MX367127B - Formulación de fármaco de liberación retardada que comprende un núcleo y un recubrimiento para el núcleo que comprende al menos dos o tres capas poliméricas. - Google Patents
Formulación de fármaco de liberación retardada que comprende un núcleo y un recubrimiento para el núcleo que comprende al menos dos o tres capas poliméricas.Info
- Publication number
- MX367127B MX367127B MX2018010475A MX2018010475A MX367127B MX 367127 B MX367127 B MX 367127B MX 2018010475 A MX2018010475 A MX 2018010475A MX 2018010475 A MX2018010475 A MX 2018010475A MX 367127 B MX367127 B MX 367127B
- Authority
- MX
- Mexico
- Prior art keywords
- polymeric material
- drug
- core
- layer
- inner layer
- Prior art date
Links
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
- 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
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
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- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic 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
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/606—Salicylic acid; Derivatives thereof having amino groups
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- 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
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
- A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
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- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
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- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic 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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- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
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- A61K9/288—Compounds of unknown constitution, e.g. material from plants or animals
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- A61K9/2886—Dragees; 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
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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
- A61K9/5084—Mixtures 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
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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)
- Physiology (AREA)
- Nutrition Science (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)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- General Preparation And Processing Of Foods (AREA)
- Grain Derivatives (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
Abstract
La liberación retardada de un fármaco al colon se logra de una formulación de liberación retardada que comprende un núcleo y un recubrimiento para el núcleo. El núcleo comprende un fármaco y un recubrimiento que comprende una capa interior y al menos una capa entre el núcleo y la capa exterior seleccionada del grupo que consiste de una capa de aislamiento y una capa interior. La capa exterior comprende una mezcla de un primer material polimérico que es susceptible a ataques por parte de la bacteria colónica, y un segundo material polimérico que tiene un umbral de pH a aproximadamente pH 5 o más alto. La capa interior comprende un tercer material polimérico que es soluble en el fluido intestinal o en el fluido gastrointestinal, tal tercer material polimérico se selecciona de ácido policarboxílico al menos parcialmente neutralizado y un polímero no iónico. En modalidades en donde el tercer material polimérico es un polímero no iónico, la capa interior comprende al menos un agente regulador del pH y una base. La capa de aislamiento comprende un polímero no iónico que es soluble en el fluido intestinal o fluido gastrointestinal. El exterior es un medio acuoso con un segundo material polimérico en un medio orgánico. Las ventajas de las formulaciones de acuerdo con la presente invención incluyen la liberación acelerada del fármaco cuando se expone a condiciones colónicas y la reducción o eliminación del efecto de los alimentos y/o alcohol en la liberación del fármaco después de la administración.
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 |
---|---|
MX367127B true MX367127B (es) | 2019-08-06 |
Family
ID=46025554
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2014012887A MX362529B (es) | 2012-04-30 | 2013-04-29 | Formulación de fármaco de liberación retardada que comprende un núcleo y un recubrimiento multicapa para el núcleo que comprende al menos tres capas poliméricas. |
MX2014012888A MX366677B (es) | 2012-04-30 | 2013-04-29 | Formulación de fármaco de liberación retardada que comprende un núcleo y un recubrimiento para el núcleo que comprende al menos dos o tres capas poliméricas. |
MX2018010475A MX367127B (es) | 2012-04-30 | 2013-04-29 | Formulación de fármaco de liberación retardada que comprende un núcleo y un recubrimiento para el núcleo que comprende al menos dos o tres capas poliméricas. |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2014012887A MX362529B (es) | 2012-04-30 | 2013-04-29 | Formulación de fármaco de liberación retardada que comprende un núcleo y un recubrimiento multicapa para el núcleo que comprende al menos tres capas poliméricas. |
MX2014012888A MX366677B (es) | 2012-04-30 | 2013-04-29 | Formulación de fármaco de liberación retardada que comprende un núcleo y un recubrimiento para el núcleo que comprende al menos dos o tres capas poliméricas. |
Country Status (40)
Country | Link |
---|---|
US (6) | US9364440B2 (es) |
EP (6) | EP2659881B1 (es) |
JP (2) | JP6621661B2 (es) |
KR (6) | KR20190127986A (es) |
CN (5) | CN104302274A (es) |
AR (1) | AR090898A1 (es) |
AU (4) | AU2013255913B2 (es) |
BR (3) | BR112014026933B1 (es) |
CA (4) | CA3080035A1 (es) |
CL (2) | CL2014002795A1 (es) |
CO (2) | CO7141433A2 (es) |
CR (4) | CR20190245A (es) |
CU (1) | CU24304B1 (es) |
CY (4) | CY1120215T1 (es) |
DK (5) | DK2659881T3 (es) |
EA (2) | EA032811B1 (es) |
ES (5) | ES2655622T3 (es) |
GE (4) | GEP201706736B (es) |
HR (2) | HRP20180068T1 (es) |
HU (5) | HUE036187T2 (es) |
JO (6) | JOP20200144A1 (es) |
LT (5) | LT2659881T (es) |
ME (2) | ME03641B (es) |
MX (3) | MX362529B (es) |
MY (3) | MY169161A (es) |
NO (1) | NO2659881T3 (es) |
NZ (3) | NZ725409A (es) |
PE (3) | PE20142442A1 (es) |
PH (2) | PH12014502340B1 (es) |
PL (5) | PL2659881T3 (es) |
PT (5) | PT2659881T (es) |
RS (5) | RS56839B1 (es) |
SA (2) | SA113340508B1 (es) |
SG (2) | SG11201406799XA (es) |
SI (5) | SI2659881T1 (es) |
TN (2) | TN2014000441A1 (es) |
TR (3) | TR201809416T4 (es) |
TW (3) | TWI700102B (es) |
UY (1) | UY34772A (es) |
WO (2) | WO2013164315A1 (es) |
Families Citing this family (27)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CU24342B1 (es) * | 2012-04-30 | 2018-05-08 | Tillotts Pharma Ag | Formulación de fármaco de liberación retardada |
HUE036187T2 (hu) * | 2012-04-30 | 2018-06-28 | Tillotts Pharma Ag | Késleltetett leadású gyógyszerkészítmény |
US20140141075A1 (en) | 2012-11-21 | 2014-05-22 | Warner Chilcott Company, Llc | 5-aminosalicylic acid capsule formulation |
PT2959892T (pt) * | 2013-02-22 | 2020-12-15 | Zeria Pharm Co Ltd | Comprimido com revestimento entérico |
UA117260C2 (uk) | 2013-10-29 | 2018-07-10 | Тиллоттс Фарма АГ | Лікарський препарат з відстроченим вивільненням |
UA117768C2 (uk) | 2013-12-24 | 2018-09-25 | Сентісс Фарма Прайвет Лімітед | Офтальмологічний розчин тартрату бримонідину для місцевого застосування |
WO2016196440A1 (en) | 2015-06-01 | 2016-12-08 | Xeno Biosciences Inc. | Methods and compositions to modulate the gut microbiota and to manage weight |
AU2016328150B2 (en) | 2015-09-23 | 2020-10-01 | 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 |
CA3045011A1 (en) * | 2016-11-30 | 2018-06-07 | Xeno Biosciences Inc. | Pharmaceutical preparations and methods to manage weight and to modulate the gut microbiota |
CA3094173A1 (en) | 2018-03-20 | 2019-09-26 | Synthetic Biologics, Inc. | Intestinal alkaline phosphatase formulations |
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