AU2017311698B2 - Formulations for oral administration of active agents - Google Patents

Formulations for oral administration of active agents Download PDF

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Publication number
AU2017311698B2
AU2017311698B2 AU2017311698A AU2017311698A AU2017311698B2 AU 2017311698 B2 AU2017311698 B2 AU 2017311698B2 AU 2017311698 A AU2017311698 A AU 2017311698A AU 2017311698 A AU2017311698 A AU 2017311698A AU 2017311698 B2 AU2017311698 B2 AU 2017311698B2
Authority
AU
Australia
Prior art keywords
unit dosage
dosage forms
active agent
therapeutically active
absorption enhancer
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
AU2017311698A
Other languages
English (en)
Other versions
AU2017311698A1 (en
Inventor
Gregory Burshtein
Hillel GALITZER
Ariel ROTHNER
Phillip M. SCHWARTZ
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.)
Entera Bio Ltd
Original Assignee
Entera Bio Ltd
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 Entera Bio Ltd filed Critical Entera Bio Ltd
Publication of AU2017311698A1 publication Critical patent/AU2017311698A1/en
Priority to AU2024211004A priority Critical patent/AU2024211004A1/en
Application granted granted Critical
Publication of AU2017311698B2 publication Critical patent/AU2017311698B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/29—Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Endocrinology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2017311698A 2016-08-17 2017-08-17 Formulations for oral administration of active agents Active AU2017311698B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2024211004A AU2024211004A1 (en) 2016-08-17 2024-08-20 Formulations for oral administration of active agents

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662375989P 2016-08-17 2016-08-17
US62/375,989 2016-08-17
PCT/IL2017/050920 WO2018033927A1 (en) 2016-08-17 2017-08-17 Formulations for oral administration of active agents

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2024211004A Division AU2024211004A1 (en) 2016-08-17 2024-08-20 Formulations for oral administration of active agents

Publications (2)

Publication Number Publication Date
AU2017311698A1 AU2017311698A1 (en) 2019-04-04
AU2017311698B2 true AU2017311698B2 (en) 2024-09-05

Family

ID=61196521

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2017311698A Active AU2017311698B2 (en) 2016-08-17 2017-08-17 Formulations for oral administration of active agents
AU2024211004A Pending AU2024211004A1 (en) 2016-08-17 2024-08-20 Formulations for oral administration of active agents

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2024211004A Pending AU2024211004A1 (en) 2016-08-17 2024-08-20 Formulations for oral administration of active agents

Country Status (14)

Country Link
US (2) US12239691B2 (enExample)
EP (1) EP3500291A4 (enExample)
JP (4) JP7530173B2 (enExample)
KR (4) KR102832566B1 (enExample)
CN (4) CN116850132A (enExample)
AU (2) AU2017311698B2 (enExample)
BR (1) BR112019003136A2 (enExample)
CA (1) CA3033259A1 (enExample)
IL (3) IL321113A (enExample)
MX (1) MX2019001850A (enExample)
NZ (1) NZ751668A (enExample)
SG (1) SG11201901070YA (enExample)
WO (1) WO2018033927A1 (enExample)
ZA (1) ZA201901370B (enExample)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016128971A1 (en) 2015-02-09 2016-08-18 Entera Bio Ltd. Treatment of bone fractures and defects
IL321113A (en) 2016-08-17 2025-07-01 Entera Bio Ltd Formulations for oral administration of active agents
UY38480A (es) * 2018-11-19 2020-06-30 Receptor Holdings Inc Aminoácidos grasos n-acilados para reducir la variabilidad de absorción en composiciones a base de cannabinoides
TW202143997A (zh) * 2020-03-18 2021-12-01 大陸商四川海思科製藥有限公司 口服藥物組合物
KR20240152916A (ko) * 2022-02-24 2024-10-22 엔테라 바이오 리미티드 부갑상선 호르몬의 경구 투여를 위한 산 중화 중합체를 포함하는 제형
KR20240152915A (ko) * 2022-02-24 2024-10-22 엔테라 바이오 리미티드 활성제의 경구 투여를 위한 산 중화 중합체를 포함하는 제형
WO2023161936A1 (en) * 2022-02-24 2023-08-31 Entera Bio Ltd. Formulations comprising acid-neutralizing polymer for oral administration of growth hormone-releasing hormone
WO2025046589A1 (en) * 2023-08-30 2025-03-06 Entera Bio Ltd. Formulations comprising a combination of acid-neutralizing polymeric and non-polymeric substances for oral administration of active agents

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US20070155664A1 (en) * 2003-07-04 2007-07-05 Nycomed Danmark A/S Parathyroid hormone (pth) containing pharmaceutical compositions for oral use
US8110547B2 (en) * 2005-01-12 2012-02-07 Emisphere Technologies, Inc. Compositions for buccal delivery of parathyroid hormone
WO2006084164A2 (en) * 2005-02-01 2006-08-10 Emisphere Technologies, Inc. Gastric retention and controlled release delivery system
US20150250729A1 (en) * 2005-11-17 2015-09-10 Moise Azria Pharmaceutical composition
WO2007121318A2 (en) * 2006-04-12 2007-10-25 Emisphere Technologies, Inc. Formulations for delivering insulin
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Also Published As

Publication number Publication date
MX2019001850A (es) 2019-05-15
JP2019524836A (ja) 2019-09-05
IL264880B1 (en) 2024-05-01
JP2024054222A (ja) 2024-04-16
EP3500291A4 (en) 2020-03-11
ZA201901370B (en) 2025-07-30
JP2025114692A (ja) 2025-08-05
CN116850132A (zh) 2023-10-10
IL321113A (en) 2025-07-01
NZ751668A (en) 2022-07-29
IL312218B2 (en) 2025-11-01
CN116831978A (zh) 2023-10-03
KR20240093678A (ko) 2024-06-24
JP7530173B2 (ja) 2024-08-07
KR102832566B1 (ko) 2025-07-09
AU2017311698A1 (en) 2019-04-04
AU2024211004A1 (en) 2024-09-05
SG11201901070YA (en) 2019-03-28
JP7736834B2 (ja) 2025-09-09
JP2022126766A (ja) 2022-08-30
BR112019003136A2 (pt) 2019-05-21
US20240415936A1 (en) 2024-12-19
JP7546622B2 (ja) 2024-09-06
KR20230088854A (ko) 2023-06-20
IL264880A (en) 2019-04-30
IL264880B2 (en) 2024-09-01
CA3033259A1 (en) 2018-02-22
IL312218A (en) 2024-06-01
KR20190039768A (ko) 2019-04-15
KR20240134254A (ko) 2024-09-06
CN109862906A (zh) 2019-06-07
KR102832565B1 (ko) 2025-07-09
US20190209657A1 (en) 2019-07-11
EP3500291A1 (en) 2019-06-26
US12239691B2 (en) 2025-03-04
WO2018033927A1 (en) 2018-02-22
CN116831977A (zh) 2023-10-03
IL312218B1 (en) 2025-07-01

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