cavités ainsi qu'au moins un principe actif pharmaceutique ou cosmétique. Cette forme galénique se caractérise en ce que le polymère de la matrice est un copolymère greffé d'alcool polyvinylique et de polyéthylèneglycol. L'invention concerne également un procédé de production de formes galéniques de ce type.
EP06818972A 2005-12-08 2006-12-04 Cachet alveolaire constitue de copolymere greffe d'alcool polyvinylique et de polyethyleneglycol Ceased EP1959921A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102005058569A DE102005058569B4 (de) 2005-12-08 2005-12-08 Schaumwafer mit Polyvinylalkohol-Polyethylenglycol-Pfropfcopolymer
PCT/EP2006/011610 WO2007065619A2 (fr) 2005-12-08 2006-12-04 Cachet alveolaire constitue de copolymere greffe d'alcool polyvinylique et de polyethyleneglycol

Publications (1)

Publication Number Publication Date
EP1959921A2 true EP1959921A2 (fr) 2008-08-27

Family

ID=37833244

Family Applications (1)

Application Number Title Priority Date Filing Date
EP06818972A Ceased EP1959921A2 (fr) 2005-12-08 2006-12-04 Cachet alveolaire constitue de copolymere greffe d'alcool polyvinylique et de polyethyleneglycol

Country Status (13)

Country Link
US (1) US20090087486A1 (fr)
EP (1) EP1959921A2 (fr)
JP (1) JP5717946B2 (fr)
KR (1) KR20080073339A (fr)
CN (2) CN104189913A (fr)
AU (1) AU2006322282B2 (fr)
BR (1) BRPI0620472A2 (fr)
CA (1) CA2630595C (fr)
DE (1) DE102005058569B4 (fr)
IL (1) IL191845A (fr)
NZ (1) NZ568781A (fr)
RU (1) RU2437648C2 (fr)
WO (1) WO2007065619A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102021106491A1 (de) 2021-03-17 2022-09-22 Lts Lohmann Therapie-Systeme Ag. Gerollte oral thin films mit hoher wirkstoffbeladung

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7776314B2 (en) 2002-06-17 2010-08-17 Grunenthal Gmbh Abuse-proofed dosage system
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
DE102004032049A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
DE102005005449A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
WO2008080773A1 (fr) * 2006-12-29 2008-07-10 Basf Se Procédé de production de formes galéniques solides contenant des copolymères greffés
CN101945646A (zh) * 2008-02-13 2011-01-12 拜耳先灵医药股份有限公司 含雌二醇的药物递送系统
WO2009100871A2 (fr) * 2008-02-13 2009-08-20 Bayer Schering Pharma Aktiengesellschaft Système d'administration de médicament présentant un effet stabilisateur
AR077420A1 (es) 2009-07-22 2011-08-24 Gruenenthal Gmbh Forma de dosificacion resistente a la manipulacion para opiaceos sensibles a la oxidacion
WO2011144727A1 (fr) * 2010-05-21 2011-11-24 Basf Se Préparations de substances bioactives à base de copolymères amphiphiles présentant une surface augmentée
ES2486791T3 (es) 2010-09-02 2014-08-19 Grünenthal GmbH Forma de dosificación resistente a la manipulación que comprende una sal inorgánica
UA112974C2 (uk) 2010-09-16 2016-11-25 Джеі. Бі. Кемікалс Енд Фармасьютікалс Лімітид Нікотиновмісна композиція (варіанти)
AU2012229476B2 (en) 2011-03-01 2016-02-25 The Procter & Gamble Company Porous disintegratable solid substrate for personal health care applications
LT2736495T (lt) 2011-07-29 2017-11-10 Grünenthal GmbH Sugadinimui atspari tabletė, pasižyminti greitu vaisto atpalaidavimu
RS56527B1 (sr) 2011-07-29 2018-02-28 Gruenenthal Gmbh Tableta za trenutno oslobađanje leka rezistentna na zloupotrebu
EP2838512B1 (fr) 2012-04-18 2018-08-22 Grünenthal GmbH Forme pharmaceutique inviolable et résistante au basculement de dose
AU2012385956B2 (en) 2012-07-23 2017-03-30 Crayola, Llc Dissolvable films and methods of using the same
US20140275148A1 (en) * 2013-03-15 2014-09-18 Novus Pharma LLC Orally administrable, self-supporting dissolving film dosage forms
MX368846B (es) 2013-07-12 2019-10-18 Gruenenthal Gmbh Forma de dosificación resistente a la alteración que contiene polímero de acetato de etilen-vinilo.
EP3073994A1 (fr) 2013-11-26 2016-10-05 Grünenthal GmbH Préparation de composition pharmaceutique en poudre par cryo-broyage
TWI525110B (zh) 2014-12-24 2016-03-11 財團法人工業技術研究院 聚合物、及包含其之醫藥組合物
JP2018526414A (ja) 2015-09-10 2018-09-13 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング 乱用抑止性の即放性製剤を用いた経口過剰摂取に対する保護
DE102017112527B4 (de) * 2017-06-07 2019-01-03 Lts Lohmann Therapie-Systeme Ag Schnell zerfallende Schaumwafer mit hohem Flächengewicht
DE102018002066A1 (de) 2018-03-14 2019-09-19 Irina Gentsinger Orale filmförmige Darreichungsform
CA3198970A1 (fr) * 2020-11-09 2022-05-12 Lts Lohmann Therapie-System Ag Film buccal mince
DE102021120937A1 (de) 2021-08-11 2023-02-16 Lts Lohmann Therapie-Systeme Ag. Oraler Dünnfilm

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL6603836A (fr) * 1965-04-13 1966-10-14
US5393528A (en) * 1992-05-07 1995-02-28 Staab; Robert J. Dissolvable device for contraception or delivery of medication
US20010006677A1 (en) * 1996-10-29 2001-07-05 Mcginity James W. Effervescence polymeric film drug delivery system
EP0845411B1 (fr) * 1996-11-29 2002-02-13 Kabushiki Kaisha Hayashibara Seibutsu Kagaku Kenkyujo Emballage pour produit d'inclusion et son procédé de fabrication
DE19652257A1 (de) * 1996-12-16 1998-06-18 Lohmann Therapie Syst Lts Einzeln dosierte, bei Kontakt mit Flüssigkeit schnell zerfallende, wirkstoff- und insbesondere aromastoffhaltige, folienförmige Darreichnungsform
DE10032456A1 (de) * 2000-07-04 2002-01-31 Lohmann Therapie Syst Lts Schnell zerfallende Darreichungsform zur Freisetzung von Wirkstoffen im Mundraum oder in Körperhöhlen
CA2473967C (fr) * 2001-10-12 2011-06-14 Monosolrx Llc Film mince pourvu d'une heterogeneite uniforme non autoagglomerante, son procede d'elaboration et systemes d'administration de medicaments ainsi produits
DE10207394B4 (de) * 2002-02-21 2007-03-29 Lts Lohmann Therapie-Systeme Ag Geschmacksmaskierte oblatenförmige Arzneizubereitung
NZ540318A (en) * 2002-10-31 2007-09-28 Umd Inc Therapeutic compositions for drug delivery to and through covering epithelia
US20040208931A1 (en) * 2002-12-30 2004-10-21 Friend David R Fast dissolving films for oral administration of drugs
HUE037508T2 (hu) * 2003-07-24 2018-09-28 Glaxosmithkline Llc Szájban oldódó filmek
CA2543324C (fr) * 2003-10-24 2011-02-01 Adhesives Research, Inc. Pellicules a desintegration rapide destinees a l'administration d'agents pharmaceutiques ou cosmetiques

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2007065619A2 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102021106491A1 (de) 2021-03-17 2022-09-22 Lts Lohmann Therapie-Systeme Ag. Gerollte oral thin films mit hoher wirkstoffbeladung
WO2022195044A1 (fr) 2021-03-17 2022-09-22 Lts Lohmann Therapie-Systeme Ag Film extra-fin enroulé à usage oral, à charge élevée en principe actif

Also Published As

Publication number Publication date
CN104189913A (zh) 2014-12-10
NZ568781A (en) 2010-10-29
CN101321515A (zh) 2008-12-10
AU2006322282A1 (en) 2007-06-14
AU2006322282B2 (en) 2011-10-06
RU2008124311A (ru) 2009-12-27
DE102005058569B4 (de) 2010-07-15
DE102005058569A1 (de) 2007-06-14
CA2630595A1 (fr) 2007-06-14
US20090087486A1 (en) 2009-04-02
BRPI0620472A2 (pt) 2012-04-17
WO2007065619A3 (fr) 2007-08-23
IL191845A0 (en) 2008-12-29
WO2007065619A2 (fr) 2007-06-14
JP2009518334A (ja) 2009-05-07
JP5717946B2 (ja) 2015-05-13
KR20080073339A (ko) 2008-08-08
CA2630595C (fr) 2014-04-22
IL191845A (en) 2012-04-30
RU2437648C2 (ru) 2011-12-27

Similar Documents

Publication Publication Date Title
DE102005058569B4 (de) Schaumwafer mit Polyvinylalkohol-Polyethylenglycol-Pfropfcopolymer
EP1296661B1 (fr) Procede de preparation de formes d'administration se decomposant rapidement pour la liberation de principes actifs dans l'espace buccal ou dans des cavites corporelles
DE102017112527B4 (de) Schnell zerfallende Schaumwafer mit hohem Flächengewicht
DE10224607B4 (de) Filmförmige, zerfallsfähige Zubereitungen zur Wirkstofffreisetzung und Verfahren zu deren Herstellung
WO2005000263A1 (fr) Forme d'administration trans-muqueuse a irritation reduite des muqueuses
WO2004054551A1 (fr) Preparations sous forme de film pour l'administration de nicotine a travers les muqueuses et procede de production desdites preparations
CA2506712C (fr) Forme d'administration se decomposant rapidement pour la liberation d'ingredients dans l'espace buccal ou dans des cavites corporelles
AU2005202270B2 (en) Rapidly Disintegrating Dosage form For Releasing Nicotine in the Oral Cavity or in Body Cavities

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20080513

AK Designated contracting states

Kind code of ref document: A2

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR

RIN1 Information on inventor provided before grant (corrected)

Inventor name: KRUMME, MARKUS

REG Reference to a national code

Ref country code: HK

Ref legal event code: DE

Ref document number: 1114561

Country of ref document: HK

17Q First examination report despatched

Effective date: 20081118

DAX Request for extension of the european patent (deleted)
REG Reference to a national code

Ref country code: HK

Ref legal event code: WD

Ref document number: 1114561

Country of ref document: HK

REG Reference to a national code

Ref country code: DE

Ref legal event code: R003

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION HAS BEEN REFUSED

18R Application refused

Effective date: 20150707