ES2604484T3 - Formulación farmacéutica de sabor enmascarado que tiene un inicio rápido de la acción - Google Patents
Formulación farmacéutica de sabor enmascarado que tiene un inicio rápido de la acción Download PDFInfo
- Publication number
- ES2604484T3 ES2604484T3 ES11736275.6T ES11736275T ES2604484T3 ES 2604484 T3 ES2604484 T3 ES 2604484T3 ES 11736275 T ES11736275 T ES 11736275T ES 2604484 T3 ES2604484 T3 ES 2604484T3
- Authority
- ES
- Spain
- Prior art keywords
- weight
- parts
- action
- phosphodiesterase inhibitor
- pharmaceutical formulation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- 239000000796 flavoring agent Substances 0.000 title 1
- 235000019634 flavors Nutrition 0.000 title 1
- 239000000203 mixture Substances 0.000 abstract description 4
- SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 abstract description 3
- 239000000905 isomalt Substances 0.000 abstract description 3
- 235000010439 isomalt Nutrition 0.000 abstract description 3
- HPIGCVXMBGOWTF-UHFFFAOYSA-N isomaltol Natural products CC(=O)C=1OC=CC=1O HPIGCVXMBGOWTF-UHFFFAOYSA-N 0.000 abstract description 3
- DEIYFTQMQPDXOT-UHFFFAOYSA-N sildenafil citrate Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O.CCCC1=NN(C)C(C(N2)=O)=C1N=C2C(C(=CC=1)OCC)=CC=1S(=O)(=O)N1CCN(C)CC1 DEIYFTQMQPDXOT-UHFFFAOYSA-N 0.000 abstract description 3
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 abstract 4
- 229940099471 Phosphodiesterase inhibitor Drugs 0.000 abstract 3
- 239000002571 phosphodiesterase inhibitor Substances 0.000 abstract 3
- 150000005846 sugar alcohols Chemical class 0.000 abstract 3
- 239000008187 granular material Substances 0.000 abstract 2
- 239000000843 powder Substances 0.000 abstract 2
- 235000017557 sodium bicarbonate Nutrition 0.000 abstract 2
- 229910000030 sodium bicarbonate Inorganic materials 0.000 abstract 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 abstract 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 abstract 1
- 239000004386 Erythritol Substances 0.000 abstract 1
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 abstract 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 abstract 1
- 229930195725 Mannitol Natural products 0.000 abstract 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 235000019414 erythritol Nutrition 0.000 abstract 1
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 abstract 1
- 229940009714 erythritol Drugs 0.000 abstract 1
- 239000000832 lactitol Substances 0.000 abstract 1
- 235000010448 lactitol Nutrition 0.000 abstract 1
- VQHSOMBJVWLPSR-JVCRWLNRSA-N lactitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-JVCRWLNRSA-N 0.000 abstract 1
- 229960003451 lactitol Drugs 0.000 abstract 1
- 239000000845 maltitol Substances 0.000 abstract 1
- 235000010449 maltitol Nutrition 0.000 abstract 1
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 abstract 1
- 229940035436 maltitol Drugs 0.000 abstract 1
- 239000000594 mannitol Substances 0.000 abstract 1
- 235000010355 mannitol Nutrition 0.000 abstract 1
- 229960001855 mannitol Drugs 0.000 abstract 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 abstract 1
- 150000007524 organic acids Chemical class 0.000 abstract 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
- 229960002639 sildenafil citrate Drugs 0.000 abstract 1
- 239000000600 sorbitol Substances 0.000 abstract 1
- 235000010356 sorbitol Nutrition 0.000 abstract 1
- 229960002920 sorbitol Drugs 0.000 abstract 1
- 239000000811 xylitol Substances 0.000 abstract 1
- 235000010447 xylitol Nutrition 0.000 abstract 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 abstract 1
- 229960002675 xylitol Drugs 0.000 abstract 1
- BNRNXUUZRGQAQC-UHFFFAOYSA-N Sildenafil Natural products CCCC1=NN(C)C(C(N2)=O)=C1N=C2C(C(=CC=1)OCC)=CC=1S(=O)(=O)N1CCN(C)CC1 BNRNXUUZRGQAQC-UHFFFAOYSA-N 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 229940094720 viagra Drugs 0.000 description 2
- 235000019658 bitter taste Nutrition 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 230000000873 masking effect Effects 0.000 description 1
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
- A61K47/02—Inorganic compounds
-
- 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
- A61K9/0058—Chewing gums
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gynecology & Obstetrics (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Composición farmacéutica para la administración oral, que comprende un inhibidor de la fosfodiesterasa seleccionado entre citrato de sildenafilo y al menos un alcohol de azúcar seleccionado entre manitol, sorbitol, xilitol, maltitol, lactitol, eritritol, treitol e Isomalt e hidrógeno carbonato de sodio como excipientes farmacéuticos en las siguientes proporciones en peso: inhibidor de la fosfodiesterasa: de 10 a 150 partes en peso en total; alcohol de azúcar: de 50 a 600 partes en peso en total; hidrógeno carbonato de sodio: de 2 a 100 partes en peso; y un ácido orgánico farmacéuticamente aceptable, en la que el inhibidor de la fosfodiesterasa y el alcohol de azúcar están presentes como una mezcla de polvo o como gránulos o como una mezcla de polvo o como gránulos en un comprimido compactado, y en la que el alcohol de azúcar incluye o es Isomalt.
Description
- Tiempo hasta el inicio de la acción [min]
- Sujeto n.º
- Viagra 50 mg Formulación de la invención
- 4
- 50 8
- 5
- 60 15
- 6
- 70 12
- 7
- 80 10
- 8
- 55 5
- 9
- 40 10
- 10
- 40
- 10
- 11
- 40 12
- 12
- 60 8
- 13
- 65 7
- 14
- 75 13
- 15
- 50 10
- 16
- 50 20
- 17
- 45 10
- 18
- 60 8
- 19
- 55 7
El sujeto 20 solo tomó la "muestra de Viagra" y después dejó la observación.
Se confirmó por 5 sujetos un mejor enmascaramiento del sabor amargo frente a una formulación comparativa que incluía solamente Isomalt.
8
Claims (1)
-
imagen1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102010024866 | 2010-06-24 | ||
| DE102010024866A DE102010024866A1 (de) | 2010-06-24 | 2010-06-24 | Formulierung zur Geschmacksmaskierung |
| PCT/EP2011/003120 WO2011160849A1 (en) | 2010-06-24 | 2011-06-24 | Taste-masked pharmaceutical formulation having accelerated onset of action |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2604484T3 true ES2604484T3 (es) | 2017-03-07 |
Family
ID=44629118
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES11736275.6T Active ES2604484T3 (es) | 2010-06-24 | 2011-06-24 | Formulación farmacéutica de sabor enmascarado que tiene un inicio rápido de la acción |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US20130150370A1 (es) |
| EP (1) | EP2585041B1 (es) |
| JP (1) | JP6013329B2 (es) |
| BR (1) | BR112012032463A2 (es) |
| CA (1) | CA2802604C (es) |
| DE (1) | DE102010024866A1 (es) |
| EA (1) | EA031697B1 (es) |
| ES (1) | ES2604484T3 (es) |
| PL (1) | PL2585041T3 (es) |
| WO (1) | WO2011160849A1 (es) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013109221A1 (en) * | 2012-01-18 | 2013-07-25 | Mahmut Bilgic | New effervescent formulations comprising sweetener composition |
| EP2942052A4 (en) * | 2013-01-07 | 2016-06-08 | Sam A Pharm Co Ltd | NEW FORMULATION OF RAPID DISSOLUTION PELLETS WITH ENHANCED SOLUBILITY |
| WO2015089105A1 (en) | 2013-12-09 | 2015-06-18 | Respira Therapeutics, Inc. | Pde5 inhibitor powder formulations and methods relating thereto |
| PL3949952T3 (pl) | 2019-04-03 | 2024-10-14 | Astellas Pharma Inc. | Kompozycja farmaceutyczna |
| WO2021194832A1 (en) | 2020-03-24 | 2021-09-30 | Commscope Technologies Llc | Radiating elements having angled feed stalks and base station antennas including same |
| CA3172693A1 (en) | 2020-03-24 | 2021-09-30 | Xiaohua Hou | Base station antennas having an active antenna module and related devices and methods |
| US12218425B2 (en) | 2020-04-28 | 2025-02-04 | Outdoor Wireless Networks LLC | Base station antennas having reflector assemblies including a nonmetallic substrate having a metallic layer thereon |
| CN215418610U (zh) | 2021-08-31 | 2022-01-04 | 康普技术有限责任公司 | 频率选择反射板和基站天线 |
| CN117199772A (zh) | 2022-06-01 | 2023-12-08 | 康普技术有限责任公司 | 基站天线 |
| US12469960B2 (en) | 2022-07-08 | 2025-11-11 | Outdoor Wireless Networks LLC | Base station antennas |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT1217445B (it) * | 1988-04-29 | 1990-03-22 | Altergon Sa | Composizione farmaceutiche orosolubili contenti acetilcisteina |
| US4942039A (en) * | 1989-05-09 | 1990-07-17 | Miles Inc. | Effervescent analgesic antacid composition having reduced sodium content |
| GT199900061A (es) * | 1998-05-15 | 2000-10-14 | Pfizer | Formulaciones farmaceuticas. |
| WO2000057857A1 (en) * | 1999-03-25 | 2000-10-05 | Yuhan Corporation | Rapidly disintegrable tablet for oral administration |
| AU2001273545A1 (en) * | 2000-07-19 | 2002-01-30 | Lavipharm Laboratories, Inc. | Sildenafil citrate solid dispersions having high water solubility |
| SE0202365D0 (sv) * | 2002-08-05 | 2002-08-05 | Pharmacia Ab | New formulation and use thereof |
| KR100503949B1 (ko) * | 2003-04-28 | 2005-07-26 | 주식회사유한양행 | 염산 온단세트론의 쓴맛을 효과적으로 은폐한 경구용 구강속붕해정 조성물 |
| DE10328180A1 (de) * | 2003-06-16 | 2005-01-13 | Südzucker AG Mannheim/Ochsenfurt | Verwendung von Isomalt als Präbiotikum |
| GB0330255D0 (en) * | 2003-12-31 | 2004-02-04 | Vectura Ltd | Multiparticulate formulations for oral delivery |
| JP2008500288A (ja) * | 2004-05-28 | 2008-01-10 | イメイジノット ピーティーワイ エルティーディー | 経口治療用化合物の供給系 |
| WO2007060682A1 (en) * | 2005-11-28 | 2007-05-31 | Strides Arcolab Limited | Effervescent granular formulations of antiretroviral drugs |
| US8642016B2 (en) * | 2006-07-21 | 2014-02-04 | Jsrnti, Llc | Medicinal delivery system, and related methods |
| KR100895942B1 (ko) * | 2007-05-08 | 2009-05-07 | 조선대학교산학협력단 | 생약 추출물을 함유하는 구강 내 속붕해성 제제 조성물 및그의 제조 방법 |
| WO2009007768A1 (en) * | 2007-07-06 | 2009-01-15 | Gumlink A/S | Compressed tablet comprising polyol |
| WO2009106824A2 (en) * | 2008-02-25 | 2009-09-03 | Cipla Limited | Pharmaceutical formulations |
| EP2361081B1 (en) * | 2008-10-14 | 2016-06-29 | McNeil AB | Multi portion intra-oral dosage form and use thereof |
-
2010
- 2010-06-24 DE DE102010024866A patent/DE102010024866A1/de not_active Withdrawn
-
2011
- 2011-06-24 JP JP2013515773A patent/JP6013329B2/ja not_active Expired - Fee Related
- 2011-06-24 EP EP11736275.6A patent/EP2585041B1/en not_active Not-in-force
- 2011-06-24 BR BR112012032463A patent/BR112012032463A2/pt not_active IP Right Cessation
- 2011-06-24 PL PL11736275T patent/PL2585041T3/pl unknown
- 2011-06-24 ES ES11736275.6T patent/ES2604484T3/es active Active
- 2011-06-24 US US13/805,587 patent/US20130150370A1/en not_active Abandoned
- 2011-06-24 CA CA2802604A patent/CA2802604C/en not_active Expired - Fee Related
- 2011-06-24 WO PCT/EP2011/003120 patent/WO2011160849A1/en not_active Ceased
- 2011-06-24 EA EA201390012A patent/EA031697B1/ru not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| CA2802604A1 (en) | 2011-12-29 |
| DE102010024866A1 (de) | 2011-12-29 |
| EP2585041A1 (en) | 2013-05-01 |
| JP6013329B2 (ja) | 2016-10-25 |
| EA031697B1 (ru) | 2019-02-28 |
| WO2011160849A1 (en) | 2011-12-29 |
| EP2585041B1 (en) | 2016-08-31 |
| EA201390012A1 (ru) | 2013-07-30 |
| JP2013529605A (ja) | 2013-07-22 |
| BR112012032463A2 (pt) | 2016-11-08 |
| US20130150370A1 (en) | 2013-06-13 |
| CA2802604C (en) | 2018-11-06 |
| PL2585041T3 (pl) | 2017-02-28 |
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