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 PDF

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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Withdrawn
Application number
EP15814377.6A
Other languages
German (de)
French (fr)
Other versions
EP3154975A1 (en
Inventor
Jung Hyun Cho
Young Keun Choi
Hyung Seo Kim
Kyeong Soo Kim
Yong Il Kim
Jae Hyun Park
Jong Soo Woo
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hanmi Pharmaceutical Co Ltd
Hanmi Pharmaceutical Industries Co Ltd
Original Assignee
Hanmi Pharmaceutical Co Ltd
Hanmi Pharmaceutical Industries Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Hanmi Pharmaceutical Co Ltd, Hanmi Pharmaceutical Industries Co Ltd filed Critical Hanmi Pharmaceutical Co Ltd
Publication of EP3154975A1 publication Critical patent/EP3154975A1/en
Publication of EP3154975A4 publication Critical patent/EP3154975A4/en
Withdrawn legal-status Critical Current

Links

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)
EP15814377.6A 2014-07-01 2015-07-01 Tenofovir disoproxil phosphate, and pharmaceutical composition thereof comprising non-metallic salt disintegrant and non-metallic salt lubricant Withdrawn EP3154975A4 (en)

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)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
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

Patent Citations (2)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
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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