WO2009106960A3 - Stable compositions of lamivudine, tenofovir and efavirenz - Google Patents

Stable compositions of lamivudine, tenofovir and efavirenz Download PDF

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Publication number
WO2009106960A3
WO2009106960A3 PCT/IB2009/000352 IB2009000352W WO2009106960A3 WO 2009106960 A3 WO2009106960 A3 WO 2009106960A3 IB 2009000352 W IB2009000352 W IB 2009000352W WO 2009106960 A3 WO2009106960 A3 WO 2009106960A3
Authority
WO
WIPO (PCT)
Prior art keywords
efavirenz
lamivudine
tenofovir
stable compositions
stable
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/IB2009/000352
Other languages
French (fr)
Other versions
WO2009106960A2 (en
Inventor
Nishant Babanrao Naware
Ramesh Manchala
Chandrasekhar Panchagnula
Shailesh Suresh Bhamare
Kishor Dattatray Deo
Sivakumaran Meenakshisunderam
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.)
Aurobindo Pharma Ltd
Original Assignee
Aurobindo Pharma 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 Aurobindo Pharma Ltd filed Critical Aurobindo Pharma Ltd
Publication of WO2009106960A2 publication Critical patent/WO2009106960A2/en
Publication of WO2009106960A3 publication Critical patent/WO2009106960A3/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
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/536—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines ortho- or peri-condensed with carbocyclic ring systems
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7076—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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

Landscapes

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

Abstract

The present invention relates to stable bilayered tablets of combination of antiretroviral agents. More particularly, the present invention relates to stable dosage forms comprising lamivudine, tenofovir disoproxil fumarate and efavirenz prepared by wet granulation.
PCT/IB2009/000352 2008-02-27 2009-02-27 Stable compositions of lamivudine, tenofovir and efavirenz Ceased WO2009106960A2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IN491CH2008 2008-02-27
IN491/CHE/2008 2008-02-27
IN2135/CHE/2008 2008-09-01
IN2135CH2008 2008-09-01

Publications (2)

Publication Number Publication Date
WO2009106960A2 WO2009106960A2 (en) 2009-09-03
WO2009106960A3 true WO2009106960A3 (en) 2009-10-22

Family

ID=40688309

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2009/000352 Ceased WO2009106960A2 (en) 2008-02-27 2009-02-27 Stable compositions of lamivudine, tenofovir and efavirenz

Country Status (1)

Country Link
WO (1) WO2009106960A2 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG10201509521WA (en) 2010-11-19 2015-12-30 Gilead Sciences Inc Therapeutic compositions comprising rilpivirine hcl and tenofovir disoproxil fumarate
CA2779052A1 (en) * 2012-05-31 2013-11-30 Pharmascience Inc. Pharmaceutical composition of entecavir and process of manufacturing
WO2017095761A1 (en) * 2015-12-02 2017-06-08 Merck Sharp & Dohme Corp. Pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate and lamivudine
WO2018028841A1 (en) * 2016-08-12 2018-02-15 Sandoz Ag Solid pharmaceutical composition of abacavir, lamivudine, and efavirenz
CN106822155B (en) * 2016-12-29 2019-10-11 东北制药集团股份有限公司 Efavirenz, lamivudine and tenofovir disoproxil fumarate triple compound tablet middle tablet and preparation method thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004089383A1 (en) * 2003-04-14 2004-10-21 Cipla Limited Pharmaceutical combinations comprising lamivudine, stavudine and efavirenz for treating viral infections
WO2006135933A2 (en) * 2005-06-13 2006-12-21 Bristol-Myers Squibb & Gilead Sciences, Llc Stable fixed-dose unitary formulations containing tenofovir, a surfactant, efavirenz and emtricitabine
WO2007068934A2 (en) * 2005-12-14 2007-06-21 Cipla Limited Pharmaceutical combination comprising nucleotide and nucleoside reverse transcriptase inhibitors (such as tenofovir and lamivudine) in different parts of the dosage unit
WO2008096369A2 (en) * 2007-02-05 2008-08-14 Matrix Laboratories Limited Pharmaceutical formulation for use in hiv therapy

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004089383A1 (en) * 2003-04-14 2004-10-21 Cipla Limited Pharmaceutical combinations comprising lamivudine, stavudine and efavirenz for treating viral infections
WO2006135933A2 (en) * 2005-06-13 2006-12-21 Bristol-Myers Squibb & Gilead Sciences, Llc Stable fixed-dose unitary formulations containing tenofovir, a surfactant, efavirenz and emtricitabine
WO2007068934A2 (en) * 2005-12-14 2007-06-21 Cipla Limited Pharmaceutical combination comprising nucleotide and nucleoside reverse transcriptase inhibitors (such as tenofovir and lamivudine) in different parts of the dosage unit
WO2008096369A2 (en) * 2007-02-05 2008-08-14 Matrix Laboratories Limited Pharmaceutical formulation for use in hiv therapy

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
FDA: "Guidance for Industry Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV", INTERNET CITATION, XP002417855, Retrieved from the Internet <URL:http://www.fda.gov/oc/initiatives/hiv/hivguidance.html> [retrieved on 20070131] *
MENENDEZ-ARIAS L: "Targeting HIV: antiretroviral therapy and development of drug resistance", TRENDS IN PHARMACOLOGICAL SCIENCES, ELSEVIER, HAYWARTH, GB, vol. 23, no. 8, 1 August 2002 (2002-08-01), pages 381 - 388, XP004386181, ISSN: 0165-6147 *

Also Published As

Publication number Publication date
WO2009106960A2 (en) 2009-09-03

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