EP3612170A4 - Method for making a transdermal fentanyl patch with even drug crystal distribution - Google Patents

Method for making a transdermal fentanyl patch with even drug crystal distribution Download PDF

Info

Publication number
EP3612170A4
EP3612170A4 EP18788597.5A EP18788597A EP3612170A4 EP 3612170 A4 EP3612170 A4 EP 3612170A4 EP 18788597 A EP18788597 A EP 18788597A EP 3612170 A4 EP3612170 A4 EP 3612170A4
Authority
EP
European Patent Office
Prior art keywords
making
drug crystal
crystal distribution
transdermal fentanyl
fentanyl patch
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Withdrawn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
EP18788597.5A
Other languages
German (de)
French (fr)
Other versions
EP3612170A1 (en
Inventor
Spiros Fotinos
Jerome LANGLUME
Jean Paul CARAVITA
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.)
Inep Europe Sarl
Original Assignee
Inep Europe Sarl
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
Priority claimed from US15/491,419 external-priority patent/US11052054B2/en
Priority claimed from US15/492,146 external-priority patent/US10377114B2/en
Priority claimed from US15/838,977 external-priority patent/US10391065B2/en
Priority claimed from US15/838,837 external-priority patent/US20180303764A1/en
Application filed by Inep Europe Sarl filed Critical Inep Europe Sarl
Publication of EP3612170A1 publication Critical patent/EP3612170A1/en
Publication of EP3612170A4 publication Critical patent/EP3612170A4/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Withdrawn legal-status Critical Current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
    • A61K9/70—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
    • A61K9/7084—Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4468—Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4535—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
    • 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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (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)
EP18788597.5A 2017-04-19 2018-04-10 Method for making a transdermal fentanyl patch with even drug crystal distribution Withdrawn EP3612170A4 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US15/491,419 US11052054B2 (en) 2017-04-19 2017-04-19 Method for manufacturing a transdermal device
US15/492,146 US10377114B2 (en) 2017-04-20 2017-04-20 Method for making a transdermal fentanyl patch with even drug crystal distribution
US15/838,977 US10391065B2 (en) 2017-04-19 2017-12-12 Method for making a transdermal fentanyl patch with even drug crystal distribution
US15/838,837 US20180303764A1 (en) 2017-04-19 2017-12-12 Method for manufacturing a transdermal device
PCT/US2018/026802 WO2018194879A1 (en) 2017-04-19 2018-04-10 Method for making a transdermal fentanyl patch with even drug crystal distribution

Publications (2)

Publication Number Publication Date
EP3612170A1 EP3612170A1 (en) 2020-02-26
EP3612170A4 true EP3612170A4 (en) 2021-01-27

Family

ID=63856066

Family Applications (1)

Application Number Title Priority Date Filing Date
EP18788597.5A Withdrawn EP3612170A4 (en) 2017-04-19 2018-04-10 Method for making a transdermal fentanyl patch with even drug crystal distribution

Country Status (2)

Country Link
EP (1) EP3612170A4 (en)
WO (1) WO2018194879A1 (en)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060078600A1 (en) * 2003-02-07 2006-04-13 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system suitable for heat application for promoting the permeation of active substances, and the use thereof
US20110111013A1 (en) * 2008-04-25 2011-05-12 Acino Ag Transdermal therapeutic system for administration of fentanyl or an analogue thereof
US20120209223A1 (en) * 2009-09-14 2012-08-16 Acino Ag Transdermal therapeutic system for administration of fentanyl or an analog thereof

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6365178B1 (en) * 1996-09-06 2002-04-02 Watson Pharmaceuticals, Inc. Method of making pressure sensitive adhesive matrix patches for transdermal drug delivery using hydrophilic salts of drugs and hydrophobic pressure sensitive adhesive dispersions
WO2001064149A1 (en) * 2000-02-29 2001-09-07 Jie Zhang Improved transdermal drug patch
US20040086551A1 (en) * 2002-10-30 2004-05-06 Miller Kenneth J. Fentanyl suspension-based silicone adhesive formulations and devices for transdermal delivery of fentanyl
AR095259A1 (en) * 2013-03-15 2015-09-30 Noven Pharma COMPOSITIONS AND METHODS FOR THE TRANSDERMAL ADMINISTRATION OF TERTIARY AMINE DRUGS
WO2016149077A2 (en) * 2015-03-13 2016-09-22 Amneal Pharmaceuticals Llc Fentanyl transdermal delivery system

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060078600A1 (en) * 2003-02-07 2006-04-13 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system suitable for heat application for promoting the permeation of active substances, and the use thereof
US20110111013A1 (en) * 2008-04-25 2011-05-12 Acino Ag Transdermal therapeutic system for administration of fentanyl or an analogue thereof
US20120209223A1 (en) * 2009-09-14 2012-08-16 Acino Ag Transdermal therapeutic system for administration of fentanyl or an analog thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2018194879A1 *

Also Published As

Publication number Publication date
EP3612170A1 (en) 2020-02-26
WO2018194879A1 (en) 2018-10-25

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