MX2009000849A - Formas de dosificacion liofilizadasdisolvibles oralmente/desintegrables que contienen particulas protegidas. - Google Patents
Formas de dosificacion liofilizadasdisolvibles oralmente/desintegrables que contienen particulas protegidas.Info
- Publication number
- MX2009000849A MX2009000849A MX2009000849A MX2009000849A MX2009000849A MX 2009000849 A MX2009000849 A MX 2009000849A MX 2009000849 A MX2009000849 A MX 2009000849A MX 2009000849 A MX2009000849 A MX 2009000849A MX 2009000849 A MX2009000849 A MX 2009000849A
- Authority
- MX
- Mexico
- Prior art keywords
- orally dissolvable
- disintegrable
- dosage forms
- forms containing
- lyophilized dosage
- Prior art date
Links
- 239000002552 dosage form Substances 0.000 title abstract 4
- 239000002245 particle Substances 0.000 title abstract 3
- 239000008186 active pharmaceutical agent Substances 0.000 abstract 3
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 239000011159 matrix material Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000011253 protective coating Substances 0.000 abstract 1
- 239000002904 solvent Substances 0.000 abstract 1
Classifications
-
- 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
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/426—1,3-Thiazoles
-
- 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
- A61K31/445—Non condensed piperidines, e.g. piperocaine
-
- 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
- A61K9/14—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
- A61K9/1635—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
- A61K9/14—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
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- 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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/2027—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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- 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
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
La presente invención proporciona una forma de dosificación disolvible/desintegrable oralmente, liofilizada, adaptada para dosificación oral directa, que incluye una partícula que contiene el ingrediente farmacéutico activo ("API") que es recubierta con un recubrimiento protector de solvente liofilizante, que protege la forma y/o atributo de la partícula y/o API y una matriz. También se proporciona un método para la fabricación de una forma de dosificación liofilizada disolvible/desintegrable oralmente de acuerdo con la presente invención y un método para el tratamiento de un paciente con una forma de dosificación de acuerdo con la presente invención.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP06291198A EP1891938A1 (en) | 2006-07-24 | 2006-07-24 | High dose orally dissolvable/disintegrable lyophilized dosage form |
EP06291458A EP1905429A1 (en) | 2006-09-18 | 2006-09-18 | Orally dissolvable/disintegrable lyophilized dosage forms containing protected particles |
US11/880,503 US20080031947A1 (en) | 2006-07-24 | 2007-07-23 | Orally dissolvable/disintegrable lyophilized dosage forms containing protected |
PCT/US2007/016690 WO2008013833A2 (en) | 2006-07-24 | 2007-07-24 | Orally dissolvable/disintegrable lyophilized dosage forms containing protected particles |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2009000849A true MX2009000849A (es) | 2009-06-30 |
Family
ID=39029455
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2009000849A MX2009000849A (es) | 2006-07-24 | 2007-07-24 | Formas de dosificacion liofilizadasdisolvibles oralmente/desintegrables que contienen particulas protegidas. |
MX2009000861A MX2009000861A (es) | 2006-07-24 | 2007-07-24 | Formas de dosis que oralmente se puede disolver/desintegrar de alta dosis. |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2009000861A MX2009000861A (es) | 2006-07-24 | 2007-07-24 | Formas de dosis que oralmente se puede disolver/desintegrar de alta dosis. |
Country Status (6)
Country | Link |
---|---|
US (2) | US20080031947A1 (es) |
EP (2) | EP2068826A2 (es) |
JP (2) | JP2009544706A (es) |
CA (2) | CA2658109A1 (es) |
MX (2) | MX2009000849A (es) |
WO (2) | WO2008013808A2 (es) |
Families Citing this family (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20080031947A1 (en) * | 2006-07-24 | 2008-02-07 | Cima Labs Inc. | Orally dissolvable/disintegrable lyophilized dosage forms containing protected |
MX2011001487A (es) * | 2008-08-08 | 2011-03-30 | Mcneil Ppc Inc | Uso de sucralosa como agente granulante. |
EP2359812A1 (en) * | 2010-01-18 | 2011-08-24 | Cephalon France | Oral lyophilised compositions |
EP2525783A1 (en) * | 2010-01-18 | 2012-11-28 | Cephalon France | Improved oral lysophilisates containing pvp/va |
EP2645943A1 (en) | 2010-12-02 | 2013-10-09 | Agile Endosurgery, Inc. | Surgical tool |
US9730885B2 (en) | 2012-07-12 | 2017-08-15 | Mallinckrodt Llc | Extended release, abuse deterrent pharmaceutical compositions |
US11058642B2 (en) * | 2013-04-22 | 2021-07-13 | Tower Laboratories Ltd | Tablets with improved friability |
US9650338B1 (en) | 2016-07-29 | 2017-05-16 | VDM Biochemicals, Inc. | Opioid antagonist compounds and methods of making and using |
US11638698B2 (en) | 2017-04-20 | 2023-05-02 | Zeenar Enterprises Pty Ltd | Liquid crystalline dosage form for administering a statin |
US20210015753A1 (en) * | 2017-11-27 | 2021-01-21 | Dsm Ip Assets B.V. | Freeze-dried multiparticulate solid dosage form |
Family Cites Families (33)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CH528266A (fr) * | 1969-11-26 | 1972-09-30 | Orsymonde | Procédé pour la préparation d'une composition lyophilisée à l'usage cosmétique ou hygiénique |
GB1447988A (en) * | 1973-04-03 | 1976-09-02 | Orsymonde | Pharmaceutical compositions |
FR2539626B2 (fr) * | 1983-01-25 | 1985-06-21 | Lafon Labor | Nouveau procede de preparation de formes galeniques utiles notamment en therapeutique, dietetique, cosmetique et diagnostic, et formes obtenues selon ce procede |
FR2561916B1 (fr) * | 1984-03-30 | 1987-12-11 | Lafon Labor | Forme galenique pour administration orale et son procede de preparation par lyophilisation d'une emission huile dans eau |
GB8724763D0 (en) * | 1987-10-22 | 1987-11-25 | Aps Research Ltd | Sustained-release formulations |
DE3824399A1 (de) * | 1988-07-19 | 1990-01-25 | Ford Werke Ag | Regelbares ringreibgetriebe |
FR2634376B1 (fr) * | 1988-07-21 | 1992-04-17 | Farmalyoc | Nouvelle forme unitaire, solide et poreuse comprenant des microparticules et/ou des nanoparticules, ainsi que sa preparation |
US5223264A (en) * | 1989-10-02 | 1993-06-29 | Cima Labs, Inc. | Pediatric effervescent dosage form |
US5178878A (en) * | 1989-10-02 | 1993-01-12 | Cima Labs, Inc. | Effervescent dosage form with microparticles |
US5558880A (en) * | 1989-12-22 | 1996-09-24 | Janssen Pharmaceutica Inc. | Pharmaceutical and other dosage forms |
US5188825A (en) * | 1989-12-28 | 1993-02-23 | Iles Martin C | Freeze-dried dosage forms and methods for preparing the same |
US5843347A (en) * | 1993-03-23 | 1998-12-01 | Laboratoire L. Lafon | Extrusion and freeze-drying method for preparing particles containing an active ingredient |
CA2128821A1 (en) * | 1993-07-27 | 1995-01-28 | Dilip J. Gole | Freeze-dried pharmaceutical dosage form and process for separation thereof |
DK9500167U3 (da) * | 1995-04-27 | 1996-01-12 | Brdr Christensens Haner A S | Afspærringsindretning af "double-block-and-bleed"-typen |
US5599846A (en) * | 1996-06-28 | 1997-02-04 | Jame Fine Chemicals, Inc. | Phenylephrine tannate compositions |
US6024981A (en) * | 1997-04-16 | 2000-02-15 | Cima Labs Inc. | Rapidly dissolving robust dosage form |
US5976577A (en) * | 1997-07-11 | 1999-11-02 | Rp Scherer Corporation | Process for preparing fast dispersing solid oral dosage form |
US6479496B1 (en) * | 1998-09-10 | 2002-11-12 | Cv Therapeutics, Inc. | Methods for treating angina with ranolazine |
US6740341B1 (en) * | 1998-11-25 | 2004-05-25 | Cima Labs Inc. | Taste masking rapid release coating system |
ATE311227T1 (de) * | 1999-12-01 | 2005-12-15 | Natco Pharma Ltd | Schnell-wirkende, gefrier-trocknete, orale, pharmazeutische formulierung für die behandlung von migräne |
US6754511B1 (en) * | 2000-02-04 | 2004-06-22 | Harris Corporation | Linear signal separation using polarization diversity |
US6316029B1 (en) * | 2000-05-18 | 2001-11-13 | Flak Pharma International, Ltd. | Rapidly disintegrating solid oral dosage form |
JP2003055197A (ja) * | 2001-06-07 | 2003-02-26 | Tanabe Seiyaku Co Ltd | 機能性粒子含有口腔内速崩壊性製剤 |
US20040137061A1 (en) * | 2001-06-07 | 2004-07-15 | Takashi Ishibashi | Functional grain-containing preparations quickly disintegrated in the oral cavity |
US20030190343A1 (en) * | 2002-03-05 | 2003-10-09 | Pfizer Inc. | Palatable pharmaceutical compositions for companion animals |
AU2003224890A1 (en) * | 2002-04-08 | 2003-10-27 | Lavipharm Laboratories Inc. | Drug-complex microparticles and methods of making/using same |
BR0314036A (pt) * | 2002-09-04 | 2005-07-12 | Ranbaxy Lab Ltd | Apresentações farmacêuticas com mascaramento de sabor e processo para sua preparação |
WO2005020994A1 (en) * | 2003-08-29 | 2005-03-10 | Lifecycle Pharma A/S | Solid dispersions comprising tacrolimus |
US20050123596A1 (en) * | 2003-09-23 | 2005-06-09 | Kohane Daniel S. | pH-triggered microparticles |
US7294347B2 (en) * | 2004-06-21 | 2007-11-13 | Council Of Scientific And Industrial Research | Coating compositions for bitterness inhibition |
US20060024370A1 (en) * | 2004-07-29 | 2006-02-02 | Cephalon France | Modafinil oral lyophilizate |
US8193211B2 (en) * | 2004-09-30 | 2012-06-05 | Supernus Pharmaceuticals, Inc. | Controlled release compositions of gamma-hydroxybutyrate |
US20080031947A1 (en) * | 2006-07-24 | 2008-02-07 | Cima Labs Inc. | Orally dissolvable/disintegrable lyophilized dosage forms containing protected |
-
2007
- 2007-07-23 US US11/880,503 patent/US20080031947A1/en not_active Abandoned
- 2007-07-23 US US11/880,531 patent/US20080031949A1/en not_active Abandoned
- 2007-07-24 CA CA002658109A patent/CA2658109A1/en not_active Abandoned
- 2007-07-24 MX MX2009000849A patent/MX2009000849A/es active IP Right Grant
- 2007-07-24 JP JP2009521804A patent/JP2009544706A/ja active Pending
- 2007-07-24 EP EP07836223A patent/EP2068826A2/en not_active Withdrawn
- 2007-07-24 CA CA002658512A patent/CA2658512A1/en not_active Abandoned
- 2007-07-24 WO PCT/US2007/016638 patent/WO2008013808A2/en active Application Filing
- 2007-07-24 WO PCT/US2007/016690 patent/WO2008013833A2/en active Application Filing
- 2007-07-24 JP JP2009521810A patent/JP2009544707A/ja active Pending
- 2007-07-24 EP EP07810726A patent/EP2068824A2/en not_active Withdrawn
- 2007-07-24 MX MX2009000861A patent/MX2009000861A/es active IP Right Grant
Also Published As
Publication number | Publication date |
---|---|
US20080031949A1 (en) | 2008-02-07 |
EP2068826A2 (en) | 2009-06-17 |
CA2658512A1 (en) | 2008-01-31 |
US20080031947A1 (en) | 2008-02-07 |
EP2068824A2 (en) | 2009-06-17 |
WO2008013808A3 (en) | 2008-05-15 |
JP2009544707A (ja) | 2009-12-17 |
CA2658109A1 (en) | 2008-01-31 |
WO2008013833A2 (en) | 2008-01-31 |
JP2009544706A (ja) | 2009-12-17 |
WO2008013808A2 (en) | 2008-01-31 |
WO2008013833A3 (en) | 2008-07-17 |
MX2009000861A (es) | 2009-06-19 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
HH | Correction or change in general | ||
FG | Grant or registration | ||
GB | Transfer or rights | ||
PD | Change of proprietorship |
Owner name: CIMA LABS INC. |