CO6351746A2 - Formulación sólida estable de un polipéptido agonista de receptor gc-c adecuado para administración oral - Google Patents
Formulación sólida estable de un polipéptido agonista de receptor gc-c adecuado para administración oralInfo
- Publication number
- CO6351746A2 CO6351746A2 CO11019927A CO11019927A CO6351746A2 CO 6351746 A2 CO6351746 A2 CO 6351746A2 CO 11019927 A CO11019927 A CO 11019927A CO 11019927 A CO11019927 A CO 11019927A CO 6351746 A2 CO6351746 A2 CO 6351746A2
- Authority
- CO
- Colombia
- Prior art keywords
- cys
- oral administration
- stable solid
- linaclotide
- formulations
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title abstract 5
- 239000000203 mixture Substances 0.000 title abstract 5
- 229920001184 polypeptide Polymers 0.000 title abstract 2
- 108090000765 processed proteins & peptides Proteins 0.000 title abstract 2
- 102000004196 processed proteins & peptides Human genes 0.000 title abstract 2
- 239000007787 solid Substances 0.000 title abstract 2
- 239000000556 agonist Substances 0.000 title 1
- KXGCNMMJRFDFNR-WDRJZQOASA-N linaclotide Chemical compound C([C@H](NC(=O)[C@@H]1CSSC[C@H]2C(=O)N[C@H]3CSSC[C@H](N)C(=O)N[C@H](C(N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=4C=CC(O)=CC=4)C(=O)N2)=O)CSSC[C@H](NC(=O)[C@H](C)NC(=O)[C@@H]2CCCN2C(=O)[C@H](CC(N)=O)NC3=O)C(=O)N[C@H](C(NCC(=O)N1)=O)[C@H](O)C)C(O)=O)C1=CC=C(O)C=C1 KXGCNMMJRFDFNR-WDRJZQOASA-N 0.000 abstract 3
- 108010024409 linaclotide Proteins 0.000 abstract 3
- 229960000812 linaclotide Drugs 0.000 abstract 3
- PLTGTJAZQRGMPP-FXQIFTODSA-N Asn-Pro-Ala Chemical compound OC(=O)[C@H](C)NC(=O)[C@@H]1CCCN1C(=O)[C@@H](N)CC(N)=O PLTGTJAZQRGMPP-FXQIFTODSA-N 0.000 abstract 1
- ISWAQPWFWKGCAL-ACZMJKKPSA-N Cys-Cys-Glu Chemical compound [H]N[C@@H](CS)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCC(O)=O)C(O)=O ISWAQPWFWKGCAL-ACZMJKKPSA-N 0.000 abstract 1
- ALNKNYKSZPSLBD-ZDLURKLDSA-N Cys-Thr-Gly Chemical compound [H]N[C@@H](CS)C(=O)N[C@@H]([C@@H](C)O)C(=O)NCC(O)=O ALNKNYKSZPSLBD-ZDLURKLDSA-N 0.000 abstract 1
- CGDZGRLRXPNCOC-SRVKXCTJSA-N Tyr-Cys-Cys Chemical compound SC[C@@H](C(O)=O)NC(=O)[C@H](CS)NC(=O)[C@@H](N)CC1=CC=C(O)C=C1 CGDZGRLRXPNCOC-SRVKXCTJSA-N 0.000 abstract 1
- 150000001413 amino acids Chemical group 0.000 abstract 1
- 108010010430 asparagine-proline-alanine Proteins 0.000 abstract 1
- 108010069495 cysteinyltyrosine Proteins 0.000 abstract 1
- 229940079593 drug Drugs 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
Classifications
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- 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
- A61K9/50—Microcapsules 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
-
- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
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- A—HUMAN NECESSITIES
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- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/10—Peptides having 12 to 20 amino acids
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- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
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- 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
-
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
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- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
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- A61K9/2022—Organic macromolecular compounds
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- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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- A61K9/50—Microcapsules 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
- A61K9/5073—Microcapsules 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
- A61K9/5078—Microcapsules 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 with drug-free core
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- A—HUMAN NECESSITIES
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
- B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
- B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N2030/022—Column chromatography characterised by the kind of separation mechanism
- G01N2030/027—Liquid chromatography
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Gastroenterology & Hepatology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Nutrition Science (AREA)
- Biochemistry (AREA)
- Pathology (AREA)
- Mechanical Engineering (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- General Physics & Mathematics (AREA)
- Food Science & Technology (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US8942208P | 2008-08-15 | 2008-08-15 | |
| US27333209P | 2009-08-03 | 2009-08-03 | |
| US23172509P | 2009-08-06 | 2009-08-06 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CO6351746A2 true CO6351746A2 (es) | 2011-12-20 |
Family
ID=41666602
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CO11019927A CO6351746A2 (es) | 2008-08-15 | 2011-02-18 | Formulación sólida estable de un polipéptido agonista de receptor gc-c adecuado para administración oral |
Country Status (32)
Families Citing this family (39)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109010254A (zh) | 2008-08-15 | 2018-12-18 | 硬木药品公司 | 适合口服给药的鸟苷酸环化酶-c受体激动剂多肽的稳定的固体制剂 |
| US20100221329A1 (en) | 2008-12-03 | 2010-09-02 | Synergy Pharmaceuticals, Inc. | Formulations of guanylate cyclase c agonists and methods of use |
| MX2012001660A (es) * | 2009-08-06 | 2012-03-26 | Ironwood Pharmaceuticals Inc | Formulaciones que contienen linaclotida para adminstracion oral. |
| WO2011020054A1 (en) * | 2009-08-13 | 2011-02-17 | Ironwood Pharmaceuticals Inc. | Method for modulating the pharmacodynamic effect of orally administered guanylate cyclase receptor agonists |
| HUE034190T2 (en) * | 2009-11-03 | 2018-01-29 | Ironwood Pharmaceuticals Inc | Linaclitaxel for the treatment of chronic constipation |
| CA2779482A1 (en) | 2009-11-09 | 2011-05-12 | Ironwood Pharmaceuticals, Inc. | Treatments for gastrointestinal disorders |
| WO2011071927A2 (en) | 2009-12-07 | 2011-06-16 | Ironwood Pharmaceuticals, Inc. | Treatments for gastrointestinal disorders |
| UA108636C2 (xx) | 2010-02-17 | 2015-05-25 | Пептид | |
| ES2919136T3 (es) * | 2010-08-11 | 2022-07-22 | Ironwood Pharmaceuticals Inc | Formulaciones estables de linaclotida |
| CN103702678A (zh) * | 2010-09-11 | 2014-04-02 | 硬木药品公司 | 便秘型肠易激综合征的治疗 |
| EP2621509A4 (en) * | 2010-09-15 | 2016-08-03 | Synergy Pharmaceuticals Inc | FORMULATIONS OF GUANYLATE CYCLASE C AGONISTS AND METHOD OF USE |
| US9616097B2 (en) * | 2010-09-15 | 2017-04-11 | Synergy Pharmaceuticals, Inc. | Formulations of guanylate cyclase C agonists and methods of use |
| US9650417B2 (en) | 2011-05-11 | 2017-05-16 | Ironwood Pharmaceuticals, Inc. | Treatments for gastrointestinal disorders |
| US9303066B2 (en) | 2011-05-11 | 2016-04-05 | Ironwood Pharmaceuticals, Inc. | Treatments for gastrointestinal disorders |
| WO2012170766A1 (en) | 2011-06-08 | 2012-12-13 | Ironwood Pharmaceuticals, Inc. | Treatments for gastrointestinal disorders |
| US9617305B2 (en) | 2011-06-08 | 2017-04-11 | Ironwood Pharmaceuticals, Inc. | Treatments for gastrointestinal disorders |
| JP6312592B2 (ja) | 2011-08-17 | 2018-04-18 | アイアンウッド ファーマシューティカルズ インコーポレイテッド | 消化器疾患の治療 |
| US20140242158A1 (en) * | 2011-09-30 | 2014-08-28 | Astellas Pharma, Inc. | Granular Pharmaceutical Composition |
| WO2014088623A1 (en) * | 2012-07-12 | 2014-06-12 | Forest Laboratories Holdings Limited | Linaclotide compositions |
| US20150361139A1 (en) * | 2013-01-30 | 2015-12-17 | Sandoz Ag | Crystalline form of linaclotide |
| CN105979959B (zh) | 2013-08-09 | 2021-11-30 | 阿德利克斯公司 | 用于抑制磷酸盐转运的化合物和方法 |
| UA119335C2 (uk) * | 2013-12-11 | 2019-06-10 | Айронвуд Фармасьютикалз, Інк. | Композиції лінаклотиду з затриманим вивільненням |
| EP3180016A4 (en) * | 2014-08-11 | 2018-01-03 | Sun Pharmaceutical Industries Ltd | Linaclotide stable composition |
| DK3006045T3 (en) * | 2014-10-07 | 2017-07-17 | Cyprumed Gmbh | Pharmaceutical formulations for oral administration of peptide or protein drugs |
| CN104569245A (zh) * | 2014-12-08 | 2015-04-29 | 江苏泰洁检测技术有限公司 | 一种工作场所脂肪族胺类中环己胺浓度测定方法 |
| US20180008547A1 (en) * | 2015-02-02 | 2018-01-11 | Aurobindo Pharma Ltd | Stable Compositions comprising Linaclotide |
| EP3302440B1 (en) * | 2015-06-05 | 2021-01-06 | Ironwood Pharmaceuticals, Inc. | Modified or targeted release formulations of linaclotide |
| US10905744B2 (en) | 2015-10-07 | 2021-02-02 | Cyprumed Gmbh | Pharmaceutical formulations for the oral delivery of peptide drugs |
| AU2017379082A1 (en) | 2016-12-21 | 2019-07-04 | Ironwood Pharmaceuticals Inc. | Methods of treating irritable bowel syndrome with modified or delayed release formulations of linaclotide |
| CN107669700A (zh) * | 2017-09-14 | 2018-02-09 | 湖南晓林生物科技发展有限公司 | 一种治疗溃疡性结肠炎的药物及其制备方法 |
| BR112021000201A2 (pt) | 2018-07-09 | 2021-08-10 | Abbott Laboratories Gmbh | composição farmacêutica contendo um peptídeo |
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