RU2016120727A - Композиция для доставки лекарственных средств - Google Patents

Композиция для доставки лекарственных средств Download PDF

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RU2016120727A
RU2016120727A RU2016120727A RU2016120727A RU2016120727A RU 2016120727 A RU2016120727 A RU 2016120727A RU 2016120727 A RU2016120727 A RU 2016120727A RU 2016120727 A RU2016120727 A RU 2016120727A RU 2016120727 A RU2016120727 A RU 2016120727A
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drug
acid
composition
layer
agent
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RU2016120727A
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Стефен Б. РАДДИ
Саймон Л. МАКГУРК
Ракеш ПАТЕЛ
Джон БУЛЛОК
Радж КЕВАЛРАМАНИ
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Алкермес Фарма Айэленд Лимитед
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    • 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
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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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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A—HUMAN NECESSITIES
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    • 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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • A—HUMAN NECESSITIES
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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    • 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
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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    • 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
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    • A61K9/5005—Wall or coating material
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Claims (23)

1. Композиция в многочастичной дозированной форме, содержащая гранулы, причем каждая гранула содержит:
ядро;
слой придающего растворимость агента;
слой частиц лекарственного средства, имеющих эффективный средний размер частиц менее чем или приблизительно 2 мкм, и поверхностный стабилизатор, адсорбированный на поверхности частиц лекарственного средства; и
полупроницаемое покрытие в качестве внешнего слоя.
2. Композиция по п.1, включающая:
ядро в центре гранулы;
слой придающего растворимость агента, расположенный снаружи ядра;
слой частиц лекарственного средства, расположенный радиально снаружи слоя придающего растворимость агента; и
полупроницаемое покрытие, расположенное радиально снаружи слоя частиц лекарственного средства.
3. Композиция по п.1, в которой ядро сформировано из инертного субстрата, придающего растворимость агента, комбинации придающего растворимость агента, смешанного со связующим веществом или носителем, частицами лекарственного средства или комбинацией частиц лекарственного средства, смешанных со связующим веществом или носителем.
4. Композиция по п.1, в которой полупроницаемое покрытие является микропористым покрытием с контролируемой пористостью, включающим полимер, который нерастворим в воздействующей среде, и порообразующую добавку, растворимую в воздействующей среде.
5. Композиция по п. 4, в которой полимер выбран из группы, состоящей из полимеров на основе целлюлозы, метакрилатов и фталатов, и в которой порообразующая добавка выбрана из группы, состоящей из ГПМЦ, ПВП, многоатомных спиртов и сахаров.
6. Композиция по п.1, в которой лекарственное средство имеет растворимость в воде не более, чем 10мг/мл при температуре 37°С.
7. Композиция по п.1, в которой частицы лекарственного средства имеют значение D90, выбранное из группы, состоящей из менее чем или приблизительно 5000 нм, 4900 нм, 4800 нм, 4700 нм, 4600 нм, 4500 нм, 4400 нм, 4300 нм, 4200 нм, 4100 нм, 4000 нм, 3900 нм, 3800 нм, 3700 нм, 3600 нм, 3500 нм, 3400 нм, 3300 нм, 3200 нм, 3100 нм, 3000 нм, 2900 нм, 2800 нм, 2700 нм, 2600 нм, 2500 нм, 2400 нм, 2300 нм, 2200 нм, 2150 нм, 2100 нм, 2075 нм и 2000 нм.
8. Композиция по п.1, в которой поверхностный стабилизатор выбран из группы, состоящей из гидроксипропилметилцеллюлозы (ГПМЦ), диоктилсульфосукцината натрия (DOSS), лаурилсульфата натрия (SLS), гидроксипропилцеллюлозы, поливинилпирролидона, дезоксихолата натрия, блок-сополимеров на основе этиленоксида и пропиленоксида, сополимеров винилпирролидона и винилацетата, лецитина, полиоксиэтиленовых эфиров сорбитана и жирных кислот, альбумина, лизоцима, желатина, макрогола 15 гидроксистеарата, тилоксапола и полиэтоксилированного касторового масла.
9. Композиция по п.1, в которой придающий растворимость агент является подходящим и присутствует в количестве, достаточном для того, чтобы растворить частицы лекарственного средства внутри композиции до доставки лекарственного средства в воздействующую среду.
10. Композиция по п.9, в которой придающий растворимость агент является поверхностно-активным агентом или изменяющим pH агентом.
11. Композиция по п.10, в которой поверхностно-активный агент выбран из группы, состоящей из анионных, катионных, цвиттерионных и неионные поверхностно-активных агентов.
12. Композиция по п.10, в которой придающий растворимость агент является изменяющим pH агентом, выбранным из слабой кислоты или слабого основания.
13. Композиция по п.12, в которой придающий растворимость агент является слабой кислотой, выбранной из группы, состоящей из адипиновой кислоты, аскорбиновой кислоты, лимонной кислоты, фумаровой кислоты, галловой кислоты, глутаровой кислоты, молочной кислоты, яблочной кислоты, малеиновой кислоты, янтарной кислоты, винной кислоты и их смесей и комбинаций; или слабым основанием, выбранным из аргинина, лизина, трометамина (TRIS), меглумина, диэтаноламина, триэтаноламина и оснований, сопряженных с фармацевтически приемлемыми слабыми кислотами, и их смесей и комбинаций.
14. Композиция по п.13, в которой основания, сопряженные с фармацевтически приемлемыми слабыми кислотами, выбраны из группы, состоящей из карбоната натрия, фосфата натрия, фосфата кальция, тринатриевого цитрата и аскорбата натрия и их смесей и комбинаций.
15. Композиция по п.1 в форме многочастичной фармацевтической дозированной формы, содержащая гранулы, причем каждая гранула содержит ядро, слой частиц лекарственного средства, полупроницаемое покрытие и придающий растворимость агент в форме слоя рН-изменяющего агента, расположенного между слоем лекарственного средства и полупроницаемым покрытием.
RU2016120727A 2009-04-09 2010-04-08 Композиция для доставки лекарственных средств RU2016120727A (ru)

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RU2011145278/15A RU2011145278A (ru) 2009-04-09 2010-04-08 Композиции клозапина с контролируемым высвобождением
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US (3) US20100260858A1 (ru)
EP (2) EP2416764A4 (ru)
JP (4) JP2012523428A (ru)
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CA2757979A1 (en) 2010-10-14
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