CY1118946T1 - Μορφοποιησεις μεθυλφαινυδατης ελεγχομενης αποδεσμευσης - Google Patents
Μορφοποιησεις μεθυλφαινυδατης ελεγχομενης αποδεσμευσηςInfo
- Publication number
- CY1118946T1 CY1118946T1 CY20171100299T CY171100299T CY1118946T1 CY 1118946 T1 CY1118946 T1 CY 1118946T1 CY 20171100299 T CY20171100299 T CY 20171100299T CY 171100299 T CY171100299 T CY 171100299T CY 1118946 T1 CY1118946 T1 CY 1118946T1
- Authority
- CY
- Cyprus
- Prior art keywords
- granules
- dose
- drug
- extended release
- children
- Prior art date
Links
- 238000013270 controlled release Methods 0.000 title abstract 2
- 239000008187 granular material Substances 0.000 abstract 6
- 239000012729 immediate-release (IR) formulation Substances 0.000 abstract 5
- 239000002775 capsule Substances 0.000 abstract 3
- 239000003814 drug Substances 0.000 abstract 3
- 229940079593 drug Drugs 0.000 abstract 3
- 238000013265 extended release Methods 0.000 abstract 3
- 208000006096 Attention Deficit Disorder with Hyperactivity Diseases 0.000 abstract 1
- 208000036864 Attention deficit/hyperactivity disease Diseases 0.000 abstract 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 abstract 1
- 239000001856 Ethyl cellulose Substances 0.000 abstract 1
- DUGOZIWVEXMGBE-UHFFFAOYSA-N Methylphenidate Chemical compound C=1C=CC=CC=1C(C(=O)OC)C1CCCCN1 DUGOZIWVEXMGBE-UHFFFAOYSA-N 0.000 abstract 1
- 239000007864 aqueous solution Substances 0.000 abstract 1
- 239000011324 bead Substances 0.000 abstract 1
- 239000007931 coated granule Substances 0.000 abstract 1
- 239000011248 coating agent Substances 0.000 abstract 1
- 238000000576 coating method Methods 0.000 abstract 1
- 238000004090 dissolution Methods 0.000 abstract 1
- 239000002552 dosage form Substances 0.000 abstract 1
- 235000019325 ethyl cellulose Nutrition 0.000 abstract 1
- 229920001249 ethyl cellulose Polymers 0.000 abstract 1
- 238000000338 in vitro Methods 0.000 abstract 1
- 238000001727 in vivo Methods 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 229960001344 methylphenidate Drugs 0.000 abstract 1
- 239000002245 particle Substances 0.000 abstract 1
- 239000000565 sealant Substances 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
- 229920003176 water-insoluble polymer Polymers 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
- A61K31/33—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
- A61K31/4458—Non condensed piperidines, e.g. piperocaine only substituted in position 2, e.g. methylphenidate
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Μια φαρμακευτική MR (ελεγχόμενης αποδέσμευσης) πολυσωματιδιακή μορφή δόσης όπως μια κάψουλα (κάψουλα MR χορήγησης μιας φοράς την ημέρα) μεθυλφαινυδάτης ενδεδειγμένη για τη μεταχείριση των παιδιών με διαταραχή υπερδραστηριότητας απόσπασης της προσοχής (ADHAD), ικανής για την παροχή μιας μερίδας της δόσης για γρήγορη ενεργοποίηση της δράσης και το υπόλοιπο της δόσης με έναν ελεγχόμενο τρόπο για περίπου 12 ώρες, αποτελείται από ένα πλήθος σωματιδίων φτιαγμένα από δύο πληθυσμούς κόκκων επιστρωμένων με το φάρμακο, τους κόκκους IR (άμεσης αποδέσμευσης) και τους κόκκους ER (εκτεταμένης αποδέσμευσης). Οι κόκκοι IR κατά προτίμηση γίνονται με τη διάταξη σε στρώματα ενός υδατικού διαλύματος που περιλαμβάνει ένα φάρμακο και έναν σταθεροποιητή στα σφαιρίδια ζάχαρης και εφαρμόζοντας έπειτα ένα σφραγιστικό κάλυμμα στους καλυμμένους με φάρμακο πυρήνες. Οι κόκκοι ER γίνονται με την εφαρμογή μιας επίστρωσης εκτεταμένης αποδέσμευσης ενός υδατο-αδιάλυτου πολυμερούς που ελέγχει το ποσοστού διάλυσης όπως η αιθυλοκυτταρίνη στους κόκκους IR. Οι κάψουλες MR παρασκευάζονται με το γέμισμα κόκκων IR και ER σε κατάλληλη αναλογία. Η δόση και η αναλογία που απαιτούνται για μια αποτελεσματική, οικονομικώς αποδοτική και υπομονετική υποχωρητική θεραπεία των παιδιών με ADHD καθορίστηκαν από τις εκτενείς κλινικές έρευνες και τους in vitro/in vivo συσχετισμούς που εκτελέσθηκαν σύμφωνα με τις Οδηγίες FDA, Καθοδήγηση για τη Βιομηχανία: Στοματικές μορφές δόσης εκτεταμένης αποδέσμευσης.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/697,803 US6344215B1 (en) | 2000-10-27 | 2000-10-27 | Methylphenidate modified release formulations |
EP01977934A EP1328251A2 (en) | 2000-10-27 | 2001-10-09 | Methylphenidate modified release formulations |
Publications (1)
Publication Number | Publication Date |
---|---|
CY1118946T1 true CY1118946T1 (el) | 2018-01-10 |
Family
ID=24802604
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CY20171100299T CY1118946T1 (el) | 2000-10-27 | 2017-03-07 | Μορφοποιησεις μεθυλφαινυδατης ελεγχομενης αποδεσμευσης |
Country Status (13)
Country | Link |
---|---|
US (1) | US6344215B1 (el) |
EP (4) | EP2103307B9 (el) |
JP (1) | JP2004512296A (el) |
AU (2) | AU2001297011B2 (el) |
CA (1) | CA2426883C (el) |
CY (1) | CY1118946T1 (el) |
DK (1) | DK2103307T3 (el) |
ES (1) | ES2618603T3 (el) |
HU (1) | HUP0303695A3 (el) |
NO (1) | NO20031843L (el) |
PL (1) | PL203828B1 (el) |
PT (1) | PT2103307T (el) |
WO (1) | WO2002034234A2 (el) |
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JP2020504763A (ja) * | 2016-11-01 | 2020-02-13 | ネオス・セラピューティクス・エルピー | メチルフェニデートを用いてadhdを処置するための小児の有効な投薬 |
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CA2366791A1 (en) * | 1999-04-06 | 2000-10-12 | Kamal K. Midha | Pharmaceutical dosage form for pulsatile delivery of d-threo-methylphenidate and a second cns stimulant |
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-
2000
- 2000-10-27 US US09/697,803 patent/US6344215B1/en not_active Expired - Lifetime
-
2001
- 2001-10-09 ES ES09164379.1T patent/ES2618603T3/es not_active Expired - Lifetime
- 2001-10-09 AU AU2001297011A patent/AU2001297011B2/en not_active Expired
- 2001-10-09 DK DK09164379.1T patent/DK2103307T3/en active
- 2001-10-09 JP JP2002537288A patent/JP2004512296A/ja active Pending
- 2001-10-09 EP EP09164379.1A patent/EP2103307B9/en not_active Revoked
- 2001-10-09 HU HU0303695A patent/HUP0303695A3/hu unknown
- 2001-10-09 AU AU9701101A patent/AU9701101A/xx active Pending
- 2001-10-09 PT PT91643791T patent/PT2103307T/pt unknown
- 2001-10-09 EP EP10183368A patent/EP2269605A3/en not_active Withdrawn
- 2001-10-09 PL PL361673A patent/PL203828B1/pl unknown
- 2001-10-09 EP EP01977934A patent/EP1328251A2/en not_active Ceased
- 2001-10-09 CA CA2426883A patent/CA2426883C/en not_active Expired - Lifetime
- 2001-10-09 EP EP10183399A patent/EP2286815A3/en not_active Withdrawn
- 2001-10-09 WO PCT/US2001/042561 patent/WO2002034234A2/en active IP Right Grant
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2003
- 2003-04-24 NO NO20031843A patent/NO20031843L/no not_active Application Discontinuation
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2017
- 2017-03-07 CY CY20171100299T patent/CY1118946T1/el unknown
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CA2426883A1 (en) | 2002-05-02 |
PL361673A1 (en) | 2004-10-04 |
PL203828B1 (pl) | 2009-11-30 |
EP2103307B1 (en) | 2016-12-07 |
EP1328251A2 (en) | 2003-07-23 |
DK2103307T3 (en) | 2017-03-13 |
WO2002034234A2 (en) | 2002-05-02 |
ES2618603T3 (es) | 2017-06-21 |
WO2002034234A3 (en) | 2002-12-05 |
EP2269605A3 (en) | 2011-06-29 |
EP2286815A2 (en) | 2011-02-23 |
EP2286815A3 (en) | 2011-06-29 |
NO20031843D0 (no) | 2003-04-24 |
EP2103307B9 (en) | 2017-03-01 |
CA2426883C (en) | 2010-08-24 |
EP2103307A3 (en) | 2010-04-28 |
EP2103307A2 (en) | 2009-09-23 |
AU2001297011B2 (en) | 2007-03-15 |
AU9701101A (en) | 2002-05-06 |
EP2269605A2 (en) | 2011-01-05 |
JP2004512296A (ja) | 2004-04-22 |
NO20031843L (no) | 2003-04-24 |
HUP0303695A3 (en) | 2010-03-29 |
HUP0303695A2 (hu) | 2004-03-01 |
US6344215B1 (en) | 2002-02-05 |
PT2103307T (pt) | 2017-03-14 |
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