AR121619A1 - 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 - Google Patents
Una forma de dosificación oral de múltiples unidades de liberación modificada de succinato de doxilamina y clorhidrato de piridoxina y un procedimiento para su preparaciónInfo
- Publication number
- AR121619A1 AR121619A1 ARP210100692A ARP210100692A AR121619A1 AR 121619 A1 AR121619 A1 AR 121619A1 AR P210100692 A ARP210100692 A AR P210100692A AR P210100692 A ARP210100692 A AR P210100692A AR 121619 A1 AR121619 A1 AR 121619A1
- Authority
- AR
- Argentina
- Prior art keywords
- modified release
- pharmaceutically acceptable
- preparation
- dosage form
- oral dosage
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 2
- 239000006186 oral dosage form Substances 0.000 title abstract 2
- 238000002360 preparation method Methods 0.000 title abstract 2
- KBAUFVUYFNWQFM-UHFFFAOYSA-N Doxylamine succinate Chemical compound OC(=O)CCC(O)=O.C=1C=CC=NC=1C(C)(OCCN(C)C)C1=CC=CC=C1 KBAUFVUYFNWQFM-UHFFFAOYSA-N 0.000 title 1
- 229960005008 doxylamine succinate Drugs 0.000 title 1
- ZUFQODAHGAHPFQ-UHFFFAOYSA-N pyridoxine hydrochloride Chemical compound Cl.CC1=NC=C(CO)C(CO)=C1O ZUFQODAHGAHPFQ-UHFFFAOYSA-N 0.000 title 1
- 229960004172 pyridoxine hydrochloride Drugs 0.000 title 1
- 235000019171 pyridoxine hydrochloride Nutrition 0.000 title 1
- 239000011764 pyridoxine hydrochloride Substances 0.000 title 1
- LXNHXLLTXMVWPM-UHFFFAOYSA-N pyridoxine Chemical compound CC1=NC=C(CO)C(CO)=C1O LXNHXLLTXMVWPM-UHFFFAOYSA-N 0.000 abstract 4
- 239000011247 coating layer Substances 0.000 abstract 3
- 239000002245 particle Substances 0.000 abstract 3
- 239000011248 coating agent Substances 0.000 abstract 2
- 238000000576 coating method Methods 0.000 abstract 2
- HCFDWZZGGLSKEP-UHFFFAOYSA-N doxylamine Chemical compound C=1C=CC=NC=1C(C)(OCCN(C)C)C1=CC=CC=C1 HCFDWZZGGLSKEP-UHFFFAOYSA-N 0.000 abstract 2
- 229960005178 doxylamine Drugs 0.000 abstract 2
- 239000010410 layer Substances 0.000 abstract 2
- 235000008160 pyridoxine Nutrition 0.000 abstract 2
- 239000011677 pyridoxine Substances 0.000 abstract 2
- 150000003839 salts Chemical class 0.000 abstract 2
- 229940011671 vitamin b6 Drugs 0.000 abstract 2
- 238000007873 sieving Methods 0.000 abstract 1
- 238000002560 therapeutic procedure Methods 0.000 abstract 1
Classifications
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- 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
-
- 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
- A61K9/5005—Wall or coating material
- A61K9/5063—Compounds of unknown constitution, e.g. material from plants or animals
-
- 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
- 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)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Botany (AREA)
- Zoology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
La presente invención se refiere una forma de dosificación oral de múltiples unidades de liberación modificada que comprende: una primera pluralidad de microgránulos de liberación modificada de doxilamina que comprende: un núcleo inerte farmacéuticamente aceptable; una capa interna de recubrimiento activo que comprende una doxilamina; opcionalmente, una capa intermedia de recubrimiento de liberación entérica; y una capa externa de recubrimiento de liberación modificada; y una segunda pluralidad de microgránulos de liberación modificada de piridoxina o de una sal farmacéuticamente aceptable de la misma que comprende: un núcleo inerte farmacéuticamente aceptable; una capa interna de recubrimiento activo que comprende piridoxina o una sal farmacéuticamente aceptable de la misma; y una capa externa de recubrimiento de liberación modificada; en donde el tamaño de partícula del núcleo inerte farmacéuticamente aceptable de la primera y segunda pluralidad de microgránulos es tal que al menos el 90% de los núcleos inertes tienen un tamaño de partícula de 300 mm a 1.700 mm y una variabilidad del tamaño de partícula de no más de 200 mm medida mediante tamizado analítico. También se refiere a un procedimiento para su preparación y su uso en terapia.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP20382227 | 2020-03-25 |
Publications (1)
Publication Number | Publication Date |
---|---|
AR121619A1 true AR121619A1 (es) | 2022-06-22 |
Family
ID=70189866
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ARP210100692A AR121619A1 (es) | 2020-03-25 | 2021-03-19 | 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 |
Country Status (26)
Country | Link |
---|---|
EP (1) | EP4125825B1 (es) |
JP (1) | JP2023520671A (es) |
KR (1) | KR20220158703A (es) |
CN (1) | CN115697311A (es) |
AR (1) | AR121619A1 (es) |
AU (1) | AU2021243600A1 (es) |
BR (1) | BR112022018366A2 (es) |
CL (1) | CL2022002572A1 (es) |
CO (1) | CO2022013621A2 (es) |
CR (1) | CR20220527A (es) |
DK (1) | DK4125825T3 (es) |
EC (1) | ECSP22082569A (es) |
ES (1) | ES2973785T3 (es) |
FI (1) | FI4125825T3 (es) |
HR (1) | HRP20240284T1 (es) |
HU (1) | HUE065414T2 (es) |
LT (1) | LT4125825T (es) |
MA (1) | MA59146B1 (es) |
MX (1) | MX2022011737A (es) |
PE (1) | PE20221832A1 (es) |
PL (1) | PL4125825T3 (es) |
PT (1) | PT4125825T (es) |
RS (1) | RS65226B1 (es) |
SI (1) | SI4125825T1 (es) |
WO (1) | WO2021191268A1 (es) |
ZA (1) | ZA202211174B (es) |
Family Cites Families (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA2392486A1 (en) * | 2002-07-05 | 2002-12-08 | Duchesnay Inc. | Pharmaceutical dosage form bearing pregnancy-friendly indicia |
CA2406592C (en) * | 2002-10-04 | 2003-09-30 | Duchesnay Inc. | Method of preparing pharmaceutical dosage forms containing multiple active ingredients |
CA2432945C (en) * | 2003-07-10 | 2004-11-23 | Duchesnay Inc. | Use of doxylamime succinate and pyridoxine hydrochloride for prophylaxis and treatment of post-surgical vomiting |
US20070141147A1 (en) * | 2005-12-21 | 2007-06-21 | Auriga Laboratories, Inc. | Sequential release pharmaceutical formulations |
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 |
BR112014020186A8 (pt) * | 2012-02-22 | 2017-07-11 | Duchesnay Inc | Formulação de doxilamina e piridoxina e/ou seus metabólitos ou sais |
DK3185856T3 (en) * | 2014-08-29 | 2018-07-30 | Duchesnay Inc | FORMULATION WITH MULTIMODAL DELIVERY OF DOXYLAMINE AND PYRIDOXIN AND / OR METABOLITES OR SALTS THEREOF |
US9526703B2 (en) * | 2014-08-29 | 2016-12-27 | Duchesnay Inc. | Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof |
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 |
HUE053082T2 (hu) * | 2018-09-27 | 2021-06-28 | Inibsa Ginecologia S A | Eljárás doxilamin-szukcinát- és piridoxin-hidroklorid-tartalmú, módosított hatóanyag-leadású, több kis egységet tartalmazó, orális adagolási forma elõállítására |
-
2021
- 2021-03-19 AR ARP210100692A patent/AR121619A1/es unknown
- 2021-03-24 AU AU2021243600A patent/AU2021243600A1/en active Pending
- 2021-03-24 PT PT217128925T patent/PT4125825T/pt unknown
- 2021-03-24 PL PL21712892.5T patent/PL4125825T3/pl unknown
- 2021-03-24 KR KR1020227032023A patent/KR20220158703A/ko active Search and Examination
- 2021-03-24 SI SI202130114T patent/SI4125825T1/sl unknown
- 2021-03-24 HR HRP20240284TT patent/HRP20240284T1/hr unknown
- 2021-03-24 EP EP21712892.5A patent/EP4125825B1/en active Active
- 2021-03-24 MX MX2022011737A patent/MX2022011737A/es unknown
- 2021-03-24 PE PE2022002070A patent/PE20221832A1/es unknown
- 2021-03-24 DK DK21712892.5T patent/DK4125825T3/da active
- 2021-03-24 JP JP2022558004A patent/JP2023520671A/ja active Pending
- 2021-03-24 LT LTEPPCT/EP2021/057555T patent/LT4125825T/lt unknown
- 2021-03-24 HU HUE21712892A patent/HUE065414T2/hu unknown
- 2021-03-24 FI FIEP21712892.5T patent/FI4125825T3/fi active
- 2021-03-24 CN CN202180037889.9A patent/CN115697311A/zh active Pending
- 2021-03-24 BR BR112022018366A patent/BR112022018366A2/pt unknown
- 2021-03-24 ES ES21712892T patent/ES2973785T3/es active Active
- 2021-03-24 MA MA59146A patent/MA59146B1/fr unknown
- 2021-03-24 WO PCT/EP2021/057555 patent/WO2021191268A1/en active Application Filing
- 2021-03-24 CR CR20220527A patent/CR20220527A/es unknown
- 2021-03-24 RS RS20240227A patent/RS65226B1/sr unknown
-
2022
- 2022-09-22 CL CL2022002572A patent/CL2022002572A1/es unknown
- 2022-09-22 CO CONC2022/0013621A patent/CO2022013621A2/es unknown
- 2022-10-12 ZA ZA2022/11174A patent/ZA202211174B/en unknown
- 2022-10-21 EC ECSENADI202282569A patent/ECSP22082569A/es unknown
Also Published As
Publication number | Publication date |
---|---|
ZA202211174B (en) | 2024-02-28 |
SI4125825T1 (sl) | 2024-04-30 |
PT4125825T (pt) | 2024-02-28 |
EP4125825B1 (en) | 2024-01-31 |
ES2973785T3 (es) | 2024-06-24 |
HUE065414T2 (hu) | 2024-05-28 |
ECSP22082569A (es) | 2022-12-30 |
KR20220158703A (ko) | 2022-12-01 |
LT4125825T (lt) | 2024-03-12 |
PE20221832A1 (es) | 2022-11-29 |
MA59146B1 (fr) | 2024-03-29 |
RS65226B1 (sr) | 2024-03-29 |
CR20220527A (es) | 2022-11-23 |
AU2021243600A1 (en) | 2022-09-29 |
DK4125825T3 (da) | 2024-02-26 |
CN115697311A (zh) | 2023-02-03 |
FI4125825T3 (fi) | 2024-02-23 |
EP4125825A1 (en) | 2023-02-08 |
WO2021191268A1 (en) | 2021-09-30 |
BR112022018366A2 (pt) | 2022-11-08 |
JP2023520671A (ja) | 2023-05-18 |
PL4125825T3 (pl) | 2024-05-06 |
CL2022002572A1 (es) | 2023-05-26 |
CO2022013621A2 (es) | 2022-10-11 |
HRP20240284T1 (hr) | 2024-05-24 |
MX2022011737A (es) | 2022-10-13 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
ES2631980T3 (es) | Formas de dosificación orales farmacéuticas que comprenden dabigatrán etexilato y sus sales farmacéuticamente aceptables | |
MX2022002952A (es) | Formulaciones de liberacion modificada de 2-[3-[4-amino-3-(2-fluor o-4-fenoxi-fenil)pirazolo[3,4-d]pirimidin-1-il]piperidina-1-carbo nil]-4-metil-4-[4-(oxetan-3-il)piperazin-1-il]pent-2-enenitrilo. | |
AR100473A2 (es) | Un método para la manufactura de una preparación para administración oral | |
JP2015511638A5 (es) | ||
AR045630A1 (es) | Formas de dosificacion de azitromicina con efectos secundarios reducidos | |
JP2013508289A5 (es) | ||
JP2017533222A5 (es) | ||
ES2525648T3 (es) | Formulaciones galénicas que comprenden Aliskiren | |
CR20150077A (es) | Composición farmacéutica oral en forma de microesferas y proceso de elaboración | |
AR078951A1 (es) | Esferoides de farmacos revestidos y usos de los mismos para la eliminacion o reduccion de afecciones tales como emesis y diarrea | |
WO2011140446A3 (en) | Pharmaceutical formulations | |
CR20140540A (es) | Nueva forma de dosificación y formulación de abediterol | |
JP2017530163A5 (es) | ||
JP2012082195A5 (es) | ||
AR121619A1 (es) | 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 | |
CN112245419A (zh) | 包括15-hepe的组合物以及使用其治疗或预防纤维化的方法 | |
PE20211462A1 (es) | Procedimiento para la preparacion de una forma de dosificacion oral de multiples unidades de liberacion modificada de succinato de doxilamina y clorhidrato de piridoxina | |
CN113893240A (zh) | 包含15-hepe的组合物和其使用方法 | |
CN113896628A (zh) | 包含15-氧代-epa或15-氧代-dgla的组合物及其制备和使用方法 | |
UY28457A1 (es) | Nueva composición | |
CO2018002046A2 (es) | Nueva composición oral de libreación retardada dual de dexlansoprazol | |
DOP2010000265A (es) | Formulacion galenica oral que comprende ketorolaco y vitaminas del complejo b, en la que la vitamina b6 se encuentra em una capa externa separada del resto de principios activos | |
Bennis et al. | Severe neurological disorders and refractory aspergillosis in an adolescent treated by vincristine and voriconazole. | |
AR075058A1 (es) | Composicion farmaceutica oral para uso en enfermedades respiratorias y proceso de fabricacion | |
AR067502A1 (es) | Pelets de administracion oral y liberacion retardada de clorhidrato de duloxetina |