[go: up one dir, main page]

EP1239847A1 - Preparation pharmaceutique lisse pour administration par mucosale dans la cavite buccale d'oxycodone ou d'une substance active analogue servant a traiter la douleur et la toxicomanie - Google Patents

Preparation pharmaceutique lisse pour administration par mucosale dans la cavite buccale d'oxycodone ou d'une substance active analogue servant a traiter la douleur et la toxicomanie

Info

Publication number
EP1239847A1
EP1239847A1 EP00993377A EP00993377A EP1239847A1 EP 1239847 A1 EP1239847 A1 EP 1239847A1 EP 00993377 A EP00993377 A EP 00993377A EP 00993377 A EP00993377 A EP 00993377A EP 1239847 A1 EP1239847 A1 EP 1239847A1
Authority
EP
European Patent Office
Prior art keywords
preparation according
active ingredient
pharmaceutical preparation
dose
therapy
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Withdrawn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
EP00993377A
Other languages
German (de)
English (en)
Inventor
Bodo Asmussen
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 EP1239847A1 publication Critical patent/EP1239847A1/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Withdrawn legal-status Critical Current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
    • A61K9/70—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
    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • A61P25/36—Opioid-abuse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/16—Otologicals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Definitions

  • the present invention relates to a sheet-like pharmaceutical preparation for the transmucosal administration of oxycodone or a pharmacologically comparable active substance in the area of the oral cavity, and to the use of such a pharmaceutical preparation in pain therapy and in substitution therapy for the treatment of opiate and cocaine dependency.
  • the invention relates to sheet-like medicinal preparations of the type mentioned which are disintegrable in aqueous media and are in the form of foils, films, papers or wafers.
  • the invention further encompasses methods which are suitable for producing such pharmaceutical preparations.
  • the use of opiates in pain therapy places special demands on the dosage forms used for this.
  • the main difficulty is to adjust the dose to the individual patient's subjective pain experience, ie as needed. It is important to avoid that the patient is exposed to unacceptable pain conditions and that tolerance development and possibly dependency develop as a result of overdosing. For this reason, it is desirable and necessary that suitable active ingredients and administration forms are available which enable a rapidly occurring analgesic effect in order to rapidly bring about a dose adjustment that is necessary if required. Therefore, the active ingredient or the dosage form should be characterized by the shortest possible flooding time. In addition, such a dosage form should be such that it can be applied by the patient himself in an uncomplicated and at the same time reliable manner.
  • flat dosage forms such as. B. film or wafer-like preparations
  • the small thickness compared to the surface results in a short diffusion path when such a dosage form is applied to the oral mucosa, for example. This leads to a rapid dissolution of the preparation under the influence of saliva and to a correspondingly quick release of the active ingredient, which can be quickly and directly absorbed through the oral mucosa.
  • DE-OS 27 46 414 which describes a film-like band of active ingredient, binder and other auxiliaries, can be regarded as fundamental for this dosage form. Due to the homogeneous thickness, density and width, there is a direct relationship between a unit length of the strip and the dose of active ingredient contained therein. The advantages of Continuous meterability was also recognized by other applicants and described in special individual variants. So DE-PS 36 30 603 describes a flat carrier material, for. B. in the form of a release paper with an active ingredient-containing coating, the latter being pre-divided in dosage units from the carrier material in a dose.
  • DE-OS 196 52 188 AI describes a flat medicinal preparation which is suitable for the application and release of the opiate anaesthetic buprenorphine in the oral cavity.
  • this dosage form a large part of the amount of active ingredient contained therein is transported and metabolized via the saliva into the stomach, since this dosage form is not or not sufficiently mucoadhesive.
  • the analgesic agents that are well suited for oral administration also include the opiate oxycodone, which has been used successfully in pain therapy for years. After oral administration, two thirds of it is bioavailable, i. H. it appears to a good effect in the bloodstream.
  • the oral mucosa for the active ingredient has sufficient permeability, taking into account the necessary dose.
  • the permeability in turn depends to a large extent on the physicochemical properties of the active ingredient.
  • Oxycodone is already effective in small amounts and has good oral absorption, the average duration of action being 4-6 h.
  • the flooding times for normal oral application are 15-30 min. This period is too long for dose adjustment as required and means an unnecessarily long waiting time for the patient to experience relief.
  • the object of the invention was therefore to provide pharmaceutical preparations based on and with the general advantages of flat active substance carriers, which by the combination with a special active substance have additional therapeutic and / or economic advantages over pharmaceutical preparations of the same active ingredient based on conventional dosage forms.
  • the active ingredient mentioned is to be released in the oral cavity in a manner without the disadvantages described in the prior art occurring.
  • the object was to provide an application form for oxycodone which releases the active ingredient in the oral cavity without having the disadvantages described in the prior art.
  • the dosage forms should also be safe and easy to use and meet the practical requirements in pain therapy or addiction weaning therapy.
  • the object of the invention was furthermore to specify production processes for such preparations which would enable production under competitive conditions.
  • the object is surprisingly achieved by a flat, film, film, paper or wafer-shaped medicinal preparation which can disintegrate in aqueous media and which contains oxycodone, or an active ingredient comparable to oxycodone, or a therapeutically suitable salt of oxycodone or the pharmacologically comparable one Has active ingredient.
  • a medicinal preparation according to the invention as claimed in claim 1 is, as will be explained in the following, far superior to a conventional dosage form for the administration of oxycodone both from an economic and therapeutic point of view and is particularly suitable on the one hand for analgesia in severe pain conditions and on the other hand also for the therapy of Addiction to opiate or cocaine in the sense of substitution therapy or a weaning program.
  • the pharmaceutical preparation according to claim 1 can be brought directly into contact with the oral mucosa during application. Due to the flat design, at least about half of the already large surface of the dosage form is immediately on the mucosa immediately after application. The oxycodone released from the preparation therefore finds two particularly favorable factors for entry into the body, namely a short diffusion path and a large diffusion area.
  • the disintegration time being a few minutes after application or after introduction into an aqueous medium
  • the superiority of an oxycodone-containing film over an oxycodone-containing tablet will therefore become apparent.
  • the advantageous properties of the preparations according to the invention appear so clearly because oxycodone is effective even in small doses.
  • the present invention combines the high effectiveness of the oxycodone with the advantageous release and release characteristics of sheet-like transmucosal dosage forms.
  • the invention thus provides pharmaceutical preparations which are capable of making a highly effective analgesic available in the body in an efficient and rapid manner.
  • the invention makes use of the fact that the oral mucosa has a good permeability for this active substance due to the physicochemical characteristics of the oxycodone, which is why it is particularly well suited for buccal or sublingual application.
  • the pharmaceutical preparation according to the invention is preferably used for the transmucosal administration of oxycodone or its pharmaceutically acceptable salts or other pharmacologically acceptable derivatives of oxycodone.
  • oxycodone possibly in the form of one of its therapeutically acceptable salts - is the most preferred active ingredient
  • the invention also includes active ingredients which are pharmacologically similar or comparable to oxycodone, since the advantages of the invention described, albeit to different degrees , can also come into play here.
  • active ingredients which are pharmacologically similar or comparable to oxycodone” are understood in particular to be those which are attributable to the opiates or opioids, since many of them have not only pharmacodynamic but also pharmacokinetic similarities to oxycodone, ie. H. Efficacy at a relatively low dose, good membrane permeability and high first-pass effect. From this group of active substances, morphine or dihydromorphine derivatives and substances from the methadone and fentanyl groups are particularly preferred.
  • the active ingredient is released by permeation through the oral mucosa.
  • the prerequisite for this is that the flat preparation is in close contact with the mucosa during the application period, that is, until the dissolution or disintegration of the preparation has taken place.
  • the pharmaceutical preparation contains an adhesion-promoting auxiliary or an auxiliary mixture which imparts bio- or mucoadhesive properties to the preparation.
  • Certain pharmaceutically customary, orally administrable auxiliaries are known to have mucosal properties.
  • mucoadhesive substances examples include polyacrylic acid, carboxymethyl cellulose, hydroxymethyl cellulose, methyl cellulose, tragacanth, alginic acid, gelatin and gum arabic.
  • various non-mucoadhesive substances are known to also form mucoadhesive properties in certain mixing ratios.
  • An example of such a mixture is glycerol monooleate / water in the ratio 84:16 (Engström et al., Pharm. Tech. Eur. 7 [1995], No. 2, pp. 14-17).
  • a two- or multi-layer structure of the dosage form of the preparation according to the invention is preferred.
  • Preferred embodiments are therefore constructed in two or more layers, one of the two layers or, in the case of a multilayer structure, one of the layers having bio- or mucoadhesive properties.
  • the latter are preferably designed such that they have or have a lower permeability for the active substance than the bio- or mucoadhesive layer. In this way it can be avoided that active substance is released into the saliva of the oral cavity, which would lead to loss of active substance.
  • the present invention also includes those preparations which, in addition to oxycodone or a comparable active ingredient, contain at least one further active ingredient for transmucosal application.
  • a preparation can be advantageous in several ways. For one thing, it is a recognized method of treating multiple symptoms or conditions that occur at the same time to administer a fixed combination of active ingredients in a single medication.
  • any therapeutically useful active ingredients can be incorporated into the preparation according to the invention.
  • the combination of an opiate active ingredient with another substance which is provided in a further embodiment of the invention and which can reduce the specific risks of opiate administration is particularly useful and advantageous.
  • opiate antagonists - or also partial opiate antagonists - such as B.
  • the medicinal preparation according to the invention is preferably pre-divided in doses and separated from one another in suitable packaging so that each dose unit can be removed, for example in the form of a blister pack, in which each dose unit is individually sealed in a deep-drawing bowl.
  • the dosage may have to be adjusted.
  • the analgesic single dose will be 5 to 20 mg, but may be significantly higher for use in addiction therapy or substitution therapy.
  • the pharmaceutical preparations are produced in several steps.
  • Two basic process variants are suitable for producing a web-shaped starting material, from which either the individual cans or entire packaging units are finally divided by cutting or punching.
  • the first group of processes includes those in which with aqueous or solvent-containing liquids, some of which are increased Can have viscosity, a tape or a process film coated evenly and then subjected to a drying process.
  • the coating composition is first produced, for which purpose at least one water-soluble polymer capable of film formation, as well as the active ingredient (s) and a suitable, vaporizable liquid must be mixed intimately.
  • the sheet-like starting material can be produced by thermoplastic molding, ie without the use of liquids. This includes all hot melt coating processes and all extrusion processes. A prerequisite in this case is that the polymer or polymer mixture capable of film formation is thermoplastic.
  • the required ingredients are mixed and shaped under the action of pressure and / or heat by extrusion, blowing or by coating tapes or foils and, after solidification, passed on for further processing.
  • Appropriately modified methods are suitable for the production of preparations according to the invention with a multilayer structure, it being irrelevant whether a plurality of sheet-like materials are produced and joined together at the same time or in succession.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Addiction (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une préparation pharmaceutique lisse du type feuille, film, papier ou fine rondelle, pouvant se désagréger dans des milieux aqueux, ladite préparation servant à l'administration par voie mucosale dans la cavité buccale de substances actives et se caractérisant en ce qu'elle contient de l'oxycodone, une substance active analogue à l'oxycodone, un sel de l'oxycodone approprié du point de vue pharmaceutique, ou un sel de la substance active analogue de point de vue pharmacologique.
EP00993377A 1999-12-14 2000-12-01 Preparation pharmaceutique lisse pour administration par mucosale dans la cavite buccale d'oxycodone ou d'une substance active analogue servant a traiter la douleur et la toxicomanie Withdrawn EP1239847A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19960154A DE19960154A1 (de) 1999-12-14 1999-12-14 Flache Arzneizubereitung zur transmucosalen Verabreichung von Oxycodon oder einem vergleichbaren Wirkstoff in der Mundhöhle, für die Anwendung in der Schmerztherapie und Suchttherapie
DE19960154 1999-12-14
PCT/EP2000/012093 WO2001043728A1 (fr) 1999-12-14 2000-12-01 Preparation pharmaceutique lisse pour administration par mucosale dans la cavite buccale d'oxycodone ou d'une substance active analogue servant a traiter la douleur et la toxicomanie

Publications (1)

Publication Number Publication Date
EP1239847A1 true EP1239847A1 (fr) 2002-09-18

Family

ID=7932547

Family Applications (1)

Application Number Title Priority Date Filing Date
EP00993377A Withdrawn EP1239847A1 (fr) 1999-12-14 2000-12-01 Preparation pharmaceutique lisse pour administration par mucosale dans la cavite buccale d'oxycodone ou d'une substance active analogue servant a traiter la douleur et la toxicomanie

Country Status (18)

Country Link
US (1) US20040024003A1 (fr)
EP (1) EP1239847A1 (fr)
JP (1) JP2003516961A (fr)
KR (1) KR100597806B1 (fr)
CN (1) CN1407889A (fr)
AR (1) AR027902A1 (fr)
AU (1) AU781946B2 (fr)
BR (1) BR0016504A (fr)
CA (1) CA2393838A1 (fr)
CZ (1) CZ20022063A3 (fr)
DE (1) DE19960154A1 (fr)
HU (1) HUP0203733A2 (fr)
IL (1) IL150127A0 (fr)
MX (1) MXPA02005857A (fr)
PL (1) PL355816A1 (fr)
RU (1) RU2002115277A (fr)
WO (1) WO2001043728A1 (fr)
ZA (1) ZA200204225B (fr)

Families Citing this family (40)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190328679A1 (en) 2001-10-12 2019-10-31 Aquestive Therapeutics, Inc. Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
US10285910B2 (en) 2001-10-12 2019-05-14 Aquestive Therapeutics, Inc. Sublingual and buccal film compositions
US20110033542A1 (en) 2009-08-07 2011-02-10 Monosol Rx, Llc Sublingual and buccal film compositions
US8900498B2 (en) 2001-10-12 2014-12-02 Monosol Rx, Llc Process for manufacturing a resulting multi-layer pharmaceutical film
US8900497B2 (en) 2001-10-12 2014-12-02 Monosol Rx, Llc Process for making a film having a substantially uniform distribution of components
US7357891B2 (en) 2001-10-12 2008-04-15 Monosol Rx, Llc Process for making an ingestible film
US8765167B2 (en) 2001-10-12 2014-07-01 Monosol Rx, Llc Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
US20070281003A1 (en) 2001-10-12 2007-12-06 Fuisz Richard C Polymer-Based Films and Drug Delivery Systems Made Therefrom
US8603514B2 (en) 2002-04-11 2013-12-10 Monosol Rx, Llc Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
US11207805B2 (en) 2001-10-12 2021-12-28 Aquestive Therapeutics, Inc. Process for manufacturing a resulting pharmaceutical film
CN1655771A (zh) * 2002-05-24 2005-08-17 艾克发照像有限责任公司 含有活性化合物且至少部分可降解的膜及其制备方法
US20040202717A1 (en) 2003-04-08 2004-10-14 Mehta Atul M. Abuse-resistant oral dosage forms and method of use thereof
CA2544776C (fr) * 2003-05-28 2014-04-15 Monosolrx Llc Films a base d'oxyde de polyethylene et systemes d'administration de medicaments en etant faits
DE10332160A1 (de) * 2003-07-15 2005-02-03 Röhm GmbH & Co. KG Multipartikuläre Arzneiform, enthaltend mucoadhaesiv formulierte Peptid- oder Protein-Wirkstoffe, sowie ein Verfahren zur Herstellung der Arzneiform
US8003122B2 (en) * 2004-03-31 2011-08-23 Cordis Corporation Device for local and/or regional delivery employing liquid formulations of therapeutic agents
US7846940B2 (en) * 2004-03-31 2010-12-07 Cordis Corporation Solution formulations of sirolimus and its analogs for CAD treatment
DE102005007859A1 (de) * 2005-02-21 2006-08-24 Lts Lohmann Therapie-Systeme Ag Vefahren für eine medikamentöse Kombinations-Behandlung, sowie hierfür geeignete Arzneimittel-Kombinationen
CN1813740B (zh) * 2005-11-22 2010-05-05 岳振江 一种含有盐酸纳洛酮的舌下膜剂及其制备方法
US9522188B2 (en) * 2005-12-13 2016-12-20 Biodelivery Sciences International, Inc. Abuse resistant transmucosal drug delivery device
DE102006027790A1 (de) * 2006-06-16 2007-12-20 Lts Lohmann Therapie-Systeme Ag Typ-2-Diabetes Kombinations-Wafer
DE102006027794A1 (de) * 2006-06-16 2007-12-20 Lts Lohmann Therapie-Systeme Ag Antihypertonie-Kombinationswafer
DE102006027793A1 (de) * 2006-06-16 2007-12-20 Lts Lohmann Therapie-Systeme Ag Opioid-Kombinations-Wafer
DE102006027791A1 (de) * 2006-06-16 2007-12-20 Lts Lohmann Therapie-Systeme Ag AchE-NMDA-Kombinationswafer
DE102006027792A1 (de) * 2006-06-16 2007-12-20 Lts Lohmann Therapie-Systeme Ag Antidepressiva-Kombinations-Wafer
KR101230804B1 (ko) * 2006-07-21 2013-02-08 바이오딜리버리 사이언시스 인터내셔널 인코포레이티드 향상된 흡수를 갖는 경점막 전달 장치
US8420110B2 (en) * 2008-03-31 2013-04-16 Cordis Corporation Drug coated expandable devices
CA2728912C (fr) * 2008-06-23 2018-04-10 Biodelivery Sciences International, Inc. Dispositifs d'administration mucosale a directions multiples et leurs procedes d'utilisation
US20110269841A1 (en) * 2010-05-03 2011-11-03 Innoteq, Inc. Thin film with methadone active ingredient
US9149959B2 (en) 2010-10-22 2015-10-06 Monosol Rx, Llc Manufacturing of small film strips
US8703177B2 (en) 2011-08-18 2014-04-22 Biodelivery Sciences International, Inc. Abuse-resistant mucoadhesive devices for delivery of buprenorphine
WO2013096811A2 (fr) * 2011-12-21 2013-06-27 Biodelivery Sciences International, Inc. Dispositifs d'administration transmucosale de médicament pour une utilisation dans le soulagement de la douleur chronique
US9901539B2 (en) 2011-12-21 2018-02-27 Biodelivery Sciences International, Inc. Transmucosal drug delivery devices for use in chronic pain relief
WO2013171146A1 (fr) * 2012-05-15 2013-11-21 Lts Lohmann Therapie-Systeme Ag Film oral contenant un résinate d'opiate à libération entérique
US12427121B2 (en) 2016-05-05 2025-09-30 Aquestive Therapeutics, Inc. Enhanced delivery epinephrine compositions
US11273131B2 (en) 2016-05-05 2022-03-15 Aquestive Therapeutics, Inc. Pharmaceutical compositions with enhanced permeation
US12433850B2 (en) 2016-05-05 2025-10-07 Aquestive Therapeutics, Inc. Enhanced delivery epinephrine and prodrug compositions
US11191737B2 (en) 2016-05-05 2021-12-07 Aquestive Therapeutics, Inc. Enhanced delivery epinephrine compositions
IL318587A (en) * 2018-07-23 2025-03-01 Trevi Therapeutics Inc Treatment of chronic cough, shortness of breath and wheezing
CA3166928A1 (fr) 2020-01-10 2021-07-15 Trevi Therapeutics, Inc. Methodes d'administration de nalbuphine
WO2023076281A1 (fr) 2021-10-25 2023-05-04 Aquestive Therapeutics, Inc. Compositions orales et nasales et méthodes de traitement

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4626539A (en) * 1984-08-10 1986-12-02 E. I. Dupont De Nemours And Company Trandermal delivery of opioids
EP0375689B1 (fr) * 1987-06-01 1992-08-12 Warner-Lambert Company Composition pharmaceutique adaptee a l administration transdermique d'un medicament opioid.
US5236714A (en) * 1988-11-01 1993-08-17 Alza Corporation Abusable substance dosage form having reduced abuse potential
DE19642043A1 (de) * 1995-10-23 1997-04-24 Hexal Ag Transdermales therapeutisches System (TTS) für die Verabreichung von Wirkstoffen zur Behandlung von Drogenabhängigkeit oder Drogensucht
DE19652188C2 (de) * 1996-12-16 2002-02-14 Lohmann Therapie Syst Lts Flache Arzneizubereitung zur Applikation und Freisetzung von Buprenorphin oder einer pharmakologisch vergleichbaren Substanz in der Mundhöhle und Verfahren zu ihrer Herstellung
WO1999015210A2 (fr) * 1997-09-26 1999-04-01 Noven Pharmaceuticals, Inc. Compositions bioadhesives et methodes d'administration locale d'agents actifs
DE19923551A1 (de) * 1999-05-21 2000-11-30 Lohmann Therapie Syst Lts Pharmazeutisches Präparat mit dem Wirkstoff Diamorphin und seine Verwendung in einem Verfahren zur Behandlung der Opiatsucht

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
MUTSCHLER E.: "Arzneimittelwirkungen", 1986, WISSENSCHAFTLICHE VERLAGSGESELLSCHAFT, STUTTGART *

Also Published As

Publication number Publication date
RU2002115277A (ru) 2004-01-10
HUP0203733A2 (en) 2003-05-28
KR20020067544A (ko) 2002-08-22
MXPA02005857A (es) 2002-10-23
IL150127A0 (en) 2002-12-01
CN1407889A (zh) 2003-04-02
PL355816A1 (en) 2004-05-17
JP2003516961A (ja) 2003-05-20
BR0016504A (pt) 2002-11-05
DE19960154A1 (de) 2001-07-12
ZA200204225B (en) 2003-03-03
AR027902A1 (es) 2003-04-16
US20040024003A1 (en) 2004-02-05
CA2393838A1 (fr) 2001-06-21
CZ20022063A3 (cs) 2002-09-11
KR100597806B1 (ko) 2006-07-10
AU781946B2 (en) 2005-06-23
AU2839201A (en) 2001-06-25
WO2001043728A1 (fr) 2001-06-21

Similar Documents

Publication Publication Date Title
EP1239847A1 (fr) Preparation pharmaceutique lisse pour administration par mucosale dans la cavite buccale d'oxycodone ou d'une substance active analogue servant a traiter la douleur et la toxicomanie
EP0949925B1 (fr) Preparation medicamenteuse plate pour administrer ou liberer, dans la cavite buccale, de la buprenorphine ou une substance comparable sur le plan pharmacologique et procede permettant de la preparer
DE68909056T2 (de) Dosierform zum vermeiden von missbrauch.
DE602004005076T2 (de) Co-extrudierte sicherheits-dosierform mit einem wirkstoff und einem adversen mittel und herstellungsverfahren dafür
DE19652268C2 (de) Arzneizubereitung für die Freisetzung von Apomorphin in der Mundhöhle
DE10224607B4 (de) Filmförmige, zerfallsfähige Zubereitungen zur Wirkstofffreisetzung und Verfahren zu deren Herstellung
DE202006018608U1 (de) Buprenorphin-Wafer zur Drogensubstitutionstherapie
DE10207394A1 (de) Geschmacksmaskierte film- oder oblatenförmige Arzneizubereitung
DE19923551A1 (de) Pharmazeutisches Präparat mit dem Wirkstoff Diamorphin und seine Verwendung in einem Verfahren zur Behandlung der Opiatsucht
EP1274405B1 (fr) Formes galeniques transdermiques ou transmucosiques comprenant une combinaison de principes actifs contenant de la nicotine, pour desintoxication de fumeurs
EP1959921A2 (fr) Cachet alveolaire constitue de copolymere greffe d'alcool polyvinylique et de polyethyleneglycol
EP1976524B2 (fr) Utilisation d'un melange de morphine et d'au moins un antagoniste des opiaces pour le traitement de la dependance aux opiaces et pour eviter l'abus non oral d'opiaces chez les personnes dependantes aux opiaces
WO2005000263A1 (fr) Forme d'administration trans-muqueuse a irritation reduite des muqueuses
EP1725225A1 (fr) Ambroxol pour le traitement de douleurs aigues
EP1850836B1 (fr) Traitement medicamenteux combine
EP1656112B1 (fr) Formules orales de la galanthamine et leurs applications
DE10163421A1 (de) Verwendung von (+)-(1S,2S)-3-(3-Dimethylamino-1-ethyl-2-methyl-propyl)phenol als Antiemetikum
EP4301335B1 (fr) Film oral mince
WO2006030030A2 (fr) Systeme pour l'administration transdermique sequentielle de substances a action systemique
EP2381933A1 (fr) Technologie de fabrication d'un pansement
EP4308078A1 (fr) Film extra-fin enroulé à usage oral, à charge élevée en principe actif
MXPA99005551A (es) Preparacion medicinal plana para fijacion y liberacion de buprenorfina o de una substancia farmacologicamente comparable en la cavidad bucal y procedimiento para su preparacion
EP1810714A1 (fr) Utilisation d'une association d'héroine et de naloxone pour la substitution de drogues
WO2010094792A1 (fr) Ensemble de secours pour la production d'un médicament pour l'application nasale d'opioïdes en cas de dyspnée
DE10251963A1 (de) Transmucosale pharmazeutische Darreichungsform

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: 20020514

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE TR

AX Request for extension of the european patent

Free format text: AL;LT;LV;MK;RO;SI

17Q First examination report despatched

Effective date: 20031106

RAP1 Party data changed (applicant data changed or rights of an application transferred)

Owner name: LTS LOHMANN THERAPIE-SYSTEME AG

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

Free format text: STATUS: THE APPLICATION HAS BEEN WITHDRAWN

18W Application withdrawn

Effective date: 20051018