EP3154975A4 - Tenofovir disoproxil phosphate, and pharmaceutical composition thereof comprising non-metallic salt disintegrant and non-metallic salt lubricant - Google Patents
Tenofovir disoproxil phosphate, and pharmaceutical composition thereof comprising non-metallic salt disintegrant and non-metallic salt lubricant Download PDFInfo
- Publication number
- EP3154975A4 EP3154975A4 EP15814377.6A EP15814377A EP3154975A4 EP 3154975 A4 EP3154975 A4 EP 3154975A4 EP 15814377 A EP15814377 A EP 15814377A EP 3154975 A4 EP3154975 A4 EP 3154975A4
- Authority
- EP
- European Patent Office
- Prior art keywords
- metallic salt
- pharmaceutical composition
- tenofovir disoproxil
- disintegrant
- lubricant
- 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.)
- Withdrawn
Links
- 150000003839 salts Chemical class 0.000 title 2
- DJCLNKKHALBVLK-PFEQFJNWSA-N [[(2R)-1-(6-aminopurin-9-yl)propan-2-yl]oxymethyl-(propan-2-yloxycarbonyloxymethoxy)phosphoryl]oxymethyl propan-2-yl carbonate phosphoric acid Chemical compound OP(O)(O)=O.N1=CN=C2N(C[C@@H](C)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C)C=NC2=C1N DJCLNKKHALBVLK-PFEQFJNWSA-N 0.000 title 1
- 239000007884 disintegrant Substances 0.000 title 1
- 239000000314 lubricant Substances 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 229950010595 tenofovir disoproxil phosphate Drugs 0.000 title 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D473/00—Heterocyclic compounds containing purine ring systems
- C07D473/26—Heterocyclic compounds containing purine ring systems with an oxygen, sulphur, or nitrogen atom directly attached in position 2 or 6, but not in both
- C07D473/32—Nitrogen atom
- C07D473/34—Nitrogen atom attached in position 6, e.g. adenine
-
- 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
-
- 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
- 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
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
- C07F9/00—Compounds containing elements of Groups 5 or 15 of the Periodic Table
- C07F9/02—Phosphorus compounds
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
- C07F9/00—Compounds containing elements of Groups 5 or 15 of the Periodic Table
- C07F9/02—Phosphorus compounds
- C07F9/547—Heterocyclic compounds, e.g. containing phosphorus as a ring hetero atom
- C07F9/6561—Heterocyclic compounds, e.g. containing phosphorus as a ring hetero atom containing systems of two or more relevant hetero rings condensed among themselves or condensed with a common carbocyclic ring or ring system, with or without other non-condensed hetero rings
- C07F9/65616—Heterocyclic compounds, e.g. containing phosphorus as a ring hetero atom containing systems of two or more relevant hetero rings condensed among themselves or condensed with a common carbocyclic ring or ring system, with or without other non-condensed hetero rings containing the ring system having three or more than three double bonds between ring members or between ring members and non-ring members, e.g. purine or analogs
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Biochemistry (AREA)
- Virology (AREA)
- General Chemical & Material Sciences (AREA)
- Botany (AREA)
- Zoology (AREA)
- Oncology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Communicable Diseases (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020140082137A KR20160003532A (en) | 2014-07-01 | 2014-07-01 | Tenofovir disoproxil phosphate, and pharmaceutical composition comprising non-metalic salt disintegrant and non-metalic salt lubricant |
PCT/KR2015/006766 WO2016003194A1 (en) | 2014-07-01 | 2015-07-01 | Tenofovir disoproxil phosphate, and pharmaceutical composition thereof comprising non-metallic salt disintegrant and non-metallic salt lubricant |
Publications (2)
Publication Number | Publication Date |
---|---|
EP3154975A1 EP3154975A1 (en) | 2017-04-19 |
EP3154975A4 true EP3154975A4 (en) | 2018-01-03 |
Family
ID=55019641
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP15814377.6A Withdrawn EP3154975A4 (en) | 2014-07-01 | 2015-07-01 | Tenofovir disoproxil phosphate, and pharmaceutical composition thereof comprising non-metallic salt disintegrant and non-metallic salt lubricant |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP3154975A4 (en) |
KR (1) | KR20160003532A (en) |
WO (1) | WO2016003194A1 (en) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR101820084B1 (en) * | 2016-03-31 | 2018-01-18 | 한미약품 주식회사 | Solid formulation for oral administration containing tenofovir disoproxil and a process for the preparation thereof |
EP3501506B1 (en) * | 2017-12-19 | 2019-10-09 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Pharmaceutical tablet composition comprising brexpiprazole |
KR102254307B1 (en) * | 2019-04-03 | 2021-05-21 | 위더스제약주식회사 | Eperisone-containing pharmaceutical having improved storage-stability |
CN111407736A (en) * | 2020-03-30 | 2020-07-14 | 苏州弘森药业股份有限公司 | Preparation process of tenofovir disoproxil fumarate tablets |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2009074351A2 (en) * | 2007-12-12 | 2009-06-18 | Ultimorphix Technologies B.V. | Solid forms of tenofovir disoproxil |
EP2860184A1 (en) * | 2013-10-09 | 2015-04-15 | Zentiva, k.s. | Dihydrogenphosphate salt of Tenofovir disoproxil |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE69831694T2 (en) | 1997-07-25 | 2006-07-13 | Gilead Sciences, Inc., Foster City | Nucleotide analog composition and synthesis procedure |
EP2440560A1 (en) | 2009-06-10 | 2012-04-18 | Ultimorphix Technologies B.v. | The succinate of tenofovir disoproxil |
CN101781334B (en) * | 2010-03-04 | 2012-11-28 | 福建广生堂药业股份有限公司 | Salt compound of tenofovir disoproxil fumarate and preparation method and medicinal application thereof |
WO2012016506A1 (en) * | 2010-08-01 | 2012-02-09 | 江苏正大天晴药业股份有限公司 | Crystals of tenofovir disoproxil fumarate |
WO2013132314A1 (en) * | 2012-03-05 | 2013-09-12 | Laurus Labs Private Limited | Tenofovir phosphate, processes for the preparation and pharmaceutical composition thereof |
KR101439255B1 (en) | 2012-08-30 | 2014-09-11 | 주식회사 종근당 | The New Tenofovir disoproxil salt and the preparation method thereof |
CN103830192A (en) * | 2012-11-27 | 2014-06-04 | 安徽贝克生物制药有限公司 | Tenofovir disoproxil fumarate tablets allowing direct powder compression and preparation method thereof |
-
2014
- 2014-07-01 KR KR1020140082137A patent/KR20160003532A/en not_active Application Discontinuation
-
2015
- 2015-07-01 EP EP15814377.6A patent/EP3154975A4/en not_active Withdrawn
- 2015-07-01 WO PCT/KR2015/006766 patent/WO2016003194A1/en active Application Filing
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2009074351A2 (en) * | 2007-12-12 | 2009-06-18 | Ultimorphix Technologies B.V. | Solid forms of tenofovir disoproxil |
EP2860184A1 (en) * | 2013-10-09 | 2015-04-15 | Zentiva, k.s. | Dihydrogenphosphate salt of Tenofovir disoproxil |
Non-Patent Citations (1)
Title |
---|
See also references of WO2016003194A1 * |
Also Published As
Publication number | Publication date |
---|---|
KR20160003532A (en) | 2016-01-11 |
WO2016003194A1 (en) | 2016-01-07 |
EP3154975A1 (en) | 2017-04-19 |
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Legal Events
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STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE |
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PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
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STAA | Information on the status of an ep patent application or granted ep patent |
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17P | Request for examination filed |
Effective date: 20161229 |
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AX | Request for extension of the european patent |
Extension state: BA ME |
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DAV | Request for validation of the european patent (deleted) | ||
DAX | Request for extension of the european patent (deleted) | ||
A4 | Supplementary search report drawn up and despatched |
Effective date: 20171201 |
|
RIC1 | Information provided on ipc code assigned before grant |
Ipc: C07D 473/34 20060101AFI20171127BHEP Ipc: C07F 9/6561 20060101ALI20171127BHEP Ipc: A61K 9/20 20060101ALI20171127BHEP Ipc: A61P 31/12 20060101ALI20171127BHEP Ipc: A61K 31/52 20060101ALI20171127BHEP Ipc: C07F 9/02 20060101ALI20171127BHEP |
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STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE APPLICATION HAS BEEN WITHDRAWN |
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18W | Application withdrawn |
Effective date: 20190626 |