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1. WO2020142538 - THERAPEUTIC AGENT PREPARATIONS FOR DELIVERY INTO A LUMEN OF THE INTESTINAL TRACT USING A SWALLOWABLE DRUG DELIVERY DEVICE

Publication Number WO/2020/142538
Publication Date 09.07.2020
International Application No. PCT/US2019/069135
International Filing Date 31.12.2019
IPC
A61F 13/00 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
FFILTERS 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
13Bandages or dressings; Absorbent pads
A61K 9/00 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
A61K 9/14 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders
A61K 9/16 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders
16Agglomerates; Granulates; Microbeadlets
A61K 9/20 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, lozenges or tablets
A61K 9/22 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, lozenges or tablets
22Sustained or differential release type
CPC
A61K 2039/505
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
505comprising antibodies
A61K 2039/542
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
54characterised by the route of administration
541Mucosal route
542oral/gastrointestinal
A61K 2039/552
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
55characterised by the host/recipient, e.g. newborn with maternal antibodies
552Veterinary vaccine
A61K 39/395
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
395Antibodies
A61K 9/0024
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
0012Galenical forms characterised by the site of application
0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
A61K 9/0053
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
0012Galenical forms characterised by the site of application
0053Mouth and digestive tract, i.e. intraoral and peroral administration
Applicants
  • INCUBE LABS, LLC [US]/[US]
Inventors
  • IMRAN, Mir
  • KORUPOLU, Radhika
  • BERAKI, Simret
  • TOLEDO, April Lynn
  • HASHIM, Mir
Agents
  • HESLIN, James M.
Priority Data
62/786,83131.12.2018US
62/812,11828.02.2019US
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) THERAPEUTIC AGENT PREPARATIONS FOR DELIVERY INTO A LUMEN OF THE INTESTINAL TRACT USING A SWALLOWABLE DRUG DELIVERY DEVICE
(FR) PRÉPARATIONS D'AGENT THÉRAPEUTIQUE À ADMINISTRER DANS UNE LUMIÈRE DU TRACTUS INTESTINAL AU MOYEN D'UN DISPOSITIF D'ADMINISTRATION DE MÉDICAMENT À AVALER
Abstract
(EN)
Embodiments of the invention provide swallowable devices, preparations and methods for delivering therapeutic agents (TA) within the GI tract. Many embodiments provide a swallowable device such as a capsule for delivering TAs into the intestinal wall (IW) or other GI location. Embodiments also provide various TA preparations such as IgG that are configured to be contained within the capsule, advanced from the capsule into the IW and degrade to release the TA into the bloodstream where they exhibit a selected plasma concentration profile which may have selected pharmacokinetic parameters. The preparation can be operably coupled to a delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the IW. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.
(FR)
La présente invention concerne, dans certains modes de réalisation, des dispositifs à avaler, des préparations et des méthodes pour administrer des agents thérapeutiques (AT) dans le tractus gastro-intestinal. Plusieurs modes de réalisation portent sur un dispositif à avaler tel qu'une capsule pour l'administration de médicaments dans la paroi intestinale ou un autre emplacement du tractus gastro-intestinal. Des modes de réalisation concernent également diverses préparations d'agent thérapeutique (AT) telles que des IgG qui sont configurées pour être contenues à l'intérieur de la capsule, transportées par la capsule dans la paroi intestinale et se dégradent pour libérer le AT dans la circulation sanguine où elles présentent un profil de concentration de plasma sélectionné qui peut avoir des paramètres pharmacocinétiques sélectionnés. La préparation peut être associée de manière fonctionnelle à un moyen d'administration qui a une première configuration dans laquelle la préparation est contenue dans la capsule, et une seconde configuration dans laquelle la préparation est amenée hors de la capsule jusque dans la paroi intestinale. Des modes de réalisation de l'invention sont particulièrement utiles pour l'administration de médicaments qui sont mal absorbés, tolérés et/ou dégradés à l'intérieur du tractus gastro-intestinal.
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