WO2014064711A3 - Methods of administering raltegravir and raltegravir compositions - Google Patents

Methods of administering raltegravir and raltegravir compositions Download PDF

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Publication number
WO2014064711A3
WO2014064711A3 PCT/IN2013/000613 IN2013000613W WO2014064711A3 WO 2014064711 A3 WO2014064711 A3 WO 2014064711A3 IN 2013000613 W IN2013000613 W IN 2013000613W WO 2014064711 A3 WO2014064711 A3 WO 2014064711A3
Authority
WO
WIPO (PCT)
Prior art keywords
raltegravir
administering
pharmaceutically acceptable
solid oral
dosage form
Prior art date
Application number
PCT/IN2013/000613
Other languages
French (fr)
Other versions
WO2014064711A2 (en
Inventor
Bandi Parthasaradhi Reddy
Male Srinivas Reddy
Podili Khadgapathi
Goli Kamalakar Reddy
Original Assignee
Hetero Research Foundation
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 Hetero Research Foundation filed Critical Hetero Research Foundation
Publication of WO2014064711A2 publication Critical patent/WO2014064711A2/en
Publication of WO2014064711A3 publication Critical patent/WO2014064711A3/en

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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
    • A61K31/495—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
    • A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • 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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The disclosure is related to amorphous raltegravir and the solid oral dosage forms of amorphous raltegravir that are of lower dosage than the commercially available reference dosage form. Provided herein are a pharmaceutical solid oral dosage form composed from (a) 300 mg of amorphous raltegravir or an equivalent amount of a pharmaceutically acceptable salt thereof; (b) a polymer; and (c) a pharmaceutically acceptable excipient and a method of reducing adverse effects of raltegravir administration in a human subject, comprising administering to the human subject a solid oral dosage form comprising 300 mg of amorphous raltegravir or an equivalent amount of a pharmaceutically acceptable salt thereof.
PCT/IN2013/000613 2012-10-22 2013-10-09 Methods of administering raltegravir and raltegravir compositions WO2014064711A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN4386CH2012 2012-10-22
IN4386/CHE/2012 2012-10-22

Publications (2)

Publication Number Publication Date
WO2014064711A2 WO2014064711A2 (en) 2014-05-01
WO2014064711A3 true WO2014064711A3 (en) 2014-06-19

Family

ID=50545424

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2013/000613 WO2014064711A2 (en) 2012-10-22 2013-10-09 Methods of administering raltegravir and raltegravir compositions

Country Status (1)

Country Link
WO (1) WO2014064711A2 (en)

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060122205A1 (en) * 2004-12-03 2006-06-08 Belyk Kevin M Potassium salt of an HIV integrase inhibitor
US20080146605A1 (en) * 2006-12-19 2008-06-19 Auspex Pharmaceuticals, Inc. Preparation and utility of ccr5 inhibitors
US20100178339A1 (en) * 2007-06-22 2010-07-15 Bristol-Myers Squibb Company Tableted compositions containing atazanavir
US20120093738A1 (en) * 2009-06-11 2012-04-19 Rubicon Research Private Limited Taste-masked oral formulations of influenza antivirals
US20120178930A1 (en) * 2009-06-02 2012-07-12 Bandi Parthasaradhi Reddy Novel polymorphs of raltegravir potassium
US20120208886A1 (en) * 2006-02-07 2012-08-16 Apr Applied Pharma Research, S.A. Moisture Resistant Container Systems for Rapidly Bioavailable Dosage Forms
US20120213851A1 (en) * 2009-10-26 2012-08-23 Majid Mahjour Solid pharmaceutical compositions containing an integrase inhibitor
US20120270888A1 (en) * 2011-04-25 2012-10-25 Bandi Parthasaradhi Reddy Pharmaceutical compositions of raltegravir, methods of preparation and use thereof
WO2012145446A1 (en) * 2011-04-22 2012-10-26 Merck Sharp & Dohme Corp. Taste-masked formulations of raltegravir
WO2012163893A1 (en) * 2011-06-01 2012-12-06 Ratiopharm Gmbh Composition and tablet comprising raltegravir

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060122205A1 (en) * 2004-12-03 2006-06-08 Belyk Kevin M Potassium salt of an HIV integrase inhibitor
US20120208886A1 (en) * 2006-02-07 2012-08-16 Apr Applied Pharma Research, S.A. Moisture Resistant Container Systems for Rapidly Bioavailable Dosage Forms
US20080146605A1 (en) * 2006-12-19 2008-06-19 Auspex Pharmaceuticals, Inc. Preparation and utility of ccr5 inhibitors
US20100178339A1 (en) * 2007-06-22 2010-07-15 Bristol-Myers Squibb Company Tableted compositions containing atazanavir
US20120178930A1 (en) * 2009-06-02 2012-07-12 Bandi Parthasaradhi Reddy Novel polymorphs of raltegravir potassium
US20120093738A1 (en) * 2009-06-11 2012-04-19 Rubicon Research Private Limited Taste-masked oral formulations of influenza antivirals
US20120213851A1 (en) * 2009-10-26 2012-08-23 Majid Mahjour Solid pharmaceutical compositions containing an integrase inhibitor
WO2012145446A1 (en) * 2011-04-22 2012-10-26 Merck Sharp & Dohme Corp. Taste-masked formulations of raltegravir
US20120270888A1 (en) * 2011-04-25 2012-10-25 Bandi Parthasaradhi Reddy Pharmaceutical compositions of raltegravir, methods of preparation and use thereof
WO2012163893A1 (en) * 2011-06-01 2012-12-06 Ratiopharm Gmbh Composition and tablet comprising raltegravir

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
KLEIN ET AL.: "A Comparison of the Single Dose Bioavailability of a Ritonavir Tablet Formulation . Relative to the Ritonavir Soft Gelatin Capsule in Healthy Adult Subjects", XVII INTERNATIONAL AIDS CONFERENCE, POSTER #TUPE0076, 3 August 2008 (2008-08-03), Retrieved from the Internet <URL:http://www.medadvocates.org/resources/confere.nces/internationaLaids-conferences/17/lopinaviUndex/17N.pdf> *

Also Published As

Publication number Publication date
WO2014064711A2 (en) 2014-05-01

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