MX377251B - Formas de dosis de liberacion controlada para substancias de farmaco de alta dosis, solubles en agua e higroscopicas. - Google Patents
Formas de dosis de liberacion controlada para substancias de farmaco de alta dosis, solubles en agua e higroscopicas.Info
- Publication number
- MX377251B MX377251B MX2012011022A MX2012011022A MX377251B MX 377251 B MX377251 B MX 377251B MX 2012011022 A MX2012011022 A MX 2012011022A MX 2012011022 A MX2012011022 A MX 2012011022A MX 377251 B MX377251 B MX 377251B
- Authority
- MX
- Mexico
- Prior art keywords
- dosage forms
- controlled release
- release dosage
- controlled
- soluble
- Prior art date
Links
- 238000013270 controlled release Methods 0.000 title abstract 6
- 239000002552 dosage form Substances 0.000 title abstract 5
- 229940088679 drug related substance Drugs 0.000 title 1
- 238000009472 formulation Methods 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- 239000003814 drug Substances 0.000 abstract 1
- 229940079593 drug Drugs 0.000 abstract 1
- 229940127022 high-dose drug Drugs 0.000 abstract 1
- 150000004677 hydrates Chemical class 0.000 abstract 1
- 239000012729 immediate-release (IR) formulation Substances 0.000 abstract 1
- 230000002035 prolonged effect Effects 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 239000012453 solvate Substances 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
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
- A61K9/20—Pills, tablets, discs, rods
- 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
-
- 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
-
- 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
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61K9/2806—Coating materials
- A61K9/2833—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
- A61K9/20—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
-
- 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
- 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
-
- 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
- A61K9/2806—Coating materials
- 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)
-
- 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
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2893—Tablet coating processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
Landscapes
- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
La presente describe formas de dosis de liberación controlada. Las formulaciones de liberación controlada aquí descritas proporcionan un suministro prolongado de fármacos de alta dosis que son altamente solubles en agua y altamente higroscópicas. En modalidades específicas, se describen formas de dosis de liberación controlada para suministrar un fármaco seleccionado de GHB y sales, hidratos, tautómeros, solventes y complejos de GHB farmacéuticamente aceptables. Las formas de dosis de liberación controlada aquí descritas pueden incorporar formulaciones tanto de liberación controlada como de liberación inmediata en una forma de dosis unitaria individual.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US31721210P | 2010-03-24 | 2010-03-24 | |
PCT/US2011/029802 WO2011119839A1 (en) | 2010-03-24 | 2011-03-24 | Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances |
Publications (2)
Publication Number | Publication Date |
---|---|
MX2012011022A MX2012011022A (es) | 2013-02-26 |
MX377251B true MX377251B (es) | 2025-03-07 |
Family
ID=44673619
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2020011961A MX2020011961A (es) | 2010-03-24 | 2011-03-24 | Formas de dosis de liberacion controlada para substancias de farmaco de alta dosis, solubles en agua e higroscopicas. |
MX2012011022A MX377251B (es) | 2010-03-24 | 2011-03-24 | Formas de dosis de liberacion controlada para substancias de farmaco de alta dosis, solubles en agua e higroscopicas. |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2020011961A MX2020011961A (es) | 2010-03-24 | 2011-03-24 | Formas de dosis de liberacion controlada para substancias de farmaco de alta dosis, solubles en agua e higroscopicas. |
Country Status (10)
Country | Link |
---|---|
US (9) | US20120076865A1 (es) |
EP (1) | EP2549987A4 (es) |
JP (1) | JP5968300B2 (es) |
CN (1) | CN102917697B (es) |
AU (1) | AU2011232408B2 (es) |
BR (1) | BR112012024019B1 (es) |
CA (1) | CA2794171C (es) |
IL (1) | IL222012A (es) |
MX (2) | MX2020011961A (es) |
WO (1) | WO2011119839A1 (es) |
Cited By (10)
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US11400065B2 (en) | 2019-03-01 | 2022-08-02 | Flamel Ireland Limited | Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state |
US11504347B1 (en) | 2016-07-22 | 2022-11-22 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
US11583510B1 (en) | 2022-02-07 | 2023-02-21 | Flamel Ireland Limited | Methods of administering gamma hydroxybutyrate formulations after a high-fat meal |
US11602513B1 (en) | 2016-07-22 | 2023-03-14 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
US11602512B1 (en) | 2016-07-22 | 2023-03-14 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
US11779557B1 (en) | 2022-02-07 | 2023-10-10 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
US11839597B2 (en) | 2016-07-22 | 2023-12-12 | 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 |
US12186296B1 (en) | 2016-07-22 | 2025-01-07 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
US12263151B2 (en) | 2024-09-18 | 2025-04-01 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
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US8771735B2 (en) | 2008-11-04 | 2014-07-08 | Jazz Pharmaceuticals, Inc. | Immediate release dosage forms of sodium oxybate |
US8778398B2 (en) * | 2008-11-04 | 2014-07-15 | Jazz Pharmaceuticals, Inc. | Immediate release formulations and dosage forms of gamma-hydroxybutyrate |
US20120076865A1 (en) | 2010-03-24 | 2012-03-29 | Jazz Pharmaceuticals, Inc. | Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances |
EP2961738B1 (en) | 2012-11-14 | 2019-12-25 | CJ CheilJedang Corporation | Production of salts of 4-hydroxybutyrate using biobased raw materials |
JP6285952B2 (ja) * | 2012-12-14 | 2018-02-28 | エスアイ・グループ・インコーポレイテッドSi Group, Inc. | 高含量のイブプロフェンナトリウム顆粒、これらの調製、及び非発泡性固体剤形の調製におけるこれらの使用 |
US20150376152A1 (en) | 2013-02-13 | 2015-12-31 | Metabolix, Inc. | Process for Ultra Pure Chemical Production from Biobased Raw Starting Materials |
US9050302B2 (en) | 2013-03-01 | 2015-06-09 | Jazz Pharmaceuticals Ireland Limited | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters |
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DK3131549T3 (en) * | 2014-07-09 | 2018-05-28 | Pf Medicament | PROCEDURE FOR TREATING MOVEMENT DISORDERS WITH BEFIRADOL |
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US10398662B1 (en) | 2015-02-18 | 2019-09-03 | Jazz Pharma Ireland Limited | GHB formulation and method for its manufacture |
FR3049463B1 (fr) | 2016-04-01 | 2019-07-05 | Debregeas Et Associes Pharma | Doses unitaires a liberation immediate de ghb ou de l'un de ses sels therapeutiquement acceptables administrees par voie orale et leur utilisation pour maintenir l'abstinence alcoolique |
US11000498B2 (en) | 2016-07-22 | 2021-05-11 | Flamel Ireland Limited | Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics |
US20180263936A1 (en) | 2017-03-17 | 2018-09-20 | Jazz Pharmaceuticals Ireland Limited | Gamma-hydroxybutyrate compositions and their use for the treatment of disorders |
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WO2019126214A1 (en) | 2017-12-18 | 2019-06-27 | Tris Pharma, Inc. | Pharmaceutical composition comprising ghb gastro-retentive raft forming systems having trigger pulse drug release |
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JP7349428B2 (ja) * | 2017-12-20 | 2023-09-22 | フラメル アイルランド リミテッド | 改善された安定性を有するパッケージされた修飾放出ガンマ-ヒドロキシブチラート製剤 |
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CN115803017A (zh) | 2020-06-18 | 2023-03-14 | 凯瑞康宁生物工程有限公司 | 水溶性活性药物成分的药物造粒物 |
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2011
- 2011-03-24 US US13/071,369 patent/US20120076865A1/en not_active Abandoned
- 2011-03-24 JP JP2013501486A patent/JP5968300B2/ja active Active
- 2011-03-24 WO PCT/US2011/029802 patent/WO2011119839A1/en active Application Filing
- 2011-03-24 MX MX2020011961A patent/MX2020011961A/es unknown
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- 2011-03-24 BR BR112012024019-6A patent/BR112012024019B1/pt active IP Right Grant
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- 2019-12-12 US US16/712,260 patent/US10987310B2/en active Active
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- 2020-06-30 US US16/916,677 patent/US10813885B1/en active Active
- 2020-09-04 US US17/012,831 patent/US10966931B2/en active Active
- 2020-09-04 US US17/012,823 patent/US10959956B2/en active Active
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2021
- 2021-04-07 US US17/224,781 patent/US11090269B1/en active Active
- 2021-07-20 US US17/380,509 patent/US11207270B2/en active Active
- 2021-12-13 US US17/549,151 patent/US20220096384A1/en not_active Abandoned
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US20210244670A1 (en) | 2021-08-12 |
BR112012024019A2 (pt) | 2016-08-30 |
MX2020011961A (es) | 2022-04-19 |
US11207270B2 (en) | 2021-12-28 |
US11090269B1 (en) | 2021-08-17 |
JP5968300B2 (ja) | 2016-08-10 |
US10758488B2 (en) | 2020-09-01 |
WO2011119839A1 (en) | 2011-09-29 |
US20200113840A1 (en) | 2020-04-16 |
BR112012024019B1 (pt) | 2021-10-19 |
US10987310B2 (en) | 2021-04-27 |
AU2011232408A1 (en) | 2012-10-11 |
MX2012011022A (es) | 2013-02-26 |
US20180318222A1 (en) | 2018-11-08 |
CA2794171A1 (en) | 2011-09-29 |
CN102917697B (zh) | 2016-01-20 |
US20220096384A1 (en) | 2022-03-31 |
AU2011232408B2 (en) | 2015-07-30 |
US10813885B1 (en) | 2020-10-27 |
US20210346300A1 (en) | 2021-11-11 |
JP2013522373A (ja) | 2013-06-13 |
US10959956B2 (en) | 2021-03-30 |
EP2549987A4 (en) | 2015-01-21 |
CA2794171C (en) | 2018-07-03 |
US20120076865A1 (en) | 2012-03-29 |
US20200397705A1 (en) | 2020-12-24 |
US20200330389A1 (en) | 2020-10-22 |
IL222012A (en) | 2017-11-30 |
US10966931B2 (en) | 2021-04-06 |
EP2549987A1 (en) | 2013-01-30 |
US20200397706A1 (en) | 2020-12-24 |
CN102917697A (zh) | 2013-02-06 |
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