US20200268681A1 - Modular transdermal delivery system and associated methods of manufacture and use - Google Patents

Modular transdermal delivery system and associated methods of manufacture and use Download PDF

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Publication number
US20200268681A1
US20200268681A1 US16/063,812 US201716063812A US2020268681A1 US 20200268681 A1 US20200268681 A1 US 20200268681A1 US 201716063812 A US201716063812 A US 201716063812A US 2020268681 A1 US2020268681 A1 US 2020268681A1
Authority
US
United States
Prior art keywords
layer
skin
drug reservoir
adhesive layer
active agent
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.)
Abandoned
Application number
US16/063,812
Other languages
English (en)
Inventor
Frank Kochinke
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.)
International Bioceutical Company LLC
Pure Ratios Holding Inc
Original Assignee
International Bioceutical Co LLC
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 International Bioceutical Co LLC filed Critical International Bioceutical Co LLC
Priority to US16/063,812 priority Critical patent/US20200268681A1/en
Assigned to PURE RATIOS HOLDING, INC reassignment PURE RATIOS HOLDING, INC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: INTERNATIONAL BIOCEUTICAL COMPANY, LLC
Assigned to INTERNATIONAL BIOCEUTICAL COMPANY, LLC reassignment INTERNATIONAL BIOCEUTICAL COMPANY, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: KOCHINKE, FRANK
Priority to US16/591,548 priority patent/US11052055B2/en
Assigned to GOTHAM GREEN ADMIN 1, LLC reassignment GOTHAM GREEN ADMIN 1, LLC SECURITY INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: Pure Ratios Holdings Inc.
Publication of US20200268681A1 publication Critical patent/US20200268681A1/en
Assigned to Pure Ratios Holdings Inc. reassignment Pure Ratios Holdings Inc. RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS). Assignors: GOTHAM GREEN ADMIN 1, LLC
Assigned to LI LENDING, LLC reassignment LI LENDING, LLC SECURITY INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PURE RATIOS HOLDING INC.
Abandoned legal-status Critical Current

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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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0276—Apparatus or processes for manufacturing adhesive dressings or bandages
    • A61F13/0279—Apparatus or processes for manufacturing adhesive dressings or bandages by attaching individual patches on moving webs
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01021—Non-adhesive bandages or dressings characterised by the structure of the dressing
    • A61F13/01029—Non-adhesive bandages or dressings characterised by the structure of the dressing made of multiple layers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0276—Apparatus or processes for manufacturing adhesive dressings or bandages
    • A61F2013/0296—Apparatus or processes for manufacturing adhesive dressings or bandages for making transdermal patches (chemical processes excluded)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/123—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated reservoirs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00—Ancillary equipment
    • A61M2209/08—Supports for equipment
    • A61M2209/088—Supports for equipment on the body

Definitions

  • post-manufacture personnel nodes, physicians, other hospital personnel, the user
  • post-manufacture options with respect to active agent, dosage, release rate, and delivery period
  • the modular transdermal delivery system includes the following elements:
  • the active agent may be administered, if desired, in the form of a salt, ester, amide, prodrug, conjugate, active metabolite, hydrate, crystalline form, enantiomer, stereoisomer, or the like, provided that the salt, ester, amide, etc. is suitable pharmacologically and/or can be converted into a pharmacologically suitable form within the transdermal system itself.
  • this may be accomplished by incorporating an activator compound or composition in the upper module, generally in the PSA layer, where that activator is selected to convert a drug precursor in the drug reservoir to a pharmacologically active form prior to release from the system and delivery into the body surface.
  • Anti-convulsant agents Azetazolamide, carbamazepine, clonazepam, clorazepate, ethosuximide, ethotoin, felbamate, lamotrigine, mephenyloin, mephobarbital, phenyloin, phenobarbital, primidone, trimethadione, vigabatrin, topiramate, and benzodiazepines.
  • CNS and respiratory stimulants Xanthines such as caffeine and theophylline; amphetamines such as amphetamine, benzphetamine, dextroamphetamine, levamphetamine, and methamphetamine; and miscellaneous stimulants such as methylphenidate, modafinil, pemoline, and sibutramine
  • Topical anti-acne agents include keratolytics such as salicylic acid, retinoic acid (“Retin-A”), and organic peroxides
  • topical antifungal agents include amphotericin B, benzoic acid, butoconazole, caprylic acid, econazole, fluconazole, itraconazole, ketoconazole, miconazole, nystatin, salicylic acid, and terconazole
  • topical antipsoriatic agents include anthralin, azathioprine, calcipotriene, calcitriol, coichicine, cyclosporine, retinoids, and vitamin A.
  • Lower module A letter-sized release liner film of choice is taped to a glass plate for easier handling
  • the desired adhesive solution is poured at the one end of the releaser liner film.
  • a coating bar of given gap height is used to even spread the adhesive solution over the backing material.
  • the coated release liner is placed into a vacuum oven overnight for removal of all solvents. Should one of the compounds loaded into the adhesive also evaporate, vacuum and temperature have to be adjusted accordingly.
  • An overage in the casting solution can be used to result in the desired compound loading in the dry adhesive.
  • the adhesive is dry and/or cured the microporous film is laminated to the adhesive. The laminate is stored for future usage.
  • the final dried films are shown in the photographs of FIG. 2 .
  • Typical and standard processes may be used, for example knife over roll coating, drying of adhesive in oven, with or without in-line cutting.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Medical Informatics (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
US16/063,812 2016-12-29 2017-12-29 Modular transdermal delivery system and associated methods of manufacture and use Abandoned US20200268681A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US16/063,812 US20200268681A1 (en) 2016-12-29 2017-12-29 Modular transdermal delivery system and associated methods of manufacture and use
US16/591,548 US11052055B2 (en) 2016-12-29 2019-10-02 Modular transdermal delivery system and associated methods of manufacture and use

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662440149P 2016-12-29 2016-12-29
US16/063,812 US20200268681A1 (en) 2016-12-29 2017-12-29 Modular transdermal delivery system and associated methods of manufacture and use
PCT/US2017/069125 WO2018126225A1 (en) 2016-12-29 2017-12-29 Modular transdermal delivery system and associated methods of manufacture and use

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2017/069125 A-371-Of-International WO2018126225A1 (en) 2016-12-29 2017-12-29 Modular transdermal delivery system and associated methods of manufacture and use

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US16/013,856 Continuation US20180296498A1 (en) 2016-12-29 2018-06-20 Modular transdermal delivery system and associated methods of manufacture and use

Publications (1)

Publication Number Publication Date
US20200268681A1 true US20200268681A1 (en) 2020-08-27

Family

ID=62710981

Family Applications (3)

Application Number Title Priority Date Filing Date
US16/063,812 Abandoned US20200268681A1 (en) 2016-12-29 2017-12-29 Modular transdermal delivery system and associated methods of manufacture and use
US16/013,856 Abandoned US20180296498A1 (en) 2016-12-29 2018-06-20 Modular transdermal delivery system and associated methods of manufacture and use
US16/591,548 Active US11052055B2 (en) 2016-12-29 2019-10-02 Modular transdermal delivery system and associated methods of manufacture and use

Family Applications After (2)

Application Number Title Priority Date Filing Date
US16/013,856 Abandoned US20180296498A1 (en) 2016-12-29 2018-06-20 Modular transdermal delivery system and associated methods of manufacture and use
US16/591,548 Active US11052055B2 (en) 2016-12-29 2019-10-02 Modular transdermal delivery system and associated methods of manufacture and use

Country Status (8)

Country Link
US (3) US20200268681A1 (ja)
EP (1) EP3573604A4 (ja)
JP (1) JP2020518325A (ja)
KR (1) KR20190122205A (ja)
CN (1) CN110475548A (ja)
AU (1) AU2017387141A1 (ja)
CA (1) CA3048897A1 (ja)
WO (1) WO2018126225A1 (ja)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024035832A1 (en) * 2022-08-10 2024-02-15 Annadurai Dharmarajan Topical product hands-free applicator drug delivery system and methods of making and using the same

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* Cited by examiner, † Cited by third party
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WO2020092990A1 (en) * 2018-11-02 2020-05-07 Eastern Virginia Medical School Pharmaceutical compositions and methods of making a patch formulation for transdermal delivery
EP4313007A1 (en) * 2021-03-31 2024-02-07 Lyfe CHNG, LLC Transdermal system, formulation, and method for the therapeutic administration of a psychedelic agent

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Also Published As

Publication number Publication date
EP3573604A1 (en) 2019-12-04
KR20190122205A (ko) 2019-10-29
EP3573604A4 (en) 2020-07-22
JP2020518325A (ja) 2020-06-25
US11052055B2 (en) 2021-07-06
CN110475548A (zh) 2019-11-19
WO2018126225A1 (en) 2018-07-05
AU2017387141A1 (en) 2019-07-18
US20200146998A1 (en) 2020-05-14
CA3048897A1 (en) 2018-07-05
US20180296498A1 (en) 2018-10-18

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