WO2016081616A3 - Transdermal patch formulations for delivery of water soluble drugs, peptides, proteins and oligosaccharides - Google Patents

Transdermal patch formulations for delivery of water soluble drugs, peptides, proteins and oligosaccharides Download PDF

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Publication number
WO2016081616A3
WO2016081616A3 PCT/US2015/061367 US2015061367W WO2016081616A3 WO 2016081616 A3 WO2016081616 A3 WO 2016081616A3 US 2015061367 W US2015061367 W US 2015061367W WO 2016081616 A3 WO2016081616 A3 WO 2016081616A3
Authority
WO
WIPO (PCT)
Prior art keywords
peptides
proteins
water soluble
oligosaccharides
delivery
Prior art date
Application number
PCT/US2015/061367
Other languages
French (fr)
Other versions
WO2016081616A2 (en
Inventor
David James Enscore
Frank Tagliaferri
Jeffrey C. GAULDING
Alan Smith
Original Assignee
4P Therapeutics
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 4P Therapeutics filed Critical 4P Therapeutics
Publication of WO2016081616A2 publication Critical patent/WO2016081616A2/en
Publication of WO2016081616A3 publication Critical patent/WO2016081616A3/en

Links

Classifications

    • 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
    • A61K9/7084Transdermal 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/727Heparin; Heparan
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/24Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/26Glucagons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/28Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/29Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/22Anxiolytics

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pain & Pain Management (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The present invention relates to patch formulations for the transdermal delivery of water soluble drugs, peptides, proteins and oligosaccharides. The patch formulations are intended for the delivery of water soluble drugs, peptides, proteins and oligosaccharides across a plurality of pre-formed aqueous microchannels in the skin. The patch formulations contain a water soluble drug, peptides, proteins or oligosaccharide dispersed in a non-adhesive biodegradable polymer and are manufactured via film casting of polymer solutions containing dispersed drug, peptide, protein or oligosaccharide onto a suitable backing material. Both rapid release formulations and prolonged release formulations are disclosed.
PCT/US2015/061367 2014-11-18 2015-11-18 Transdermal patch formulations for delivery of water soluble drugs, peptides, proteins and oligosaccharides WO2016081616A2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201462081149P 2014-11-18 2014-11-18
US62/081,149 2014-11-18
US201462086340P 2014-12-02 2014-12-02
US62/086,340 2014-12-02

Publications (2)

Publication Number Publication Date
WO2016081616A2 WO2016081616A2 (en) 2016-05-26
WO2016081616A3 true WO2016081616A3 (en) 2016-08-18

Family

ID=56014678

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2015/061367 WO2016081616A2 (en) 2014-11-18 2015-11-18 Transdermal patch formulations for delivery of water soluble drugs, peptides, proteins and oligosaccharides

Country Status (1)

Country Link
WO (1) WO2016081616A2 (en)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018511355A (en) 2015-01-28 2018-04-26 クロノ セラピューティクス インコーポレイテッドChrono Therapeutics Inc. Drug delivery method and system
US10679516B2 (en) 2015-03-12 2020-06-09 Morningside Venture Investments Limited Craving input and support system
JP2020503950A (en) 2017-01-06 2020-02-06 クロノ セラピューティクス インコーポレイテッドChrono Therapeutics Inc. Device and method for transdermal drug delivery
EP3384904A1 (en) * 2017-04-03 2018-10-10 tesa Labtec GmbH Pharmaceutical preparation for dermal administration
CN108451899B (en) * 2018-04-18 2020-08-14 南京健友生化制药股份有限公司 Production method of fondaparinux sodium injection
AU2019279884A1 (en) 2018-05-29 2020-12-10 Morningside Venture Investments Limited Drug delivery methods and systems
DE102018130469A1 (en) 2018-11-30 2020-06-04 Lts Lohmann Therapie-Systeme Ag Transdermal therapeutic system with diffusion barrier
ES2936735B2 (en) * 2021-09-20 2023-11-29 Paterna Jesus Paterna Device for manually preparing transdermal therapeutic systems and procedure

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5633009A (en) * 1990-11-28 1997-05-27 Sano Corporation Transdermal administration of azapirones
US20040087543A1 (en) * 2002-04-25 2004-05-06 Zachary Shriver Methods and products for mucosal delivery
WO2004039428A2 (en) * 2002-10-31 2004-05-13 Transpharma Medical Ltd. Transdermal delivery system for dried particulate or lyophilized medications
US20050256045A1 (en) * 2004-05-13 2005-11-17 Mahmoud Ameri Apparatus and method for transdermal delivery of parathyroid hormone agents
US20080255034A1 (en) * 2005-10-06 2008-10-16 Pantec Biosolutions Ag Transdermal Delivery System for Treating Infertility
WO2010029552A1 (en) * 2008-09-10 2010-03-18 Transpharma Medical Ltd. Transdermal delivery of oligosaccharides
US20100292183A1 (en) * 2009-05-15 2010-11-18 Shanmugavel Madasamy Tetracycline and uses thereof
WO2011064760A1 (en) * 2009-11-30 2011-06-03 Nokia Corporation Method and apparatus for providing access to social content
US20120264703A1 (en) * 2010-11-30 2012-10-18 Arifulla Khan Methods And Compositions For The Treatment Of Anxiety Disorders, Including Post Traumatic Stress Disorder (PTSD) And Related Central Nervous System (CNS) Disorders.
AU2014202524A1 (en) * 2008-03-31 2014-05-29 Passport Technologies, Inc. Permeant delivery system and methods for use thereof

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5633009A (en) * 1990-11-28 1997-05-27 Sano Corporation Transdermal administration of azapirones
US20040087543A1 (en) * 2002-04-25 2004-05-06 Zachary Shriver Methods and products for mucosal delivery
WO2004039428A2 (en) * 2002-10-31 2004-05-13 Transpharma Medical Ltd. Transdermal delivery system for dried particulate or lyophilized medications
US20060121104A1 (en) * 2002-10-31 2006-06-08 Meir Stern Transdermal delivery system for dried particulate or lyophilized medications
US20050256045A1 (en) * 2004-05-13 2005-11-17 Mahmoud Ameri Apparatus and method for transdermal delivery of parathyroid hormone agents
US20080255034A1 (en) * 2005-10-06 2008-10-16 Pantec Biosolutions Ag Transdermal Delivery System for Treating Infertility
AU2014202524A1 (en) * 2008-03-31 2014-05-29 Passport Technologies, Inc. Permeant delivery system and methods for use thereof
WO2010029552A1 (en) * 2008-09-10 2010-03-18 Transpharma Medical Ltd. Transdermal delivery of oligosaccharides
US20100292183A1 (en) * 2009-05-15 2010-11-18 Shanmugavel Madasamy Tetracycline and uses thereof
WO2011064760A1 (en) * 2009-11-30 2011-06-03 Nokia Corporation Method and apparatus for providing access to social content
US20120264703A1 (en) * 2010-11-30 2012-10-18 Arifulla Khan Methods And Compositions For The Treatment Of Anxiety Disorders, Including Post Traumatic Stress Disorder (PTSD) And Related Central Nervous System (CNS) Disorders.

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
GANNU, R ET AL.: "Enhanced Bioavailability of Buspirone From Reservoir-Based Transdermal Therapeutic System, Optimization of Formulation Employing Box-Behnken Statistical Design.", AAPS PHARMSCI TECH., vol. 11, no. 2;, June 2010 (2010-06-01), pages 985 *
LING, MH ET AL.: "Dissolving polymer microneedle patches for rapid and efficient transdermal delivery of insulin to diabetic rats.", ACTA BIOMATERIALIA., vol. 9, June 2013 (2013-06-01) *
MUIJSERS, RBR ET AL.: "Transdermal Fentanyl.", ADIS DRUG EVALUATION., vol. 61, no. 15;, 2001, pages 2291 *
ZHU, Z ET AL.: "Rapidly Dissolvable Microneedle Patches for Transdermal Delivery of Exenatide.", PHARMACEUTICAL RESEARCH, vol. 31, May 2014 (2014-05-01) *

Also Published As

Publication number Publication date
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