WO2007112287A3 - Hme transdermal compositions containing testosterone - Google Patents

Hme transdermal compositions containing testosterone Download PDF

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Publication number
WO2007112287A3
WO2007112287A3 PCT/US2007/064716 US2007064716W WO2007112287A3 WO 2007112287 A3 WO2007112287 A3 WO 2007112287A3 US 2007064716 W US2007064716 W US 2007064716W WO 2007112287 A3 WO2007112287 A3 WO 2007112287A3
Authority
WO
WIPO (PCT)
Prior art keywords
testosterone
laminate
period
hme
hours
Prior art date
Application number
PCT/US2007/064716
Other languages
French (fr)
Other versions
WO2007112287A2 (en
Inventor
Michael M Crowley
Justin M Keen
John J Koleng
Randall Mack
Terri Sebree
Theodore M Smith
Feng Zhang
Original Assignee
Auxilium Pharmaceuticals Inc
Michael M Crowley
Justin M Keen
John J Koleng
Randall Mack
Terri Sebree
Theodore M Smith
Feng Zhang
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 Auxilium Pharmaceuticals Inc, Michael M Crowley, Justin M Keen, John J Koleng, Randall Mack, Terri Sebree, Theodore M Smith, Feng Zhang filed Critical Auxilium Pharmaceuticals Inc
Publication of WO2007112287A2 publication Critical patent/WO2007112287A2/en
Publication of WO2007112287A3 publication Critical patent/WO2007112287A3/en

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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7069—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide

Landscapes

  • Health & Medical Sciences (AREA)
  • Nutrition Science (AREA)
  • Physiology (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)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

A bioadhesive laminate comprising testosterone and methods for its preparation are provided. The laminate comprises a hot-melt extruded (HME) drug reservoir layer comprising testosterone and an inert backing layer. The drug reservoir layer comprises a thermoplastic bioadhesive composition containing testosterone and the inert backing layer. The laminate is adapted for transdermal administration. When administered buccally to a subject, the laminate provides therapeutically effective plasma levels of testosterone such that the Cmax of testosterone is less than about 1000 ng/dL and the Tmax falls within the period of about two to fifteen hours. In a particular embodiment, the laminate provides therapeutic plasma levels of testosterone in the range of about 300 to 1000 ng/dL throughout a period of about one to twenty four hours after buccal administration to a subject. The laminate provides an in vitro controlled release of testosterone for a period of about four to thirty hours after exposure to an aqueous assay medium.
PCT/US2007/064716 2006-03-24 2007-03-22 Hme transdermal compositions containing testosterone WO2007112287A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US78550106P 2006-03-24 2006-03-24
US60/785,501 2006-03-24

Publications (2)

Publication Number Publication Date
WO2007112287A2 WO2007112287A2 (en) 2007-10-04
WO2007112287A3 true WO2007112287A3 (en) 2009-03-26

Family

ID=38541816

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/064716 WO2007112287A2 (en) 2006-03-24 2007-03-22 Hme transdermal compositions containing testosterone

Country Status (1)

Country Link
WO (1) WO2007112287A2 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008028047A2 (en) * 2006-08-30 2008-03-06 Lab International Srl Bioadhesive film drug delivery system
ES2385231T3 (en) * 2007-07-04 2012-07-19 Acino Ag Tank system with a closed membrane
US20140271867A1 (en) * 2013-03-15 2014-09-18 Monosol Rx, Llc Film delivery system for active ingredients
WO2014144366A1 (en) * 2013-03-15 2014-09-18 Monosol Rx, Llc. Steroid hormone delivery systems and methods of preparing the same

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040018241A1 (en) * 1997-09-26 2004-01-29 Noven Pharmaceuticals, Inc. Bioadhesive compositions and methods for topical administration of active agents
US20050169977A1 (en) * 2003-10-28 2005-08-04 Noven Pharmaceuticals, Inc. Compositions and methods for controlling drug loss and delivery in transdermal drug delivery systems

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040018241A1 (en) * 1997-09-26 2004-01-29 Noven Pharmaceuticals, Inc. Bioadhesive compositions and methods for topical administration of active agents
US20050169977A1 (en) * 2003-10-28 2005-08-04 Noven Pharmaceuticals, Inc. Compositions and methods for controlling drug loss and delivery in transdermal drug delivery systems

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DOBS ET AL.: "Pharmacokinetics, Efficacy, and Safety of a Permeation-Enhanced Testosterone Transdermal System in Comparison with Bi-Weekly Injections of Testosterone Enanthate for the Treatment of Hypogonadal Men.", THE JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM, vol. 84, no. 10, 12 July 1999 (1999-07-12), pages 3469 - 3478 *

Also Published As

Publication number Publication date
WO2007112287A2 (en) 2007-10-04

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