RU2012144848A - FAST DISSOLVING SYSTEMS RELEASING MEDICINES - Google Patents

FAST DISSOLVING SYSTEMS RELEASING MEDICINES Download PDF

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Publication number
RU2012144848A
RU2012144848A RU2012144848/15A RU2012144848A RU2012144848A RU 2012144848 A RU2012144848 A RU 2012144848A RU 2012144848/15 A RU2012144848/15 A RU 2012144848/15A RU 2012144848 A RU2012144848 A RU 2012144848A RU 2012144848 A RU2012144848 A RU 2012144848A
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RU
Russia
Prior art keywords
rapidly dissolving
dissolving film
oral rapidly
dysphagia
oral
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RU2012144848/15A
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Russian (ru)
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RU2560693C2 (en
Inventor
Доминик КОСТАНТИНИ
Original Assignee
Биоальянс Фарма
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Priority claimed from US12/729,735 external-priority patent/US20110237563A1/en
Priority claimed from EP10305288A external-priority patent/EP2377526A1/en
Application filed by Биоальянс Фарма filed Critical Биоальянс Фарма
Publication of RU2012144848A publication Critical patent/RU2012144848A/en
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Publication of RU2560693C2 publication Critical patent/RU2560693C2/en

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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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • 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
    • 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
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics

Abstract

1. Оральная быстро растворяющаяся пленка, содержащая онандосетрон, гидрофильное связывающее вещество и/или водорастворимые разбавители для лечения или предотвращения рвоты у пациентов с дисфагией, причем для облегчения проглатывания упомянутой быстро растворяющейся пленки не требуется добавления воды.2. Оральная быстро растворяющаяся пленка по п.1, где дисфагия - это риск аспирации.3. Оральная быстро растворяющаяся пленка для применения по пунктам 1 или 2, где дисфагия - это одинофагия.4. Оральная быстро растворяющаяся пленка по п.1, где дисфагия вызвана мукозитами, связанными с химиотерапией и/или радиотерапией.5. Оральная быстро растворяющаяся пленка по п.1, где дисфагия связана со сниженным слюноотделением.6. Оральная быстро растворяющаяся пленка по п.1, где дисфагия связана с раком головы и шеи или пищевода.7. Оральная быстро растворяющаяся пленка по п.1, которая содержит ондансетрон в количестве от 0,05 до 50 мас.%.8. Оральная быстро растворяющаяся пленка по п.1, которая содержит один или большее число гидрофильных связывающих веществ и водорастворимый разбавитель в количестве от 40 до 80 масс.%.9. Оральная быстро растворяющаяся пленка по п.8, в которой гидрофильное связующее вещество представляет собой поливиниловый спирт10. Оральная быстро растворяющаяся пленка по п.8, в которой водорастворимый разбавитель является рисовым крахмалом.11. Оральная быстро растворяющаяся пленка по п.8, в которой ондансетрон находится в основной форме.12. Оральная быстро растворяющаяся пленка по п.8, которая содержит ондансетрон основной, поливиниловый спирт, полиэтиленгликоль, глицерин безводный, рисовый крахмал, полисорбат, этанол и очищ�1. An oral rapidly dissolving film containing onandosetron, a hydrophilic binding agent and / or water-soluble diluents for treating or preventing vomiting in patients with dysphagia, without adding water to facilitate swallowing of said rapidly dissolving film. 2. The oral rapidly dissolving film of claim 1, wherein dysphagia is a risk of aspiration. Oral rapidly dissolving film for use according to claims 1 or 2, where dysphagia is odnophagia. 4. The oral rapidly dissolving film of claim 1, wherein the dysphagia is caused by mucositis associated with chemotherapy and / or radiotherapy. The oral rapidly dissolving film of claim 1, wherein dysphagia is associated with decreased salivation. The oral rapidly dissolving film of claim 1, wherein the dysphagia is associated with cancer of the head and neck or esophagus. Oral rapidly dissolving film according to claim 1, which contains ondansetron in an amount of from 0.05 to 50 wt.%. 8. Oral rapidly dissolving film according to claim 1, which contains one or more hydrophilic binders and a water-soluble diluent in an amount of from 40 to 80 wt.%. 9. The oral rapidly dissolving film of claim 8, wherein the hydrophilic binder is polyvinyl alcohol. The oral rapidly dissolving film of claim 8, wherein the water soluble diluent is rice starch. The oral rapidly dissolving film of claim 8, wherein the ondansetron is in a basic form. The oral rapidly dissolving film of claim 8, which contains ondansetron basic, polyvinyl alcohol, polyethylene glycol, anhydrous glycerin, rice starch, polysorbate, ethanol and purification�

Claims (19)

1. Оральная быстро растворяющаяся пленка, содержащая онандосетрон, гидрофильное связывающее вещество и/или водорастворимые разбавители для лечения или предотвращения рвоты у пациентов с дисфагией, причем для облегчения проглатывания упомянутой быстро растворяющейся пленки не требуется добавления воды.1. An oral rapidly dissolving film containing onandosetron, a hydrophilic binding agent and / or water-soluble diluents for treating or preventing vomiting in patients with dysphagia, without adding water to facilitate swallowing of said rapidly dissolving film. 2. Оральная быстро растворяющаяся пленка по п.1, где дисфагия - это риск аспирации.2. The oral rapidly dissolving film of claim 1, wherein dysphagia is a risk of aspiration. 3. Оральная быстро растворяющаяся пленка для применения по пунктам 1 или 2, где дисфагия - это одинофагия.3. Oral rapidly dissolving film for use according to paragraphs 1 or 2, where dysphagia is odnophagia. 4. Оральная быстро растворяющаяся пленка по п.1, где дисфагия вызвана мукозитами, связанными с химиотерапией и/или радиотерапией.4. The oral rapidly dissolving film of claim 1, wherein the dysphagia is caused by mucositis associated with chemotherapy and / or radiotherapy. 5. Оральная быстро растворяющаяся пленка по п.1, где дисфагия связана со сниженным слюноотделением.5. The oral rapidly dissolving film of claim 1, wherein the dysphagia is associated with reduced salivation. 6. Оральная быстро растворяющаяся пленка по п.1, где дисфагия связана с раком головы и шеи или пищевода.6. The oral rapidly dissolving film of claim 1, wherein the dysphagia is associated with cancer of the head and neck or esophagus. 7. Оральная быстро растворяющаяся пленка по п.1, которая содержит ондансетрон в количестве от 0,05 до 50 мас.%.7. Oral rapidly dissolving film according to claim 1, which contains ondansetron in an amount of from 0.05 to 50 wt.%. 8. Оральная быстро растворяющаяся пленка по п.1, которая содержит один или большее число гидрофильных связывающих веществ и водорастворимый разбавитель в количестве от 40 до 80 масс.%.8. Oral rapidly dissolving film according to claim 1, which contains one or more hydrophilic binders and a water-soluble diluent in an amount of from 40 to 80 wt.%. 9. Оральная быстро растворяющаяся пленка по п.8, в которой гидрофильное связующее вещество представляет собой поливиниловый спирт9. The oral rapidly dissolving film of claim 8, wherein the hydrophilic binder is polyvinyl alcohol 10. Оральная быстро растворяющаяся пленка по п.8, в которой водорастворимый разбавитель является рисовым крахмалом.10. The oral rapidly dissolving film of claim 8, wherein the water soluble diluent is rice starch. 11. Оральная быстро растворяющаяся пленка по п.8, в которой ондансетрон находится в основной форме.11. The oral rapidly dissolving film of claim 8, wherein the ondansetron is in a basic form. 12. Оральная быстро растворяющаяся пленка по п.8, которая содержит ондансетрон основной, поливиниловый спирт, полиэтиленгликоль, глицерин безводный, рисовый крахмал, полисорбат, этанол и очищенную воду.12. The oral rapidly dissolving film of claim 8, which contains basic ondansetron, polyvinyl alcohol, polyethylene glycol, anhydrous glycerin, rice starch, polysorbate, ethanol and purified water. 13. Оральная быстро растворяющаяся пленка, содержащая биоактивный агент, гидрофильное связующее вещество и/или водорастворимый разбавитель для лечения дисфагии.13. An oral rapidly dissolving film containing a bioactive agent, a hydrophilic binder, and / or a water soluble diluent for treating dysphagia. 14. Оральная быстро растворяющаяся пленка по п.13, в которой биоактивный агент представляет собой ингибитор протонной помпы (PPI), анти-Н2 или прокинетический агент.14. The oral rapidly dissolving film of claim 13, wherein the bioactive agent is a proton pump inhibitor (PPI), anti-H2, or a prokinetic agent. 15. Оральная быстро растворяющаяся пленка по п.13 или 14, которая содержит от 0,05 до 50 мас.% от упомянутого биоактивного агента.15. Oral rapidly dissolving film according to item 13 or 14, which contains from 0.05 to 50 wt.% From the said bioactive agent. 16. Оральная быстро растворяющаяся пленка по п.13, которая содержит от 40 до 80 масс.% от одного или большего числа ингредиентов, составляющих гидрофильное связующее вещество и водорастворимый разбавитель.16. The oral rapidly dissolving film of claim 13, which contains from 40 to 80% by weight of one or more ingredients comprising a hydrophilic binder and a water-soluble diluent. 17. Оральная быстро растворяющаяся пленка по п.16, в которой гидрофильное связующее вещество является поливиниловым спиртом.17. The oral rapidly dissolving film of claim 16, wherein the hydrophilic binder is polyvinyl alcohol. 18. Оральная быстро растворяющаяся пленка по п.16, в которой водорастворимый разбавитель является рисовым крахмалом.18. The oral rapidly dissolving film of claim 16, wherein the water soluble diluent is rice starch. 19. Оральная быстро растворяющаяся пленка по п.13, содержащая ондансетрон основной, поливиниловый спирт, полиэтиленгликоль, глицерин безводный, рисовый крахмал, полисорбат, этанол и очищенную воду. 19. Oral rapidly dissolving film according to item 13, containing ondansetron basic, polyvinyl alcohol, polyethylene glycol, anhydrous glycerin, rice starch, polysorbate, ethanol and purified water.
RU2012144848/15A 2010-03-23 2011-03-23 Rapidly dissolving medication-releasing systems RU2560693C2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP10305288.2 2010-03-23
US12/729,735 US20110237563A1 (en) 2010-03-23 2010-03-23 Fast dissolving drug delivery systems
US12/729,735 2010-03-23
EP10305288A EP2377526A1 (en) 2010-03-23 2010-03-23 Fast dissolving drug delivery systems
PCT/EP2011/054482 WO2011117313A1 (en) 2010-03-23 2011-03-23 Fast dissolving drug delivery systems

Publications (2)

Publication Number Publication Date
RU2012144848A true RU2012144848A (en) 2014-04-27
RU2560693C2 RU2560693C2 (en) 2015-08-20

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Country Status (9)

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EP (1) EP2549988A1 (en)
KR (1) KR20130012067A (en)
CN (1) CN103025321A (en)
AU (1) AU2011231645A1 (en)
BR (1) BR112012024092A2 (en)
CA (1) CA2794042A1 (en)
RU (1) RU2560693C2 (en)
WO (1) WO2011117313A1 (en)
ZA (1) ZA201207900B (en)

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Publication number Publication date
RU2560693C2 (en) 2015-08-20
CA2794042A1 (en) 2011-09-29
WO2011117313A1 (en) 2011-09-29
AU2011231645A2 (en) 2012-12-20
AU2011231645A1 (en) 2012-10-18
CN103025321A (en) 2013-04-03
EP2549988A1 (en) 2013-01-30
ZA201207900B (en) 2013-06-26
KR20130012067A (en) 2013-01-31
BR112012024092A2 (en) 2016-09-06

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