EP3706792A1 - Système de microaiguilles pour l'application d'un vaccin contre l'hépatite - Google Patents

Système de microaiguilles pour l'application d'un vaccin contre l'hépatite

Info

Publication number
EP3706792A1
EP3706792A1 EP18811721.2A EP18811721A EP3706792A1 EP 3706792 A1 EP3706792 A1 EP 3706792A1 EP 18811721 A EP18811721 A EP 18811721A EP 3706792 A1 EP3706792 A1 EP 3706792A1
Authority
EP
European Patent Office
Prior art keywords
formulation
hbsag
microneedle array
polyvinylpyrrolidone
microneedle
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.)
Pending
Application number
EP18811721.2A
Other languages
German (de)
English (en)
Inventor
Andreas Henning
Heiko Spilgies
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.)
LTS Lohmann Therapie Systeme AG
Original Assignee
LTS Lohmann Therapie Systeme AG
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 LTS Lohmann Therapie Systeme AG filed Critical LTS Lohmann Therapie Systeme AG
Publication of EP3706792A1 publication Critical patent/EP3706792A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/29—Hepatitis virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • A61K39/29—Hepatitis virus
    • A61K39/292—Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • 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
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023—Drug applicators using microneedles
    • 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
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/30—Vaccines
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2730/00—Reverse transcribing DNA viruses
    • C12N2730/00011—Details
    • C12N2730/10011—Hepadnaviridae
    • C12N2730/10111—Orthohepadnavirus, e.g. hepatitis B virus
    • C12N2730/10134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

Definitions

  • the skin consists of several layers.
  • the outermost skin layer, the stratum corneum, has known barrier properties to prevent intrusion
  • Microneedle systems as well as their manufacture are described in the prior art and are also described as micro (needle) array patches (MAP, "Micro Array Patch”).
  • the microneedle system may, in a preferred embodiment, comprise an applicator, such as a triggering device, which is controlled electrically or mechanically.
  • the applicator can, for example, have a piston which seals the
  • (Wider-) hooks may be formed, wherein one or more of these microneedles has one or more such hooks. Furthermore, the microneedles
  • the following are preferred in a formulation for making the microneedles besides PVP consisting of or comprising: disaccharide, preferably trehalose, nonionic surfactants, preferably polysorbate (ethoxylated sorbitan fatty acid esters such as Tween), polyalcohol, especially glycerol (glycerol ).
  • disaccharide preferably trehalose
  • nonionic surfactants preferably polysorbate (ethoxylated sorbitan fatty acid esters such as Tween), polyalcohol, especially glycerol (glycerol ).
  • the liquid formulation e.g. to a microneedle array (MNA) with 1-20% (m / m) residual water content, followed by a correspondingly changed by the loss of water composition of the MNA.
  • MNA microneedle array
  • Adjuvants can get along, see Figure 1.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Biotechnology (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medical Informatics (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne un système de microaiguilles (en abrégé MNS) utilisé pour l'application intradermique d'un vaccin contre l'hépatite et plus précisément l'antigène HBsAg.
EP18811721.2A 2017-11-10 2018-11-12 Système de microaiguilles pour l'application d'un vaccin contre l'hépatite Pending EP3706792A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102017126501.5A DE102017126501A1 (de) 2017-11-10 2017-11-10 Mikronadelsystem zur Applikation eines Hepatitis-Impfstoffes
PCT/EP2018/080986 WO2019092257A1 (fr) 2017-11-10 2018-11-12 Système de microaiguilles pour l'application d'un vaccin contre l'hépatite

Publications (1)

Publication Number Publication Date
EP3706792A1 true EP3706792A1 (fr) 2020-09-16

Family

ID=64564815

Family Applications (1)

Application Number Title Priority Date Filing Date
EP18811721.2A Pending EP3706792A1 (fr) 2017-11-10 2018-11-12 Système de microaiguilles pour l'application d'un vaccin contre l'hépatite

Country Status (11)

Country Link
US (1) US20210369839A1 (fr)
EP (1) EP3706792A1 (fr)
JP (2) JP2021502353A (fr)
KR (1) KR20200087187A (fr)
CN (1) CN111315410A (fr)
AU (1) AU2018365396A1 (fr)
BR (1) BR112020007980A2 (fr)
CA (1) CA3082197A1 (fr)
DE (1) DE102017126501A1 (fr)
MX (1) MX2020004868A (fr)
WO (1) WO2019092257A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102021118997A1 (de) 2021-07-22 2023-01-26 Lts Lohmann Therapie-Systeme Ag. Mikronadelarray mit Antiseptika

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6595947B1 (en) 2000-05-22 2003-07-22 Becton, Dickinson And Company Topical delivery of vaccines
US6589202B1 (en) * 2000-06-29 2003-07-08 Becton Dickinson And Company Method and apparatus for transdermally sampling or administering a substance to a patient
GB0017999D0 (en) 2000-07-21 2000-09-13 Smithkline Beecham Biolog Novel device
DK1335711T3 (da) 2000-09-08 2007-11-26 Alza Corp Transdermal indretning
DE10353629A1 (de) 2003-11-17 2005-06-16 Lts Lohmann Therapie-Systeme Ag Vorrichtung zur transdermalen Verabreichung von Wirkstoffen
EP2121111B1 (fr) * 2007-01-22 2018-03-14 Corium International, Inc. Applicateurs pour micro-aiguilles
AU2011258288B2 (en) * 2010-05-28 2015-02-12 Kindeva Drug Delivery L.P. Aqueous formulations for coating microneedle arrays
JP5808102B2 (ja) * 2010-07-22 2015-11-10 コスメディ製薬株式会社 抗原を含有する経皮免疫製剤およびその製造方法
WO2013151044A1 (fr) * 2012-04-05 2013-10-10 久光製薬株式会社 Dispositif de ponction et son procédé de fabrication
CN105311000B (zh) * 2014-06-27 2019-03-05 中科微针（北京）科技有限公司 自溶性微针透皮贴片及其制备方法
US10792042B2 (en) * 2015-01-15 2020-10-06 Ethicon, Inc. Circular staplers having resorbable microneedles containing active agents
JP2017051312A (ja) * 2015-09-08 2017-03-16 富士フイルム株式会社 マイクロニードルアレイ
EP3412312B1 (fr) * 2016-02-03 2021-08-25 Cosmed Pharmaceutical Co., Ltd. Liquide de revêtement pour micro-aiguilles, substance de revêtement de micro-aiguille et ensemble de micro-aiguilles

Also Published As

Publication number Publication date
MX2020004868A (es) 2020-08-13
DE102017126501A1 (de) 2019-05-16
AU2018365396A1 (en) 2020-05-14
RU2020116222A3 (fr) 2022-03-23
JP2021502353A (ja) 2021-01-28
CA3082197A1 (fr) 2019-05-16
CN111315410A (zh) 2020-06-19
BR112020007980A2 (pt) 2020-10-20
WO2019092257A1 (fr) 2019-05-16
KR20200087187A (ko) 2020-07-20
US20210369839A1 (en) 2021-12-02
JP2023169415A (ja) 2023-11-29
RU2020116222A (ru) 2021-11-18

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