DE1001772T1 - Verbesserte verabreichungstechnik für multiple medikamentengaben - Google Patents

Verbesserte verabreichungstechnik für multiple medikamentengaben

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Publication number
DE1001772T1
DE1001772T1 DE1001772T DE98926529T DE1001772T1 DE 1001772 T1 DE1001772 T1 DE 1001772T1 DE 1001772 T DE1001772 T DE 1001772T DE 98926529 T DE98926529 T DE 98926529T DE 1001772 T1 DE1001772 T1 DE 1001772T1
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methylphenidate
threo
acid methyl
dosage form
methyl ester
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Maghsoud M. Dariani
Atul M. Mehta
Andrew L. Zeitlin
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    • 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
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • 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
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D211/00—Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings
    • C07D211/04—Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D211/06—Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having no double bonds between ring members or between ring members and non-ring members
    • C07D211/08—Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having no double bonds between ring members or between ring members and non-ring members with hydrocarbon or substituted hydrocarbon radicals directly attached to ring carbon atoms
    • C07D211/18—Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having no double bonds between ring members or between ring members and non-ring members with hydrocarbon or substituted hydrocarbon radicals directly attached to ring carbon atoms with substituted hydrocarbon radicals attached to ring carbon atoms
    • C07D211/34—Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having no double bonds between ring members or between ring members and non-ring members with hydrocarbon or substituted hydrocarbon radicals directly attached to ring carbon atoms with substituted hydrocarbon radicals attached to ring carbon atoms with hydrocarbon radicals, substituted by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals
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    • C12P17/00—Preparation of heterocyclic carbon compounds with only O, N, S, Se or Te as ring hetero atoms
    • C12P17/10—Nitrogen as only ring hetero atom
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    • C12P41/00—Processes using enzymes or microorganisms to separate optical isomers from a racemic mixture
    • C12P41/006—Processes using enzymes or microorganisms to separate optical isomers from a racemic mixture by reactions involving C-N bonds, e.g. nitriles, amides, hydantoins, carbamates, lactames, transamination reactions, or keto group formation from racemic mixtures
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
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    • 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
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    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
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Claims (16)

PATENTANSPRÜCHE
1. Eine Dosierungsform für die orale Verabreichung eines 2-Piperidylessigsäuremethylesther-Medikaments (Methylphenidat-Medikaments), zwei Gruppen von Teilchen
umfassend , wobei jedes dieses Medikament enthält, und: a. diese erste Gruppe von Teilchen eine substantielle Sofortdosis dieses Medikaments bei Ingestion durch ein Säugetier ergibt und
b. die zweite Gruppe von Teilchen überzogene Teilchen umfasst, wobei diese überzogenen Teilchen von etwa 2 bis etwa 75 Gew.-% dieses Medikaments in
Beimischung von einem oder mehreren Bindemitteln umfasst, wobei dieser Überzug ein pharmazeutisch akzeptables Ammoniomethacrylat in ausreichender Menge umfasst, um von etwa 2 Stunden bis etwa 7 Stunden nach dieser Ingestion verzögert eine Dosis
dieser medikamentösen Behandlung abzugeben.
2. Die Dosierungsform des Anspruchs 1, wobei die erste Gruppe von Teilchen ein pharmazeutisch akzeptables Salz von 2-Piperidylessigsäuremethylesther (Methylphenidat) in Pulverform umfasst.
3. Die Dosierungsform des Anspruchs 1, wobei die zweite Gruppe von Teilchen überzogene Teilchen umfasst, die ein pharmazeutisch akzeptables Salz von 2-Piperidylessigsäuremethylesther (Methylphenidat) umfassen.
4. Die Dosierungsform des Anspruchs 2, wobei die Menge des pharmazeutisch akzeptablen Salzes von 2-Piperidylessigsäuremethylesther (Methylphenidat) in der ersten Gruppe von Teilchen von etwa 2 bis etwa 99
Gew.-%/ auf der Grundlage des Gewichts dieser Teilchen ist.
5. Die Dosierungsform des Anspruchs 4, wobei das pharmazeutisch akzeptable Salz von 2-Piperidylessigsäuremethylesther (Methylphenidat) D, L-threo-2-Piperidylessigsäuremethylesther-Hydrochlorid (D,L-threo-Methylphenidathydrochlorid) umfasst.
6. Die Dosierungsform des Anspruchs 3, wobei das pharmazeutisch akzeptable Salz von 2-Piperidylessigsäuremethylesther (Methylphenidat) D, L-threo-2-Piperidylessigsäuremethylesther-Hydrochlorid (D,L-threo-Methylphenidathydrochlorid) umfasst.
7. Die Dosierungsform des Anspruchs 1, wobei die zweite Gruppe von Teilchen von etwa .20 Gew.-% bis etwa 50 Gew.-% an Füllstoff, auf der Grundlage des Gesamtgewichts des Polymers enthält.
8. Die Dosierungsform des Anspruchs 7, wobei der Füllstoff aus der durch Talk, Kolloid-Kiesel, geräucherten Kiesel, Gips und Glycerinmonostearat gebildeten Gruppe ausgewählt ist.
9. Die Dosierungsform des Anspruchs 8, wobei dieser Füllstoff Talk ist.
10. Die Dosierungsform des Anspruchs 9, wobei die Menge an
Talk von etwa 35 Gew.-% bis etwa 45 Gew.-% an Füllstoff, auf der Grundlage des Gesamtgewichts des Polymers ist.
11. Die Dosierungsform des Anspruchs 10, wobei die Menge an
Talk von etwa 38 Gew.-% bis etwa 42 Gew.-% an Füllstoff, auf der Grundlage des Gesamtgewichts des Polymers ist.
12. Die Dosierungsform des Anspruchs 11, wobei die Menge an Talk etwa 40 Gew.-% an Füllstoff, auf der Grundlage des Gesamtgewichts des Polymers ist.
13. Die Dosierungsform des Anspruchs 1, wobei das Ammoniomethacrylat-Copolymer Acrylgruppen und quartäre Aminogruppen in einem Verhältnis von etwa 10:1 bis etwa 50:1 umfasst.
14. Die Dosierungsform des Anspruchs 13, wobei dieses
Verhältnis von etwa 15:1 bis etwa 45:1 reicht.
15. Die Dosierungsform des Anspruchs 14, wobei dieses
Verhältnis von etwa 15:1 bis etwa 20:1 reicht.
16. Die Dosierungsform des Anspruchs 15, wobei dieses Verhältnis von etwa 30:1 bis etwa 40:1 reicht.
17. Die Dosierungsform des Anspruchs 1, ein erstes Ammoniomethacrylat-Copolymer umfassend, das als polymerisierte Einheiten Acrylgruppen und Trimethylammonioethylmethacrylat in einem Verhältnis von ^. etwa 30:1 bis bis etwa 40:1 enthält und ein zweites
(Ammoniomethacrylat)-Copolymer, das als polymerisierte Einheiten Acrylgruppen und
Triethylammonioethylmethacrylat in einem Verhältnis von etwa 15:1 bis bis etwa 20:1 enthält.
18. Die Dosierungsform des Anspruchs 17, wobei das Verhältnis dieses ersten Copolymers zu diesem zweiten Copolymer von etwa 90:10 bis etwa 99:1 reicht.
19. Die Dosierungsform des Anspruchs 18, wobei das
Verhältnis dieses ersten Copolymers zu diesem zweiten Copolymer von etwa 93:7 bis etwa 97:3 reicht.
20. Die Dosierungsform des Anspruchs 19, wobei das Verhältnis dieses ersten Copolymers zu diesem zweiten Copolymer etwa 95:5 ist.
21. Die Dosierungsform des Anspruchs 1, wobei die
Zeitverzögerung von etwa 3 bis etwa 6 Stunden reicht.
22. Die Dosierungsform des Anspruchs 1, wobei die Zeitverzögerung von etwa 4 bis etwa 5 Stunden reicht.
23. Eine Dosierungsform für einmal-tägliche orale
Verabreichung eines 2-Piperidylessigsäuremethylesther-Medikaments (Methylphenidat-Medikaments), umfassend: a. Teilchen, die von etwa 2 Gew.-% bis etwa 99 Gew.-% dieses 2-Piperidylessigsäuremethylesther-Medikaments (Methylphenidat-Medikaments) in Beimischung mit einem oder mehreren Bindemitteln,
b. einen Außenüberzug auf diesem 2-Piperidylessigsäuremethylesther-Medikament (Methylphenidat-Medikament), der ein Ammoniomethacrylat-Copolymer in einer ausreichenden Menge umfasst/ um zeitverzögert über von etwa 2
Stunden bis etwa 7 Stunden nach der Verabreichung eine Dosis dieses
2-Piperidylessigsäuremethylesthers (Methylphenidats) zu ergeben und
c. auf der Außenfläche dieses Überzugs eine Schicht, die dieses 2-Piperidylessigsäuremethylesther-Medikament (Methylphenidat-Medikament) umfasst, um eine wesentliche Sofortdosis dieses 2-Piperidylessigsäuremethylesthers(Methylphenidats) bei Verabreichung zu ergeben.
24. Die Dosierungsform des Anspruchs 23, wobei dieses 2-Piperidylessigsäuremethylesther (Methylphenidat) D, L-threo-2-Piperidylessigsäuremethylesther-Hydrochlorid (D,L-threo-Methylphenidathydrochlorid) ist.
25. Die Dosierungsform des Anspruchs 23, wobei dieses 2-Piperidylessigsäuremethylesther (Methylphenidat) D-threo-2-Piperidylessigsäuremethylesther-Hydrochlorid (D-threo-Methylphenidathydrochlorid) ist.
26. Die Dosierungsform des Anspruchs 23, wobei die
Beschichtung ein erstes Ammoniomethacrylat Copolymer umfasst, das als polymerisierte Einheiten Acrylgrupen und Trimethylammonioethylmethacrylat in einem Verhältnis von etwa 30:1 bis etwa 40:1 enthält und ein zweites Ammoniomethacrylat Copolymer, das als polymerisierte Einheiten Acrylgrupen Trimethylammonioethylmethacrylat in einem Verhältnis von etwa 15:1 bis etwa 20:1 enthält.
27. Eine Dosierungsform für die orale Verabreichung von D-threo-2-Piperidylessigsäuremethylesther (D-threo-Methylphenidat)-hydrochlorid, die zwei Gruppen von Teilchen umfasst, wovon jedes D-threo-2-
10
15
20
28,
25
29.
30
HE/EP 1 001 772T1
• ma · « ,-ti
35
Piperidylessigsäuremethylesther (D-threo-Methylphenidat) enthält, wobei:
a. diese erste Gruppe von Teilchen D-threo-2-Piperidylessigsäuremethylesther-Hydrochlorid (D-threo-Methylphenidathydrochlorid) umfasst und eine substantielle Sofortdosis dieses D-threo-2-Piperldylessigsäuremethylesthers (D-threo-Methylphenidats) bei Ingestion durch ein Säugetier ergibt und
b. die zweite Gruppe von Teilchen überzogene Teilchen umfasst, wobei diese überzogenen Teilchen von etwa 2 bis etwa 75 Gew.-% an D-threo-2-Piperidylessigsäuremethylesther-Hydrochlorid (D-threo-Methylphenidathydrochlorid) in Beimischung von einem oder mehreren Bindemitteln umfasst, wobei diese Beschichtung ein pharmazeutisch akzeptables Ammoniomethacrylat-Copolymer in ausreichender Menge umfasst, um von etwa 2 Stunden bis etwa 7 Stunden nach dieser Ingestion verzögert eine Dosis des D-threo-2-Piperldylessigsäuremethylesther (D-threo-Methylphenidat s) zu ergeben.
Eine Dosierungsform eines pharmazeutisch akzeptablen Salzes von D-threo-2-Piperidylessigsäuremethylesther (D-threo-Methylphenidat), die ein in vitro Freisetzungsprofil ergibt, das zwei
Medikamentfreisetzungspulse umfasst, wobei diese Pulse zeitlich durch von etwa 2 Stunden bis etwa 7 Stunden getrennt sind.
Eine Dosierungsform eines pharmazeutisch akzeptablen Salzes von D-threo-2-Piperidylessigsäuremethylesther (D-threo-Methylphenidat), die eine in vivo Plasmakonzentration dieses D-threo-2-Piperldylessigsäuremethylesthers (D-threo-Methylphenidat s) ergibt, die zwei Maxima umfasst, wobei diese Maxima zeitlich durch von etwa 2 Stunden bis etwa
7 Stunden getrennt sind und wobei sich die Höhe dieser Maxima um mehr als 30% unterscheidet.
30. _. Eine Dosierungsform nach Anspruch 23, wobei das
Ammoniomethacrylat-Copolymer ein erstes Copolymer von Methylmethacrylat, Ethylacrylat und TAMCl in einem Verhältnis von 2:1:0.1 und ein zweites Copolymer von Methylmethacrylat, Ethylacrylat und TAMCl in einem Verhältnis von 2:1:0.2 umfasst.
31. Ein Verfahren zur Krankheitsbehandlung in einem Patient bei Bedarf einer Behandlung, eine Verabreichung einer Dosierungsform an den Patienten umfassend, die eine einmal tägliche Verabreichung von D-threo-2-Piperidylessigsäuremethylesther-Hydrochlorid (D-threo-Methylphenidathydrochlorid) ergibt, wobei diese Dosierungsform zwei Gruppen von Teilchen umfasst, wovon j edes D-threo-2-Piperidylessigsäuremethylesther (Methylphenidat) enthält, und wobei:
a. diese erste Gruppe von Teilchen von etwa 2 bis etwa 99 Gew.-% an D-threo-2-
Piperidylessigsäuremethylesther (Methylphenidat)-
hydrochlorid umfasst und eine substantielle Sofortdosis dieses D-threo-2-Piperldylessigsäuremethylesther (D-threo-Methylphenidat)-hydrochlorids bei Ingestion durch ein Säugetier ergibt und
b. die zweite Gruppe von Teilchen überzogene Teilchen umfasst, wobei diese überzogenen Teilchen von etwa 2 bis etwa 75 Gew.-% an D-threo-2-
Piperldylessigsäuremethylesther (D-threo-Methylphenidat) in Beimischung von einem oder mehreren Bindemitteln umfasst und eine Beschichtung, die aus einem pharmazeutisch akzeptablen Ammoniomethacrylat-Copolymer besteht, in ausreichender Menge, um von etwa 4 Stunden bis etwa 7 Stunden nach dieser Ingestion verzögert eine
&Pgr;:&iacgr;!
Dosis des D-threo-2-Piperidylessigsäuremethylesther -Hydrochlorids (D-threo-Methylphenidathydrochlorids) zu ergeben.
32. Eine Dosierungsform eines pharmazeutisch akzeptablen Salzes von 2-Piperidylessigsäuremethylesther (von Methylphenidat), die ein in vitro Freisetzungsprofil ergibt, das zwei Medikamentfreisetzungspulse umfasst, wobei diese Pulse zeitlich durch von etwa zwei Stunden bis etwa sieben Stunden getrennt sind.
33. Eine Dosierungsform eines pharmazeutisch akzeptablen Salzes von 2-Piperidylessigsäuremethylesther (von Methylphenidat), die eine in vivo Plasmakonzentration dieses 2-Piperidylessigsäuremethylesthers (Methylphenidats) ergibt, die zwei Maxima umfasst, wobei diese Maxima zeitlich durch von etwa 2 Stunden bis etwa 7 Stunden getrennt sind und wobei sich die Höhe dieser Maxima um mehr als 30% unterscheidet.
DE1001772T 1997-07-14 1998-06-09 Verbesserte verabreichungstechnik für multiple medikamentengaben Pending DE1001772T1 (de)

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