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WO2009124357A1 - Formulations orales à dissolution rapide pour médicaments critiques - Google Patents

Formulations orales à dissolution rapide pour médicaments critiques Download PDF

Info

Publication number
WO2009124357A1
WO2009124357A1 PCT/AU2009/000449 AU2009000449W WO2009124357A1 WO 2009124357 A1 WO2009124357 A1 WO 2009124357A1 AU 2009000449 W AU2009000449 W AU 2009000449W WO 2009124357 A1 WO2009124357 A1 WO 2009124357A1
Authority
WO
WIPO (PCT)
Prior art keywords
formulation
tablet
critical drug
critical
drug
Prior art date
Application number
PCT/AU2009/000449
Other languages
English (en)
Inventor
Malvin Leonard Eutick
Original Assignee
Malvin Leonard Eutick
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
Priority claimed from AU2008901738A external-priority patent/AU2008901738A0/en
Application filed by Malvin Leonard Eutick filed Critical Malvin Leonard Eutick
Publication of WO2009124357A1 publication Critical patent/WO2009124357A1/fr

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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

Definitions

  • the invention described herein relates generally the provision and formulation for fast dissolving oral formulations for critical drugs in some drug classes where this is a clinical advantage.
  • the invention is directed to fast melt, including effervescent, oral formulations of critical drugs which dissolve in the mouth in less than thirty seconds, and to devices for delivery of those formulations, although the scope of the invention is not necessarily limited thereto.
  • drugs have be delivered in a number of ways, formulated accordingly. Tablets can be administered, which dissolve in the stomach, or in the bowels if coated to pass through the stomach. Dissolution of tablets takes between 10 and 90 minutes. Syrups, which are meant to be swallowed, can be administered, and then behave in the same way as tablets, except that there is no dissolution delay.
  • Drugs can be injected for faster action, generally necessitating a trained person for administration.
  • transdermal patches for delayed delivery for example 72 hours release for fentanyl patches
  • rapid delivery for example nitroglycerine patches
  • the patches have some advantages, but disadvantages can include skin reactions and variability of delivery depending on the skin.
  • Transdermal creams such as testosterone gels, give variable results and are best used directly on the reproductive organs due to low skin thickness and directness of action.
  • Mechanisms for lung delivery are good for lung diseases, for example cystic fibrosis or asthma.
  • Nasal delivery usually as a spray, is also a rapid delivery option, but may involve different pharmacokinetics to the same drug when administered orally.
  • Results of nasal administration may vary, depending on the condition of the nasal tissue, and can be irritating to the patient and also usually require a patient to be conscious.
  • Formulations suitable for buccal or sub lingual administration have also been developed, variations of which can include sprays, drops, wafers and lozenges.
  • the invention provides a fast dissolving, including effervescent, oral formulation tablet comprising at least one critical drug, mannitol, sorbitol, a disintegrant and a glidant, wherein the tablet dissolves in the mouth or between the lips and the gums in less than 30 seconds.
  • the invention provides a device when used for dispensing the tablet of the first embodiment, the device comprising a chamber for storing at least one tablet, an opening for release of the tablet from the device, a mechanism for moving the tablet from the chamber to the opening, and an actuator for activating the mechanism.
  • the critical drugs of the invention may include all drugs which are used to effect a rapid response in a patient.
  • drugs include the following: i. Drugs for short rapid action pain control, for example fentanyl and its related substances, morphine and salts, methadone, hydromorphone, codeine, tramadol, oxycodone, nalbuphone and all other opioids, ketamine, paracetamol and other non steroidal anti-inflammatory actives such as diclofenac, sunlidac and ibuprofen; paracetamol; ii.
  • Drugs for short rapid action pain control for example fentanyl and its related substances, morphine and salts, methadone, hydromorphone, codeine, tramadol, oxycodone, nalbuphone and all other opioids, ketamine, paracetamol and other non steroidal anti-inflammatory actives such as diclofenac, sunlidac and ibuprofen; paracetamol; ii
  • Drugs for nausea control either during events such as migraines, cancer treatments, trauma, or other non specific events that cause a nauseous reaction, such as travel sickness or premenstrual syndrome, drugs such as metoclopamide, cyclizine, promethazine and levopromethazine, droperidol, odansetron and its analogues such as granisetron, drugs for travel sickness such as hyoscine hydrobromide, drugs for migraine such as sumitriptan and its analogues, ergotamine, caffeine; iii. Drugs for the control of vomiting or gagging; iv.
  • Anticonvulsants and anti-spasmodics such as midazolam, clonazepam, carbamazepine, topiramate, and phenobarbitone;
  • Drugs for rapid control of epileptic or similar fits such as valproate, phenytoin, lamotrigine, tiagabine, levetiracetam, pregabalin, primidone, clonazepam, gabapentin, diazepam or midazolam for the f ⁇ per se
  • Anaesthetics such as ketamine, or other drugs with a rapid oral action
  • Drugs for the treatment of sleep disturbances for example melatonin
  • Drugs for the treatment of psychiatric disturbances such as mania, anxiety and psychoses, for example, moclobemide, amitriptyline, clomipramine, droperidol, lorazepam, diazapam and analogues, clozapine, flupenthixol, doxepin, and SSRTs, buspirone and propanolol, or other beta blockers used for anxiety disorders; ix. Drugs for treating attention deficit disorders (ADHD) such as methylphenidate; x. Drugs used to treat addiction or to block the effect of drugs of addiction such as methadone, naltrexone, buprenorphine and mixtures of such drugs or similar drugs; xi.
  • ADHD attention deficit disorders
  • Drugs for treating movement disorders such as tetrabenazine; and xii. Drugs for treating Parkinson's or Altzheimer's Disease.
  • the concentration of the active drug in the formulation can be any practicable amount, but is preferably in the range from l ⁇ g to 500mg.
  • the tablet of the invention can comprise more than one drug if required, in relative concentrations as required.
  • the disintegrant can be any practicable disintegrant, but is preferably crospovidone, croscarmellose, sodium starch glycolate, or combinations thereof.
  • the glidant can be any practicable glidant, but is preferably a silica-based glidant.
  • the tablet of the invention can also include a flavouring to disguise the taste and/or odour of the drug.
  • the tablet can also include a sweetener to assist with the disguise of taste of the drug.
  • the tablet can also include an anesthetic, for example benzoyl alcohol, to detract from the taste and odour of the drug.
  • an anesthetic for example benzoyl alcohol
  • the tablet can also include excipients such as sucralose, starch, maltose, and lactose.
  • excipients such as sucralose, starch, maltose, and lactose.
  • the tablet can also include an effervescing agent.
  • the tablet can also include a pH modifying agent such as lemon flavour or a pharmaceutically appropriate acid, such as citric acid. Lowering the pH of the mouth below pH 7 increases saliva production and assists in the dissolution of the tablet of the invention.
  • the tablet can be any size, but is preferably 1 mm to 15 mm in diameter.
  • the tablet of the invention can be administered orally to a patient in any practicable manner.
  • the tablet is also contemplated for patients who are incapacitated by their condition, for example a patient in the throes of a seizure, or a patient immobilized by the pain and nausea associated with a migraine. These types of incapacitation can prevent the patient from opening the mouth to receive a tablet.
  • the tablet can be inserted into the oral cavity, or even between the lip and the gum, where it rapidly dissolves to release the active drug for transmembrane absorption in the mouth.
  • the tablets of the invention provide improved and enhanced absorption of the active drug, particularly in situations where the patient is incapacitated, or where the drug is more reliably and reproducibly absorbed from the mouth than when administered by other means.
  • the device of the invention can be any configuration practicable for storage and dispensing as defined in this embodiment.
  • the chamber of the device can be any suitable shape and size to accommodate one or more tablets of the invention.
  • the chamber can be secure, such that once opened, is unable to be re-opened to remove the tablets. This also provides a humidity control to prevent premature dissolution in the device, and prevents sticking or cross adherence between tablets.
  • the tablets can be loaded into the chamber in a cartridge, to be dispensed one at a time, thereby also maintaining control of the humidity of the environment of the remainder of the tablets, and preventing premature dissolution of the tablets.
  • the opening of the device can be a reversibly closable opening, or a permanently open opening, for example a movable flap can cover the opening, which flap is lifted manually or automatically when the tablet is released.
  • the opening may be able to be rotated in any of three dimensions to allow better access for patients.
  • the mechanism can be any practicable mechanism, including a spring or similar driving mechanism such as a ratchet, that moves the tablet or cartridge of tablets along the storage chamber to dispense the tablet or one tablet at a time from the opening.
  • a spring or similar driving mechanism such as a ratchet
  • the actuator can be any practicable actuator for activating the spring mechanism.
  • the actuator is preferably a knob or lever which is easy to press, push or pull.
  • the device can also have a soft or hard mouthpiece or lip guide, to allow the tablet to be guided to the mouth or gums without damaging same.
  • the device can also be dated, and incorporate a counter which allows determination of the number of tablets used, and the date of activation. In cases of critical and dangerous drugs such as opioids, the device can be fitted with a timer to only allow activation of tablet delivery at certain time intervals, for example hourly or daily.
  • the device facilitates administration of the tablet of the invention, avoiding excessive handling of the tablet.
  • the device has a housing for a cartridge of tablets, a spring means at the base of the housing which pushes the housing in the direction which forces the end of the cartridge of tablets toward an opening in the device, and a cover which includes a lever, When the lever is actuated, the cover opens, allowing the spring to push against the cartridge, and a projection on the underside of the cover then causes the topmost tablet to slide out of the opening.
  • a tablet of the invention Delivery of a tablet of the invention is simple and uncomplicated.
  • the tablet is simply placed in the mouth. Therefore, even persons not speaking the language of the manufacturer can follow a simple drawing indicating use.
  • the tablet will have dissolved before the patient has time to consider spitting it out, gagging on it or vomiting it away.
  • the tablets of the invention provide safety of delivery.
  • the tablets dissolve too rapidly to cause choking , which is a hazard with lozenges, or difficulty with swallowing, which is very often an issue with traditional tablets or syrups.
  • the tablet of the invention allows a very rapid and visible delivery that, once given, cannot be stopped .
  • the device of the invention allows careful accounting of the number of tablets administered.
  • the controlled delivery device delivers one tablet at a time, which allows accounting both by counting at delivery, or by inspection of the number of tablets remaining in the cartridge after administration.
  • the device may be fitted with a timer to only allow activation of tablet delivery at certain time intervals, such as hourly or daily.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention porte sur un comprimé de formulation orale à dissolution rapide comprenant un médicament critique, un glissant, un désintégrant, le comprimé se dissolvant dans la bouche en moins de 30 secondes. L'invention porte également sur un dispositif pour distribuer le comprimé de l'invention.
PCT/AU2009/000449 2008-04-10 2009-04-09 Formulations orales à dissolution rapide pour médicaments critiques WO2009124357A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU2008901738A AU2008901738A0 (en) 2008-04-10 Fast Dissolving Oral Formulations for Critical Drugs
AU2008901738 2008-04-10

Publications (1)

Publication Number Publication Date
WO2009124357A1 true WO2009124357A1 (fr) 2009-10-15

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WO (1) WO2009124357A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8524733B2 (en) 2008-09-18 2013-09-03 Auspex Pharmaceuticals Benzoquinoline inhibitors of vesicular monoamine transporter 2
WO2014144512A1 (fr) 2013-03-15 2014-09-18 Aprecia Pharmaceuticals Company Forme pharmaceutique à dispersion rapide contenant du lévétiracétam
US9233959B2 (en) 2012-09-18 2016-01-12 Auspex Pharmaceuticals, Inc. Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
US9550780B2 (en) 2012-09-18 2017-01-24 Auspex Pharmaceuticals, Inc. Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
US10513488B2 (en) 2013-12-03 2019-12-24 Auspex Pharmaceuticals, Inc. Methods of manufacturing benzoquinoline compounds
CN111888396A (zh) * 2020-08-06 2020-11-06 山东明仁福瑞达制药股份有限公司 一种治疗颈椎病的药物组合物及其制备方法和应用
US11160786B2 (en) 2013-03-15 2021-11-02 Aprecia Pharmaceuticals LLC Rapid disperse dosage form
WO2021243399A1 (fr) * 2020-06-02 2021-12-09 Ix Biopharma Limited Procédés de traitement de trouble dépressif majeur et de dépression résistante au traitement
US11357772B2 (en) 2015-03-06 2022-06-14 Auspex Pharmaceuticals, Inc. Methods for the treatment of abnormal involuntary movement disorders

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3410455A (en) * 1965-12-30 1968-11-12 Centromint Co Establishment Va Dispensing device for tablets
US6187337B1 (en) * 1994-01-27 2001-02-13 The Board Of Regents Of The University Of Oklahoma Rapidly dissolving dosage form
WO2001039749A2 (fr) * 1999-11-30 2001-06-07 Panacea Biotec Limited Composition a dissolution rapide et a gout sucre de longue duree
US6316029B1 (en) * 2000-05-18 2001-11-13 Flak Pharma International, Ltd. Rapidly disintegrating solid oral dosage form
WO2002055061A2 (fr) * 2001-01-11 2002-07-18 Particle And Coating Technologies, Inc. Procede relatif a l'elaboration de comprimes poreux a proprietes de dissolution ameliorees
WO2003051338A1 (fr) * 2001-12-17 2003-06-26 Spi Pharma, Inc. Systeme glucidique co-traite utilise en tant que matrice a dissolution rapide pour formes posologiques solides
EP1369109A1 (fr) * 2001-03-06 2003-12-10 Kyowa Hakko Kogyo Co., Ltd. Preparations se delitant rapidement dans la bouche
WO2004100857A2 (fr) * 2003-05-07 2004-11-25 Akina, Inc. Granules a teneur elevee en plastique, destines a la fabrication de comprimes a dissolution rapide
WO2006079922A2 (fr) * 2005-01-28 2006-08-03 Pfizer Products Inc. Liants microporeux a desintegration rapide

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3410455A (en) * 1965-12-30 1968-11-12 Centromint Co Establishment Va Dispensing device for tablets
US6187337B1 (en) * 1994-01-27 2001-02-13 The Board Of Regents Of The University Of Oklahoma Rapidly dissolving dosage form
WO2001039749A2 (fr) * 1999-11-30 2001-06-07 Panacea Biotec Limited Composition a dissolution rapide et a gout sucre de longue duree
US6316029B1 (en) * 2000-05-18 2001-11-13 Flak Pharma International, Ltd. Rapidly disintegrating solid oral dosage form
WO2002055061A2 (fr) * 2001-01-11 2002-07-18 Particle And Coating Technologies, Inc. Procede relatif a l'elaboration de comprimes poreux a proprietes de dissolution ameliorees
EP1369109A1 (fr) * 2001-03-06 2003-12-10 Kyowa Hakko Kogyo Co., Ltd. Preparations se delitant rapidement dans la bouche
WO2003051338A1 (fr) * 2001-12-17 2003-06-26 Spi Pharma, Inc. Systeme glucidique co-traite utilise en tant que matrice a dissolution rapide pour formes posologiques solides
WO2004100857A2 (fr) * 2003-05-07 2004-11-25 Akina, Inc. Granules a teneur elevee en plastique, destines a la fabrication de comprimes a dissolution rapide
WO2006079922A2 (fr) * 2005-01-28 2006-08-03 Pfizer Products Inc. Liants microporeux a desintegration rapide

Cited By (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8524733B2 (en) 2008-09-18 2013-09-03 Auspex Pharmaceuticals Benzoquinoline inhibitors of vesicular monoamine transporter 2
US11033540B2 (en) 2012-09-18 2021-06-15 Auspex Pharmaceuticals, Inc. Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
US9233959B2 (en) 2012-09-18 2016-01-12 Auspex Pharmaceuticals, Inc. Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
US11666566B2 (en) 2012-09-18 2023-06-06 Auspex Pharmaceuticals, Inc. Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
US9296739B2 (en) 2012-09-18 2016-03-29 Auspex Pharmaceuticals, Inc. Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
US9346800B2 (en) 2012-09-18 2016-05-24 Auspex Pharmaceuticals, Inc. Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
US9550780B2 (en) 2012-09-18 2017-01-24 Auspex Pharmaceuticals, Inc. Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
US9814708B2 (en) 2012-09-18 2017-11-14 Auspex Pharmaceuticals, Inc. Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
US11160786B2 (en) 2013-03-15 2021-11-02 Aprecia Pharmaceuticals LLC Rapid disperse dosage form
WO2014144512A1 (fr) 2013-03-15 2014-09-18 Aprecia Pharmaceuticals Company Forme pharmaceutique à dispersion rapide contenant du lévétiracétam
EP2968994A4 (fr) * 2013-03-15 2016-03-16 Aprecia Pharmaceuticals Co Forme pharmaceutique à dispersion rapide contenant du lévétiracétam
US10513488B2 (en) 2013-12-03 2019-12-24 Auspex Pharmaceuticals, Inc. Methods of manufacturing benzoquinoline compounds
US12077487B2 (en) 2013-12-03 2024-09-03 Auspex Pharmaceuticals, Inc. Methods of manufacturing benzoquinoline compounds
US11357772B2 (en) 2015-03-06 2022-06-14 Auspex Pharmaceuticals, Inc. Methods for the treatment of abnormal involuntary movement disorders
US11446291B2 (en) 2015-03-06 2022-09-20 Auspex Pharmaceuticals, Inc. Methods for the treatment of abnormal involuntary movement disorders
US11564917B2 (en) 2015-03-06 2023-01-31 Auspex Pharmaceuticals, Inc. Methods for the treatment of abnormal involuntary movement disorders
US11648244B2 (en) 2015-03-06 2023-05-16 Auspex Pharmaceuticals, Inc. Methods for the treatment of abnormal involuntary movement disorders
US12016858B2 (en) 2015-03-06 2024-06-25 Auspex Pharmaceuticals, Inc. Methods for the treatment of abnormal involuntary movement disorders
WO2021243399A1 (fr) * 2020-06-02 2021-12-09 Ix Biopharma Limited Procédés de traitement de trouble dépressif majeur et de dépression résistante au traitement
CN111888396A (zh) * 2020-08-06 2020-11-06 山东明仁福瑞达制药股份有限公司 一种治疗颈椎病的药物组合物及其制备方法和应用

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