WO2011084618A3 - Compositions and methods for oral drug delivery - Google Patents

Compositions and methods for oral drug delivery Download PDF

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Publication number
WO2011084618A3
WO2011084618A3 PCT/US2010/060809 US2010060809W WO2011084618A3 WO 2011084618 A3 WO2011084618 A3 WO 2011084618A3 US 2010060809 W US2010060809 W US 2010060809W WO 2011084618 A3 WO2011084618 A3 WO 2011084618A3
Authority
WO
WIPO (PCT)
Prior art keywords
methods
drug delivery
oral drug
compositions
pharmaceutical composition
Prior art date
Application number
PCT/US2010/060809
Other languages
French (fr)
Other versions
WO2011084618A2 (en
Inventor
William W. Lee
Feng Lu
Yin Min
Liuying Shao
Hao SHE
Zhou Shen
Original Assignee
Nod Pharmaceuticals, 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
Priority claimed from CN200910201248.3A external-priority patent/CN102100912B/en
Priority claimed from CN201010227045.4A external-priority patent/CN102335431B/en
Application filed by Nod Pharmaceuticals, Inc. filed Critical Nod Pharmaceuticals, Inc.
Priority to JP2012544835A priority Critical patent/JP2013514976A/en
Priority to CA2784120A priority patent/CA2784120A1/en
Priority to EP10795591A priority patent/EP2512454A2/en
Priority to AU2010339907A priority patent/AU2010339907A1/en
Publication of WO2011084618A2 publication Critical patent/WO2011084618A2/en
Publication of WO2011084618A3 publication Critical patent/WO2011084618A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/2278Vasoactive intestinal peptide [VIP]; Related peptides (e.g. Exendin)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/28Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893Tablet coating processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Vascular Medicine (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The invention provides a pharmaceutical composition for oral drug delivery comprising a solid dosage form containing an effective amount of a therapeutic agent, a permeation enhancer and a pharmaceutically acceptable excipient and a bioadhesive layer containing a bioadhesive polymer, and optionally comprising an impermeable or semi-permeable layer having an opening capable of directing a unidirectional release of the therapeutic agent and the permeation enhancer from the solid dosage form. Methods of making and using the present pharmaceutical composition are also provided.
PCT/US2010/060809 2009-12-16 2010-12-16 Compositions and methods for oral drug delivery WO2011084618A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2012544835A JP2013514976A (en) 2009-12-16 2010-12-16 Compositions and methods for oral drug delivery
CA2784120A CA2784120A1 (en) 2009-12-16 2010-12-16 Compositions and methods for oral drug delivery
EP10795591A EP2512454A2 (en) 2009-12-16 2010-12-16 Compositions and methods for oral drug delivery
AU2010339907A AU2010339907A1 (en) 2009-12-16 2010-12-16 Compositions and methods for oral drug delivery

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US28714609P 2009-12-16 2009-12-16
CN200910201248.3 2009-12-16
CN200910201248.3A CN102100912B (en) 2009-12-16 2009-12-16 Administration composition and preparation method and using method thereof
US61/287,146 2009-12-16
CN201010227045.4A CN102335431B (en) 2010-07-14 2010-07-14 A kind of administration composition and preparation and application thereof
CN201010227045.4 2010-07-14
US36591610P 2010-07-20 2010-07-20
US61/365,916 2010-07-20

Publications (2)

Publication Number Publication Date
WO2011084618A2 WO2011084618A2 (en) 2011-07-14
WO2011084618A3 true WO2011084618A3 (en) 2012-01-19

Family

ID=44306059

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2010/060809 WO2011084618A2 (en) 2009-12-16 2010-12-16 Compositions and methods for oral drug delivery

Country Status (5)

Country Link
EP (1) EP2512454A2 (en)
JP (1) JP2013514976A (en)
AU (1) AU2010339907A1 (en)
CA (1) CA2784120A1 (en)
WO (1) WO2011084618A2 (en)

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US20110182985A1 (en) * 2010-01-28 2011-07-28 Coughlan David C Solid Pharmaceutical Composition with Enhancers and Methods of Preparing thereof
AU2011343190B2 (en) 2010-12-16 2016-12-08 Novo Nordisk A/S Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
CN106117343B (en) 2011-04-12 2020-11-03 诺沃—诺迪斯克有限公司 Double acylated GLP-1 derivatives
WO2013012954A2 (en) * 2011-07-19 2013-01-24 Baxter International Inc. Resorption enhancers as additives to improve the oral formulation of non-anticoagulant sulfated polysaccharides
DK2827845T3 (en) 2012-03-22 2019-04-01 Novo Nordisk As COMPOSITIONS INCLUDING A PROCEDURE AND PREPARING THEREOF
US10933120B2 (en) 2012-03-22 2021-03-02 Novo Nordisk A/S Compositions of GLP-1 peptides and preparation thereof
RS64942B1 (en) 2012-03-22 2024-01-31 Novo Nordisk As Compositions comprising a delivery agent and preparation thereof
US9993430B2 (en) 2012-06-20 2018-06-12 Novo Nordisk A/S Tablet formulation comprising semaglutide and a delivery agent
JP2016525524A (en) * 2013-07-24 2016-08-25 ノヴォ ノルディスク アー/エス Pharmaceutical composition for oral insulin administration comprising a tablet core and an anionic copolymer coating
KR101768446B1 (en) * 2014-03-21 2017-08-17 애니젠 주식회사 Novel Exenatide Analogs and Uses thereof
AU2015258859B2 (en) 2014-05-15 2020-07-23 Rani Therapeutics, Llc Pharmaceutical compositions and methods for fabrication of solid masses comprising polypeptides and/or proteins
US11548940B2 (en) 2014-05-15 2023-01-10 Rani Therapeutics, Llc Anti-interleukin antibody preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
CN107205949A (en) * 2015-01-29 2017-09-26 诺和诺德股份有限公司 Discharge comprising label and immediately the pharmaceutical composition that oral GLP 1 is administered that is used for being coated
EP3250191B1 (en) * 2015-01-29 2024-01-17 Novo Nordisk A/S Tablets comprising glp-1 agonist and enteric coating
US20180000742A1 (en) * 2015-01-29 2018-01-04 Novo Nordisk A/S Pharmaceutical Composition for Oral Insulin Administration Comprising a Tablet Core and a Polyvinyl Alcohol Coating
PT3280447T (en) * 2015-04-08 2019-05-14 Torrent Pharmaceuticals Ltd Pharmaceutical formulations
JP7202070B2 (en) * 2015-05-01 2023-01-11 ラニ セラピューティクス, エルエルシー Pharmaceutical compositions and methods for fabrication of solid masses containing polypeptides and/or proteins
CN104998251A (en) * 2015-07-08 2015-10-28 哈尔滨吉象隆生物技术有限公司 Intestinal absorption promoting liraglutide salt for preparing oral enteric-coated preparations
CN105079793A (en) * 2015-07-18 2015-11-25 哈尔滨吉象隆生物技术有限公司 Liraglutide and metformin hydrochloride compound preparation applicable to oral administration
CN105079794A (en) * 2015-07-18 2015-11-25 哈尔滨吉象隆生物技术有限公司 Liraglutide and sulfonylurea compound preparation for oral administration
RU2617049C1 (en) * 2016-05-12 2017-04-19 Федеральное государственное бюджетное учреждение "Национальный исследовательский центр "Курчатовский институт" Anticancer drug based on niclosamide
TWI804571B (en) 2018-02-02 2023-06-11 丹麥商諾佛 儂迪克股份有限公司 Solid compositions comprising a glp-1 agonist and a salt of n-(8-(2-hydroxybenzoyl)amino)caprylic acid
TWI829687B (en) 2018-05-07 2024-01-21 丹麥商諾佛 儂迪克股份有限公司 Solid compositions comprising a glp-1 agonist and a salt of n-(8-(2-hydroxybenzoyl)amino)caprylic acid

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EP0460921A2 (en) * 1990-06-04 1991-12-11 Aicello Chemical Company Limited Large intestinal dissociative hard capsules
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US20020044975A1 (en) * 1994-04-22 2002-04-18 Shunsuke Watanabe Colon-specific drug release system
WO2005002549A1 (en) * 2003-07-04 2005-01-13 Nycomed Danmark Aps Parathyroid hormone (pth) containing pharmaceutical compositions for oral use

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Publication number Priority date Publication date Assignee Title
EP0454383A1 (en) * 1990-04-23 1991-10-30 Aicello Chemical Co., Ltd. Large intestinal dissociative polypeptide series oral formulation
EP0460921A2 (en) * 1990-06-04 1991-12-11 Aicello Chemical Company Limited Large intestinal dissociative hard capsules
US20020044975A1 (en) * 1994-04-22 2002-04-18 Shunsuke Watanabe Colon-specific drug release system
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WO2000041740A2 (en) * 1999-01-11 2000-07-20 The Regents Of The University Of California Particles for oral delivery of peptides and proteins
WO2005002549A1 (en) * 2003-07-04 2005-01-13 Nycomed Danmark Aps Parathyroid hormone (pth) containing pharmaceutical compositions for oral use

Also Published As

Publication number Publication date
WO2011084618A2 (en) 2011-07-14
CA2784120A1 (en) 2011-07-14
AU2010339907A1 (en) 2012-07-05
EP2512454A2 (en) 2012-10-24
JP2013514976A (en) 2013-05-02

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