CY1118946T1 - Μορφοποιησεις μεθυλφαινυδατης ελεγχομενης αποδεσμευσης - Google Patents

Μορφοποιησεις μεθυλφαινυδατης ελεγχομενης αποδεσμευσης

Info

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
Application number
CY20171100299T
Other languages
English (en)
Inventor
Marie J Bettman
Dan L Hensley
Phillip J Percel
Gopi M Venkatesh
Krishna S Vishnupad
Original Assignee
Shire Pharmaceuticals Ireland Limited
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=24802604&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CY1118946(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Shire Pharmaceuticals Ireland Limited filed Critical Shire Pharmaceuticals Ireland Limited
Publication of CY1118946T1 publication Critical patent/CY1118946T1/el

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4458Non condensed piperidines, e.g. piperocaine only substituted in position 2, e.g. methylphenidate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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
    • A61K9/5078Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5084Mixtures 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.
CY20171100299T 2000-10-27 2017-03-07 Μορφοποιησεις μεθυλφαινυδατης ελεγχομενης αποδεσμευσης CY1118946T1 (el)

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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CA2426883A1 (en) 2002-05-02
PL361673A1 (en) 2004-10-04
PL203828B1 (pl) 2009-11-30
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ES2618603T3 (es) 2017-06-21
WO2002034234A3 (en) 2002-12-05
EP2269605A3 (en) 2011-06-29
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CA2426883C (en) 2010-08-24
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HUP0303695A3 (en) 2010-03-29
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US6344215B1 (en) 2002-02-05
PT2103307T (pt) 2017-03-14

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