ES2530681T3 - Composiciones farmacéuticas flotantes de liberación controlada - Google Patents
Composiciones farmacéuticas flotantes de liberación controlada Download PDFInfo
- Publication number
- ES2530681T3 ES2530681T3 ES10728844T ES10728844T ES2530681T3 ES 2530681 T3 ES2530681 T3 ES 2530681T3 ES 10728844 T ES10728844 T ES 10728844T ES 10728844 T ES10728844 T ES 10728844T ES 2530681 T3 ES2530681 T3 ES 2530681T3
- Authority
- ES
- Spain
- Prior art keywords
- controlled release
- release compositions
- coated
- pharmaceutical controlled
- chapter
- Prior art date
- Legal status (The legal status 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 status listed.)
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Classifications
-
- 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
- A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
-
- 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
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
-
- 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
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
-
- 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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- 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
- A61K9/5015—Organic compounds, e.g. fats, sugars
-
- 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
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
-
- 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
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
-
- 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
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Composición farmacéutica que comprende una pluralidad de micropartículas revestidas de liberación controlada que comprenden cada una un núcleo flotante, en la superficie del que se deposita una capa que contiene al menos un principio activo, estando dicha capa revestida con un revestimiento de liberación controlada, caracterizada por el hecho de que dicho núcleo flotante comprende al menos un 50 % en peso de acetato ftalato de celulosa y presenta una densidad aparente después de la sedimentación tal como se describe en la Farmacopea Europea, edición 6.4, en el capítulo 02.09.34, menor o igual que 0,6 g/ml y dichas micropartículas revestidas presentan una densidad aparente después de la sedimentación tal como se describe en la Farmacopea Europea, edición 6.4, en el capítulo 02.09.34, menor o igual que 0,7 g/ml.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR0953601A FR2945947B1 (fr) | 2009-05-29 | 2009-05-29 | Compositions pharmaceutiques flottantes a liberation controlee |
PCT/FR2010/051038 WO2010136739A2 (fr) | 2009-05-29 | 2010-05-28 | Compositions pharmaceutiques flottantes à libération contrôlée |
Publications (1)
Publication Number | Publication Date |
---|---|
ES2530681T3 true ES2530681T3 (es) | 2015-03-04 |
Family
ID=41470914
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ES10728844T Active ES2530681T3 (es) | 2009-05-29 | 2010-05-28 | Composiciones farmacéuticas flotantes de liberación controlada |
Country Status (14)
Country | Link |
---|---|
US (2) | US9561179B2 (es) |
EP (1) | EP2435030B1 (es) |
JP (1) | JP5680627B2 (es) |
CN (1) | CN102448448A (es) |
CA (1) | CA2763539C (es) |
CY (1) | CY1116018T1 (es) |
DK (1) | DK2435030T3 (es) |
ES (1) | ES2530681T3 (es) |
FR (1) | FR2945947B1 (es) |
HR (1) | HRP20150123T1 (es) |
PL (1) | PL2435030T3 (es) |
PT (1) | PT2435030E (es) |
SI (1) | SI2435030T1 (es) |
WO (1) | WO2010136739A2 (es) |
Families Citing this family (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2945947B1 (fr) | 2009-05-29 | 2011-07-29 | Flamel Tech Sa | Compositions pharmaceutiques flottantes a liberation controlee |
JP6042880B2 (ja) * | 2011-06-01 | 2016-12-14 | エフ エム シー コーポレーションFmc Corporation | 放出を制御された固形剤形 |
CN104797604B (zh) * | 2012-08-24 | 2018-03-06 | 陶氏环球技术有限责任公司 | 在碱金属羧酸盐和脂族羧酸的存在下制备酯化纤维素醚的方法 |
WO2014055738A1 (en) * | 2012-10-04 | 2014-04-10 | Fmc Corporation | Controlled release solid dose forms |
WO2014055740A1 (en) * | 2012-10-04 | 2014-04-10 | Fmc Corporation | Controlled release solid dose forms |
EP2837391B1 (en) * | 2013-08-12 | 2017-05-10 | Shin-Etsu Chemical Co., Ltd. | Hypromellose acetate succinate for use as hot-melt extrusion carrier, hot-melt extrusion composition, and method for producing hot-melt extrudate |
US11602512B1 (en) | 2016-07-22 | 2023-03-14 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
UY37341A (es) | 2016-07-22 | 2017-11-30 | Flamel Ireland Ltd | Formulaciones de gamma-hidroxibutirato de liberación modificada con farmacocinética mejorada |
US11602513B1 (en) | 2016-07-22 | 2023-03-14 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
US11986451B1 (en) | 2016-07-22 | 2024-05-21 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
US11504347B1 (en) | 2016-07-22 | 2022-11-22 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
CN107184565B (zh) * | 2017-06-01 | 2018-04-03 | 海南妙音春制药有限公司 | 一种布洛芬缓释胶囊的制备方法 |
CN109078186B (zh) * | 2017-06-14 | 2021-09-03 | 江苏恒瑞医药股份有限公司 | 一种胃漂浮组合物及其制备方法 |
WO2019126218A1 (en) | 2017-12-18 | 2019-06-27 | Tris Pharma, Inc. | Modified release drug powder composition comprising gastro-retentive raft forming systems having trigger pulse drug release |
WO2019126215A1 (en) | 2017-12-18 | 2019-06-27 | Tris Pharma, Inc. | Ghb pharmaceutical compositions comprising a floating interpenetrating polymer network forming system |
US11337920B2 (en) | 2017-12-18 | 2022-05-24 | Tris Pharma, Inc. | Pharmaceutical composition comprising GHB gastro-retentive raft forming systems having trigger pulse drug release |
AU2020231916A1 (en) | 2019-03-01 | 2021-08-05 | Flamel Ireland Limited | Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state |
CN112385816A (zh) * | 2020-11-09 | 2021-02-23 | 江苏里物食品科技有限公司 | 一种用于食品增鲜的酵母提取物 |
JP2022150038A (ja) * | 2021-03-25 | 2022-10-07 | 富士フイルムビジネスイノベーション株式会社 | 樹脂粒子 |
US11583510B1 (en) | 2022-02-07 | 2023-02-21 | Flamel Ireland Limited | Methods of administering gamma hydroxybutyrate formulations after a high-fat meal |
US11779557B1 (en) | 2022-02-07 | 2023-10-10 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
Family Cites Families (24)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5512411B2 (es) | 1974-03-12 | 1980-04-02 | ||
US4101650A (en) | 1977-04-06 | 1978-07-18 | Zaidan Hojin Biseibutsu Kagaku Kenkyu Kai | Pepstatin floating minicapsules |
US4309406A (en) * | 1979-07-10 | 1982-01-05 | American Home Products Corporation | Sustained release pharmaceutical compositions |
JPS62195323A (ja) | 1986-02-24 | 1987-08-28 | Eisai Co Ltd | 胃内滞留型粒子 |
DE3803482A1 (de) * | 1988-02-05 | 1989-08-17 | Lohmann Therapie Syst Lts | Schwimmfaehiges orales therapeutisches system |
US5681585A (en) * | 1991-12-24 | 1997-10-28 | Euro-Celtique, S.A. | Stabilized controlled release substrate having a coating derived from an aqueous dispersion of hydrophobic polymer |
DE69331906T2 (de) * | 1992-08-05 | 2002-12-19 | Faulding F H & Co Ltd | Granulierte pharmazeutische zusammensetzung |
FR2725623A1 (fr) | 1994-10-18 | 1996-04-19 | Flamel Tech Sa | Microcapsules medicamenteuses et/ou nutritionnelles pour administration per os |
US20040018236A1 (en) * | 1995-05-08 | 2004-01-29 | Robert Gurny | Nanoparticles for oral administration of pharmaceutical agents of low solubility |
SE9702533D0 (sv) * | 1997-07-01 | 1997-07-01 | Astra Ab | New oral formulation |
IN186245B (es) | 1997-09-19 | 2001-07-14 | Ranbaxy Lab Ltd | |
WO2001058424A1 (en) * | 2000-02-09 | 2001-08-16 | West Pharmaceutical Services Drug Delivery & Clinical Research Centre Limited | Floating drug delivery composition |
WO2002102415A1 (en) | 2001-06-18 | 2002-12-27 | Blue Cross Laboratories Limited | Gastric floating system |
FR2830447B1 (fr) * | 2001-10-09 | 2004-04-16 | Flamel Tech Sa | Forme galenique orale microparticulaire pour la liberation retardee et controlee de principes actifs pharmaceutiques |
US20040208936A1 (en) * | 2002-07-22 | 2004-10-21 | Roland Chorin | Novel compositions |
FR2842735B1 (fr) | 2002-07-26 | 2006-01-06 | Flamel Tech Sa | Microcapsules a liberation modifiee de principes actifs peu solubles pour l'administration per os |
FR2842736B1 (fr) * | 2002-07-26 | 2005-07-22 | Flamel Tech Sa | Formulation pharmaceutique orale sous forme d'une pluralite de microcapsules permettant la liberation prolongee de principe(s) actif(s) peu soluble(s) |
GB0427455D0 (en) * | 2004-12-15 | 2005-01-19 | Jagotec Ag | Dosage forms |
WO2006131790A2 (en) * | 2005-06-09 | 2006-12-14 | Flamel Technologies | Oral ribavirin pharmaceutical composition |
EP1745775B1 (en) | 2005-07-19 | 2008-05-28 | Ethypharm | Gastroretentive formulations and manufacturing process thereof. |
CN101288659B (zh) | 2007-04-18 | 2014-06-18 | 王雷波 | 一种胃内漂浮型微丸及其制备方法 |
JP2008273909A (ja) * | 2007-05-07 | 2008-11-13 | Sekisui Chem Co Ltd | 医薬組成物 |
FR2930147B1 (fr) | 2008-04-18 | 2013-02-08 | Flamel Tech Sa | Forme orale solide dotee d'un double profil de liberation |
FR2945947B1 (fr) | 2009-05-29 | 2011-07-29 | Flamel Tech Sa | Compositions pharmaceutiques flottantes a liberation controlee |
-
2009
- 2009-05-29 FR FR0953601A patent/FR2945947B1/fr active Active
-
2010
- 2010-05-28 CN CN2010800245916A patent/CN102448448A/zh active Pending
- 2010-05-28 US US12/790,201 patent/US9561179B2/en active Active
- 2010-05-28 PT PT107288441T patent/PT2435030E/pt unknown
- 2010-05-28 EP EP10728844.1A patent/EP2435030B1/fr active Active
- 2010-05-28 DK DK10728844.1T patent/DK2435030T3/en active
- 2010-05-28 WO PCT/FR2010/051038 patent/WO2010136739A2/fr active Application Filing
- 2010-05-28 ES ES10728844T patent/ES2530681T3/es active Active
- 2010-05-28 PL PL10728844T patent/PL2435030T3/pl unknown
- 2010-05-28 SI SI201030876T patent/SI2435030T1/sl unknown
- 2010-05-28 CA CA2763539A patent/CA2763539C/fr active Active
- 2010-05-28 JP JP2012512441A patent/JP5680627B2/ja active Active
-
2015
- 2015-02-02 HR HRP20150123AT patent/HRP20150123T1/hr unknown
- 2015-02-19 CY CY20151100177T patent/CY1116018T1/el unknown
-
2016
- 2016-07-01 US US15/201,000 patent/US10092511B2/en active Active
Also Published As
Publication number | Publication date |
---|---|
CA2763539C (fr) | 2018-10-23 |
JP2012528134A (ja) | 2012-11-12 |
CA2763539A1 (fr) | 2010-12-02 |
FR2945947B1 (fr) | 2011-07-29 |
WO2010136739A2 (fr) | 2010-12-02 |
CY1116018T1 (el) | 2017-01-25 |
HRP20150123T1 (hr) | 2015-04-10 |
US20160310420A1 (en) | 2016-10-27 |
EP2435030B1 (fr) | 2014-11-26 |
PT2435030E (pt) | 2015-02-27 |
SI2435030T1 (sl) | 2015-04-30 |
JP5680627B2 (ja) | 2015-03-04 |
US9561179B2 (en) | 2017-02-07 |
US20100310667A1 (en) | 2010-12-09 |
WO2010136739A3 (fr) | 2011-11-10 |
FR2945947A1 (fr) | 2010-12-03 |
CN102448448A (zh) | 2012-05-09 |
PL2435030T3 (pl) | 2015-04-30 |
DK2435030T3 (en) | 2015-02-23 |
US10092511B2 (en) | 2018-10-09 |
EP2435030A2 (fr) | 2012-04-04 |
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