EP2029098A2 - Comprimé plat combiné pour le sevrage tabagique - Google Patents
Comprimé plat combiné pour le sevrage tabagiqueInfo
- Publication number
- EP2029098A2 EP2029098A2 EP07725805A EP07725805A EP2029098A2 EP 2029098 A2 EP2029098 A2 EP 2029098A2 EP 07725805 A EP07725805 A EP 07725805A EP 07725805 A EP07725805 A EP 07725805A EP 2029098 A2 EP2029098 A2 EP 2029098A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- nicotine
- derivatives
- preparation according
- group
- pharmaceutical preparation
- 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- Withdrawn
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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61P25/30—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
Definitions
- the present invention relates to rapidly disintegrating oral dosage forms for the administration of drug combinations for smoking cessation containing nicotine, a nicotine salt, a nicotine derivative or a substance with nicotinergic activity, in combination with another active ingredient.
- the invention further relates to the use of such dosage forms for the treatment of nicotine dependence, nicotine substitution or smoking cessation, and the use of nicotine or its salts or derivatives for the preparation of dosage forms for the treatment of nicotine dependency.
- Tobacco mainly occurring alkaloid nicotine has a similar addictive effect to other intoxicants, which leads to a physical dependence.
- the toxic effects of nicotine, which is a strong neurotoxin, are pushed back by habituation in smokers.
- Nicotine reaches the brain shortly after inhalation and acts there on acetylcholine receptors, triggering a series of physiological reactions. This leads to an increase in the heart rate, narrowing of blood Vessels with concomitant increase in blood pressure and a significant decrease in skin temperature. In addition, psychomotor performance as well as attention and memory performance are increased via central effects.
- Nicotine consumption is a major cause of vascular disease, hypertension, cancer and asthma and the associated long-term consequences such as stroke, heart attack, chronic bronchitis, COPD (chronic obstructive pulmonary disease), smoker's leg, atherosclerosis and visual disturbances.
- COPD chronic obstructive pulmonary disease
- the withdrawal from addiction dependence is therefore facilitated if nicotine needs are met in some other way, at least during a weaning phase.
- a nicotine substitution therapy This can be done, for example, by means of so-called nicotine patches, which release nicotine via the skin to the human organism and thus suppress the nicotine withdrawal symptoms, thereby facilitating smoking cessation.
- TTS transdermal therapeutic systems
- the combination of nicotine or nicotinergic agents with an antidepressant in a drug form is therefore desirable because it facilitates the patient's intake and also minimizes the risk of misuse.
- administration to the patient should be as simple as possible and the patient should not have any reservations taking the medication, eg due to the size of the dosage form or the like.
- the disadvantages of known dosage forms should be avoided.
- Dosage forms of a hydrophilic polymer film, which disintegrates in the oral cavity, is dissolved, are incorporated in the at least two active ingredients, wherein at least one of the active ingredients nicotine, a nicotine salt, a nicotine derivative or a substance with nicotine effect, and at least one further active ingredient is included , where this further active ingredient belongs to the group of psychologically active substances.
- the dosage forms of the invention contain a combination of the active ingredient nicotine, or a nicotine salt, a nicotine derivative or a substance with nicotinergic activity, collectively referred to as nicotinic drugs, with at least one other acting on the central nervous system substance.
- the combination of the active ingredients in the dosage form according to the invention makes it easier for the patient to take both active ingredients.
- the combination of nicotine-active substances which of course also includes nicotine, nicotine salts and nicotine derivatives, with a centrally acting active substance, eg an antidepressant, can effectively suppress both the physical and mental withdrawal symptoms.
- a centrally acting active substance eg an antidepressant
- the dosage form according to the invention offers the TTS the advantage that the active ingredients can be dosed so low that the person suffering from withdrawal always applies a dosage form when he would reach for the cigarette.
- the urge to do something active against withdrawal which manifests itself in normal circumstances in the lighting of a cigarette, is also gratified.
- the satisfaction of this urge is in the smoking cessation a not to be underestimated component, since smoking is not only with maintaining nicotine levels, but always associated with a relaxing activity.
- concentration spikes of nicotine are produced in the blood, so that, in contrast to the continuous delivery of nicotine from a TTS with a constant plasma level, a concentration course analogous to smoking is obtained.
- these taste or aroma substances which are particularly pleasant to the touch, may be added.
- the ratio of the active substances to one another it is additionally possible to adapt the dosages to the respective requirements.
- the nicotine content be slowly lowered during weaning, so that the number nicotinic acetylcholine receptors again adapts to the normal physiological conditions.
- the antidepressants given to suppress mental dependency can be gradually dosed.
- the wafer is made of a laminate, then during production e.g. only the layer thickness of an active substance-containing layer or the concentration of the active ingredient can be changed.
- drugs with different concentration e.g. only the layer thickness of an active substance-containing layer or the concentration of the active ingredient can be changed.
- the active substance content but the same active ingredient ratio can be easily produced via different area blanks of the dosage form.
- the wafers according to the invention can easily be carried with the active substance combinations because of their flat form, e.g. in the wallet, and are also immediately available on the go and easy to take.
- Suitable water-soluble or swellable polymers for the hydrophilic water-soluble and / or swellable polymer film are base polymers of polymers from the group comprising dextran, polysaccharides, including starch and starch derivatives, cellulose derivatives, such as carboxymethylcellulose, ethyl or propylcellulose, hydroxypropylmethylcellulose, Hydroxypropyl cellulose, sodium carboxymethyl cellulose (eg Walocel), methylcellulose, hydroxyethylcellulose and hydroxypropylethylcellulose, polyvinyl alcohol
- polyethylene glycols polyacrylic acids, polyacrylates, polyvinylpyrrolidones, alginates, pectins, gelatin, alginic acid, collagen, chitosan, arabinogalactan, galactomannan, agar-agar, agarose, carrageenan natural gums, tragacanth, fumed silica, bentonite, and derivatives of aforementioned hydrophilic polymers or combinations of two or more of these polymers.
- the polymer film can also be made of a polyvinyl alcohol
- Polyethylene glycol graft copolymer be prepared.
- the proportion of polymer in a dosage form according to the invention is preferably from 5 to 95% by weight, more preferably from 15 to 75% by weight, based on the dry mass of the administration.
- the substance acting on the central nervous system in addition to nicotine in the dosage forms according to the invention is preferably an active substance from the group of psychotropic drugs which comprises the active ingredient groups of the antidepressants, tranquilizers, nootropics, neuroleptics, psychotonics or psychomimetics.
- the invention also includes nicotine-containing dosage forms of the type mentioned, which contain two or more psychotropic drugs from said active substance groups as additional active ingredients.
- the additional agent acting on the central nervous system may be selected from the group consisting of phenothiazines, azaphenothiazines, thioxanthenes, butyrophenones, diphenylbutylpiperidines, iminodibenzyl derivatives, iminostilbene derivatives, dibenzocycloheptadiene derivatives, dibenzodiazepine derivatives, dibenzoxepine derivatives, benzodiazepines, indole derivatives, phenylethylamine derivatives and hypericin derivatives and pharmaceutically acceptable salts or derivatives of these compounds, wherein the active ingredient from the group comprising chlorproxnazine, perphenazine, sulpiride, clozapine, risperidone, reserpine, lorazepam, mirtazapine, maprotiline, mianserin, tranylcypromine, moclobemide, oxitriptan, viloxa zin
- Brotizolam, triazolam and Buprion are preferably used as antidepressants.
- Nicotine hydrochloride, nicotine dihydrochloride, nicotine sulfate, nicotine bitartrate, nicotine zinc chloride and nicotine salicylate may be used as nicotine salts or nicotine derivatives in the dosage forms according to the invention, either singly or in combination, or else in combination with nicotine.
- the dose of the substance acting on the central nervous system is adjusted to the dose of nicotine present in the dosage form such that both active ingredients build up the respectively therapeutically favorable plasma level as far as possible.
- the pharmaceutical preparation according to the invention contains a combination of two active substances, namely nicotine, a nicotine salt, a nicotine derivative or a nicotine-active substance, and, as further active ingredient component, additionally a substance acting on the central nervous system, which is selected from the abovementioned substances or substance groups can be.
- the drug in another embodiment, the drug
- nicotinic active substances which may also be nicotine, a nicotine salt or a nicotine derivative, and one of the previously defined centrally acting substances, wherein the maximum number of combined active ingredients does not exceed five.
- the drug formulation contains a nicotinic drug, which may also be nicotine, a nicotine salt or a nicotine derivative, and at least two of those previously defined centrally acting substances, the maximum number of combined active substances not exceeding five.
- a nicotinic drug which may also be nicotine, a nicotine salt or a nicotine derivative, and at least two of those previously defined centrally acting substances, the maximum number of combined active substances not exceeding five.
- the dosage forms according to the invention not only enable nicotine substitution, but at the same time permit treatment of the mental dependency component of nicotine addiction.
- moisturizers may be added to the film, e.g. Glycerol, propylene glycol, sorbitol, mannitol, polyethylene glycol, polyglycerol esters and the like.
- antioxidants may be added to the wafer to stabilize the film and the active agents, e.g. Vitamin C (ascorbic acid), ascorbyl palmitate, vitamin E (tocopherol acetate), hydroxybenzoic acid derivatives.
- active agents e.g. Vitamin C (ascorbic acid), ascorbyl palmitate, vitamin E (tocopherol acetate), hydroxybenzoic acid derivatives.
- acidic and basic ion exchangers can also be used as stabilizers.
- buffering systems can be added to the film. Flavors and aromas in particular can mask the often bad taste or smell of the active ingredients and / or give the dosage form a pleasant taste, so that the willingness to take the medication by the patient is significantly improved.
- the addition of buffering systems serves, on the one hand, to stabilize the film and the active ingredients against external influences and during storage, and on the other hand, it is possible to adjust the pH of the administration form to a physiologically acceptable pH, so that mucous membrane irritation is avoided ,
- a buffer system can also improve the solubility of acidic or basic drugs in the matrix.
- the administration forms according to the invention are thin, for example in the form of a wafer.
- the thickness of the dosage form is preferably 0.1 to 5 mm, more preferably 0.5 to 1 mm.
- the lower limit for the thickness of the dosage forms is about 50 microns.
- the area of the dosage form is between 0.09 cm 2 and 12 cm 2 , preferably between 1 cm 2 and 8 cm 2 , and particularly preferably between 3 cm 2 and 6 cm 2 .
- the wafers of the present invention include a disintegrant or wicking agent, e.g. a bicarbonate-acid mixture or an Aerosil, which is activated by contact with liquid and accelerates the disintegration of the wafer after application and thus also the release of active ingredient.
- a disintegrant or wicking agent e.g. a bicarbonate-acid mixture or an Aerosil
- the wafer is present as a foam, so that the Wirkstoffabgäbe due to the increased surface area is even faster.
- one or more of the active ingredients may also be present in liquid form in the cavities of the foam.
- P ⁇ neations managerer eg substances from the groups of fatty alcohols, fatty acids, Polyoxyethylenfettalkoholether, Polyoxyethylenfettklaklar, fatty alcohol esters and fatty acid esters, especially sorbitan monolaurate or esters of long-chain fatty acids with methyl, ethyl or Isopropyl alcohol, or esters of fatty alcohols with acetic acid or lactic acid, or else substances such as DMSO (dimethyl sulfoxide) and oleic diethanolamine may be added.
- the proportion of these substances is 0.1 to 25 wt .-%, preferably from 1 to 10
- composition of the wafer may contain compounds that retard drug release (e.g., microencapsulation).
- the wafer has mucoadhesive properties so that it adheres to the mucous membrane until it is completely dissolved.
- At least one of the active ingredients is bound to an ion exchanger so that the hydrophilic polymer disintegrates rapidly in the oral cavity, but the release of the active ingredient is delayed or takes place at a changed pH, for example in the gastrointestinal tract.
- active substances with different mechanisms of action and absorption can be administered in one dosage form, ie at least one of the released active substances is either absorbed at the site of application, eg via the oral mucosa or it is transported on and resorbed at another location.
- the wafer can also be constructed as a laminate with different layers, wherein the active ingredients are contained in discrete layers, which are spatially separated from each other and differ in their construction.
- the active ingredients can be released at different sites of action or even delayed, if the disintegration time of the different layers of the wafer differs.
- the active ingredients may be arranged in layers which disintegrate at different rates so that the entire preparation has a sustained-release effect.
- one of the outer layers may be mucoadhesive to promote adherence of the dosage form to the mucosa and to facilitate drug absorption across the mucosa through direct contact.
- Decay in aqueous medium of the dosage form of the invention is preferably in the range of 1 second to 5 minutes, more preferably in the range of 5 seconds to 1 minute, and most preferably in the range of 10 seconds to 30 seconds.
- administration forms according to the invention are advantageously suitable for administering medicaments in the oral cavity or for rectal, vaginal or intravenous administration. nasal administration. They can be used in human medicine as well as in veterinary medicine.
- the present invention is further directed to the use of one of the active ingredient combination according to the invention for the preparation of an oral dosage form for smoker's reconciliation, wherein the dosage form is preferably formulated as a wafer.
- the present invention is directed to a method for therapeutic smoking cessation, wherein the administration of a previously described Wirkstoffkombinati- on of nicotine and centrally acting substance by means of an orally administered dosage form with transmucosal absorption takes place.
- the present invention is also directed to a process for producing a sheet-like dosage form, which comprises the following steps: preparing a solution comprising at least one polymer and at least two active substances, one of which is a nicotine, a nicotine salt, a nicotine derivative or a nicotine nerg-acting substance and the other is a psychotropic drug contains; - spreading the solution on a coating base; and
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Organic Chemistry (AREA)
- Addiction (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Psychiatry (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
La présente invention concerne des formes galéniques orales se décomposant rapidement, pour l'administration de combinaisons d'agents actifs en vue du sevrage tabagique, avec une teneur en nicotine, un sel nicotinique, un dérivé de nicotine ou une substance à effet nicotinique, en combinaison avec un autre agent actif, ainsi que l'utilisation de telles formes pharmaceutiques pour le traitement de la dépendance à la nicotine, pour un substitut nicotinique ou pour le sevrage tabagique et l'utilisation de la nicotine ou de ses sels ou dérivés pour la préparation de formes pharmaceutiques en vue du traitement de la dépendance à la nicotine. L'agent actif à administrer en combinaison est une substance à action centrale, de préférence un antidépresseur, pour lutter contre la dépendance physique dans le cadre d'une thérapie de sevrage tabagique. La prise de la combinaison d'agents actifs doit être réalisée de manière simple et fiable pour le patient et exclure sensiblement les effets secondaires.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102006027795A DE102006027795A1 (de) | 2006-06-16 | 2006-06-16 | Raucherentwöhnungs-Kombinationswafer |
PCT/EP2007/004937 WO2007144081A2 (fr) | 2006-06-16 | 2007-06-04 | Comprimé plat combiné pour le sevrage tabagique |
Publications (1)
Publication Number | Publication Date |
---|---|
EP2029098A2 true EP2029098A2 (fr) | 2009-03-04 |
Family
ID=38662687
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP07725805A Withdrawn EP2029098A2 (fr) | 2006-06-16 | 2007-06-04 | Comprimé plat combiné pour le sevrage tabagique |
Country Status (8)
Country | Link |
---|---|
US (1) | US20100233244A1 (fr) |
EP (1) | EP2029098A2 (fr) |
JP (1) | JP2009539893A (fr) |
CN (1) | CN101472556A (fr) |
BR (1) | BRPI0711996A2 (fr) |
CA (1) | CA2654477A1 (fr) |
DE (1) | DE102006027795A1 (fr) |
WO (1) | WO2007144081A2 (fr) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20090258865A1 (en) | 2008-03-28 | 2009-10-15 | Hale Biopharma Ventures, Llc | Administration of benzodiazepine compositions |
PT3415139T (pt) | 2011-06-14 | 2022-06-20 | Neurelis Inc | Administração de benzodiazepina |
US9687445B2 (en) | 2012-04-12 | 2017-06-27 | Lts Lohmann Therapie-Systeme Ag | Oral film containing opiate enteric-release beads |
CN103044307A (zh) * | 2013-01-24 | 2013-04-17 | 吉林三善恩科技开发有限公司 | 以2,4-二羟基苯甲酸为前驱体的吡拉西坦药物共晶及其制备方法 |
CN104621327B (zh) * | 2015-01-23 | 2018-03-16 | 广东工业大学 | 一种替烟口嚼糖及其制备方法 |
Family Cites Families (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2703795A (en) * | 1994-06-23 | 1996-01-19 | Procter & Gamble Company, The | Treatment of nicotine craving and/or smoking withdrawal symptoms with a transdermal or transmucosal composition containing nicotine and caffeine or xanthine |
DE10018834A1 (de) * | 2000-04-15 | 2001-10-25 | Lohmann Therapie Syst Lts | Transdermale oder transmucosale Darreichungsformen mit einer nicotinhaltigen Wirkstoffkombination zur Raucherentwöhnung |
DE10107659B4 (de) * | 2001-02-19 | 2008-03-13 | Lts Lohmann Therapie-Systeme Ag | Mucoadhäsive zerfallsfähige Arzneizubereitung zur Wirkstoffverabreichung in der Veterinär- und Humanmedizin |
CA2449415A1 (fr) * | 2001-04-20 | 2002-10-31 | Lavipharm Laboratories Inc. | Distribution intrabucale de nicotine destinee a arreter de fumer |
DE10224607B4 (de) * | 2002-06-04 | 2008-03-13 | Lts Lohmann Therapie-Systeme Ag | Filmförmige, zerfallsfähige Zubereitungen zur Wirkstofffreisetzung und Verfahren zu deren Herstellung |
DE10256775A1 (de) * | 2002-12-05 | 2004-06-24 | Lts Lohmann Therapie-Systeme Ag | Filmförmige Zubereitungen zur transmucosalen Verabreichung von Nicotin, sowie Verfahren zu deren Herstellung |
DE10328942A1 (de) * | 2003-06-27 | 2005-01-27 | Lts Lohmann Therapie-Systeme Ag | Transmukosale Darreichungsformen mit verminderter Schleimhautirritation |
US20070059346A1 (en) * | 2003-07-01 | 2007-03-15 | Todd Maibach | Film comprising therapeutic agents |
US20070042023A1 (en) * | 2005-08-22 | 2007-02-22 | National Starch And Chemical Investment Holding Corporation | Dissolvable film |
-
2006
- 2006-06-16 DE DE102006027795A patent/DE102006027795A1/de not_active Withdrawn
-
2007
- 2007-06-04 CN CNA2007800225022A patent/CN101472556A/zh active Pending
- 2007-06-04 WO PCT/EP2007/004937 patent/WO2007144081A2/fr active Application Filing
- 2007-06-04 BR BRPI0711996-8A patent/BRPI0711996A2/pt not_active IP Right Cessation
- 2007-06-04 CA CA002654477A patent/CA2654477A1/fr not_active Abandoned
- 2007-06-04 JP JP2009514662A patent/JP2009539893A/ja not_active Withdrawn
- 2007-06-04 US US12/308,428 patent/US20100233244A1/en not_active Abandoned
- 2007-06-04 EP EP07725805A patent/EP2029098A2/fr not_active Withdrawn
Non-Patent Citations (1)
Title |
---|
See references of WO2007144081A2 * |
Also Published As
Publication number | Publication date |
---|---|
DE102006027795A1 (de) | 2007-12-20 |
WO2007144081A2 (fr) | 2007-12-21 |
US20100233244A1 (en) | 2010-09-16 |
CA2654477A1 (fr) | 2007-12-21 |
BRPI0711996A2 (pt) | 2011-12-27 |
CN101472556A (zh) | 2009-07-01 |
WO2007144081A3 (fr) | 2008-04-10 |
JP2009539893A (ja) | 2009-11-19 |
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