HRP20171944T1 - Oralno otapajući filmovi - Google Patents
Oralno otapajući filmovi Download PDFInfo
- Publication number
- HRP20171944T1 HRP20171944T1 HRP20171944TT HRP20171944T HRP20171944T1 HR P20171944 T1 HRP20171944 T1 HR P20171944T1 HR P20171944T T HRP20171944T T HR P20171944TT HR P20171944 T HRP20171944 T HR P20171944T HR P20171944 T1 HRP20171944 T1 HR P20171944T1
- Authority
- HR
- Croatia
- Prior art keywords
- film
- polymer
- nicotine
- neutralizing agent
- potassium
- Prior art date
Links
- SNICXCGAKADSCV-JTQLQIEISA-N (-)-Nicotine Chemical compound CN1CCC[C@H]1C1=CC=CN=C1 SNICXCGAKADSCV-JTQLQIEISA-N 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 6
- 230000003472 neutralizing effect Effects 0.000 claims 6
- 229960002715 nicotine Drugs 0.000 claims 6
- SNICXCGAKADSCV-UHFFFAOYSA-N nicotine Natural products CN1CCCC1C1=CC=CN=C1 SNICXCGAKADSCV-UHFFFAOYSA-N 0.000 claims 6
- -1 poly(ethylacrylate-methacrylic acid) copolymer Polymers 0.000 claims 6
- 239000003795 chemical substances by application Substances 0.000 claims 5
- 229920002959 polymer blend Polymers 0.000 claims 4
- 229920006254 polymer film Polymers 0.000 claims 4
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 3
- 229920000642 polymer Polymers 0.000 claims 3
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims 2
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims 2
- 239000000872 buffer Substances 0.000 claims 2
- 238000005266 casting Methods 0.000 claims 2
- 238000001035 drying Methods 0.000 claims 2
- 239000000945 filler Substances 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- BWHMMNNQKKPAPP-UHFFFAOYSA-L potassium carbonate Chemical compound [K+].[K+].[O-]C([O-])=O BWHMMNNQKKPAPP-UHFFFAOYSA-L 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims 1
- 239000013543 active substance Substances 0.000 claims 1
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 claims 1
- 239000006172 buffering agent Substances 0.000 claims 1
- 229910000019 calcium carbonate Inorganic materials 0.000 claims 1
- 229940111685 dibasic potassium phosphate Drugs 0.000 claims 1
- 229940061607 dibasic sodium phosphate Drugs 0.000 claims 1
- ZPWVASYFFYYZEW-UHFFFAOYSA-L dipotassium hydrogen phosphate Chemical compound [K+].[K+].OP([O-])([O-])=O ZPWVASYFFYYZEW-UHFFFAOYSA-L 0.000 claims 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims 1
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 claims 1
- 239000001095 magnesium carbonate Substances 0.000 claims 1
- 229910000021 magnesium carbonate Inorganic materials 0.000 claims 1
- VTHJTEIRLNZDEV-UHFFFAOYSA-L magnesium dihydroxide Chemical compound [OH-].[OH-].[Mg+2] VTHJTEIRLNZDEV-UHFFFAOYSA-L 0.000 claims 1
- 239000000347 magnesium hydroxide Substances 0.000 claims 1
- 229910001862 magnesium hydroxide Inorganic materials 0.000 claims 1
- 239000004014 plasticizer Substances 0.000 claims 1
- 239000011736 potassium bicarbonate Substances 0.000 claims 1
- 229910000028 potassium bicarbonate Inorganic materials 0.000 claims 1
- 235000015497 potassium bicarbonate Nutrition 0.000 claims 1
- 229910000027 potassium carbonate Inorganic materials 0.000 claims 1
- 235000011181 potassium carbonates Nutrition 0.000 claims 1
- TYJJADVDDVDEDZ-UHFFFAOYSA-M potassium hydrogencarbonate Chemical compound [K+].OC([O-])=O TYJJADVDDVDEDZ-UHFFFAOYSA-M 0.000 claims 1
- 229910000029 sodium carbonate Inorganic materials 0.000 claims 1
- 235000017550 sodium carbonate Nutrition 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- 229940062627 tribasic potassium phosphate Drugs 0.000 claims 1
- 229940001496 tribasic sodium phosphate Drugs 0.000 claims 1
- LWIHDJKSTIGBAC-UHFFFAOYSA-K tripotassium phosphate Chemical compound [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 claims 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
Classifications
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- 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
- 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
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/465—Nicotine; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/724—Cyclodextrins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
-
- 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
-
- 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
-
- 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
- A61P39/00—General protective or antinoxious agents
- A61P39/02—Antidotes
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Neurosurgery (AREA)
- Addiction (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Inorganic Chemistry (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Psychiatry (AREA)
- Toxicology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Plant Substances (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Cosmetics (AREA)
Claims (6)
1. Oralno otapajući filmski pripravak, naznačen time što sadrži:
a.) preneutralizirani enterički polimer, koji je poli(etilakrilat-metakrilno kiselinski) kopolimer;
b.) najmanje jedno alkalno neutralizirajuće sredstvo; i
c.) najmanje jedno aktivno sredstvo, koji je nikotinsko ulje.
2. Filmski pripravak u skladu s patentnim zahtjevom 1, naznačen time što se navedeno alkalno neutralizirajuće sredstvo bira iz skupine koju čine natrijev karbonat, natrijev bikarbonat, kalijev karbonat, kalijev bikarbonat, dvobazni natrijev fosfat, trobazni natrijev fosfat, dvobazni kalijev fosfat, trobazni kalijev fosfat, kalcijev karbonat, magnezijev karbonat, natrijev hidroksid, magnezijev hidroksid, kalijev hidroksid, aluminijev hidroksid, te njihove smjese.
3. Filmski pripravak u skladu s patentnim zahtjevom 1 ili 2, naznačen time što navedeno alkalno neutralizirajuće sredstvo i navedeni aktivni nikotin se drži odvojeno unutar filma prije oralne primjene.
4. Filmski pripravak u skladu s patentnim zahtjevom 3, naznačen time što je film višekomponentni oralno otapajući film, koji sadrži:
(a) prvu komponentu, koja sadrži alkalno neutralizirajuće sredstvo i punilo topljivo u vodi; i
(b) drugu komponentu, koja sadrži aktivni nikotin, koji je nikotinsko ulje, preneutralizirani enterički polimer koji je poli(etilakrilat-metakrilno kiselinski) kopolimer, te plastifikator.
5. Postupak dobivanje oralno otapajući filmski pripravak, naznačen time što se sastoji u koracima:
(a) neutraliziranja enteričkog polimera koji je poli(etilakrilat-metakrilno kiselinski) kopolimer miješanjem s alkalnim neutralizirajućim sredstvomu prisutnosti otapala kako bi se dobilo smjesu polimera;
(b) dodatnog dodavanja aktivnog nikotina koji je nikotinsko ulje u smjesu polimera;
(c) lijevanja smjese polimera na pogodnu površinu; i
(d) sušenja navedene smjese polimera kako bi se dobilo polimerni film.
6. Postupak u skladu s patentnim zahtjevom 5, naznačen time što dodatno uključuje sljedeće korake:
(e) otapanja alkalnog puferskog sredstva i punila topljivog u vodi u vodi kako bi se dobilo pufersku smjesu;
(f) lijevanja puferske smjese na polimerni film, čime se dobije obloženi polimerni film; i
(g) sušenja navedenog obloženog polimernog filma.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US48985503P | 2003-07-24 | 2003-07-24 | |
EP04778981.3A EP1648421B1 (en) | 2003-07-24 | 2004-07-22 | Orally dissolving films |
PCT/US2004/023719 WO2005009386A2 (en) | 2003-07-24 | 2004-07-22 | Orally dissolving films |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20171944T1 true HRP20171944T1 (hr) | 2018-01-26 |
Family
ID=34102944
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20171944TT HRP20171944T1 (hr) | 2003-07-24 | 2017-12-14 | Oralno otapajući filmovi |
Country Status (24)
Country | Link |
---|---|
US (1) | US9675548B2 (hr) |
EP (2) | EP1648421B1 (hr) |
JP (4) | JP2006528636A (hr) |
CN (1) | CN100508976C (hr) |
AR (1) | AR045076A1 (hr) |
AU (2) | AU2004259006B2 (hr) |
BR (1) | BRPI0412752B8 (hr) |
CA (1) | CA2533577C (hr) |
CL (2) | CL2008002406A1 (hr) |
DK (2) | DK2446881T3 (hr) |
ES (2) | ES2654062T3 (hr) |
HK (1) | HK1169802A1 (hr) |
HR (1) | HRP20171944T1 (hr) |
HU (1) | HUE037508T2 (hr) |
LT (1) | LT1648421T (hr) |
MX (1) | MXPA06000852A (hr) |
PE (1) | PE20050496A1 (hr) |
PL (2) | PL1648421T3 (hr) |
PT (2) | PT1648421T (hr) |
RU (2) | RU2351315C2 (hr) |
SI (1) | SI1648421T1 (hr) |
TW (1) | TW200514579A (hr) |
UY (1) | UY28431A1 (hr) |
WO (1) | WO2005009386A2 (hr) |
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BRPI0415741B1 (pt) | 2003-11-07 | 2013-07-23 | composições de tabaco e métodos de fabricação de uma composição de tabaco | |
US8627828B2 (en) | 2003-11-07 | 2014-01-14 | U.S. Smokeless Tobacco Company Llc | Tobacco compositions |
DE102005033943A1 (de) * | 2005-07-20 | 2007-02-22 | Hexal Ag | Nicht-ausspuckbarer, oraler, schnell-zerfallender Film für ein Neuroleptikum |
DE102005058569B4 (de) * | 2005-12-08 | 2010-07-15 | Lts Lohmann Therapie-Systeme Ag | Schaumwafer mit Polyvinylalkohol-Polyethylenglycol-Pfropfcopolymer |
US7810507B2 (en) | 2006-02-10 | 2010-10-12 | R. J. Reynolds Tobacco Company | Smokeless tobacco composition |
WO2007095600A2 (en) * | 2006-02-17 | 2007-08-23 | Novartis Ag | Disintegrable oral films |
US20100015068A1 (en) * | 2006-07-06 | 2010-01-21 | Massachusetts Institute Of Technology | Methods and Compositions For Altering Biological Surfaces |
WO2008080773A1 (de) * | 2006-12-29 | 2008-07-10 | Basf Se | Verfahren zur herstellung von festen dosierungsformen enthaltend pfropfcopolymere |
FR2912915B1 (fr) * | 2007-02-28 | 2012-11-16 | Pf Medicament | Film a desintegration rapide pour l'administration buccale de substances actives. |
CA2678876C (en) * | 2007-03-07 | 2015-11-24 | Novartis Ag | Orally administrable films |
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- 2004-07-22 EP EP12152301.3A patent/EP2446881B1/en not_active Expired - Lifetime
- 2004-07-22 PL PL12152301T patent/PL2446881T3/pl unknown
- 2004-07-22 PE PE2004000696A patent/PE20050496A1/es active IP Right Grant
- 2004-07-22 US US10/565,706 patent/US9675548B2/en active Active
- 2004-07-22 BR BRPI0412752A patent/BRPI0412752B8/pt active IP Right Grant
- 2004-07-22 AR ARP040102603A patent/AR045076A1/es unknown
- 2004-07-22 LT LTEP04778981.3T patent/LT1648421T/lt unknown
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2008
- 2008-01-14 RU RU2008101513/15A patent/RU2008101513A/ru not_active Application Discontinuation
- 2008-08-14 CL CL2008002406A patent/CL2008002406A1/es unknown
- 2008-08-14 CL CL2008002407A patent/CL2008002407A1/es unknown
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2010
- 2010-02-25 JP JP2010040716A patent/JP5378270B2/ja not_active Expired - Lifetime
- 2010-09-28 AU AU2010224456A patent/AU2010224456B9/en not_active Expired
- 2010-10-08 JP JP2010228787A patent/JP5038477B2/ja not_active Expired - Lifetime
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2011
- 2011-08-08 JP JP2011172951A patent/JP5572133B2/ja not_active Expired - Lifetime
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2012
- 2012-10-22 HK HK12110485.7A patent/HK1169802A1/xx unknown
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2017
- 2017-12-14 HR HRP20171944TT patent/HRP20171944T1/hr unknown
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