CA2904327C - Pharmaceuticals for oral delivery - Google Patents

Pharmaceuticals for oral delivery Download PDF

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Publication number
CA2904327C
CA2904327C CA2904327A CA2904327A CA2904327C CA 2904327 C CA2904327 C CA 2904327C CA 2904327 A CA2904327 A CA 2904327A CA 2904327 A CA2904327 A CA 2904327A CA 2904327 C CA2904327 C CA 2904327C
Authority
CA
Canada
Prior art keywords
dosage form
compound
citric acid
oral dosage
solid oral
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
CA2904327A
Other languages
English (en)
French (fr)
Other versions
CA2904327A1 (en
Inventor
Stephen M. Carl
John Stanley Vrettos
William Stern
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.)
Enteris Biopharma Inc
Original Assignee
Enteris Biopharma Inc
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 Enteris Biopharma Inc filed Critical Enteris Biopharma Inc
Publication of CA2904327A1 publication Critical patent/CA2904327A1/en
Application granted granted Critical
Publication of CA2904327C publication Critical patent/CA2904327C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • 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
    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/351—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom not condensed with another ring
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
    • 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
    • A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
    • 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
    • A61K31/65—Tetracyclines
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7012—Compounds having a free or esterified carboxyl group attached, directly or through a carbon chain, to a carbon atom of the saccharide radical, e.g. glucuronic acid, neuraminic acid
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/7036—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61P31/04—Antibacterial agents
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Emergency Medicine (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Dermatology (AREA)
  • Virology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CA2904327A 2013-03-05 2014-03-05 Pharmaceuticals for oral delivery Active CA2904327C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201361772927P 2013-03-05 2013-03-05
US61/772,927 2013-03-05
US201461925443P 2014-01-09 2014-01-09
US61/925,443 2014-01-09
PCT/US2014/020763 WO2014138241A1 (en) 2013-03-05 2014-03-05 Pharmaceuticals for oral delivery

Publications (2)

Publication Number Publication Date
CA2904327A1 CA2904327A1 (en) 2014-09-12
CA2904327C true CA2904327C (en) 2021-06-08

Family

ID=50391422

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2904327A Active CA2904327C (en) 2013-03-05 2014-03-05 Pharmaceuticals for oral delivery

Country Status (10)

Country Link
US (4) US9457086B2 (enExample)
EP (1) EP2964193B1 (enExample)
JP (1) JP6375314B2 (enExample)
CN (1) CN105101950B (enExample)
AU (3) AU2014225822B2 (enExample)
CA (1) CA2904327C (enExample)
DK (1) DK2964193T3 (enExample)
ES (1) ES2774962T3 (enExample)
IL (1) IL240666A0 (enExample)
WO (1) WO2014138241A1 (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050282756A1 (en) 2004-06-18 2005-12-22 Mehta Nozer M Oral delivery of peptide pharmaceutical compositions
US8377863B2 (en) 2007-05-29 2013-02-19 Unigene Laboratories Inc. Peptide pharmaceutical for oral delivery
DK2964193T3 (da) 2013-03-05 2020-03-16 Enteris Biopharma Inc Lægemidler til oral indgivelse
AU2016206950B2 (en) * 2015-01-12 2021-05-06 Enteris Biopharma, Inc. Solid oral dosage forms
TW202136318A (zh) 2020-01-28 2021-10-01 美商建南德克公司 用於治療癌症的 IL15/IL15R α 異二聚體 Fc 融合蛋白質
US12180307B2 (en) 2022-06-13 2024-12-31 B.A.I. Laboratories, Llc Interleukin-13 binding cyclic oligopeptides and methods of use thereof
US12466883B1 (en) 2024-05-13 2025-11-11 Lumen Bioscience, Inc. Leptin compositions and methods of making and using the same to support weight loss and/or maintenance

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JPS57146723A (en) * 1981-03-06 1982-09-10 Toyo Jozo Co Ltd Pharmaceutical preparation having improved absorption
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US5789234A (en) 1987-08-14 1998-08-04 Unigene Laboratories, Inc. Expression systems for amidating enzyme
US5912014A (en) 1996-03-15 1999-06-15 Unigene Laboratories, Inc. Oral salmon calcitonin pharmaceutical products
DE69841939D1 (de) 1997-04-16 2010-11-25 Unigene Lab Inc Direkte expression von peptiden ins kulturmedium
WO2001056594A1 (en) 2000-02-04 2001-08-09 Unigene Laboratories, Inc. Nasal calcitonin formulations
US6673574B2 (en) 2000-11-30 2004-01-06 Unigene Laboratories Inc. Oral delivery of peptides using enzyme-cleavable membrane translocators
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JP2004528345A (ja) 2001-04-30 2004-09-16 シャイア ラボラトリーズ，インコーポレイテッド Ａｃｅ／ｎｅｐインヒビターおよびバイオアベイラビリティーエンハンサーを含む薬学的組成物
US8088734B2 (en) 2003-01-21 2012-01-03 Unigene Laboratories Inc. Oral delivery of peptides
US20050215476A1 (en) 2004-01-21 2005-09-29 Unigene Laboratories Inc. Amidated parathyroid hormone fragments and uses thereof
US8227241B2 (en) 2004-03-12 2012-07-24 Unigene Laboratories, Inc. Bacterial host cell for the direct expression of peptides
KR20050104152A (ko) 2004-04-28 2005-11-02 최승호 경구용 약물의 흡수를 증진하는 약제학적 조성물
US20050282756A1 (en) 2004-06-18 2005-12-22 Mehta Nozer M Oral delivery of peptide pharmaceutical compositions
WO2006026592A2 (en) * 2004-08-27 2006-03-09 Spherics, Inc. Oral administration of poorly absorbed drugs, methods and compositions related thereto
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EP1964566A4 (en) * 2005-12-22 2009-01-07 Asubio Pharma Co Ltd PREPARATION HAVING IMPROVED BIOABSORPTION CAPACITY OF SAPROPTERIN CHLORHYDRATE
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DK2964193T3 (da) 2013-03-05 2020-03-16 Enteris Biopharma Inc Lægemidler til oral indgivelse
AU2016206950B2 (en) 2015-01-12 2021-05-06 Enteris Biopharma, Inc. Solid oral dosage forms

Also Published As

Publication number Publication date
US9744140B2 (en) 2017-08-29
EP2964193A1 (en) 2016-01-13
US20170319502A1 (en) 2017-11-09
JP2016510747A (ja) 2016-04-11
AU2014225822B2 (en) 2017-05-04
US20140255479A1 (en) 2014-09-11
AU2018206721A1 (en) 2018-08-09
JP6375314B2 (ja) 2018-08-15
CA2904327A1 (en) 2014-09-12
IL240666A0 (en) 2015-10-29
WO2014138241A1 (en) 2014-09-12
HK1216082A1 (zh) 2016-10-14
CN105101950A (zh) 2015-11-25
ES2774962T3 (es) 2020-07-23
CN105101950B (zh) 2019-10-11
AU2017202900A1 (en) 2017-06-01
EP2964193B1 (en) 2019-12-11
AU2017202900B2 (en) 2018-04-26
US20170056328A1 (en) 2017-03-02
AU2014225822A1 (en) 2015-09-03
US20160296624A1 (en) 2016-10-13
AU2018206721B2 (en) 2019-07-11
DK2964193T3 (da) 2020-03-16
US9526785B2 (en) 2016-12-27
US9457086B2 (en) 2016-10-04

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