DK2884961T3 - Methylphenidat-tyggetablet med forlænget frigivelse - Google Patents

Methylphenidat-tyggetablet med forlænget frigivelse Download PDF

Info

Publication number
DK2884961T3
DK2884961T3 DK13752782.6T DK13752782T DK2884961T3 DK 2884961 T3 DK2884961 T3 DK 2884961T3 DK 13752782 T DK13752782 T DK 13752782T DK 2884961 T3 DK2884961 T3 DK 2884961T3
Authority
DK
Denmark
Prior art keywords
methylphenidate
release
mph
tablet
chewable tablet
Prior art date
Application number
DK13752782.6T
Other languages
English (en)
Inventor
Yu-Hsing Tu
Kalyan Kathala
Ashok Perumal
Original Assignee
Tris Pharma Inc
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=49029241&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2884961(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Tris Pharma Inc filed Critical Tris Pharma Inc
Application granted granted Critical
Publication of DK2884961T3 publication Critical patent/DK2884961T3/da

Links

Classifications

    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4458—Non condensed piperidines, e.g. piperocaine only substituted in position 2, e.g. methylphenidate
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/58—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. poly[meth]acrylate, polyacrylamide, polystyrene, polyvinylpyrrolidone, polyvinylalcohol or polystyrene sulfonic acid resin
    • A61K47/585—Ion exchange resins, e.g. polystyrene sulfonic acid resin
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (22)

1. Methylphenidat-tyggetablet med forlænget frigivelse, der har en terapeutisk effektiv øjeblikkelig frigivelse og en 12 timer forlænget frigivelsesprofil, hvor nævnte tyggetablet er en ensartet fast dispersion omfattende: (a) en methylphenidat-komponent med vedvarende frigivelse omfattende et vanduopløseligt, vand-permeabelt, pH-uafghængigt barriere-belagt, methylphenidat-ionbytterresin-kompleks i en polymerisk matrix, hvor nævnte barriere-belægning tilvejebringer egenskaber af vedvarende frigivelse til methylphenidatet og er overtrukket methylphenidat-ionbytterresin-kompleks-matricen; (b) en første komponent med øjeblikkelig frigivelse, der omfatter et ubelagt methylphenidat-ionbytterresin-kompleks; (c) en anden methylphenidat-komponent med øjeblikkelig frigivelse, der omfatter et ukomplekseret methylphenidat; hvor nævnte første komponent med øjeblikkelig frigivelse (b) har en langsommere indtræden af frigivelse end (c); hvor 50% vægt/vægt til 90% vægt/vægt af den aktive methylphenidat-komponent er tilvejebragt af komponenten med vedvarende frigivelse baseret på den samlede mængde af methylphenidat i tabletten, og hvor nævnte tyggetablet er i stand til at blive opdelt og tilvejebringe tabletdele, som opretholder en terapeutisk effektiv øjeblikkelig frigivelse og en 12 timer forlænget frigivelsesprofil .
2. Methylphenidat-tyggetablet med forlænget frigivelse, der har en 12 timer forlænget frigivelsesprofil og en hurtig indtræden, hvor nævnte tyggetablet er en ensartet fast dispersion omfattende: (a) en methylphenidatkomponent med vedvarende frigivelse omfattende 15% vægt/vægt til 25% vægt/vægt af et hærdet, vanduopløseligt, vandpermeabelt, ikke-ionisk, pH-uafhængigt barriere-belagt, methylphenidatbarriere-ionbytterresin-kompleks i en polyvinylpyrrolidonmatrix, hvor nævnte barriere-belægning er overtrukket methylphenidat-ionbytterresin-kompleks-matricen og omfatter polyvinylacetat, en stabilisator og et blødgøringsmiddel; (b) en første komponent med øjeblikkelig frigivelse, der omfatter et methylphenidat-ionbytterresin-kompleks og (c) en anden methylphenidat-komponent med øjeblikkelig frigivelse, der omfatter en aktiv methylphenidat-komponent og farmaceutisk acceptable excipienser; hvor nævnte første komponent med øjeblikkelig frigivelse (b) har en langsommere indtræden af frigivelse end (c); hvor 50% vægt/vægt til 90% vægt/vægt af den aktive methylphenidat-komponent er tilvejebragt af komponenten med vedvarende frigivelse baseret på den samlede mængde af methylphenidat i tabletten, og hvor nævnte tyggetablet er i stand til at blive opdelt og tilvejebringe tabletdele, som opretholder en terapeutisk effektiv øjeblikkelig frigivelse og 12 timer forlænget frigivelsesprofil.
3. Tyggetablet ifølge krav 1, hvor tyggetabletten har en farmakokinetisk profil, hvori den enkelte middelværdi for plasmakoncentrationsprofil for methylphenidat har en geometrisk middelværdi for området under kurven (AUC)o-æ på omkring 110 ng-t/mLtil omkring 140 ng-t/mL, en geometrisk middelværdi C max på omkring 10 ng/ml_ til omkring 15 ng/ml_, Tmax på omkring 4 timer til omkring 5,25 timer og T1/2 på omkring 5 timer til omkring 7 timer efterfølgende en enkelt oral indgivelse afen tyggetablet med forlænget frigivelse i en dosis svarende til 40 mg racemisk methylphenidat HCI hos voksne.
4. Methylphenidat-tyggetablet med forlænget frigivelse ifølge krav 1 eller krav 3, hvor the farmakokinetiske profil af methylphenidat har en geometrisk middelværdi for AUCo-00 på omkring 113 ng-t/mL under fastende betingelser og omkring 138 ng-t/mL under fodrede betingelser, en geometrisk middelværdi Cmax på omkring 12 ng/mLtil omkring 13 ng/mL under fastende og fodrede betingelser, en aritmetisk middelværdi Tmax på omkring 4 til omkring 4,5 timer under fastende og fodrede betingelser og en aritmetisk middelværdi T1/2 på omkring 5,2 timer under fastende og fodrede betingelser efterfølgende en enkelt oral indgivelse af en tyggetablet i en dosis svarende til 40 mg racemisk methylphenidat HCI hos voksne.
5. Methylphenidat-tyggetablet med forlænget frigivelse ifølge et hvilket som helst af kravene 1 til 4, hvor methylphenidat-komponenten med vedvarende frigivelse tilvejebringer 60% vægt/vægt til 80% vægt/vægt af methylphenidatet i tyggetabletten, baseret på den samlede mængde af methylphenidat i tabletten.
6. Methylphenidat-tyggetablet med forlænget frigivelse ifølge et hvilket som helst af kravene 1 til 5, hvor methylphenidat-komponenterne med øjeblikkelig frigivelse (b) og (c) sammen omfatter 20% vægt/vægt til 40% vægt/vægt af methylphenidatet i tyggetabletten, baseret på den samlede mængde af methylphenidat i tabletten.
7. Methylphenidat-tyggetablet med forlænget frigivelse ifølge et hvilket som helst af kravene 1 til 6, hvor methylphenidat-ionbytterresin-komplekset med øjeblikkelige frigivelse (b) er 5% vægt/vægt til 35% vægt/vægt af methylphenidatet i tyggetabletten, baseret på den samlede mængde af methylphenidat i tabletten.
8. Methylphenidat-tyggetablet med forlænget frigivelse ifølge et hvilket som helst af kravene 1 til 7, hvor det ukomplekserede methylphenidat med øjeblikkelig frigivelse er 5% vægt/vægt til 35% vægt/vægt af methylphenidatet i tyggetabletten.
9. Methylphenidat-tyggetablet med forlænget frigivelse ifølge et hvilket som helst af kravene 1 til 5, hvor methylphenidat-ionbytterresin-komplekset med øjeblikkelig frigivelse tilvejebringer omkring 15% vægt/vægt af methylphenidatet i tabletten og ukomplekseret methylphenidat med øjeblikkelig frigivelse og hurtigere indtræden tilvejebringer omkring 15% vægt/vægt af methylphenidatet i tabletten, baseret på den samlede mængde af methylphenidat i tabletten.
10. Methylphenidat-tyggetablet med forlænget frigivelse ifølge et hvilket som helst af kravene 1 til 9, hvor det aktive methylphenidat-lægemiddel er valgt fra racemisk methylphenidat og dexmethylphenidat eller et salt eller hydrat deraf, hvor det aktive methylphenidat-lægemiddel eventuelt er methylphenidat HCI.
11. Methylphenidat-tyggetablet med forlænget frigivelse ifølge et hvilket som helst af kravene 1 til 10, hvor forholdet af det ubelagte MHP- ion bytterresin-kompleks med øjeblikkelig frigivelse (b) til den ukomplekserede MPH-komponent med øjeblikkelig frigivelse (c) er i området fra omkring 3:1 baseret på den samlede vægt af komponenterne med øjeblikkelig frigivelse.
12. Methylphenidat-tyggetablet med forlænget frigivelse ifølge et hvilket som helst af kravene 1 til 10, hvor tabletten har en hårdhed i området fra 8 kp til 23 kp.
13. Methylphenidat-tyggetablet med forlænget frigivelse ifølge et hvilket som helst af kravene 1 til 12 hvor den vanduopløselige, vandpermeable, pH-uafhængige barriere-belægning har en trækstyrke i et område fra 150% til 400% og er valgt fra (a) en hærdet, vandpermeabel, ikke-ionisk, pH-uafhængig barrierebelægning omfattende polyvinylacetat, en stabilisator, og et blødgøringsmiddel, påført som en vandig dispersion; (b) en ionisk, pH-uafhængig, akryl-baseret belægning omfattende en polymer eller copolymer omfattende ethylakrylat og methylmethakrylat påført som en vandig dispersion; hvor den akryl-baserede belægning eventuelt omfatter en blanding af (i) et poly(ethylakrylat-co-methylmethakrylat-co-trimethylammonioethylmethakrylatklorid i et forhold på 1:2:0,1 og (ii) poly(ethylakrylat-co-methylmethakrylat-co-trimethylammonioethylmethakrylatklorid) i et forhold på 1:2:0,2; og (c) en solvent-baseret ethylcellulose-belægning, eventuelt med et blødgøringsmiddel.
14. Methylphenidat-tyggetablet med forlænget frigivelse, der har en 12 timer forlænget frigivelsesprofilog en hurtig indtræden ifølge et hvilket som helst af kravene 2 og 5 til 12 eller en methylphenidat-tyggetablet med forlænget frigivelse ifølge krav 13, hvor barriere-belægningen overtrukket methylphenidat-ionbytterresink-ompleks-matricen er en hærdet, vanduopløselig, vandpermeabel, ikke-ionisk, pH-uafhængig barriere-belægning omfattende 70% vægt/vægt til 90% vægt/vægt polyvinylacetat, en stabilisator, og 2% vægt/vægt til 10% vægt/vægt af et blødgøringsmiddel baseret på vægten af barriere-belægningen.
15. Methylphenidat-tyggetablet med forlænget frigivelse ifølge et hvilket som helst af kravene 1 til 14, hvor tabletten yderligere omfatter et ikke-funktionelt ydre topbelægningslag.
16. Methylphenidat-tyggetablet med forlænget frigivelse ifølge krav 14, hvor methylphenidat-ionbytterresin-komplekset med øjeblikkelig frigivelse yderligere omfatter et overflade og/eller pigment-belægningslag.
17. Methylphenidat-tyggetablet med forlænget frigivelse ifølge et hvilket som helst af kravene 1 til 16, som er forsynet med indsnit.
18. Methylphenidat-tyggetablet med forlænget frigivelse ifølge et hvilket som helst af kravene 1 til 17, som yderligere omfatter et eller flere farmaceutisk inaktive excipienser, hvor eventuelt (a) excipienserne er valgt fra gruppen bestående af mannitol, xanthangummi, mikrokrystallinsk cellulose, guargummi og blandinger deraf; (b) desintegratoren er crospovidon; (c) smørremidlerne er valgt fra en eller flere af talkum, magnesiumstearat og blandinger deraf; og/eller (d) buffermidlet er valgt fra citronsyre og salte deraf.
19. Methylphenidat-tyggetablet med forlænget frigivelse ifølge krav 1 omfattende: 15% vægt/vægt til 20% vægt/vægt belagt methylphenidat-ionbytterresin-kompleks, som er komponenten med vedvarende frigivelse; 1,5% vægt/vægt til 5% vægt/vægt ubelagt methylphenidat-ionbytterresin-kompleks, som er komponenten med øjeblikkelig frigivelse med langsommere indtræden; 0,5% vægt/vægt til 1% vægt/vægt af et methylphenidat, som er komponenten med øjeblikkelig frigivelse med hurtigere indtræden; 45% vægt/vægt to 85% vægt/vægt af et eller flere fyldstoffer; 5% vægt/vægt til 10% vægt/vægt af en eller flere desintegratorer; 0,1% vægt/vægt til 10% vægt/vægt af et eller flere buffermidler; 1% vægt/vægt til 3% vægt/vægt af et eller flere sødestoffer; 1,1 % vægt/vægt til 3% vægt/vægt aromamidler; 1,2% til 3% vægt/vægt af et eller flere smøremidler; 0,01% til 1% vægt/vægt af et eller flere glidemidler; 0,01% til 0,5% vægt/vægt af et eller flere farvemidler, hvor vægtprocenterne er baseret på den samlede tabletvægt forud for en hvilken som helst eventuel ikke-funktionel tablet-belægning.
20. Methylphenidat-tyggetablet med forlænget frigivelse ifølge krav 1 omfattende: 16% vægt/vægt til 18% vægt/vægt belagt methylphenidat-ionbytterresin-kompleks, som er komponenten med vedvarende frigivelse; 2% vægt/vægt til 3% vægt/vægt ubelagt methylphenidat-ionbytterresin-kompleks, som er komponenten med øjeblikkelig frigivelse med langsommere indtræden; 0,5 % vægt/vægt til 0,8 % vægt/vægt af et ukomplekseret methylphenidat, som er komponenten med øjeblikkelig frigivelse med hurtigere indtræden; 50 % vægt/vægt til 70% vægt/vægt af et eller flere fyldstoffer; 7% vægt/vægt til 8% vægt/vægt af en eller flere desintegratorer; 0,5% vægt/vægt to 1,5% vægt/vægt af et eller flere buffermidler; 1% vægt/vægt til 2% vægt/vægt af et eller flere sødestoffer; 0,1 % vægt/vægt til 1% vægt/vægt aromastoffer; 1,5% vægt/vægt til 3% vægt/vægt af et eller flere smøremidler; 0,01% til 1% vægt/vægt af et eller flere glidemidler; 0,02% til 0,08% vægt/vægt af et eller flere farvestoffer, hvor vægtprocenterne er baseret på den samlede tabletvægt forud for en hvilken som helst eventuel ikke-funktionel tablet-belægning.
21. Methylphenidat-tyggetablet med forlænget frigivelse ifølge et hvilket som helst af kravene 1 til 20 til anvendelse i behandling af et individ.
22. Enkelt methylphenidat-tyggetablet med forlænget frigivelse til anvendelse i et individ ifølge krav 21, hvor en terapeutisk effektiv mængde af methylphenidat leveres over mindst tolv timer til et individ.
DK13752782.6T 2012-08-15 2013-08-14 Methylphenidat-tyggetablet med forlænget frigivelse DK2884961T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261683513P 2012-08-15 2012-08-15
US201361774783P 2013-03-08 2013-03-08
PCT/US2013/054930 WO2014028610A1 (en) 2012-08-15 2013-08-14 Methylphenidate extended release chewable tablet

Publications (1)

Publication Number Publication Date
DK2884961T3 true DK2884961T3 (da) 2019-04-23

Family

ID=49029241

Family Applications (1)

Application Number Title Priority Date Filing Date
DK13752782.6T DK2884961T3 (da) 2012-08-15 2013-08-14 Methylphenidat-tyggetablet med forlænget frigivelse

Country Status (9)

Country Link
US (15) US8999386B2 (da)
EP (1) EP2884961B1 (da)
AU (1) AU2013302657B2 (da)
BR (1) BR112015003120B1 (da)
CA (1) CA2880456A1 (da)
DK (1) DK2884961T3 (da)
ES (1) ES2717469T3 (da)
IL (1) IL236847B (da)
WO (1) WO2014028610A1 (da)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11400065B2 (en) 2019-03-01 2022-08-02 Flamel Ireland Limited Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
US11504347B1 (en) 2016-07-22 2022-11-22 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11583510B1 (en) 2022-02-07 2023-02-21 Flamel Ireland Limited Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
US11602512B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602513B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11779557B1 (en) 2022-02-07 2023-10-10 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11839597B2 (en) 2016-07-22 2023-12-12 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11986451B1 (en) 2016-07-22 2024-05-21 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5479086B2 (ja) 2006-03-16 2014-04-23 トリス・フアルマ・インコーポレーテツド 薬剤−イオン交換樹脂複合体を含有する放出調節製剤
AU2013302657B2 (en) * 2012-08-15 2018-08-09 Tris Pharma, Inc. Methylphenidate extended release chewable tablet
US11590228B1 (en) 2015-09-08 2023-02-28 Tris Pharma, Inc Extended release amphetamine compositions
KR20240033130A (ko) * 2016-11-01 2024-03-12 네오스 테라퓨틱스, 엘피 Adhd의 치료를 위한 메틸페니데이트의 효과적인 아동 투여
TWI791590B (zh) * 2017-08-14 2023-02-11 美商瓦特隆電子製造公司 接合石英件之方法及接合之石英的石英電極及其他裝置
US11590081B1 (en) 2017-09-24 2023-02-28 Tris Pharma, Inc Extended release amphetamine tablets
WO2020115709A1 (en) * 2018-12-06 2020-06-11 Flamel Ireland Limited Modified release pharmaceutical composition
US11918689B1 (en) 2020-07-28 2024-03-05 Tris Pharma Inc Liquid clonidine extended release composition
CA3239786A1 (en) * 2021-12-03 2023-06-08 Kapish KARAN An organic chewable composition comprising certified organic ingredients, and process for preparing the same
CN116036036B (zh) * 2021-12-10 2024-04-16 中国人民解放军军事科学院军事医学研究院 一种盐酸哌甲酯缓释咀嚼片及其制备方法和其应用

Family Cites Families (139)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US659463A (en) 1899-11-18 1900-10-09 E & A H Batcheller Company Heel-attaching machine.
US692988A (en) 1901-05-20 1902-02-11 Seneca Falls Mfg Company Drill-chuck.
US2507631A (en) 1944-01-19 1950-05-16 Ciba Pharm Prod Inc Pyridine and piperidine compounds and process of making same
US2957880A (en) 1953-12-23 1960-10-25 Ciba Pharm Prod Inc Process for the conversion of stereoisomers
US2990332A (en) 1958-04-02 1961-06-27 Wallace & Tiernan Inc Pharmaceutical preparations comprising cation exchange resin adsorption compounds and treatment therewith
US3138525A (en) 1961-06-16 1964-06-23 Hoffmann La Roche Castor wax-amprotropine-resin compositions
US3499960A (en) 1965-01-25 1970-03-10 Merck & Co Inc Palatable coated particles of an anion exchange resin
US3594470A (en) 1968-02-19 1971-07-20 Abbott Lab Chewable tablets including coated particles of pseudoephedrine-weak cation exchange resin
GB1218102A (en) 1968-03-15 1971-01-06 Philips Nv Improvements in medicaments comprising drug/ion-exchange resin compounds
LU63060A1 (da) 1971-04-26 1971-08-26
DE2246037B2 (de) 1972-09-20 1975-02-27 Taeschner & Co, 8831 Kipfenberg Peroral anwendbares Arzneimittel mit verzögerter Resorbierbarkeit in Suspensionsform
DE2322883A1 (de) 1973-05-07 1974-11-28 Roehm Gmbh Wasserloesliche polymerisate
US4221778A (en) 1979-01-08 1980-09-09 Pennwalt Corporation Prolonged release pharmaceutical preparations
CH655507B (da) 1983-01-12 1986-04-30
US4765989A (en) 1983-05-11 1988-08-23 Alza Corporation Osmotic device for administering certain drugs
US4762709A (en) 1983-09-16 1988-08-09 Pennwalt Corporation Liquid prolonged release pharmaceutical formulations containing ionic constituents
IE56999B1 (en) 1983-12-22 1992-03-11 Elan Corp Plc Pharmaceutical formulation
US4876094A (en) 1984-01-13 1989-10-24 Battelle Development Corporation Controlled release liquid dosage formulation
IE58110B1 (en) 1984-10-30 1993-07-14 Elan Corp Plc Controlled release powder and process for its preparation
US4600645A (en) 1985-01-31 1986-07-15 Warner-Lambert Company Process for treating dosage forms
EP0227814A1 (en) 1985-07-02 1987-07-08 The Upjohn Company Therapeutic formulations with bimodal release characteristics
GB8518301D0 (en) 1985-07-19 1985-08-29 Fujisawa Pharmaceutical Co Hydrodynamically explosive systems
JPS62103012A (ja) 1985-10-23 1987-05-13 Eisai Co Ltd 多重顆粒
US4794001A (en) 1986-03-04 1988-12-27 American Home Products Corporation Formulations providing three distinct releases
DE3617432A1 (de) 1986-05-23 1987-11-26 Standard Elektrik Lorenz Ag Elektronenstrahlerzeugungssystem
US4752470A (en) 1986-11-24 1988-06-21 Mehta Atul M Controlled release indomethacin
US4910932A (en) 1987-01-05 1990-03-27 Honigman Michael L Modular building system
US4894239A (en) 1987-06-02 1990-01-16 Takeda Chemical Industries, Ltd. Sustained-release preparation and production thereof
GB2206880B (en) 1987-07-16 1991-04-24 Farmos Oy Optical isomers of an imidazole derivative
US4961932A (en) 1987-10-26 1990-10-09 Alza Corporation Plurality of tiny pills in liquid dosage form
US5219563A (en) 1988-05-11 1993-06-15 Glaxo Group Limited Drug adsorbates
IL90245A (en) 1988-05-11 1994-04-12 Glaxo Group Ltd Resin adsorption containing ranitidine together with synthetic resin replaces cations, its preparation and pharmaceutical preparations containing it
US4996047A (en) 1988-11-02 1991-02-26 Richardson-Vicks, Inc. Sustained release drug-resin complexes
US4999189A (en) 1988-11-14 1991-03-12 Schering Corporation Sustained release oral suspensions
US5186930A (en) 1988-11-14 1993-02-16 Schering Corporation Sustained release oral suspensions
US5275819A (en) 1989-02-06 1994-01-04 Amer Particle Technologies Inc. Drug loaded pollen grains with an outer coating for pulsed delivery
AU629915B2 (en) 1989-02-16 1992-10-15 British Technology Group Limited Dispensing device
US5156850A (en) 1990-08-31 1992-10-20 Alza Corporation Dosage form for time-varying patterns of drug delivery
US5422121A (en) 1990-11-14 1995-06-06 Rohm Gmbh Oral dosage unit form
US5275820A (en) 1990-12-27 1994-01-04 Allergan, Inc. Stable suspension formulations of bioerodible polymer matrix microparticles incorporating drug loaded ion exchange resin particles
JP3278192B2 (ja) 1992-04-03 2002-04-30 ロート製薬株式会社 徐放性液剤
US5260068A (en) 1992-05-04 1993-11-09 Anda Sr Pharmaceuticals Inc. Multiparticulate pulsatile drug delivery system
GB9215585D0 (en) 1992-07-22 1992-09-02 Powder Systems Ltd Multipurpose apparatus
DE4319649A1 (de) 1993-03-18 1994-09-22 Asta Medica Ag Feste Flupirtin enthaltende orale Darreichungsformen mit kontrollierter Wirkstoffabgabe
JP2916978B2 (ja) 1993-08-25 1999-07-05 エスエス製薬株式会社 放出開始制御型製剤
US5411745A (en) 1994-05-25 1995-05-02 Euro-Celtique, S.A. Powder-layered morphine sulfate formulations
US6431440B1 (en) 1998-03-17 2002-08-13 Konica Corporation Radiation image reading method and radiation image reading apparatus
US6026277A (en) 1997-10-20 2000-02-15 Gavrilovich; Charles D. Mobile communication system with moving base station
HUP9700322A3 (en) 1995-06-09 2001-03-28 Euro Celtique Sa Formulations and methods for providing prolonged local anesthesia
GB9514451D0 (en) 1995-07-14 1995-09-13 Chiroscience Ltd Sustained-release formulation
AU711729B2 (en) 1995-08-29 1999-10-21 Exxon Chemical Patents Inc. Radiation tolerant polypropylene and its useful articles
US5837284A (en) * 1995-12-04 1998-11-17 Mehta; Atul M. Delivery of multiple doses of medications
JPH09323180A (ja) 1996-06-04 1997-12-16 Asahi Optical Co Ltd スケーリング補正機能を持つレーザ描画装置
AU4801497A (en) 1996-09-30 1998-04-24 Alza Corporation Dosage form and method for administering drug
CN1179450A (zh) 1996-10-15 1998-04-22 罗姆和哈斯公司 含有离子交换树脂的涂料组合物
US6919373B1 (en) 1996-11-12 2005-07-19 Alza Corporation Methods and devices for providing prolonged drug therapy
PT946145E (pt) 1996-12-20 2008-10-17 Mcneil Ppc Inc Fármacos antitússicos libertados por resinas de troca iónica
DE19709532A1 (de) 1997-03-10 1998-09-17 Basf Ag Verwendung von redispergierbaren Polymerpulvern oder Polymergranulaten zum Überziehen von pharmazeutischen oder agrochemischen Darreichungsformen
DE19709663A1 (de) 1997-03-10 1998-09-17 Basf Ag Verwendung von redispergierbaren Polymerpulvern oder Polymergranulaten als Bindemittel zur Herstellung von festen pharmazeutischen Darreichungsformen
US5980882A (en) 1997-04-16 1999-11-09 Medeva Pharmaceuticals Manufacturing Drug-resin complexes stabilized by chelating agents
GB9707934D0 (en) 1997-04-18 1997-06-04 Danbiosyst Uk Improved delivery of drugs to mucosal surfaces
DE19732903A1 (de) 1997-07-30 1999-02-04 Falk Pharma Gmbh Pellet-Formulierung zur Behandlung des Intestinaltraktes
EP0943341A1 (en) 1998-02-18 1999-09-22 Oscar Gold Procedure to prepare granulated compositions that contain erythromycin macrolides and procedure to prepare pharmaceutical compositions that contain said macrolides
IT1304271B1 (it) 1998-03-17 2001-03-13 Tecno 5 S R L Gruppo serigrafico polifunzionale per macchine a giostra per la stampa serigrafica a piu' colori di contenitori con superfici curve.
US6322819B1 (en) 1998-10-21 2001-11-27 Shire Laboratories, Inc. Oral pulsed dose drug delivery system
CA2348871C (en) 1998-11-02 2009-04-14 John G. Devane Multiparticulate modified release composition
US20070160675A1 (en) 1998-11-02 2007-07-12 Elan Corporation, Plc Nanoparticulate and controlled release compositions comprising a cephalosporin
US20060240105A1 (en) 1998-11-02 2006-10-26 Elan Corporation, Plc Multiparticulate modified release composition
JP2002531515A (ja) 1998-12-11 2002-09-24 ファーマソリューションズ・インコーポレイテッド 水に難溶性の薬剤のための自己乳化組成物
US7083808B2 (en) 1998-12-17 2006-08-01 Euro-Celtique S.A. Controlled/modified release oral methylphenidate formulations
US6419960B1 (en) 1998-12-17 2002-07-16 Euro-Celtique S.A. Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations
AU1998200A (en) 1999-01-07 2000-07-24 Elan Corporation, Plc Multiparticulate oral dosage forms
US6248363B1 (en) 1999-11-23 2001-06-19 Lipocine, Inc. Solid carriers for improved delivery of active ingredients in pharmaceutical compositions
WO2000059481A1 (en) 1999-04-06 2000-10-12 Pharmaquest Ltd. PHARMACEUTICAL DOSAGE FORM FOR PULSATILE DELIVERY OF d-threo-METHYLPHENIDATE AND A SECOND CNS STIMULANT
US6057289A (en) 1999-04-30 2000-05-02 Pharmasolutions, Inc. Pharmaceutical composition comprising cyclosporin in association with a carrier in a self-emulsifying drug delivery system
DE19927689A1 (de) 1999-06-17 2000-12-21 Gruenenthal Gmbh Orale Darreichungsformen zur Verabreichung einer fixen Kombination von Tramadol und Diclofenac
US6384020B1 (en) 1999-07-14 2002-05-07 Shire Laboratories, Inc. Rapid immediate release oral dosage form
DE60115840T2 (de) 2000-01-19 2006-07-13 Mannkind Corp., Danbury Formulierung mit mehrfach gepulster wirkstofffreisetzung
US6322011B1 (en) 2000-03-14 2001-11-27 Illinois Tool Works Inc. Electrostatic coating system and dual lip bell cup therefor
US7067116B1 (en) 2000-03-23 2006-06-27 Warner-Lambert Company Llc Fast dissolving orally consumable solid film containing a taste masking agent and pharmaceutically active agent at weight ratio of 1:3 to 3:1
SE0001151D0 (sv) 2000-03-31 2000-03-31 Amarin Dev Ab Method for producing a controlled-release composition
GB0019651D0 (en) 2000-08-10 2000-09-27 Reckitt & Colmann Prod Ltd Compositions
JP3380536B2 (ja) 2000-08-25 2003-02-24 日本圧着端子製造株式会社 圧接コネクタの受取装置及びこれを備えた自動圧接機
IL145106A0 (en) 2000-08-30 2002-06-30 Pfizer Prod Inc Intermittent administration of a geowth hormone secretagogue
US6344215B1 (en) 2000-10-27 2002-02-05 Eurand America, Inc. Methylphenidate modified release formulations
EP1240897B1 (en) 2001-03-14 2006-06-21 Pfizer Products Inc. Pharmaceutical tablet and process for making thereof
WO2003020242A1 (en) 2001-08-29 2003-03-13 Srl Technologies, Inc. Sustained release preparations
US7700561B2 (en) 2002-02-22 2010-04-20 Shire Llc Abuse-resistant amphetamine prodrugs
JP4732696B2 (ja) 2002-04-09 2011-07-27 フラメル・テクノロジー 活性成分の改変された放出のための、マイクロカプセルの水性懸濁液形態での経口医薬品製剤
RU2004139045A (ru) 2002-06-05 2005-09-10 Бейлор Колледж Оф Медисин (Us) Последовательности cdr3 t-клеточного рецептора и способы детекции
US8216609B2 (en) 2002-08-05 2012-07-10 Torrent Pharmaceuticals Limited Modified release composition of highly soluble drugs
EP1545461A4 (en) 2002-09-09 2011-06-22 Endo Pharmaceuticals Inc COMBINED ANALGESIC COMPOSITION WITH IMMEDIATE AND PROLONGED RELEASE
US6913768B2 (en) 2002-09-24 2005-07-05 Shire Laboratories, Inc. Sustained release delivery of amphetamine salts
US20060018972A1 (en) 2002-11-26 2006-01-26 Upm Pharmaceuticals, Inc. Aqueous sustained-release drug delivery system for highly water-soluble electrolytic drugs
US20070036851A1 (en) 2002-12-23 2007-02-15 Deepak Thassu Acid labile drug compositions
WO2004060354A1 (en) 2002-12-31 2004-07-22 Augsburger Larry L Methods for making pharmaceutical dosage forms containing active cushioning components
WO2004067039A1 (en) 2003-01-28 2004-08-12 Collegium Pharmaceutical, Inc. Multiparticulate compositions of milnacipran for oral administration
CH712083B1 (de) 2003-02-05 2017-07-31 Siegfried Ag Verfahren zur Herstellung von d-threo-2-Phenyl-2-piperidin-2-yl-essigsäureestern.
EP1667658A2 (en) 2003-09-03 2006-06-14 Mallinckrodt Inc. Granular sustained release preparation and production thereof
WO2005035000A1 (en) 2003-10-08 2005-04-21 Mallinckrodt Inc. Methylphenidate solution and associated methods of administration and production
US20050220881A1 (en) 2003-10-10 2005-10-06 Bvm Holding Co. Pharmaceutical composition
US20050266032A1 (en) 2003-12-17 2005-12-01 Sovereign Pharmaceuticals, Ltd. Dosage form containing multiple drugs
US20050232987A1 (en) 2004-03-12 2005-10-20 Viswanathan Srinivasan Dosage form containing a morphine derivative and another drug
US20050232986A1 (en) 2003-12-17 2005-10-20 David Brown Dosage form containing promethazine and another drug
US20050181050A1 (en) * 2004-01-28 2005-08-18 Collegium Pharmaceutical, Inc. Dosage forms using drug-loaded ion exchange resins
JP2005306778A (ja) 2004-04-21 2005-11-04 Basf Ag 徐放性製剤及びその製造方法
US20050265955A1 (en) 2004-05-28 2005-12-01 Mallinckrodt Inc. Sustained release preparations
ES2261006B1 (es) 2004-06-10 2007-11-01 Laboratorios Rubio, S.A. Pellet multicapa de liberacion controlada de metilfenidato.
WO2006022996A2 (en) 2004-08-04 2006-03-02 Sovereign Pharmaceuticals, Ltd. Dosage form containing multiple drugs
DK1791530T3 (da) 2004-08-23 2008-10-27 Pejo Iserlohn Heilmittel Und D Farmaceutisk komposition indeholdende et psykostimulerende middel
WO2006101536A1 (en) 2004-11-04 2006-09-28 Akina, Inc. Fast-melting tablets having taste-masking and sustained release properties
US8318210B2 (en) 2005-02-28 2012-11-27 Neos Therapeutics, Lp Compositions and methods of making sustained release liquid formulations
FR2891459B1 (fr) 2005-09-30 2007-12-28 Flamel Technologies Sa Microparticules a liberation modifiee d'au moins un principe actif et forme galenique orale en comprenant
US20070092553A1 (en) 2005-10-21 2007-04-26 Pfab Lp Compositions and methods of making rapidly dissolving lonically masked formulations
WO2007100777A2 (en) 2006-02-28 2007-09-07 The Mclean Hospital Corporation Methods for the treatment of adhd and related disorders
JP5479086B2 (ja) 2006-03-16 2014-04-23 トリス・フアルマ・インコーポレーテツド 薬剤−イオン交換樹脂複合体を含有する放出調節製剤
US20080064694A1 (en) * 2006-09-11 2008-03-13 Auriga Laboratories, Inc. Multi-Phase Release Methscopolamine Compositions
US8287848B2 (en) 2006-10-03 2012-10-16 Tris Pharma Inc Formulations containing an ionic mineral-ion exchange resin complex and uses thereof
US20080118570A1 (en) 2006-11-20 2008-05-22 Zhi Liu Polymer coated drug-ion exchange resins and methods
US8394415B2 (en) 2006-11-21 2013-03-12 Mcneil-Ppc, Inc Modified release analgesic suspensions
EP3050568B1 (en) 2007-03-13 2020-12-02 JDS Therapeutics, LLC Methods and compositions for the sustained release of chromium
JP2010529040A (ja) 2007-05-30 2010-08-26 ネオス・セラピューティクス・エルピー イオン性樹脂系の懸濁液における薬物放出の調節
US8202542B1 (en) 2007-05-31 2012-06-19 Tris Pharma Abuse resistant opioid drug-ion exchange resin complexes having hybrid coatings
US20100260844A1 (en) 2008-11-03 2010-10-14 Scicinski Jan J Oral pharmaceutical dosage forms
WO2010053306A2 (ko) 2008-11-07 2010-05-14 주식회사 삼양사 메칠페니데이트의 방출 제어용 약제학적 조성물
US8283472B2 (en) 2009-01-09 2012-10-09 Mallinckrodt Llc Synthesis of methylphenidate and analogs thereof
EP2451274B1 (en) * 2009-07-08 2017-10-04 Charleston Laboratories, Inc. Pharmaceutical compositions
US8470375B1 (en) 2010-01-05 2013-06-25 Neos Therapeutics, Lp Method of formulating and designing liquid drug suspensions containing ion exchange resin particles
GB201002612D0 (en) 2010-02-16 2010-03-31 Jagotec Ag Improvements in or relating to organic compounds
EP2549986B1 (en) 2010-03-24 2019-10-30 Northeastern University Multi-compartmental macrophage delivery
US8623409B1 (en) 2010-10-20 2014-01-07 Tris Pharma Inc. Clonidine formulation
CA2825991C (en) * 2011-02-15 2019-03-12 Tris Pharma, Inc. Extended release powder and aqueous suspension comprising methylphenidate
US8287903B2 (en) 2011-02-15 2012-10-16 Tris Pharma Inc Orally effective methylphenidate extended release powder and aqueous suspension product
WO2013003622A1 (en) 2011-06-28 2013-01-03 Neos Therapeutics, Lp Dosage forms for oral administration and methods of treatment using the same
CA2758556A1 (en) 2011-11-17 2013-05-17 Pharmascience Inc. Pharmaceutical composition of amphetamine mixed salts
KR101437219B1 (ko) 2012-05-10 2014-09-03 엘지전자 주식회사 법랑 조성물, 그 제조방법 및 조리기기
US9181100B2 (en) * 2012-06-27 2015-11-10 National Cheng Kung University Method of transferring a graphene film
AU2013302657B2 (en) * 2012-08-15 2018-08-09 Tris Pharma, Inc. Methylphenidate extended release chewable tablet
US9180104B2 (en) 2013-03-13 2015-11-10 Tris Pharma, Inc. Benzonatate modified release solid tablets and capsules

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11504347B1 (en) 2016-07-22 2022-11-22 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602512B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602513B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11766418B2 (en) 2016-07-22 2023-09-26 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11826335B2 (en) 2016-07-22 2023-11-28 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11839597B2 (en) 2016-07-22 2023-12-12 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11896572B2 (en) 2016-07-22 2024-02-13 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11986451B1 (en) 2016-07-22 2024-05-21 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11400065B2 (en) 2019-03-01 2022-08-02 Flamel Ireland Limited Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
US11583510B1 (en) 2022-02-07 2023-02-21 Flamel Ireland Limited Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
US11779557B1 (en) 2022-02-07 2023-10-10 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics

Also Published As

Publication number Publication date
US9844544B2 (en) 2017-12-19
US20160310479A1 (en) 2016-10-27
US20140294916A1 (en) 2014-10-02
US20160022576A1 (en) 2016-01-28
US20170216270A1 (en) 2017-08-03
ES2717469T3 (es) 2019-06-21
US20160143846A1 (en) 2016-05-26
US9844545B2 (en) 2017-12-19
US20160143854A1 (en) 2016-05-26
US11633389B2 (en) 2023-04-25
CA2880456A1 (en) 2014-02-20
US20230233542A1 (en) 2023-07-27
BR112015003120A2 (pt) 2019-12-17
AU2013302657B2 (en) 2018-08-09
AU2013302657A1 (en) 2015-02-26
US9180100B2 (en) 2015-11-10
US20210213007A1 (en) 2021-07-15
US11103495B2 (en) 2021-08-31
US20140287041A1 (en) 2014-09-25
US20210038588A1 (en) 2021-02-11
US9545399B2 (en) 2017-01-17
US20150157574A1 (en) 2015-06-11
WO2014028610A1 (en) 2014-02-20
US10857143B2 (en) 2020-12-08
BR112015003120B1 (pt) 2022-08-09
EP2884961B1 (en) 2019-03-06
IL236847B (en) 2019-05-30
US20190030014A1 (en) 2019-01-31
US20200188378A1 (en) 2020-06-18
US10507203B2 (en) 2019-12-17
EP2884961A1 (en) 2015-06-24
US8999386B2 (en) 2015-04-07
US11103494B2 (en) 2021-08-31
IL236847A0 (en) 2015-03-31
US9295642B2 (en) 2016-03-29
US20210093623A1 (en) 2021-04-01
US20170319566A1 (en) 2017-11-09

Similar Documents

Publication Publication Date Title
US11103494B2 (en) Methylphenidate extended release chewable tablet
RU2445092C2 (ru) Композиция, содержащая средство против деменции
US8580301B2 (en) Psychostimulant containing pharmaceutical composition
US20230181477A1 (en) Extended release amphetamine tablets
US20230233683A1 (en) Extended release amphetamine compositions
US20190151246A1 (en) Delayed-release tablets of methylphenidate