CA2854164C - Dermal delivery compositions and methods - Google Patents

Dermal delivery compositions and methods Download PDF

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Publication number
CA2854164C
CA2854164C CA2854164A CA2854164A CA2854164C CA 2854164 C CA2854164 C CA 2854164C CA 2854164 A CA2854164 A CA 2854164A CA 2854164 A CA2854164 A CA 2854164A CA 2854164 C CA2854164 C CA 2854164C
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CA
Canada
Prior art keywords
composition
progestin
oxidant
bht
psa
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.)
Active
Application number
CA2854164A
Other languages
English (en)
French (fr)
Other versions
CA2854164A1 (en
Inventor
Charles G. ARNOLD
Agis Kydonieus
Thomas M. Rossi
Alfred F. ALTOMARI
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.)
Agile Therapeutics Inc
Original Assignee
Agile Therapeutics Inc
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 Agile Therapeutics Inc filed Critical Agile Therapeutics Inc
Publication of CA2854164A1 publication Critical patent/CA2854164A1/en
Application granted granted Critical
Publication of CA2854164C publication Critical patent/CA2854164C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/567Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703Transdermal 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
    • A61K9/7038Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
    • A61K9/7061Polyacrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703Transdermal 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
    • A61K9/7038Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CA2854164A 2011-11-04 2012-11-02 Dermal delivery compositions and methods Active CA2854164C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201161555546P 2011-11-04 2011-11-04
US61/555,546 2011-11-04
US201261645778P 2012-05-11 2012-05-11
US61/645,778 2012-05-11
PCT/US2012/063314 WO2013067346A1 (en) 2011-11-04 2012-11-02 Dermal delivery compositions and methods

Publications (2)

Publication Number Publication Date
CA2854164A1 CA2854164A1 (en) 2013-05-10
CA2854164C true CA2854164C (en) 2021-04-13

Family

ID=47278507

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2854164A Active CA2854164C (en) 2011-11-04 2012-11-02 Dermal delivery compositions and methods

Country Status (17)

Country Link
US (3) US9364487B2 (enExample)
EP (1) EP2773333B1 (enExample)
JP (1) JP6316749B2 (enExample)
KR (1) KR20140088199A (enExample)
CN (1) CN103957899A (enExample)
AU (1) AU2012332254B2 (enExample)
BR (1) BR112014010670A2 (enExample)
CA (1) CA2854164C (enExample)
EA (1) EA026664B1 (enExample)
ES (1) ES2762460T3 (enExample)
HK (1) HK1200317A1 (enExample)
IL (1) IL232258A0 (enExample)
IN (1) IN2014DN03247A (enExample)
MX (1) MX353713B (enExample)
PH (1) PH12014501000A1 (enExample)
WO (1) WO2013067346A1 (enExample)
ZA (1) ZA201402988B (enExample)

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Publication number Priority date Publication date Assignee Title
US9301920B2 (en) 2012-06-18 2016-04-05 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
RS62297B1 (sr) 2011-11-23 2021-09-30 Therapeuticsmd Inc Prirodne kombinovane hormonske supstitucione formulacije i terapije
US20130338122A1 (en) 2012-06-18 2013-12-19 Therapeuticsmd, Inc. Transdermal hormone replacement therapies
US20150196640A1 (en) 2012-06-18 2015-07-16 Therapeuticsmd, Inc. Progesterone formulations having a desirable pk profile
US10806697B2 (en) 2012-12-21 2020-10-20 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10806740B2 (en) 2012-06-18 2020-10-20 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US11246875B2 (en) 2012-12-21 2022-02-15 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US11266661B2 (en) 2012-12-21 2022-03-08 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10568891B2 (en) 2012-12-21 2020-02-25 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10537581B2 (en) 2012-12-21 2020-01-21 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US9180091B2 (en) 2012-12-21 2015-11-10 Therapeuticsmd, Inc. Soluble estradiol capsule for vaginal insertion
US10471072B2 (en) 2012-12-21 2019-11-12 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
GB2521632B (en) * 2013-12-23 2020-12-16 Linscott Goode Steven Vermin control compositions
JP2017516768A (ja) 2014-05-22 2017-06-22 セラピューティックスエムディー インコーポレーテッドTherapeuticsmd, Inc. 天然の併用ホルモン補充療法剤及び療法
US10098894B2 (en) 2014-07-29 2018-10-16 Therapeuticsmd, Inc. Transdermal cream
US9844558B1 (en) 2015-04-30 2017-12-19 Amag Pharmaceuticals, Inc. Methods of reducing risk of preterm birth
US10328087B2 (en) 2015-07-23 2019-06-25 Therapeuticsmd, Inc. Formulations for solubilizing hormones
US10556922B2 (en) 2015-09-29 2020-02-11 Amag Pharmaceuticals, Inc. Crystalline and amorphous forms of 17-alpha-hydroxyprogesterone caproate
US10286077B2 (en) 2016-04-01 2019-05-14 Therapeuticsmd, Inc. Steroid hormone compositions in medium chain oils
US9931349B2 (en) 2016-04-01 2018-04-03 Therapeuticsmd, Inc. Steroid hormone pharmaceutical composition
TWI857942B (zh) * 2017-10-30 2024-10-11 日商帝國製藥股份有限公司 經皮投與製劑
WO2019088005A1 (ja) * 2017-10-30 2019-05-09 科研製薬株式会社 爪白癬治療用の外用製剤
CA3113399C (en) * 2018-09-19 2023-09-26 Isp Investments Llc Peroxide stable polymer composition and process for its preparation and applications thereof
CN113455506A (zh) * 2021-06-29 2021-10-01 无锡宏霸医疗科技有限公司 一种适用于日化产品的水相除臭去味剂及其制备方法
CN114259498B (zh) * 2021-12-02 2023-04-28 南通联亚药业股份有限公司 一种包含去氧孕烯和炔雌醇的药物组合物及其制备方法和应用

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* Cited by examiner, † Cited by third party
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US5656286A (en) 1988-03-04 1997-08-12 Noven Pharmaceuticals, Inc. Solubility parameter based drug delivery system and method for altering drug saturation concentration
US5554381A (en) * 1993-08-09 1996-09-10 Cygnus, Inc. Low flux matrix system for delivering potent drugs transdermally
FR2739031B1 (fr) * 1995-09-27 1997-11-21 Lhd Lab Hygiene Dietetique Systeme matriciel transdermique d'administration d'un oestrogene et/ou d'un progestatif a base de copolymere styrene-isoprene-styrene, procede de preparation et utilisation en therapeutique
DE19700913C2 (de) * 1997-01-14 2001-01-04 Lohmann Therapie Syst Lts Transdermales therapeutisches System zur Abgabe von Hormonen
IT1294748B1 (it) * 1997-09-17 1999-04-12 Permatec Tech Ag Formulazione per un dispositivo transdermico
GB9720470D0 (en) * 1997-09-25 1997-11-26 Ethical Pharmaceuticals South Inhibition of crystallization in transdermal devices
EP1197212A4 (en) * 1999-07-01 2004-06-02 Hisamitsu Pharmaceutical Co ADHESIVE COMPOSITION FOR PERCUTANE ABSORPTION
US7045145B1 (en) 1999-11-24 2006-05-16 Agile Therapeutics, Inc. Transdermal contraceptive delivery system and process
US7384650B2 (en) * 1999-11-24 2008-06-10 Agile Therapeutics, Inc. Skin permeation enhancement composition for transdermal hormone delivery system
NZ518723A (en) * 1999-11-24 2004-04-30 Agile Therapeutics Inc Improved transdermal contraceptive delivery system and process
ATE479419T1 (de) * 2000-02-17 2010-09-15 Basf Se Wässrige dispersion wasserunlöslicher organischer uv-filtersubstanzen
JP4422430B2 (ja) * 2003-05-14 2010-02-24 帝國製薬株式会社 エストロゲン及び/又はプロゲストゲン含有外用貼付剤
WO2006036899A2 (en) * 2004-09-27 2006-04-06 Corium International, Inc. Transdermal systems for the delivery of estrogens and progestins
US8241664B2 (en) * 2005-04-15 2012-08-14 Clarus Therapeutics, Inc Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
US8663681B2 (en) * 2005-05-26 2014-03-04 Teva Women's Health, Inc. Oral dosage forms comprising progesterone and methods of making and using the same
US10137135B2 (en) * 2005-08-15 2018-11-27 Allergan Sales, Llc Formulations and methods for providing progestin-only contraception while minimizing adverse side effects associated therewith
DE102006050558B4 (de) * 2006-10-26 2009-03-26 Lts Lohmann Therapie-Systeme Ag Transdermales therapeutisches System enthaltend Norelgestromin zur Kontrazeption und Hormonsubstitution
AU2007325207A1 (en) * 2006-11-29 2008-06-05 Wyeth Estrogen/ serm and estrogen/ progestin bi-layer tablets
US20100292660A1 (en) 2007-07-10 2010-11-18 Agis Kydonieus Dermal delivery device with ultrasonic weld
US20100178323A1 (en) 2007-07-10 2010-07-15 Agis Kydonieus Dermal Delivery Device
BRPI0814697B8 (pt) 2007-07-10 2021-05-25 Agile Therapeutics Inc dispositivo de liberação de fármacos
US20090285893A1 (en) * 2008-05-19 2009-11-19 The Procter & Gamble Company Treatment of heart failure in women
EP2410859A4 (en) * 2009-03-27 2013-03-13 Agile Therapeutics Inc TRANSDERMAL ADMINISTRATION

Also Published As

Publication number Publication date
CA2854164A1 (en) 2013-05-10
US9364487B2 (en) 2016-06-14
US20130116222A1 (en) 2013-05-09
HK1200317A1 (en) 2015-08-07
CN103957899A (zh) 2014-07-30
EA026664B1 (ru) 2017-05-31
MX353713B (es) 2018-01-24
IL232258A0 (en) 2014-06-30
US20160250226A1 (en) 2016-09-01
BR112014010670A2 (pt) 2017-05-09
WO2013067346A1 (en) 2013-05-10
US20180325916A1 (en) 2018-11-15
JP6316749B2 (ja) 2018-04-25
EP2773333A1 (en) 2014-09-10
MX2014005294A (es) 2014-09-22
ES2762460T3 (es) 2020-05-25
AU2012332254B2 (en) 2017-06-22
NZ624117A (en) 2016-02-26
AU2012332254A1 (en) 2014-05-15
JP2014532719A (ja) 2014-12-08
PH12014501000A1 (en) 2014-06-09
HK1201152A1 (en) 2015-08-28
ZA201402988B (en) 2015-11-25
EA201400543A1 (ru) 2014-09-30
IN2014DN03247A (enExample) 2015-05-22
EP2773333B1 (en) 2019-10-02
KR20140088199A (ko) 2014-07-09

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Effective date: 20171101