CA3033259A1 - Formulations for oral administration of active agents - Google Patents

Formulations for oral administration of active agents Download PDF

Info

Publication number
CA3033259A1
CA3033259A1 CA3033259A CA3033259A CA3033259A1 CA 3033259 A1 CA3033259 A1 CA 3033259A1 CA 3033259 A CA3033259 A CA 3033259A CA 3033259 A CA3033259 A CA 3033259A CA 3033259 A1 CA3033259 A1 CA 3033259A1
Authority
CA
Canada
Prior art keywords
unit dosage
dosage form
active agent
therapeutically active
dosage forms
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
CA3033259A
Other languages
English (en)
French (fr)
Inventor
Gregory Burshtein
Ariel ROTHNER
Phillip M. SCHWARTZ
Hillel GALITZER
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 CA3033259A1 publication Critical patent/CA3033259A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/2004—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
    • 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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Endocrinology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Physiology (AREA)
  • Nutrition Science (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)
CA3033259A 2016-08-17 2017-08-17 Formulations for oral administration of active agents Pending CA3033259A1 (en)

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

Publications (1)

Publication Number Publication Date
CA3033259A1 true CA3033259A1 (en) 2018-02-22

Family

ID=61196521

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3033259A Pending CA3033259A1 (en) 2016-08-17 2017-08-17 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) KR20230088854A (enExample)
CN (4) CN109862906A (enExample)
AU (2) AU2017311698B2 (enExample)
BR (1) BR112019003136A2 (enExample)
CA (1) CA3033259A1 (enExample)
IL (3) IL264880B2 (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
CN114949185A (zh) 2015-02-09 2022-08-30 安特拉贝欧有限公司 骨质疏松症的治疗
JP7530173B2 (ja) 2016-08-17 2024-08-07 エンテラ バイオ エルティーディー． 活性薬剤の経口投与のための製剤
AU2019385420A1 (en) * 2018-11-19 2021-07-08 Spoke Sciences, Inc. N-acylated fatty amino acids to reduce absorption variability in cannabinoid based compositions
EP4122483B1 (en) * 2020-03-18 2025-04-30 Xizang Haisco Pharmaceutical Co., Ltd. Oral pharmaceutical composition
IL315198A (en) * 2022-02-24 2024-10-01 Entera Bio Ltd Formulations comprising acid-neutralizing polymer for oral administration of active agents
WO2023161936A1 (en) * 2022-02-24 2023-08-31 Entera Bio Ltd. Formulations comprising acid-neutralizing polymer for oral administration of growth hormone-releasing hormone
EP4482515A4 (en) * 2022-02-24 2025-12-31 Entera Bio Ltd FORMULATIONS COMPRISING AN ACID-NEUTRALIZING POLYMER FOR ORAL ADMINISTRATION OF PARATHYROID 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

Family Cites Families (57)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5360793A (en) 1993-05-24 1994-11-01 Sterling Winthrop Inc. Rafting antacid formulation
US6984728B2 (en) 1993-09-24 2006-01-10 Schering Corporation Recombinant infectious laryngotracheitis virus and uses thereof
CN1162917A (zh) 1994-10-07 1997-10-22 伯温德药品服务公司 肠内涂层组合物，用其涂覆的方法和涂覆制品
US5650386A (en) 1995-03-31 1997-07-22 Emisphere Technologies, Inc. Compositions for oral delivery of active agents
CA2220301C (en) 1995-06-02 2006-02-21 Alza Corporation Osmotic device with delayed activation of drug delivery and complete drug release
JP3880093B2 (ja) 1995-08-08 2007-02-14 エーザイ・アール・アンド・ディー・マネジメント株式会社 錠剤
JP3220373B2 (ja) 1995-11-28 2001-10-22 バイエル薬品株式会社 持続性ニフエジピン製剤
IT1282650B1 (it) 1996-02-19 1998-03-31 Jagotec Ag Compressa farmaceutica,caratterizzata da elevato aumento di volume a contatto con liquidi biologici
EP0943336A1 (en) 1996-09-04 1999-09-22 Dott Research Laboratory Peptide-containing pharmaceutical compositions for oral administration
US6531152B1 (en) 1998-09-30 2003-03-11 Dexcel Pharma Technologies Ltd. Immediate release gastrointestinal drug delivery system
AU3240900A (en) 1999-02-22 2000-09-04 Emisphere Holdings, Inc. Solid oral dosage form containing heparin or a heparinoid in combination with a carrier
WO2000050386A1 (en) 1999-02-26 2000-08-31 Emisphere Technologies, Inc. Compounds and compositions for delivering active agents
ATE288415T1 (de) 1999-04-05 2005-02-15 Emisphere Tech Inc Dinatrium-salze, monohydrate und ethanol-solvate
US6632451B2 (en) 1999-06-04 2003-10-14 Dexcel Pharma Technologies Ltd. Delayed total release two pulse gastrointestinal drug delivery system
MXPA02004092A (es) 1999-11-05 2003-02-12 Emisphere Tech Inc Compuestos y composiciones de acido fenilaminocarboxilico para administrar agentes activos.
WO2001034114A1 (en) 1999-11-12 2001-05-17 Emisphere Technologies, Inc. Liquid heparin formulation
ATE443527T1 (de) 2001-08-17 2009-10-15 Novartis Pharma Gmbh 5-cnac zur oralen verabreichung von parathormonfragmenten
US7297794B2 (en) 2001-11-13 2007-11-20 Emisphere Technologies, Inc. Phenoxy amine compounds and compositions for delivering active agents
JP5196701B2 (ja) 2001-11-29 2013-05-15 エミスフィアー テクノロジーズ インコーポレイテッド クロモリンナトリウムの経口投与用製剤
AU2002354497A1 (en) * 2001-12-19 2003-06-30 Sanwa Kagaku Kenkyusho Co., Ltd Release control type formed product
US20030198666A1 (en) 2002-01-07 2003-10-23 Richat Abbas Oral insulin therapy
US20050054557A1 (en) 2002-05-09 2005-03-10 Goldberg Michael M. Compositions for delivering parathyroid hormone and calcitonin
PE20040724A1 (es) 2002-08-01 2004-12-06 Novartis Ag Composicion para la administracion oral de calcitonina
WO2005002549A1 (en) * 2003-07-04 2005-01-13 Nycomed Danmark Aps Parathyroid hormone (pth) containing pharmaceutical compositions for oral use
JP2005281231A (ja) 2004-03-30 2005-10-13 Bioserentack Co Ltd 小腸ターゲットタイプの経口ｄｄｓ製剤
US20060052306A1 (en) 2004-05-10 2006-03-09 Nastech Pharmaceutical Company Inc. GRAS composition for enhanced mucosal delivery of parathyroid hormone
US20060078623A1 (en) 2004-08-13 2006-04-13 Emisphere Technologies, Inc. Pharmaceutical formulations containing microparticles or nanoparticles of a delivery agent
JP2006111558A (ja) 2004-10-14 2006-04-27 Bioserentack Co Ltd 多層構造を有する錠剤状の小腸粘膜付着性経口製剤
MX2007005991A (es) * 2004-11-19 2007-07-20 Smithkline Beecham Corp Producto farmaceutico.
WO2006076692A1 (en) 2005-01-12 2006-07-20 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
US8673352B2 (en) 2005-04-15 2014-03-18 Mcneil-Ppc, Inc. Modified release dosage form
JP5123471B2 (ja) 2005-08-18 2013-01-23 帝人ファーマ株式会社 用量調整が容易な製剤
JP5222727B2 (ja) 2005-09-06 2013-06-26 オーラメッド・ファーマスーティカルズ・インコーポレイテッド タンパク質を経口投与するための方法及び組成物
US7629331B2 (en) 2005-10-26 2009-12-08 Cydex Pharmaceuticals, Inc. Sulfoalkyl ether cyclodextrin compositions and methods of preparation thereof
WO2007061829A2 (en) 2005-11-17 2007-05-31 Novartis Ag Pharmaceutical composition
US20070178155A1 (en) 2006-01-31 2007-08-02 Jiang David Yihai Preparation for gastric buoyant sustained drug release dosage form
US7704977B2 (en) * 2006-04-07 2010-04-27 Merrion Research Iii Limited Solid oral dosage form containing an enhancer
US8927015B2 (en) * 2006-04-12 2015-01-06 Emisphere Technologies, Inc. Formulations for delivering insulin
ES2538254T3 (es) 2006-04-18 2015-06-18 Emisphere Technologies, Inc. Agentes de administración de dialquil éter
WO2008122966A2 (en) * 2007-04-04 2008-10-16 Sigmoid Pharma Limited A pharmaceutical composition of tacrolimus
WO2008132727A2 (en) 2007-04-26 2008-11-06 Technion Research And Development Foundation Ltd Oral delivery of proteins and peptides
EP2200592A2 (en) 2007-09-11 2010-06-30 Orahealth Corporation Adhering troches with topically active ingredients for treatment of throat, esophagus, and stomach
WO2009080764A2 (en) 2007-12-20 2009-07-02 Abylnx N.V. Oral or nasal administration of compounds comprising amino acid sequences
IT1393244B1 (it) 2008-07-18 2012-04-12 Universita' Degli Studi Di Milano Sistema per il rilascio al colon di farmaci suscettibili di degradazione enzimatica e/o scarsamente assorbiti nel tratto gastrointestinale
CA2734442C (en) 2008-08-18 2016-08-16 Oramed Ltd Methods and compositions for oral administration of proteins
US20110182985A1 (en) * 2010-01-28 2011-07-28 Coughlan David C Solid Pharmaceutical Composition with Enhancers and Methods of Preparing thereof
MX2012012050A (es) 2010-04-16 2012-11-22 Novartis Ag Metodos y composiciones para mejorar la oseointegracion de implantes.
HUE036066T2 (hu) 2010-12-16 2018-06-28 Novo Nordisk As GLP-1 agonistát és N-(8-(2-hidroxibenzoil)amino)kaprilsav sóját tartalmazó szilárd készítmények
EP2747563A4 (en) 2011-08-26 2015-06-24 Aegis Therapeutics Llc COMPOSITIONS AND METHODS FOR ORAL ADMINISTRATION OF MEDICINAL PRODUCTS
WO2013067309A1 (en) 2011-11-04 2013-05-10 Xion Pharmaceutical Corporation Methods and compositions for oral administration of melanocortin receptor agonist compounds
WO2013189988A1 (en) * 2012-06-20 2013-12-27 Novo Nordisk A/S Tablet formulation comprising a peptide and a delivery agent
US9803731B2 (en) 2014-04-24 2017-10-31 American Axle & Manufacturing, Inc. Actuator device having cam and follower and controller configured to employ rate-based methodology to identify positioning of follower on cam at predetermined location
EP2975118B1 (en) 2014-07-16 2016-08-24 Johann Wolfgang Goethe-Universität, Frankfurt am Main Generation of a mesenchymal stromal cell bank from the pooled mononuclear cells of multiple bone marrow donors
CN114949185A (zh) 2015-02-09 2022-08-30 安特拉贝欧有限公司 骨质疏松症的治疗
JP7530173B2 (ja) 2016-08-17 2024-08-07 エンテラ バイオ エルティーディー． 活性薬剤の経口投与のための製剤
JP7419862B2 (ja) 2020-02-14 2024-01-23 株式会社リコー 潤滑剤供給装置、プロセスカートリッジ、及び、画像形成装置

Also Published As

Publication number Publication date
CN116831977A (zh) 2023-10-03
CN116850132A (zh) 2023-10-10
JP2025114692A (ja) 2025-08-05
US20240415936A1 (en) 2024-12-19
JP7530173B2 (ja) 2024-08-07
AU2017311698A1 (en) 2019-04-04
CN109862906A (zh) 2019-06-07
CN116831978A (zh) 2023-10-03
KR20230088854A (ko) 2023-06-20
ZA201901370B (en) 2025-07-30
JP2024054222A (ja) 2024-04-16
US20190209657A1 (en) 2019-07-11
IL264880B1 (en) 2024-05-01
IL312218B1 (en) 2025-07-01
EP3500291A1 (en) 2019-06-26
AU2024211004A1 (en) 2024-09-05
US12239691B2 (en) 2025-03-04
KR20240093678A (ko) 2024-06-24
JP2022126766A (ja) 2022-08-30
KR102832566B1 (ko) 2025-07-09
IL321113A (en) 2025-07-01
AU2017311698B2 (en) 2024-09-05
JP2019524836A (ja) 2019-09-05
IL312218A (en) 2024-06-01
SG11201901070YA (en) 2019-03-28
IL264880B2 (en) 2024-09-01
KR20190039768A (ko) 2019-04-15
IL312218B2 (en) 2025-11-01
MX2019001850A (es) 2019-05-15
WO2018033927A1 (en) 2018-02-22
JP7546622B2 (ja) 2024-09-06
KR20240134254A (ko) 2024-09-06
IL264880A (en) 2019-04-30
EP3500291A4 (en) 2020-03-11
KR102832565B1 (ko) 2025-07-09
NZ751668A (en) 2022-07-29
JP7736834B2 (ja) 2025-09-09
BR112019003136A2 (pt) 2019-05-21

Similar Documents

Publication Publication Date Title
US20240398904A1 (en) Formulations for oral administration of active agents
US20240415936A1 (en) Formulations for oral administration of active agents
IL312219A (en) DSG2 preparations and methods
IL315201A (en) Formulations comprising acid-neutralizing polymer for oral administration of parathyroid hormone
CA3011657C (en) Formulations for oral administration of active agents
BR122024010024A2 (pt) Forma de dosagem multiunitária de composição farmacêutica, uso de uma forma de dosagem multiunitária de composição farmacêutica, uso de uma forma de dosagem unitária de composição farmacêutica, forma de dosagem multiunitária, e, kit

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20220809

EEER Examination request

Effective date: 20220809

EEER Examination request

Effective date: 20220809

EEER Examination request

Effective date: 20220809