HRP20121033T1 - Praškasta formulacija za valganciklovir - Google Patents
Praškasta formulacija za valganciklovir Download PDFInfo
- Publication number
- HRP20121033T1 HRP20121033T1 HRP20121033TT HRP20121033T HRP20121033T1 HR P20121033 T1 HRP20121033 T1 HR P20121033T1 HR P20121033T T HRP20121033T T HR P20121033TT HR P20121033 T HRP20121033 T HR P20121033T HR P20121033 T1 HRP20121033 T1 HR P20121033T1
- Authority
- HR
- Croatia
- Prior art keywords
- dosage form
- form according
- solid dosage
- amount
- bulking agent
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 4
- WPVFJKSGQUFQAP-GKAPJAKFSA-N Valcyte Chemical compound N1C(N)=NC(=O)C2=C1N(COC(CO)COC(=O)[C@@H](N)C(C)C)C=N2 WPVFJKSGQUFQAP-GKAPJAKFSA-N 0.000 title 1
- 238000009472 formulation Methods 0.000 title 1
- 239000000843 powder Substances 0.000 title 1
- 229960002149 valganciclovir Drugs 0.000 title 1
- 239000007909 solid dosage form Substances 0.000 claims 7
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 claims 4
- ZORWARFPXPVJLW-MTFPJWTKSA-N [2-[(2-amino-6-oxo-3h-purin-9-yl)methoxy]-3-hydroxypropyl] (2s)-2-amino-3-methylbutanoate;hydron;chloride Chemical compound Cl.N1C(N)=NC(=O)C2=C1N(COC(CO)COC(=O)[C@@H](N)C(C)C)C=N2 ZORWARFPXPVJLW-MTFPJWTKSA-N 0.000 claims 4
- 239000004067 bulking agent Substances 0.000 claims 4
- 229960004983 valganciclovir hydrochloride Drugs 0.000 claims 4
- 239000002552 dosage form Substances 0.000 claims 3
- 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
- 239000001530 fumaric acid Substances 0.000 claims 2
- 239000000594 mannitol Substances 0.000 claims 2
- 235000010355 mannitol Nutrition 0.000 claims 2
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- 241000701022 Cytomegalovirus Species 0.000 claims 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 1
- 241000700584 Simplexvirus Species 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 230000001404 mediated effect Effects 0.000 claims 1
- 239000007787 solid Substances 0.000 claims 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61K9/08—Solutions
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/20—Antivirals for DNA viruses
- A61P31/22—Antivirals for DNA viruses for herpes viruses
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Virology (AREA)
- Biophysics (AREA)
- Communicable Diseases (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oncology (AREA)
- Biotechnology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Claims (9)
1. Čvrsti farmaceutski dozirni oblik, naznačen time, da je za oralnu primjenu, nakon što se dobije u vodi, a sadrži:
(a) terapeutski učinkovitu količinu valganciklovir-hidroklorida; i
(b) fumarnu kiselinu prisutnu u dovoljnoj količini za stabilizaciju valganciklovir-hidroklorida u predodređenoj količini vode.
2. Čvrsti dozirni oblik prema zahtjevu 1, naznačen time, da je valganciklovir-hidroklorid prisutan u količini od oko 10 do oko 90 masenih % od ukupnog sastava.
3. Čvrsti dozirni oblik prema zahtjevu 1, naznačen time, da je fumarna kiselina prisutna u količini koja snižava pH vrijednost dobivene otopine valganciklovir-hidroklorida i to na pH vrijednost od oko 3,8 ili niže.
4. Čvrsti dozirni oblik prema zahtjevu 1, naznačen time, da nadalje sadrži učinkovitu količinu nehigroskopnog sredstva za povećanje obujma.
5. Čvrsti dozirni oblik prema zahtjevu 4, naznačen time, da je nehigroskopno sredstvo za povećanje obujma odabrano iz skupine koju čine manitol i laktoza.
6. Čvrsti dozirni oblik prema zahtjevu 4 ili 5, naznačen time, da nehigroskopno sredstvo za povećanje obujma je manitol.
7. Čvrsti dozirni oblik prema zahtjevima 4 do 6, naznačen time, da je nehigroskopno sredstvo za povećanje obujma prisutno u količini od oko 90 masenih % od ukupnog sastava.
8. Čvrsti dozirni oblik prema zahtjevima 1 do 7, naznačen time, da dozirni oblik ima sljedeći sastav:
[image]
9. Uporaba dozirnih oblika prema zahtjevima 1 do 8, naznačena time, da je za proizvodnju lijeka za liječenje virusa herpes simpleks i bolesti posredovanih citomegalovirusom.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US87463406P | 2006-12-13 | 2006-12-13 | |
| PCT/EP2007/063151 WO2008071573A2 (en) | 2006-12-13 | 2007-12-03 | Powder formulation for valganciclovir |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20121033T1 true HRP20121033T1 (hr) | 2013-01-31 |
Family
ID=39410167
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20121033TT HRP20121033T1 (hr) | 2006-12-13 | 2012-12-14 | Praškasta formulacija za valganciklovir |
Country Status (31)
| Country | Link |
|---|---|
| US (6) | US20080146591A1 (hr) |
| EP (1) | EP2101733B1 (hr) |
| JP (1) | JP5111517B2 (hr) |
| KR (1) | KR101116553B1 (hr) |
| CN (1) | CN101541310B (hr) |
| AR (1) | AR065541A1 (hr) |
| AU (1) | AU2007332640B2 (hr) |
| BR (1) | BRPI0720118B8 (hr) |
| CA (1) | CA2671470C (hr) |
| CL (1) | CL2007003564A1 (hr) |
| CO (1) | CO6220902A2 (hr) |
| CR (1) | CR10822A (hr) |
| DK (1) | DK2101733T3 (hr) |
| ES (1) | ES2391912T3 (hr) |
| HR (1) | HRP20121033T1 (hr) |
| IL (1) | IL198854A (hr) |
| MA (1) | MA31280B1 (hr) |
| MX (1) | MX2009005921A (hr) |
| MY (1) | MY152540A (hr) |
| NO (1) | NO339838B1 (hr) |
| NZ (1) | NZ577179A (hr) |
| PE (1) | PE20081578A1 (hr) |
| PL (1) | PL2101733T3 (hr) |
| PT (1) | PT2101733E (hr) |
| RS (1) | RS52457B (hr) |
| RU (1) | RU2440118C2 (hr) |
| SI (1) | SI2101733T1 (hr) |
| TW (1) | TWI341730B (hr) |
| UA (1) | UA93599C2 (hr) |
| WO (1) | WO2008071573A2 (hr) |
| ZA (1) | ZA200903840B (hr) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009111739A2 (en) * | 2008-03-07 | 2009-09-11 | Exley Ray W | Treatment of herpes virus related diseases |
| CN102048677B (zh) * | 2009-11-09 | 2014-03-05 | 杭州赛利药物研究所有限公司 | 一种盐酸缬更昔洛韦固体制剂及其制备方法 |
| WO2011113013A2 (en) | 2010-03-11 | 2011-09-15 | Hemaquest Pharmaceuticals, Inc. | Methods and compositions for treating viral or virally-induced conditions |
| ES2621257T3 (es) | 2012-04-20 | 2017-07-03 | Annji Pharmaceutical Co., Ltd. | Ésteres de ciclopropanocarboxilato de análogos de purinas |
| WO2014106962A1 (ko) | 2013-01-07 | 2014-07-10 | 삼아제약 주식회사 | 향상된 용해도를 갖는 신규한 속용성 과립제형 |
| EP3027215B1 (en) * | 2013-08-02 | 2017-05-03 | Ali Raif Ilaç Sanayi ve Ticaret Anonim Sirketi | Powder formulation of valganciclovir |
| CN104055746B (zh) * | 2014-07-12 | 2017-06-30 | 河北仁合益康药业有限公司 | 一种盐酸缬更昔洛韦包衣片剂组合物 |
| RU2720805C1 (ru) * | 2019-05-22 | 2020-05-13 | Общество с ограниченной ответственностью "Трейдсервис" | Фармацевтическая композиция валганцикловира |
| AU2020283590A1 (en) | 2019-05-31 | 2022-01-20 | Viracta Subsidiary, Inc. | Methods of treating virally associated cancers with histone deacetylase inhibitors |
| CN110613718A (zh) * | 2019-09-19 | 2019-12-27 | 湖北科益药业股份有限公司 | 一种缬更昔洛韦组合物 |
| CN110934823B (zh) * | 2019-12-27 | 2022-03-01 | 湖北康源药业有限公司 | 一种盐酸缬更昔洛韦口服溶液及制备方法 |
| WO2021161317A1 (en) * | 2020-02-12 | 2021-08-19 | Cts Chemical Industries Ltd. | Stable pharmaceutical compositions comprising valgancyclovir and uses thereof |
| CN114028347B (zh) * | 2021-11-30 | 2023-05-12 | 海南皇隆制药股份有限公司 | 注射用帕瑞昔布钠及其制备方法 |
| CN115569113B (zh) * | 2022-09-19 | 2023-11-10 | 江苏汉晨药业有限公司 | 一种盐酸缬更昔洛韦口服溶液 |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR880002139B1 (ko) | 1983-04-08 | 1988-10-17 | 베링거 인겔하임 리미티드 | 경구 투여용 정제의 제조방법 |
| US5840891A (en) | 1994-07-28 | 1998-11-24 | Syntex (U.S.A.) Inc. | 2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl) methoxy-1,3-propanediol derivative |
| US5840890A (en) | 1996-01-26 | 1998-11-24 | Syntex (U.S.A.) Inc. | Process for preparing a 2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl)methoxy-1,3-propanediol derivative |
| EP1017372A4 (en) * | 1997-10-03 | 2006-05-24 | Smithkline Beecham Corp | SOLID GALENIC FORMS WITH CONTROLLED LITHIUM CARBONATE RELEASE |
| US6221917B1 (en) * | 1997-12-30 | 2001-04-24 | American Home Products Corporation | Pharmaceutical composition containing bupropion hydrochloride and a stabilizer |
| CA2244097A1 (en) * | 1998-08-21 | 2000-02-21 | Bernard Charles Sherman | Pharmaceutical composition comprising bupropion hydrochloride and fumaric acid |
| US20020143058A1 (en) * | 2001-01-24 | 2002-10-03 | Taro Pharmaceutical Inductries Ltd. | Process for preparing non-hygroscopic sodium valproate composition |
| ATE382338T1 (de) * | 2003-03-19 | 2008-01-15 | Jordanian Pharmaceutical Mfg | Nicht-hygroskopische pharmazeutische zusammensetzungen die nicht hydratisierte quinolon-carbonsäure enthalten |
| CN1860120A (zh) * | 2003-08-28 | 2006-11-08 | 兰贝克赛实验室有限公司 | 无定形盐酸缬更昔洛韦 |
| EP1725217B1 (en) | 2004-03-10 | 2008-08-06 | Ranbaxy Laboratories, Ltd. | Processes for the preparation of solid dosage forms of amorphous valganciclovir hydrochloride |
| AU2006284053B2 (en) | 2005-08-22 | 2010-04-22 | Novartis Ag | Pharmaceutical compositions comprising a pH-dependent drug, a pH modifier and a retarding agent |
-
2007
- 2007-12-03 WO PCT/EP2007/063151 patent/WO2008071573A2/en active Application Filing
- 2007-12-03 EP EP07847662A patent/EP2101733B1/en active Active
- 2007-12-03 BR BRPI0720118A patent/BRPI0720118B8/pt active IP Right Grant
- 2007-12-03 PL PL07847662T patent/PL2101733T3/pl unknown
- 2007-12-03 PT PT07847662T patent/PT2101733E/pt unknown
- 2007-12-03 SI SI200731076T patent/SI2101733T1/sl unknown
- 2007-12-03 RU RU2009126616/15A patent/RU2440118C2/ru active
- 2007-12-03 ES ES07847662T patent/ES2391912T3/es active Active
- 2007-12-03 DK DK07847662.9T patent/DK2101733T3/da active
- 2007-12-03 MY MYPI20092409 patent/MY152540A/en unknown
- 2007-12-03 CN CN2007800443008A patent/CN101541310B/zh active Active
- 2007-12-03 JP JP2009540707A patent/JP5111517B2/ja active Active
- 2007-12-03 AU AU2007332640A patent/AU2007332640B2/en active Active
- 2007-12-03 UA UAA200907074A patent/UA93599C2/ru unknown
- 2007-12-03 NZ NZ577179A patent/NZ577179A/en unknown
- 2007-12-03 CA CA2671470A patent/CA2671470C/en active Active
- 2007-12-03 KR KR1020097014059A patent/KR101116553B1/ko active IP Right Grant
- 2007-12-03 MX MX2009005921A patent/MX2009005921A/es active IP Right Grant
- 2007-12-03 RS RS20120429A patent/RS52457B/en unknown
- 2007-12-10 CL CL200703564A patent/CL2007003564A1/es unknown
- 2007-12-11 TW TW096147281A patent/TWI341730B/zh active
- 2007-12-11 AR ARP070105524A patent/AR065541A1/es not_active Application Discontinuation
- 2007-12-11 US US12/001,290 patent/US20080146591A1/en not_active Abandoned
- 2007-12-12 PE PE2007001774A patent/PE20081578A1/es not_active Application Discontinuation
-
2009
- 2009-05-20 IL IL198854A patent/IL198854A/en active IP Right Grant
- 2009-05-21 CR CR10822A patent/CR10822A/es unknown
- 2009-05-22 CO CO09053156A patent/CO6220902A2/es not_active Application Discontinuation
- 2009-06-02 ZA ZA200903840A patent/ZA200903840B/xx unknown
- 2009-06-05 MA MA31956A patent/MA31280B1/fr unknown
- 2009-06-11 NO NO20092254A patent/NO339838B1/no not_active IP Right Cessation
-
2012
- 2012-12-14 HR HRP20121033TT patent/HRP20121033T1/hr unknown
-
2013
- 2013-02-05 US US13/759,348 patent/US8889109B2/en active Active
-
2014
- 2014-10-31 US US14/529,839 patent/US9642911B2/en active Active
-
2017
- 2017-04-05 US US15/479,544 patent/US20170266286A1/en not_active Abandoned
- 2017-12-19 US US15/846,991 patent/US20180153998A1/en not_active Abandoned
-
2018
- 2018-12-19 US US16/225,433 patent/US11185588B2/en active Active
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