CY1114499T1 - Βιοδιαθεσιμες στερεες δοσολογικες μορφες μεταξαλονης - Google Patents
Βιοδιαθεσιμες στερεες δοσολογικες μορφες μεταξαλονηςInfo
- Publication number
- CY1114499T1 CY1114499T1 CY20131100902T CY131100902T CY1114499T1 CY 1114499 T1 CY1114499 T1 CY 1114499T1 CY 20131100902 T CY20131100902 T CY 20131100902T CY 131100902 T CY131100902 T CY 131100902T CY 1114499 T1 CY1114499 T1 CY 1114499T1
- Authority
- CY
- Cyprus
- Prior art keywords
- dosage form
- metaxalone
- blade
- rpm
- stirred
- Prior art date
Links
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
- A61K31/33—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
- A61K31/42—Oxazoles
- A61K31/421—1,3-Oxazoles, e.g. pemoline, trimethadione
-
- 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
- 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
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- 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
- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
- A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Physical Education & Sports Medicine (AREA)
- Inorganic Chemistry (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Neurology (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Μια φαρμακευτική στερεή δοσολογική μορφή περιλαμβάνει μεταξαλόνη και τουλάχιστον ένα έκδοχο σκόνης, όπου η μεταξαλόνη αναμειγνύεται σε ξηρή κατάσταση με το τουλάχιστον ένα έκδοχο σκόνης· το μείγμα μεταξαλόνης/σκόνης στη συνέχεια διαβρέχεται και κοκκοποιείται με τουλάχιστον ένα φαρμακευτικώς αποδεκτό πτητικό υγρό· και το υγρό κοκκοποίημα στη συνέχεια ξηραίνεται, αλέθεται και κατόπιν αναμειγνύεται με άλλα έκδοχα σκόνης για να δώσει το τελικό μείγμα μεταξαλόνης/σκόνης το οποίο στη συνέχεια συμπιέζεται για να παραχθεί η φαρμακευτική στερεή δοσολογική μορφή, και όπου: (i) 13% κατά βάρος ή περισσότερο της εν λόγω μεταξαλόνης διαλύεται περίπου 30 λεπτά από τη στιγμή που η εν λόγω δοσολογική μορφή τοποθετηθεί σε ένα αιχμηρό γυάλινο δοχείο διάλυσης πληρωμένο με 1000 mL απιονισμένου νερού, διατηρούμενο στους 25°C και αναδευόμενο σε μια ταχύτητα πτερυγίου 100 rpm χρησιμοποιώντας μια USP Τύπου II (πτερυγίου) συσκευή· ή (ii) 28% κατά βάρος ή περισσότερο της εν λόγω μεταξαλόνης διαλύεται περίπου 30 λεπτά από τη στιγμή που η εν λόγω δοσολογική μορφή τοποθετηθεί σε ένα πρότυπο γυάλινο δοχείο διάλυσης πληρωμένο με 1000 mL απιονισμένου νερού, διατηρούμενο στους 35°C και αναδευόμενο σε μια ταχύτητα πτερυγίου 100 rpm χρησιμοποιώντας μια USP Τύπου II (πτερυγίου) συσκευή· ή (iii) 27% κατά βάρος ή περισσότερο της εν λόγω μεταξαλόνης διαλύεται περίπου 30 λεπτά από τη στιγμή που η εν λόγω δοσολογική μορφή τοποθετηθεί σε ένα αιχμηρό γυάλινο δοχείο διάλυσης πληρωμένο με 500 mL ενός υδατικού διαλύματος 0.1% κατά βάρος Λαυρυλοθειικού Νατρίου ανά όγκο νερού, διατηρούμενο στους 37°C και αναδευόμενο σε μια ταχύτητα πτερυγίου 50 rpm χρησιμοποιώντας μια USP Τύπου II (πτερυγίου) συσκευή.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US55125704P | 2004-03-08 | 2004-03-08 | |
EP09165833.6A EP2110124B1 (en) | 2004-03-08 | 2005-03-08 | Bioavailable Solid Dosage Forms of Metaxalone |
Publications (1)
Publication Number | Publication Date |
---|---|
CY1114499T1 true CY1114499T1 (el) | 2016-10-05 |
Family
ID=34964783
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CY20131100902T CY1114499T1 (el) | 2004-03-08 | 2013-10-15 | Βιοδιαθεσιμες στερεες δοσολογικες μορφες μεταξαλονης |
Country Status (11)
Country | Link |
---|---|
US (7) | US20050276844A1 (el) |
EP (2) | EP2110124B1 (el) |
CN (2) | CN103284965A (el) |
AU (1) | AU2005221659B2 (el) |
CA (1) | CA2563739C (el) |
CY (1) | CY1114499T1 (el) |
DK (1) | DK2110124T3 (el) |
ES (1) | ES2430849T3 (el) |
MX (1) | MXPA06010146A (el) |
NZ (1) | NZ588259A (el) |
WO (1) | WO2005087204A1 (el) |
Families Citing this family (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2004019937A1 (en) * | 2002-09-02 | 2004-03-11 | Sun Pharmaceutical Industries Limited | Pharmaceutical composition of metaxalone with enhanced oral bioavailability |
WO2007079198A2 (en) * | 2005-12-29 | 2007-07-12 | Teva Pharmaceutical Industries Ltd. | Metaxalone formulations and methods for the preparation thereof |
WO2009019662A2 (en) * | 2007-08-09 | 2009-02-12 | Ranbaxy Laboratories Limited | Oral metaxalone compositions |
WO2009085637A1 (en) * | 2007-12-21 | 2009-07-09 | Url Pharma, Inc. | Amorphous metaxalone and amorphous dispersions thereof |
DK2421513T3 (en) | 2009-04-24 | 2018-03-26 | Iceutica Pty Ltd | UNKNOWN FORMULATION WITH INDOMETHACIN |
AU2010239082B2 (en) * | 2009-04-24 | 2014-10-16 | Iceutica Pty Ltd | A novel formulation of metaxalone |
CN102232938B (zh) * | 2010-05-06 | 2014-06-11 | 杭州赛利药物研究所有限公司 | 美他沙酮胶囊及其制备方法 |
KR20160039608A (ko) * | 2013-07-22 | 2016-04-11 | 아이슈티카 인코포레이티드 | 메탁살론 제형 |
US9526734B2 (en) | 2014-06-09 | 2016-12-27 | Iceutica Pty Ltd. | Formulation of meloxicam |
US11672781B2 (en) * | 2018-05-07 | 2023-06-13 | Prana Biosciences Inc | Metaxalone formulations |
CN109157527B (zh) * | 2018-07-25 | 2021-05-04 | 珠海润都制药股份有限公司 | 一种厄贝沙坦胶囊及其制备方法 |
US20200405693A1 (en) * | 2019-06-25 | 2020-12-31 | Primus Pharmaceuticals, Inc. | Reduced dose metaxalone formulations |
US11918559B2 (en) * | 2019-06-25 | 2024-03-05 | Primus Pharmceuticals, Inc. | Reduced dose metaxalone formulations |
Family Cites Families (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4036957A (en) * | 1975-11-18 | 1977-07-19 | A. H. Robins Company, Inc. | Phenoxy compounds in combinations to suppress gastric bleeding in aspirin therapy |
US3993767A (en) * | 1975-11-18 | 1976-11-23 | A. H. Robins Company, Incorporated | Compositions to suppress gastric bleeding in indomethacin and phenylbutazone therapy |
JP3766468B2 (ja) * | 1996-04-18 | 2006-04-12 | 麒麟麦酒株式会社 | レーザ印字用媒体 |
US5800834A (en) * | 1996-06-10 | 1998-09-01 | Spireas; Spiridon | Liquisolid systems and methods of preparing same |
US6096337A (en) | 1996-06-10 | 2000-08-01 | Spireas; Spiridon | Liquisolid systems and methods of preparing same |
DE19930143C1 (de) * | 1999-06-30 | 2001-07-12 | Wincor Nixdorf Gmbh & Co Kg | Geräteanordnung mit einer in einem Gehäuse gehaltenen Baugruppe |
US6407128B1 (en) * | 2001-12-03 | 2002-06-18 | Elan Pharmaceuticals, Inc. | Method for increasing the bioavailability of metaxalone |
WO2004019937A1 (en) * | 2002-09-02 | 2004-03-11 | Sun Pharmaceutical Industries Limited | Pharmaceutical composition of metaxalone with enhanced oral bioavailability |
CA2534924A1 (en) * | 2003-08-08 | 2005-02-24 | Elan Pharma International Ltd. | Novel metaxalone compositions |
-
2005
- 2005-03-08 US US11/075,170 patent/US20050276844A1/en not_active Abandoned
- 2005-03-08 CN CN2013101287061A patent/CN103284965A/zh active Pending
- 2005-03-08 DK DK09165833.6T patent/DK2110124T3/da active
- 2005-03-08 NZ NZ588259A patent/NZ588259A/xx not_active IP Right Cessation
- 2005-03-08 AU AU2005221659A patent/AU2005221659B2/en not_active Ceased
- 2005-03-08 CN CNA200580014388XA patent/CN1980642A/zh active Pending
- 2005-03-08 ES ES09165833T patent/ES2430849T3/es active Active
- 2005-03-08 EP EP09165833.6A patent/EP2110124B1/en active Active
- 2005-03-08 MX MXPA06010146A patent/MXPA06010146A/es active IP Right Grant
- 2005-03-08 EP EP05732516A patent/EP1755559A1/en not_active Ceased
- 2005-03-08 CA CA2563739A patent/CA2563739C/en not_active Expired - Fee Related
- 2005-03-08 WO PCT/US2005/007480 patent/WO2005087204A1/en active Application Filing
-
2009
- 2009-05-15 US US12/466,544 patent/US20100099723A1/en not_active Abandoned
-
2011
- 2011-02-03 US US13/020,347 patent/US20110124694A1/en not_active Abandoned
-
2012
- 2012-10-31 US US13/665,695 patent/US20130245082A1/en not_active Abandoned
- 2012-10-31 US US13/665,868 patent/US20130245083A1/en not_active Abandoned
-
2013
- 2013-10-15 CY CY20131100902T patent/CY1114499T1/el unknown
-
2015
- 2015-08-10 US US14/822,771 patent/US20160158203A1/en not_active Abandoned
- 2015-08-21 US US14/832,580 patent/US20150352080A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
DK2110124T3 (da) | 2013-10-21 |
AU2005221659B2 (en) | 2008-07-03 |
CA2563739C (en) | 2013-07-09 |
MXPA06010146A (es) | 2007-05-11 |
US20130245082A1 (en) | 2013-09-19 |
CN1980642A (zh) | 2007-06-13 |
AU2005221659A1 (en) | 2005-09-22 |
CN103284965A (zh) | 2013-09-11 |
US20150352080A1 (en) | 2015-12-10 |
EP2110124B1 (en) | 2013-07-17 |
EP1755559A1 (en) | 2007-02-28 |
CA2563739A1 (en) | 2005-09-22 |
US20110124694A1 (en) | 2011-05-26 |
US20050276844A1 (en) | 2005-12-15 |
EP2110124A1 (en) | 2009-10-21 |
US20100099723A1 (en) | 2010-04-22 |
ES2430849T3 (es) | 2013-11-22 |
US20160158203A1 (en) | 2016-06-09 |
US20130245083A1 (en) | 2013-09-19 |
NZ588259A (en) | 2012-09-28 |
WO2005087204A1 (en) | 2005-09-22 |
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