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DK2844222T3 - Lægemiddelformulering med forsinket udløsning - Google Patents

Lægemiddelformulering med forsinket udløsning Download PDF

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Publication number
DK2844222T3
DK2844222T3 DK13723033T DK13723033T DK2844222T3 DK 2844222 T3 DK2844222 T3 DK 2844222T3 DK 13723033 T DK13723033 T DK 13723033T DK 13723033 T DK13723033 T DK 13723033T DK 2844222 T3 DK2844222 T3 DK 2844222T3
Authority
DK
Denmark
Prior art keywords
pharmaceutical formulation
delayed delivery
delayed
delivery
formulation
Prior art date
Application number
DK13723033T
Other languages
English (en)
Inventor
Thomas Buser
Frédéric Jean-Claude Goutte
Abdul Waseh Basit
Felipe José Oliveria Varum
Ana Cristina Freire
González Roberto Carlos Bravo
Original Assignee
Tillotts Pharma Ag
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=46025554&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2844222(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Tillotts Pharma Ag filed Critical Tillotts Pharma Ag
Application granted granted Critical
Publication of DK2844222T3 publication Critical patent/DK2844222T3/da

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/60Salicylic acid; Derivatives thereof
    • A61K31/606Salicylic acid; Derivatives thereof having amino groups
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/60Salicylic acid; Derivatives thereof
    • A61K31/612Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
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    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
    • 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
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
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    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
    • A61K9/2806Coating materials
    • A61K9/288Compounds of unknown constitution, e.g. material from plants or animals
    • AHUMAN NECESSITIES
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    • 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
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    • 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
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P1/10Laxatives
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    • A61P1/12Antidiarrhoeals
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Botany (AREA)
  • Zoology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Medicinal Preparation (AREA)
  • Laminated Bodies (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • General Preparation And Processing Of Foods (AREA)
  • Grain Derivatives (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
DK13723033T 2012-04-30 2013-04-29 Lægemiddelformulering med forsinket udløsning DK2844222T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261640217P 2012-04-30 2012-04-30
EP12166110.2A EP2659881B1 (en) 2012-04-30 2012-04-30 A delayed release drug formulation
PCT/EP2013/058923 WO2013164316A1 (en) 2012-04-30 2013-04-29 A delayed release drug formulation

Publications (1)

Publication Number Publication Date
DK2844222T3 true DK2844222T3 (da) 2019-12-09

Family

ID=46025554

Family Applications (5)

Application Number Title Priority Date Filing Date
DK12166110.2T DK2659881T3 (da) 2012-04-30 2012-04-30 Lægemiddelformulering med forsinket udløsning
DK17188821.7T DK3278792T3 (da) 2012-04-30 2013-04-29 Lægemiddelformulering med forsinket udløsning
DK13719543.4T DK2844220T3 (da) 2012-04-30 2013-04-29 Lægemiddelformulering med forsinket udløsning
DK13723033T DK2844222T3 (da) 2012-04-30 2013-04-29 Lægemiddelformulering med forsinket udløsning
DK17156227.5T DK3189830T3 (da) 2012-04-30 2013-04-29 Lægemiddelformulering med forsinket udløsning

Family Applications Before (3)

Application Number Title Priority Date Filing Date
DK12166110.2T DK2659881T3 (da) 2012-04-30 2012-04-30 Lægemiddelformulering med forsinket udløsning
DK17188821.7T DK3278792T3 (da) 2012-04-30 2013-04-29 Lægemiddelformulering med forsinket udløsning
DK13719543.4T DK2844220T3 (da) 2012-04-30 2013-04-29 Lægemiddelformulering med forsinket udløsning

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK17156227.5T DK3189830T3 (da) 2012-04-30 2013-04-29 Lægemiddelformulering med forsinket udløsning

Country Status (41)

Country Link
US (6) US9364440B2 (da)
EP (6) EP2659881B1 (da)
JP (2) JP6621662B2 (da)
KR (6) KR102177773B1 (da)
CN (5) CN106983735A (da)
AR (1) AR090898A1 (da)
AU (4) AU2013255914B2 (da)
BR (3) BR122019022551B1 (da)
CA (4) CA2871016C (da)
CL (2) CL2014002795A1 (da)
CO (2) CO7141433A2 (da)
CR (4) CR20190245A (da)
CU (1) CU24304B1 (da)
CY (4) CY1120215T1 (da)
DK (5) DK2659881T3 (da)
EA (2) EA032514B1 (da)
ES (6) ES2655622T3 (da)
GE (4) GEP201706736B (da)
HR (2) HRP20180068T1 (da)
HU (5) HUE036187T2 (da)
JO (6) JOP20200144A1 (da)
LT (5) LT2659881T (da)
ME (2) ME03364B (da)
MX (4) MX373249B (da)
MY (3) MY169161A (da)
NO (1) NO2659881T3 (da)
NZ (3) NZ629260A (da)
PE (3) PE20150129A1 (da)
PH (2) PH12014502340B1 (da)
PL (5) PL2659881T3 (da)
PT (5) PT2659881T (da)
RS (5) RS56839B1 (da)
SA (2) SA113340508B1 (da)
SG (2) SG11201406799XA (da)
SI (5) SI2659881T1 (da)
SM (5) SMT201800095T1 (da)
TN (2) TN2014000442A1 (da)
TR (3) TR201905226T4 (da)
TW (3) TWI618547B (da)
UY (1) UY34772A (da)
WO (2) WO2013164315A1 (da)

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HRP20192210T1 (hr) * 2012-04-30 2020-02-21 Tillotts Pharma Ag Formulacija lijeka s produženim otpuštanjem
DK2659881T3 (da) 2012-04-30 2018-02-05 Tillotts Pharma Ag Lægemiddelformulering med forsinket udløsning
US20140141075A1 (en) 2012-11-21 2014-05-22 Warner Chilcott Company, Llc 5-aminosalicylic acid capsule formulation
CN105025888B (zh) * 2013-02-22 2018-10-12 志瑞亚新药工业株式会社 肠溶片
WO2015062640A1 (en) 2013-10-29 2015-05-07 Tillotts Pharma Ag A delayed release drug formulation
US10517869B2 (en) 2013-12-24 2019-12-31 Sentiss Pharma Private Limited Topical brimonidine tartrate ophthalmic solution
EP3302703B1 (en) 2015-06-01 2021-08-25 Xeno Biosciences Inc. Compositions for use in modulating the gut microbiota and managing weight
CA2999367C (en) 2015-09-23 2023-09-26 Xw Laboratories Inc. Prodrugs of gamma-hydroxybutyric acid, compositions and uses thereof
CN105816883B (zh) * 2016-02-03 2018-12-14 华南师范大学 一种负载抗癌药物姜黄素的益生菌叶酸靶向载体及其制备方法
EP3257501A1 (en) 2016-06-14 2017-12-20 Tillotts Pharma AG Multiple unit dosage form comprising a core with individual core units covered by a mucoadhesive material, and an enteric core coating
US11311573B2 (en) * 2016-11-30 2022-04-26 Xeno Biosciences Inc. Pharmaceutical preparations and methods to manage weight and to modulate the gut microbiota
ES3032290T3 (en) 2018-03-20 2025-07-16 Theriva Biologics Inc Intestinal alkaline phosphatase formulations
IL277496B2 (en) * 2018-03-23 2025-01-01 Palatin Technologies Inc Melanocortin receptor-specific peptide formulations and methods for specific administration to the gastrointestinal tract
WO2020106757A1 (en) 2018-11-19 2020-05-28 Progenity, Inc. Ingestible device for delivery of therapeutic agent to the gastrointestinal tract
EP3662900A1 (en) * 2018-12-07 2020-06-10 Tillotts Pharma AG Colonic drug delivery formulation
ES2994844T3 (en) 2018-12-07 2025-02-03 Tillotts Pharma Ag Colonic drug delivery formulation
EP3662895A1 (en) 2018-12-07 2020-06-10 Tillotts Pharma AG A process for manufacturing reducing sugar-free 5-asa tablet cores
EP3662898A1 (en) 2018-12-07 2020-06-10 Tillotts Pharma AG Solid composition comprising mesalazine
EP3662901B1 (en) 2018-12-07 2025-01-01 Tillotts Pharma AG Delayed release drug formulation comprising an outerlayer with an enzymatically degradable polymer, its composition and its method of manufacturing
HUE057346T2 (hu) * 2018-12-10 2022-05-28 Aphaia Ip Ag Orális gyógyászati adagolási forma metabolikus rendellenességek és rokon betegségek enterokinek megtervezett felszabadításával történõ kezelésére
CN111617047B (zh) * 2019-02-27 2021-06-22 广州喜鹊医药有限公司 一种含tbn或其盐或其水合物的药物组合物及其制备方法
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