MX2021003357A - Procedimiento para la preparacion de una forma de dosificacion oral de multiples unidades de liberacion modificada de succinato de doxilamina y clorhidrato de piridoxina. - Google Patents

Procedimiento para la preparacion de una forma de dosificacion oral de multiples unidades de liberacion modificada de succinato de doxilamina y clorhidrato de piridoxina.

Info

Publication number
MX2021003357A
MX2021003357A MX2021003357A MX2021003357A MX2021003357A MX 2021003357 A MX2021003357 A MX 2021003357A MX 2021003357 A MX2021003357 A MX 2021003357A MX 2021003357 A MX2021003357 A MX 2021003357A MX 2021003357 A MX2021003357 A MX 2021003357A
Authority
MX
Mexico
Prior art keywords
modified release
preparation
dosage form
oral dosage
multiple unit
Prior art date
Application number
MX2021003357A
Other languages
English (en)
Inventor
I Valls Marc Saura
Troyano Joaquín Nebot
I Juanes Ramon M Roca
Original Assignee
Italfarmaco Spa
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 Italfarmaco Spa filed Critical Italfarmaco Spa
Publication of MX2021003357A publication Critical patent/MX2021003357A/es

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)
  • 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)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La presente invención se refiere a un procedimiento para la preparación de una forma de dosificación oral de múltiples unidades de liberación modificada que comprende una pluralidad de pellets de liberación modificada de doxilamina o una sal de la misma y una pluralidad de pellets de liberación modificada de piridoxina o una sal de la misma, en el que el procedimiento comprende recubrir los pellets de doxilamina que tienen la capa de recubrimiento activa interna y la capa de recubrimiento entérico intermedia y los pellets de piridoxina que tienen la capa de recubrimiento activa interna, en el que la etapa de recubrimiento comprende la pulverización simultánea de una mezcla que comprende los agentes de recubrimiento de liberación entérica y modificada y la adición de agentes formadores de poros en forma de polvo.
MX2021003357A 2018-09-27 2019-09-27 Procedimiento para la preparacion de una forma de dosificacion oral de multiples unidades de liberacion modificada de succinato de doxilamina y clorhidrato de piridoxina. MX2021003357A (es)

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
MX2021003357A true MX2021003357A (es) 2021-08-11

Family

ID=63722327

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2021003357A MX2021003357A (es) 2018-09-27 2019-09-27 Procedimiento para la preparacion de una forma de dosificacion oral de multiples unidades de liberacion modificada de succinato de doxilamina y clorhidrato de piridoxina.

Country Status (31)

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

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
KR20090005237A (ko) * 2006-05-22 2009-01-12 테바 파마슈티컬 인더스트리즈 리미티드 둘록세틴 염산염 지연 방출형 제제
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
HUE052301T2 (hu) * 2012-02-22 2021-04-28 Duchesnay Inc Doxil-amin és piridoxin és/vagy metabolitjainak vagy sóinak készítmény
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
PL3185856T3 (pl) 2014-08-29 2018-09-28 Duchesnay Inc. Wielomodalne formulacje uwalniania doksylaminy i pirydoksyny i/lub ich metabolitów lub soli
US10111838B2 (en) * 2014-11-26 2018-10-30 Evonik Roehm 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
BR112021005192A8 (pt) 2023-04-11
PT3628311T (pt) 2021-02-09
AU2019348630B2 (en) 2024-07-11
EA202190700A1 (ru) 2021-07-01
ES2847648T3 (es) 2021-08-03
AR116480A1 (es) 2021-05-12
WO2020064985A1 (en) 2020-04-02
EP3628311A1 (en) 2020-04-01
CY1123785T1 (el) 2022-05-27
DOP2021000052A (es) 2021-06-30
CR20210208A (es) 2021-06-23
CN112839638B (zh) 2023-12-19
KR20210066864A (ko) 2021-06-07
BR112021005192A2 (pt) 2021-06-08
DK3628311T3 (da) 2021-02-01
JP2022502406A (ja) 2022-01-11
NI202100021A (es) 2021-06-30
ZA202101279B (en) 2021-10-27
PH12021550640A1 (en) 2022-02-14
CN112839638A (zh) 2021-05-25
SA521421557B1 (ar) 2022-10-30
SI3628311T1 (sl) 2021-04-30
PL3628311T3 (pl) 2021-07-05
HRP20210181T1 (hr) 2021-03-19
MY197676A (en) 2023-07-03
EP3628311B1 (en) 2020-11-11
JP7444862B2 (ja) 2024-03-06
AU2019348630A1 (en) 2021-05-13
CL2021000687A1 (es) 2021-08-06
HUE053082T2 (hu) 2021-06-28
CO2021005412A2 (es) 2021-05-10
ECSP21029863A (es) 2021-05-31
RS61368B1 (sr) 2021-02-26
PE20211462A1 (es) 2021-08-05
UA127768C2 (uk) 2023-12-27

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