UA112345C2 - Спосіб виготовлення за допомогою іонного желатинування інтестинальних альгінатних мікрокапсул, які містять диклофенак або одну із його солей, і багаточасткова фармацевтична композиція, що містить такі мікрокапсули - Google Patents
Спосіб виготовлення за допомогою іонного желатинування інтестинальних альгінатних мікрокапсул, які містять диклофенак або одну із його солей, і багаточасткова фармацевтична композиція, що містить такі мікрокапсулиInfo
- Publication number
- UA112345C2 UA112345C2 UAA201410294A UAA201410294A UA112345C2 UA 112345 C2 UA112345 C2 UA 112345C2 UA A201410294 A UAA201410294 A UA A201410294A UA A201410294 A UAA201410294 A UA A201410294A UA 112345 C2 UA112345 C2 UA 112345C2
- Authority
- UA
- Ukraine
- Prior art keywords
- microcapsules
- salts
- diclofenac
- solution
- intestinal
- Prior art date
Links
- 239000003094 microcapsule Substances 0.000 title abstract 5
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 title abstract 3
- DCOPUUMXTXDBNB-UHFFFAOYSA-N diclofenac Chemical compound OC(=O)CC1=CC=CC=C1NC1=C(Cl)C=CC=C1Cl DCOPUUMXTXDBNB-UHFFFAOYSA-N 0.000 title abstract 3
- 229960001259 diclofenac Drugs 0.000 title abstract 3
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 3
- 150000003839 salts Chemical class 0.000 title abstract 3
- 230000000968 intestinal effect Effects 0.000 title abstract 2
- 229940072056 alginate Drugs 0.000 title 1
- 235000010443 alginic acid Nutrition 0.000 title 1
- 229920000615 alginic acid Polymers 0.000 title 1
- 238000004519 manufacturing process Methods 0.000 title 1
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 abstract 2
- 239000003814 drug Substances 0.000 abstract 2
- 238000000034 method Methods 0.000 abstract 2
- 239000000243 solution Substances 0.000 abstract 2
- 230000003110 anti-inflammatory effect Effects 0.000 abstract 1
- 239000007864 aqueous solution Substances 0.000 abstract 1
- 239000007900 aqueous suspension Substances 0.000 abstract 1
- 159000000007 calcium salts Chemical class 0.000 abstract 1
- 239000007910 chewable tablet Substances 0.000 abstract 1
- 239000011248 coating agent Substances 0.000 abstract 1
- 238000000576 coating method Methods 0.000 abstract 1
- 229940079593 drug Drugs 0.000 abstract 1
- 238000001035 drying Methods 0.000 abstract 1
- IDGUHHHQCWSQLU-UHFFFAOYSA-N ethanol;hydrate Chemical compound O.CCO IDGUHHHQCWSQLU-UHFFFAOYSA-N 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000000843 powder Substances 0.000 abstract 1
- 239000012266 salt solution Substances 0.000 abstract 1
- 238000007873 sieving Methods 0.000 abstract 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 abstract 1
- 235000017557 sodium bicarbonate Nutrition 0.000 abstract 1
- 239000007787 solid Substances 0.000 abstract 1
- 210000002784 stomach Anatomy 0.000 abstract 1
- 239000000126 substance Substances 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 abstract 1
- 239000003826 tablet Substances 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
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
-
- 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
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- 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
- A61K47/30—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
-
- 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
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
-
- 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
- A61K9/14—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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
-
- 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
- A61K9/2072—Pills, 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
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
-
- 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
- A61K9/5084—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
-
- 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
- A61K9/5089—Processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Physiology (AREA)
- Dispersion Chemistry (AREA)
- Nutrition Science (AREA)
- Inorganic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Rheumatology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Винахід належить до фармацевтики і стосується способу виготовлення інтестинальних мікрокапсул без покриття, що містять диклофенак або одну із його солей з задовільною протизапальною активністю і низькою агресивністю відносно шлунка, і фармацевтичної композиції, що містить вищезазначені речовини. Спосіб включає у себе: а) приготування розчину у суміші вода-етанол з альгінатною сіллю, додавання диклофенаку або однієї із його солей, попередньо розбавлених поверхнево-активною речовиною і бікарбонатом натрію; b) додавання цього попереднього розчину до розчину з сіллю кальцію; с) повторне суспендування отриманих мікрокапсул, відокремлених у водному розчині альгінатної солі; і d) відокремлення, висушування і послідовне просіювання крізь сита з комірками 1000 і 250 мікронів отриманих мікрокапсул; і відбір фракції, що залишається між цими двома ситами. Запропонована фармацевтична композиція може мати форму ліків для перорального введення, включаючи тверді таблетки, таблетки для жування, порошки для водної суспензії тощо.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/EP2012/054904 WO2013139377A1 (en) | 2012-03-20 | 2012-03-20 | Method for producing enteric alginate microcapsules via ionic gelation containing diclofenac or one of the salts thereof and multiparticled pharmaceutical composition containing them |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| UA112345C2 true UA112345C2 (uk) | 2016-08-25 |
Family
ID=45855800
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| UAA201410294A UA112345C2 (uk) | 2012-03-20 | 2012-03-20 | Спосіб виготовлення за допомогою іонного желатинування інтестинальних альгінатних мікрокапсул, які містять диклофенак або одну із його солей, і багаточасткова фармацевтична композиція, що містить такі мікрокапсули |
Country Status (15)
| Country | Link |
|---|---|
| US (2) | US9668978B2 (uk) |
| EP (1) | EP2827843B1 (uk) |
| CN (1) | CN104244927B (uk) |
| AR (1) | AR090187A1 (uk) |
| BR (1) | BR112014023278B1 (uk) |
| CA (1) | CA2899664C (uk) |
| CL (2) | CL2014002465A1 (uk) |
| ES (1) | ES2584403T3 (uk) |
| MX (1) | MX354454B (uk) |
| PH (1) | PH12014501981B1 (uk) |
| PL (1) | PL2827843T3 (uk) |
| SG (1) | SG11201505320TA (uk) |
| UA (1) | UA112345C2 (uk) |
| WO (1) | WO2013139377A1 (uk) |
| ZA (1) | ZA201406886B (uk) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10786458B2 (en) | 2015-03-31 | 2020-09-29 | Laboratorios Bago S.A. | Procedure for preparing enteric-coated pellets containing a proton pump inhibitor and multi-particle pharmaceutical compositions containing them |
| EP3377046A1 (en) * | 2015-11-17 | 2018-09-26 | Rontis Hellas S.A. | Pharmaceutical composition containing a non-steroidal antiinflammatory drug and a proton pump inhibitor |
| CN109498571B (zh) * | 2018-11-19 | 2019-09-10 | 朗天药业(湖北)有限公司 | 一种艾司奥美拉唑钠缓释微球及其制备方法 |
| TW202126301A (zh) | 2019-10-04 | 2021-07-16 | 愛爾蘭商席歐拉斯製藥有限公司 | 小兒懸浮調配物 |
| CN112494450A (zh) * | 2020-12-12 | 2021-03-16 | 海南海神同洲制药有限公司 | 化学药专用口腔崩解片包覆结构及其制备方法 |
| CN115317464B (zh) * | 2022-09-01 | 2023-08-08 | 苏州弘森药业股份有限公司 | 一种双氯芬酸钾微胶囊及其制备方法 |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0520119A1 (de) | 1991-06-17 | 1992-12-30 | Spirig Ag Pharmazeutische Präparate | Neue orale Diclofenaczubereitung |
| EP0653935B1 (en) | 1992-08-05 | 2002-05-08 | F.H. FAULDING & CO. LIMITED | Pelletised pharmaceutical composition |
| ES2068762B1 (es) * | 1993-07-21 | 1995-12-01 | Lipotec Sa | Un nuevo preparado farmaceutico para mejorar la biodisponibilidad de drogas de dificil absorcion y procedimiento para su obtencion. |
| US6096344A (en) * | 1995-07-28 | 2000-08-01 | Advanced Polymer Systems, Inc. | Bioerodible porous compositions |
| SE9600070D0 (sv) * | 1996-01-08 | 1996-01-08 | Astra Ab | New oral pharmaceutical dosage forms |
| US7687542B2 (en) * | 1996-05-17 | 2010-03-30 | Kowa Pharmaeuticals America, Inc. | Rapidly bioavailable tablet and capsule formulations of diclofenac |
| US6544556B1 (en) * | 2000-09-11 | 2003-04-08 | Andrx Corporation | Pharmaceutical formulations containing a non-steroidal antiinflammatory drug and a proton pump inhibitor |
| AR044398A1 (es) | 2004-05-19 | 2005-09-14 | Bago Sa Labor | Procedimiento para la elaboracion de microcapsulas recubiertas que contienen agentes farmacologicamente activos y composiciones farmaceuticas conteniendo dichas microcapsulas". |
-
2012
- 2012-03-20 WO PCT/EP2012/054904 patent/WO2013139377A1/en not_active Ceased
- 2012-03-20 MX MX2014011289A patent/MX354454B/es active IP Right Grant
- 2012-03-20 EP EP12709640.2A patent/EP2827843B1/en active Active
- 2012-03-20 CN CN201280071655.7A patent/CN104244927B/zh not_active Expired - Fee Related
- 2012-03-20 PL PL12709640.2T patent/PL2827843T3/pl unknown
- 2012-03-20 BR BR112014023278-4A patent/BR112014023278B1/pt not_active IP Right Cessation
- 2012-03-20 CA CA2899664A patent/CA2899664C/en active Active
- 2012-03-20 ES ES12709640.2T patent/ES2584403T3/es active Active
- 2012-03-20 SG SG11201505320TA patent/SG11201505320TA/en unknown
- 2012-03-20 UA UAA201410294A patent/UA112345C2/uk unknown
- 2012-03-20 US US14/386,377 patent/US9668978B2/en active Active
-
2013
- 2013-02-27 AR ARP130100626A patent/AR090187A1/es not_active Application Discontinuation
-
2014
- 2014-09-05 PH PH12014501981A patent/PH12014501981B1/en unknown
- 2014-09-17 CL CL2014002465A patent/CL2014002465A1/es unknown
- 2014-09-19 ZA ZA2014/06886A patent/ZA201406886B/en unknown
-
2016
- 2016-12-27 CL CL2016003348A patent/CL2016003348A1/es unknown
-
2017
- 2017-03-09 US US15/454,127 patent/US9918941B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| SG11201505320TA (en) | 2015-08-28 |
| BR112014023278A2 (uk) | 2017-06-20 |
| CA2899664C (en) | 2019-07-09 |
| MX2014011289A (es) | 2015-02-17 |
| WO2013139377A1 (en) | 2013-09-26 |
| MX354454B (es) | 2018-03-06 |
| AR090187A1 (es) | 2014-10-22 |
| BR112014023278B1 (pt) | 2021-11-16 |
| CN104244927A (zh) | 2014-12-24 |
| PH12014501981A1 (en) | 2014-11-24 |
| CL2014002465A1 (es) | 2015-05-08 |
| EP2827843A1 (en) | 2015-01-28 |
| CN104244927B (zh) | 2017-03-15 |
| ZA201406886B (en) | 2015-06-24 |
| US20150072000A1 (en) | 2015-03-12 |
| CA2899664A1 (en) | 2013-09-26 |
| ES2584403T3 (es) | 2016-09-27 |
| US9668978B2 (en) | 2017-06-06 |
| US20170172934A1 (en) | 2017-06-22 |
| PH12014501981B1 (en) | 2014-11-24 |
| EP2827843B1 (en) | 2016-05-25 |
| US9918941B2 (en) | 2018-03-20 |
| CL2016003348A1 (es) | 2018-03-23 |
| PL2827843T3 (pl) | 2016-11-30 |
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