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WO2018154395A3 - Controlled release pharmaceutical composition of varenicline - Google Patents

Controlled release pharmaceutical composition of varenicline Download PDF

Info

Publication number
WO2018154395A3
WO2018154395A3 PCT/IB2018/000635 IB2018000635W WO2018154395A3 WO 2018154395 A3 WO2018154395 A3 WO 2018154395A3 IB 2018000635 W IB2018000635 W IB 2018000635W WO 2018154395 A3 WO2018154395 A3 WO 2018154395A3
Authority
WO
WIPO (PCT)
Prior art keywords
varenicline
controlled release
pharmaceutical composition
release pharmaceutical
tablet
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.)
Ceased
Application number
PCT/IB2018/000635
Other languages
French (fr)
Other versions
WO2018154395A2 (en
Inventor
Jaya Abraham
Tae Kyung Kim
Tae Hee Han
Ji Eun Ahn
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.)
Alvogen Malta Operations (row) Ltd
Original Assignee
Alvogen Malta Operations (row) 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 Alvogen Malta Operations (row) Ltd filed Critical Alvogen Malta Operations (row) Ltd
Priority to PCT/IB2018/000635 priority Critical patent/WO2018154395A2/en
Publication of WO2018154395A2 publication Critical patent/WO2018154395A2/en
Publication of WO2018154395A3 publication Critical patent/WO2018154395A3/en
Anticipated expiration legal-status Critical
Ceased 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
    • 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
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention refers to tablet form with controlled release of Varenicline, which is used in the pharmacy and medicine and especially to reduce the nicotine addiction, to support the suspension and limit the use of tobacco products. The tablet can be with one-layer or two-layer core which is formed from the active substance Varenicline free base and the excipients mannitol, cellulose powder, magnesium stearate and hydroxypropyl methylcellulose with molecular weight from 100 000 to 200 000. The advantage of the tablet form with controlled release, according to the invention, is its good stability, uniformity of content and good bioavailability, with low amplitude of Cmax and Cmjn and possibility to overcome the side effects from the rapid release of Varenicline as nausea and headache.
PCT/IB2018/000635 2018-06-11 2018-06-11 Controlled release pharmaceutical composition of varenicline Ceased WO2018154395A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IB2018/000635 WO2018154395A2 (en) 2018-06-11 2018-06-11 Controlled release pharmaceutical composition of varenicline

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2018/000635 WO2018154395A2 (en) 2018-06-11 2018-06-11 Controlled release pharmaceutical composition of varenicline

Publications (2)

Publication Number Publication Date
WO2018154395A2 WO2018154395A2 (en) 2018-08-30
WO2018154395A3 true WO2018154395A3 (en) 2019-02-28

Family

ID=62842155

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2018/000635 Ceased WO2018154395A2 (en) 2018-06-11 2018-06-11 Controlled release pharmaceutical composition of varenicline

Country Status (1)

Country Link
WO (1) WO2018154395A2 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11040983B1 (en) 2020-08-14 2021-06-22 Almatica Pharma Llc Cocrystal of varenicline and oxalic acid, pharmaceutical composition thereof, and methods of use thereof
US20230056424A1 (en) * 2021-11-05 2023-02-23 Alfred E. Tiefenbacher (Gmbh & Co. Kg) Prevention of the conversion of pharmaceutical agents into toxic n-nitrosamine compounds

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030180360A1 (en) * 2001-11-30 2003-09-25 Pfizer Inc. Pharmaceutical compositions of 5,7,14-triazatetracyclo[10.3.1.02,11.04,9]-hexadeca-2 (11),3,5,7,9-pentaene
WO2009027786A2 (en) * 2007-08-29 2009-03-05 Pfizer Inc. Matrix dosage forms of varenicline

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HRP20050506A2 (en) 1997-12-31 2006-03-31 Pfizer Products Inc. Aryl fused azapolycyclic compounds
NZ528210A (en) 2001-05-14 2005-04-29 Pfizer Prod Inc Tartrate salts of 5,8,14-triazatetracyclo[10.3.1.02,11.04,9]-hexadeca-2(11),3,5,7,9-pentaene and pharmaceutical compositions thereof
HRP20030911A2 (en) 2001-05-14 2004-02-29 Pfizer Prod Inc Citrate salt 5,8,14,-triazatetracyclo (10.3.1.0<sup>2,11</sup>.0<sup>4,9</sup>)-hexadeca-2 (11), 3,5,7,9-pentaene
CA2468705A1 (en) 2001-11-29 2003-06-05 Pfizer Products Inc. Succinic acid salts of 5,8,14-triazatetracyclo'10.3.1.0<2,11>.0<4,9>-hexadeca-2(11),3,5,7,9-pentaene and pharmaceutical compositions thereof
EP1843769A1 (en) 2005-01-07 2007-10-17 Pfizer Products Incorporated Fast-disintegrating dosage forms of 5,8,14-triazatetracyclo[10.3.1.02,11.04,9]-hexadeca-2(11),3,5,7,9-pentaene
WO2009034431A2 (en) 2007-09-10 2009-03-19 Pfizer Inc. Controlled-release dosage forms for varenicline

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030180360A1 (en) * 2001-11-30 2003-09-25 Pfizer Inc. Pharmaceutical compositions of 5,7,14-triazatetracyclo[10.3.1.02,11.04,9]-hexadeca-2 (11),3,5,7,9-pentaene
WO2009027786A2 (en) * 2007-08-29 2009-03-05 Pfizer Inc. Matrix dosage forms of varenicline

Also Published As

Publication number Publication date
WO2018154395A2 (en) 2018-08-30

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