HRP20120545T1 - Farmaceutski oblici sa poboljšanim farmakokinetičkim svojstvima - Google Patents
Farmaceutski oblici sa poboljšanim farmakokinetičkim svojstvima Download PDFInfo
- Publication number
- HRP20120545T1 HRP20120545T1 HRP20120545TT HRP20120545T HRP20120545T1 HR P20120545 T1 HRP20120545 T1 HR P20120545T1 HR P20120545T T HRP20120545T T HR P20120545TT HR P20120545 T HRP20120545 T HR P20120545T HR P20120545 T1 HRP20120545 T1 HR P20120545T1
- Authority
- HR
- Croatia
- Prior art keywords
- drug formulation
- formulation according
- vardenafil
- sugar alcohol
- drug
- Prior art date
Links
- 239000013583 drug formulation Substances 0.000 claims abstract 12
- 150000005846 sugar alcohols Chemical class 0.000 claims abstract 6
- FBCDRHDULQYRTB-UHFFFAOYSA-N 2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonylphenyl]-5-methyl-7-propyl-1h-imidazo[5,1-f][1,2,4]triazin-4-one;trihydrate;hydrochloride Chemical compound O.O.O.Cl.CCCC1=NC(C)=C(C(N=2)=O)N1NC=2C(C(=CC=1)OCC)=CC=1S(=O)(=O)N1CCN(CC)CC1 FBCDRHDULQYRTB-UHFFFAOYSA-N 0.000 claims abstract 4
- SECKRCOLJRRGGV-UHFFFAOYSA-N Vardenafil Chemical compound CCCC1=NC(C)=C(C(N=2)=O)N1NC=2C(C(=CC=1)OCC)=CC=1S(=O)(=O)N1CCN(CC)CC1 SECKRCOLJRRGGV-UHFFFAOYSA-N 0.000 claims abstract 4
- 229960002381 vardenafil Drugs 0.000 claims abstract 4
- 229960004573 vardenafil hydrochloride trihydrate Drugs 0.000 claims abstract 4
- 239000000203 mixture Substances 0.000 claims abstract 2
- 239000000126 substance Substances 0.000 claims 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 claims 2
- 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 claims 2
- 229930195725 Mannitol Natural products 0.000 claims 2
- 239000000594 mannitol Substances 0.000 claims 2
- 235000010355 mannitol Nutrition 0.000 claims 2
- 210000000214 mouth Anatomy 0.000 claims 2
- 239000002504 physiological saline solution Substances 0.000 claims 2
- 239000000600 sorbitol Substances 0.000 claims 2
- 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 claims 1
- 239000012458 free base Substances 0.000 claims 1
- 238000004806 packaging method and process Methods 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 238000009512 pharmaceutical packaging Methods 0.000 claims 1
- 239000012267 brine Substances 0.000 abstract 2
- HPALAKNZSZLMCH-UHFFFAOYSA-M sodium;chloride;hydrate Chemical compound O.[Na+].[Cl-] HPALAKNZSZLMCH-UHFFFAOYSA-M 0.000 abstract 2
- 238000009472 formulation Methods 0.000 abstract 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
- A61K31/53—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
-
- 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
- A61K9/20—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
- A61K9/2013—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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Abstract
Formulacija lijeka koja se brzo otapa u ustima i sadrži a vardenafil hidroklorid trihidrat i b šećerni alkohol naznačena time da se barem doze vardenafila u obliku tvari koja je primijenjena otapa kod °C u ml fiziološke rasoline i brzina otpuštanja iz formulacije lijeka u ml fiziološke rasoline u prvih minuta u USP mješalici sa lopaticama kod rotacija u minuti pri °C je najmanje Patent sadrži još patentnih zahtjeva
Claims (9)
1. Formulacija lijeka koja se brzo otapa u ustima i sadrži a) vardenafil hidroklorid trihidrat i b) šećerni alkohol, naznačena time da se barem 80% doze vardenafila u obliku tvari koja je primijenjena otapa kod 25°C u 10 ml fiziološke rasoline i brzina otpuštanja iz formulacije lijeka u 900 ml fiziološke rasoline u prvih 5 minuta u USP mješalici sa lopaticama kod 50 rotacija u minuti pri 37 °C je najmanje 70%.
2. Formulacija lijeka prema zahtjevu 1, naznačena time da sadrži vardenafil hidroklorid trihidrat u mljevenom, amorfnom ili već otopljenom obliku.
3. Formulacija lijeka prema zahtjevu 1, naznačena time da sadrži vardenafil hidroklorid trihidrat u mikroniziranom obliku sa srednjom veličinom čestice manjom od 20 µm.
4. Formulacija lijeka prema jednom ili više zahtjeva 1 do 3, naznačena time da sadrži od 40% do 99% šećernih alkohola.
5. Formulacija lijeka prema jednom ili više zahtjeva 1 do 4, naznačena time da kao šećerni alkohol sadrži manitol.
6. Formulacija lijeka prema jednom ili više zahtjeva 1 do 5, naznačena time da kao šećerni alkohol sadrži sorbitol.
7. Formulacija lijeka prema jednom ili više zahtjeva 1 do 5, naznačena time da kao šećerni alkohol sadrži smjesu manitola i sorbitola.
8. Formulacija lijeka prema jednom ili više zahtjeva 1 do 7, naznačena time da sadrži između 0.8% i 25% vardenafila, izračunato kao slobodna baza vardenafila.
9. Formulacija lijeka prema bilo kojem od zahtjeva 1 do 5 naznačena time da je u ambalaži za lijekove, sa uputom na informacijskom listu, naljepnici ili kutiji pakiranja da je formulaciju lijeka potrebno staviti u usnu šupljinu, te nakon što se razgradi treba progutati.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102005009240A DE102005009240A1 (de) | 2005-03-01 | 2005-03-01 | Arzneiformen mit verbesserten pharmakokinetischen Eigenschaften |
| PCT/EP2006/001393 WO2006092207A1 (de) | 2005-03-01 | 2006-02-16 | Arzneiformen mit verbesserten pharmakokinetischen eigenschaften |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20120545T1 true HRP20120545T1 (hr) | 2012-07-31 |
Family
ID=36264023
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20120545TT HRP20120545T1 (hr) | 2005-03-01 | 2012-07-05 | Farmaceutski oblici sa poboljšanim farmakokinetičkim svojstvima |
Country Status (39)
| Country | Link |
|---|---|
| US (2) | US8613950B2 (hr) |
| EP (2) | EP2377523A1 (hr) |
| JP (1) | JP5122984B2 (hr) |
| KR (1) | KR101360526B1 (hr) |
| CN (2) | CN102198140B (hr) |
| AR (2) | AR053552A1 (hr) |
| AT (1) | ATE552828T1 (hr) |
| AU (1) | AU2006220100B2 (hr) |
| BR (1) | BRPI0609375A2 (hr) |
| CA (1) | CA2599617C (hr) |
| CR (2) | CR9339A (hr) |
| CY (1) | CY1112874T1 (hr) |
| DE (1) | DE102005009240A1 (hr) |
| DK (1) | DK1858490T3 (hr) |
| DO (1) | DOP2006000049A (hr) |
| ES (1) | ES2384109T3 (hr) |
| GT (1) | GT200600097A (hr) |
| HK (1) | HK1118457A1 (hr) |
| HN (1) | HN2006009000A (hr) |
| HR (1) | HRP20120545T1 (hr) |
| IL (2) | IL185552A (hr) |
| MA (1) | MA29376B1 (hr) |
| MX (1) | MX2007010527A (hr) |
| MY (2) | MY148698A (hr) |
| NO (2) | NO332368B1 (hr) |
| NZ (1) | NZ561004A (hr) |
| PE (2) | PE20061015A1 (hr) |
| PL (1) | PL1858490T3 (hr) |
| PT (1) | PT1858490E (hr) |
| RS (1) | RS52374B (hr) |
| RU (2) | RU2423970C2 (hr) |
| SG (1) | SG160330A1 (hr) |
| SI (1) | SI1858490T1 (hr) |
| TN (1) | TNSN07336A1 (hr) |
| TW (1) | TWI387465B (hr) |
| UA (1) | UA93200C2 (hr) |
| UY (1) | UY29395A1 (hr) |
| WO (1) | WO2006092207A1 (hr) |
| ZA (1) | ZA200707320B (hr) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10232113A1 (de) | 2002-07-16 | 2004-01-29 | Bayer Ag | Vardenafil Hydrochlorid Trihydrat enthaltende Arzneimittel |
| DE102005009240A1 (de) * | 2005-03-01 | 2006-09-07 | Bayer Healthcare Ag | Arzneiformen mit verbesserten pharmakokinetischen Eigenschaften |
| DE102005009241A1 (de) * | 2005-03-01 | 2006-09-07 | Bayer Healthcare Ag | Arzneiformen mit kontrollierter Bioverfügbarkeit |
| FR2906140B1 (fr) * | 2006-09-22 | 2008-12-05 | Philippe Perovitch | Forme galenique pour l'administration par voie trans-muqueuse de principes actifs |
| DE102007027067A1 (de) | 2007-06-12 | 2008-12-18 | Ratiopharm Gmbh | Verfahren zur Herstellung eines Arzneimittels enthaltend Vardenafil Hydrochlorid Trihydrat |
| DE102009020888A1 (de) | 2009-05-12 | 2010-11-18 | Ratiopharm Gmbh | Schmelztablette, enthaltend ein Vardenafil-Salz |
| CN102458475B (zh) | 2009-05-20 | 2016-03-30 | 大日本住友制药株式会社 | 压制包衣的口腔崩解片 |
| GB2497728A (en) | 2011-12-14 | 2013-06-26 | Londonpharma Ltd | Statin formulations for transmucosal delivery |
| GB2497933B (en) * | 2011-12-21 | 2014-12-24 | Londonpharma Ltd | Drug delivery technology |
| CN103372014B (zh) * | 2012-04-26 | 2015-10-21 | 齐鲁制药有限公司 | 一种能快速溶出、稳定的盐酸伐地那非口服固体制剂及其制备方法 |
| CN102727455B (zh) * | 2012-07-03 | 2016-06-29 | 北京科信必成医药科技发展有限公司 | 一种他达那非口腔崩解片及其制备方法 |
| US20160317542A1 (en) | 2013-12-09 | 2016-11-03 | Respira Therapeutics, Inc. | Pde5 inhibitor powder formulations and methods relating thereto |
| CN110193015A (zh) * | 2018-02-27 | 2019-09-03 | 广州朗圣药业有限公司 | 一种盐酸伐地那非口腔崩解片及其制备方法 |
| CN108272765B (zh) * | 2018-04-26 | 2021-02-02 | 江西杏林白马药业股份有限公司 | 含盐酸伐地那非的药物组合物、口崩片及其制备、应用 |
| KR20210005224A (ko) | 2018-05-02 | 2021-01-13 | 훼링 비.브이. | 개선된 약학적 제형 |
| CN110840851A (zh) * | 2019-08-16 | 2020-02-28 | 天津仁卫生物医药科技有限公司 | 一种盐酸伐地那非口腔崩解片及其制备方法 |
| IT201900020350A1 (it) | 2019-11-05 | 2021-05-05 | Alpex Pharma Sa | Formulazione orodispersibile di vardenafil |
| WO2021222739A1 (en) | 2020-04-30 | 2021-11-04 | Nanocopoeia, Llc | Orally disintegrating tablet comprising amorphous solid dispersion of nilotinib |
| CN114848603B (zh) * | 2022-04-25 | 2023-12-12 | 湖北菲瑞生物药业有限公司 | 一种伐地那非冻干闪释片及其制备工艺 |
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2005
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