EA202190700A1 - Способ получения многоэлементной пероральной дозированной лекарственной формы с модифицированным высвобождением сукцината доксиламина и гидрохлорида пиридоксина - Google Patents

Способ получения многоэлементной пероральной дозированной лекарственной формы с модифицированным высвобождением сукцината доксиламина и гидрохлорида пиридоксина

Info

Publication number
EA202190700A1
EA202190700A1 EA202190700A EA202190700A EA202190700A1 EA 202190700 A1 EA202190700 A1 EA 202190700A1 EA 202190700 A EA202190700 A EA 202190700A EA 202190700 A EA202190700 A EA 202190700A EA 202190700 A1 EA202190700 A1 EA 202190700A1
Authority
EA
Eurasian Patent Office
Prior art keywords
modified release
dosage form
elemental
microspheres
doxylamine succinate
Prior art date
Application number
EA202190700A
Other languages
English (en)
Inventor
Марк Саура И Вайс
Хоакин Небот Трояно
Рамон М. Рока И Хуанес
Original Assignee
Инибса Гинекологиа, С.А.
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
Application filed by Инибса Гинекологиа, С.А. filed Critical Инибса Гинекологиа, С.А.
Publication of EA202190700A1 publication Critical patent/EA202190700A1/ru

Links

Classifications

    • 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
    • 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
    • A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
    • 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
    • A61K31/4415—Pyridoxine, i.e. Vitamin B6
    • 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
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • 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
    • A61K9/5089—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Настоящее изобретение относится к способу получения многоэлементной пероральной дозированной лекарственной формы с модифицированным высвобождением, содержащей множество микросфер с модифицированным высвобождением доксиламина или соответствующей соли и микросфер с модифицированным высвобождением пиридоксина или соответствующей соли; причем способ включает покрытие микросфер доксиламина, имеющих внутренний активный покровный слой и промежуточный кишечнорастворимый покровный слой, и микросфер пиридоксина, имеющих внутренний активный покровный слой, при этом стадия покрытия включает одновременное распыление смеси, содержащей кишечнорастворимые покровные вещества и покровные вещества с модифицированным высвобождением, и добавление порообразующих веществ в порошкообразной форме.
EA202190700A 2018-09-27 2019-09-27 Способ получения многоэлементной пероральной дозированной лекарственной формы с модифицированным высвобождением сукцината доксиламина и гидрохлорида пиридоксина EA202190700A1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP18382687.4A EP3628311B1 (en) 2018-09-27 2018-09-27 A process for the preparation of a modified release multiple unit oral dosage form of doxylamine succinate and pyridoxine hydrochloride
PCT/EP2019/076140 WO2020064985A1 (en) 2018-09-27 2019-09-27 A process for the preparation of a modified release multiple unit oral dosage form of doxylamine succinate and pyridoxine hydrochloride

Publications (1)

Publication Number Publication Date
EA202190700A1 true EA202190700A1 (ru) 2021-07-01

Family

ID=63722327

Family Applications (1)

Application Number Title Priority Date Filing Date
EA202190700A EA202190700A1 (ru) 2018-09-27 2019-09-27 Способ получения многоэлементной пероральной дозированной лекарственной формы с модифицированным высвобождением сукцината доксиламина и гидрохлорида пиридоксина

Country Status (31)

Country Link
EP (1) EP3628311B1 (ru)
JP (1) JP7444862B2 (ru)
KR (1) KR20210066864A (ru)
CN (1) CN112839638B (ru)
AR (1) AR116480A1 (ru)
AU (1) AU2019348630B2 (ru)
BR (1) BR112021005192A8 (ru)
CL (1) CL2021000687A1 (ru)
CO (1) CO2021005412A2 (ru)
CR (1) CR20210208A (ru)
CY (1) CY1123785T1 (ru)
DK (1) DK3628311T3 (ru)
DO (1) DOP2021000052A (ru)
EA (1) EA202190700A1 (ru)
EC (1) ECSP21029863A (ru)
ES (1) ES2847648T3 (ru)
HR (1) HRP20210181T1 (ru)
HU (1) HUE053082T2 (ru)
MX (1) MX2021003357A (ru)
MY (1) MY197676A (ru)
NI (1) NI202100021A (ru)
PE (1) PE20211462A1 (ru)
PH (1) PH12021550640A1 (ru)
PL (1) PL3628311T3 (ru)
PT (1) PT3628311T (ru)
RS (1) RS61368B1 (ru)
SA (1) SA521421557B1 (ru)
SI (1) SI3628311T1 (ru)
UA (1) UA127768C2 (ru)
WO (1) WO2020064985A1 (ru)
ZA (1) ZA202101279B (ru)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR121619A1 (es) * 2020-03-25 2022-06-22 Inibsa Ginecologia S A Una forma de dosificación oral de múltiples unidades de liberación modificada de succinato de doxilamina y clorhidrato de piridoxina y un procedimiento para su preparación

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IE55745B1 (en) * 1983-04-06 1991-01-02 Elan Corp Plc Sustained absorption pharmaceutical composition
CA2350195C (en) * 2000-12-20 2003-06-10 Duchesnay Inc. Rapid onset formulation of pyridoxine hydrochloride and doxylamine succinate
US20070141147A1 (en) * 2005-12-21 2007-06-21 Auriga Laboratories, Inc. Sequential release pharmaceutical formulations
WO2007139886A2 (en) * 2006-05-22 2007-12-06 Teva Pharmaceutical Industries Ltd. Duloxetine hydrochloride delayed release formulations
ES2376095B1 (es) * 2008-10-02 2013-01-24 Laboratorios Del Dr. Esteve, S.A. Pellets entéricos de duloxetina.
CA2761212A1 (en) 2011-12-07 2013-06-07 Pharmascience Inc. Disintegrant-free delayed release doxylamine and pyridoxine formulation and process of it manufacturing
WO2013123569A1 (en) 2012-02-22 2013-08-29 Duchesnay Inc. Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
EP2787971A4 (en) * 2012-02-22 2015-04-29 Duchesnay Inc FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND / OR THEIR METABOLITES OR SALTS
CN103142552A (zh) * 2013-02-22 2013-06-12 广州科的信医药技术有限公司 一种洛伐他汀肠溶缓释微丸胶囊及其制备方法
CN103690506B (zh) * 2013-11-08 2015-05-13 舒泰神（北京）生物制药股份有限公司 一种曲司氯铵缓释组合物及其制备方法
PT3185856T (pt) 2014-08-29 2018-10-09 Duchesnay Inc Formulação de libertação plurimodal de doxilamina e pirodoxina e/ou seus metabolitos ou sais
WO2016083278A1 (en) * 2014-11-26 2016-06-02 Evonik Röhm Gmbh Pharmaceutical or nutraceutical composition with resistance against the influence of ethanol
CN106606502B (zh) * 2015-10-27 2019-12-31 四川海思科制药有限公司 一种琥珀酸多西拉敏盐酸吡哆醇肠溶片药物组合物及其制备方法

Also Published As

Publication number Publication date
SA521421557B1 (ar) 2022-10-30
ZA202101279B (en) 2021-10-27
ES2847648T3 (es) 2021-08-03
CL2021000687A1 (es) 2021-08-06
PE20211462A1 (es) 2021-08-05
JP7444862B2 (ja) 2024-03-06
WO2020064985A1 (en) 2020-04-02
DK3628311T3 (da) 2021-02-01
AR116480A1 (es) 2021-05-12
EP3628311A1 (en) 2020-04-01
KR20210066864A (ko) 2021-06-07
HUE053082T2 (hu) 2021-06-28
BR112021005192A2 (pt) 2021-06-08
RS61368B1 (sr) 2021-02-26
SI3628311T1 (sl) 2021-04-30
CN112839638B (zh) 2023-12-19
ECSP21029863A (es) 2021-05-31
AU2019348630B2 (en) 2024-07-11
CY1123785T1 (el) 2022-05-27
PH12021550640A1 (en) 2022-02-14
MX2021003357A (es) 2021-08-11
CR20210208A (es) 2021-06-23
AU2019348630A1 (en) 2021-05-13
PT3628311T (pt) 2021-02-09
MY197676A (en) 2023-07-03
DOP2021000052A (es) 2021-06-30
BR112021005192A8 (pt) 2023-04-11
CN112839638A (zh) 2021-05-25
UA127768C2 (uk) 2023-12-27
NI202100021A (es) 2021-06-30
EP3628311B1 (en) 2020-11-11
PL3628311T3 (pl) 2021-07-05
CO2021005412A2 (es) 2021-05-10
JP2022502406A (ja) 2022-01-11
HRP20210181T1 (hr) 2021-03-19

Similar Documents

Publication Publication Date Title
EA201891087A1 (ru) Ингибиторы ret
SG11202104460UA (en) Compounds, pharmaceutical compositions, and methods of preparing compounds and of their use as atr kinase inhibitors
RU2014145557A (ru) Комбинированный состав, содержащий многокомпонентную сфероидальную таблетку (мкст), заключенную в твердую капсулу, и способ его приготовления
CL2018001686A1 (es) Métodos y composiciones particularmente para el tratamiento del trastorno por déficit de atención (divisional solicitud 201701026)
EA201792689A1 (ru) Производные 2-(пиразолопиридин-3-ил)пиримидина в качестве ингибиторов jak
EA201790650A1 (ru) Лекарственная форма и способы применения абиратерона ацетата
MY189306A (en) Tablet
EA202090508A1 (ru) Изготовление фармацевтических составов
SG11202110674XA (en) Compound, method and pharmaceutical composition for modulating expression of dux4
DK3641730T3 (da) Partikel og farmaceutisk sammensætning, der omfatter en uopløselig camptothecinforbindelse med dobbelt kerneskalstruktur og fremgangsmåde til fremstilling heraf
MX2022006518A (es) Composición farmaceutica de clozapina de liberación prolongada.
IL276430A (en) A pharmaceutical compound, its cures, its formulations, and methods for its preparation and use
IL285378A (en) A heterocyclic compound, a medical preparation containing it, a method for its preparation, and its use
EA202190700A1 (ru) Способ получения многоэлементной пероральной дозированной лекарственной формы с модифицированным высвобождением сукцината доксиламина и гидрохлорида пиридоксина
EA202090913A1 (ru) Композиция таблеток с модифицированным высвобождением, содержащая мирабегрон
PH12015000297A1 (en) Pharmaceutical combination preparation
MX2019004938A (es) Cápsula compleja que contiene esomeprazol y método de preparación de esta.
SA517380942B1 (ar) صيغة إطلاق متعددة النماذج للدوكسيلامين والبيريدوكسين و/أو نواتج أيض أو أملاح منها
TW201613584A (en) Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
MX2018002449A (es) Formulaciones de liberacion retardada, metodos de fabricacion y uso de las mismas.
TH149179B (th) องค์ประกอบทางเภสัชกรรม, รูปแบบเภสัชภัณฑ์, กระบวนการในการเตรียม องค์ประกอบ และรูปแบบดังกล่าว, วิธีการในการรักษา และการใช้องค์ประกอบ และรูปแบบดังกล่าว
EA201600332A3 (ru) Фармацевтическая композиция в форме таблеток, покрытых кишечнорастворимой оболочкой, и способ ее получения
UA102073U (uk) Фармацевтичний препарат на основі сератіопептидази у формі таблеток
IN2014CH00984A (ru)