MA59146B1 - Forme posologique orale à unités multiples et à libération modifiée de succinate de doxylamine et d'hydrochlorure de pyridoxine et son procédé de préparation - Google Patents
Forme posologique orale à unités multiples et à libération modifiée de succinate de doxylamine et d'hydrochlorure de pyridoxine et son procédé de préparationInfo
- Publication number
- MA59146B1 MA59146B1 MA59146A MA59146A MA59146B1 MA 59146 B1 MA59146 B1 MA 59146B1 MA 59146 A MA59146 A MA 59146A MA 59146 A MA59146 A MA 59146A MA 59146 B1 MA59146 B1 MA 59146B1
- Authority
- MA
- Morocco
- Prior art keywords
- modified release
- preparation
- dosage form
- pharmaceutically acceptable
- coating layer
- Prior art date
Links
- 238000002360 preparation method Methods 0.000 title abstract 3
- 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 abstract 2
- 229960005008 doxylamine succinate Drugs 0.000 title abstract 2
- ZUFQODAHGAHPFQ-UHFFFAOYSA-N pyridoxine hydrochloride Chemical compound Cl.CC1=NC=C(CO)C(CO)=C1O ZUFQODAHGAHPFQ-UHFFFAOYSA-N 0.000 title abstract 2
- 229960004172 pyridoxine hydrochloride Drugs 0.000 title abstract 2
- 235000019171 pyridoxine hydrochloride Nutrition 0.000 title abstract 2
- 239000011764 pyridoxine hydrochloride Substances 0.000 title abstract 2
- 239000002552 dosage form Substances 0.000 title 1
- 239000011247 coating layer Substances 0.000 abstract 5
- LXNHXLLTXMVWPM-UHFFFAOYSA-N pyridoxine Chemical compound CC1=NC=C(CO)C(CO)=C1O LXNHXLLTXMVWPM-UHFFFAOYSA-N 0.000 abstract 4
- 239000002245 particle Substances 0.000 abstract 3
- 229960005178 doxylamine Drugs 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
- 238000000034 method Methods 0.000 abstract 2
- 239000006186 oral dosage form Substances 0.000 abstract 2
- 239000008188 pellet 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
- 239000007937 lozenge Substances 0.000 abstract 1
- 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
- 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
- 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
- A61K9/5089—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)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (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
Forme posologique par voie orale à unités multiples à libération modifiée de succinate de doxylamine et chlorhydrate de pyridoxine et procédé pour sa préparation. La présente invention se rapporte à une forme posologique par voie orale à unités multiples à libération modifiée comprenant : une première pluralité de pastilles à libération modifiée de doxylamine comprenant : un noyau inerte pharmaceutiquement acceptable ; une couche de revêtement interne active comprenant une doxylamine ; éventuellement une couche de revêtement à libération entérique intermédiaire ; et une couche de revêtement à libération modifiée externe ; et une seconde pluralité de pastilles à libération modifiée de pyridoxine ou son sel pharmaceutiquement acceptable comprenant : un noyau inerte pharmaceutiquement acceptable ; une couche de revêtement interne active comprenant de la pyridoxine ou son sel pharmaceutiquement acceptable ; et une couche de revêtement à libération modifiée externe ; la taille de particule du noyau inerte pharmaceutiquement acceptable de la première et de la seconde pluralité de pastilles étant telle qu'au moins 90 % des noyaux inertes ont une taille de particule de 300 µm à 1 700 µm et une variabilité de taille de particule non supérieure à 200 µm mesurée par tamisage analytique. L'invention se rapporte également à un procédé pour sa préparation et son utilisation en thérapie.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP20382227 | 2020-03-25 | ||
| PCT/EP2021/057555 WO2021191268A1 (fr) | 2020-03-25 | 2021-03-24 | Forme posologique par voie orale à unités multiples à libération modifiée de succinate de doxylamine et chlorhydrate de pyridoxine et un procédé pour sa préparation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MA59146B1 true MA59146B1 (fr) | 2024-03-29 |
Family
ID=70189866
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MA59146A MA59146B1 (fr) | 2020-03-25 | 2021-03-24 | Forme posologique orale à unités multiples et à libération modifiée de succinate de doxylamine et d'hydrochlorure de pyridoxine et son procédé de préparation |
Country Status (30)
| Country | Link |
|---|---|
| EP (1) | EP4125825B1 (fr) |
| JP (1) | JP7735301B2 (fr) |
| KR (1) | KR102979874B1 (fr) |
| CN (1) | CN115697311B (fr) |
| AR (1) | AR121619A1 (fr) |
| AU (1) | AU2021243600B2 (fr) |
| BR (1) | BR112022018366A2 (fr) |
| CL (1) | CL2022002572A1 (fr) |
| CO (1) | CO2022013621A2 (fr) |
| CR (1) | CR20220527A (fr) |
| DK (1) | DK4125825T3 (fr) |
| EC (1) | ECSP22082569A (fr) |
| ES (1) | ES2973785T3 (fr) |
| FI (1) | FI4125825T3 (fr) |
| HR (1) | HRP20240284T1 (fr) |
| HU (1) | HUE065414T2 (fr) |
| JO (1) | JOP20220229A1 (fr) |
| LT (1) | LT4125825T (fr) |
| MA (1) | MA59146B1 (fr) |
| MX (1) | MX2022011737A (fr) |
| PE (1) | PE20221832A1 (fr) |
| PH (1) | PH12022552521A1 (fr) |
| PL (1) | PL4125825T3 (fr) |
| PT (1) | PT4125825T (fr) |
| RS (1) | RS65226B1 (fr) |
| SI (1) | SI4125825T1 (fr) |
| SM (1) | SMT202400158T1 (fr) |
| UA (1) | UA129276C2 (fr) |
| WO (1) | WO2021191268A1 (fr) |
| ZA (1) | ZA202211174B (fr) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AR132739A1 (es) | 2023-05-22 | 2025-07-23 | Italfarmaco Spa | Una forma de dosificación oral de unidades múltiples de succinato de doxilamina y clorhidrato de piridoxina sin dióxido de titanio |
| US12303604B1 (en) | 2024-10-16 | 2025-05-20 | Currax Pharmaceuticals Llc | Pharmaceutical formulations comprising naltrexone and/or bupropion |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2558396B2 (ja) * | 1990-06-28 | 1996-11-27 | 田辺製薬株式会社 | 放出制御型製剤 |
| CA2392486A1 (fr) * | 2002-07-05 | 2002-12-08 | Duchesnay Inc. | Forme posologique pharmaceutique portant une inscription pour les femmes enceintes |
| CA2406592C (fr) * | 2002-10-04 | 2003-09-30 | Duchesnay Inc. | Mode de preparation de formes posologiques pharmaceutiques contenant de multiples principes actifs |
| CA2432945C (fr) * | 2003-07-10 | 2004-11-23 | Duchesnay Inc. | Utilisation d'un succinate de doxylamine et de chlorhydrate de pyridoxinium pour la prophylaxie et le traitement des nausees post-chirurgical |
| US20070141147A1 (en) * | 2005-12-21 | 2007-06-21 | Auriga Laboratories, Inc. | Sequential release pharmaceutical formulations |
| US9943489B2 (en) * | 2010-02-03 | 2018-04-17 | Pharmatwob Ltd. | Extended release formulations of rasagiline and uses thereof |
| CA2761212A1 (fr) * | 2011-12-07 | 2013-06-07 | Pharmascience Inc. | Formulation de pyridoxine et de doxylamine a action retardee sans delitant et son procede de fabrication |
| WO2013123569A1 (fr) | 2012-02-22 | 2013-08-29 | Duchesnay Inc. | Formulation à base de doxylamine et de pyridoxine et/ou de métabolites ou de sels associés |
| JP5914701B2 (ja) * | 2012-02-22 | 2016-05-11 | デュシネイ・インコーポレイテッド | ドキシラミンおよびピリドキシン、ならびに／またはその代謝物もしくは塩の製剤 |
| SG11201701448XA (en) * | 2014-08-29 | 2017-03-30 | Duchesnay Inc | Plurimodal release formulation of doxylamine and pyridoxine 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 |
| RS61368B1 (sr) * | 2018-09-27 | 2021-02-26 | Inibsa Ginecologia S A | Postupak za pripremu višejediničnog oralnog doznog oblika sa modifikovanim oslobađanjem doksilamin sukcinata i piridoksin hidrohlorida |
-
2021
- 2021-03-19 AR ARP210100692A patent/AR121619A1/es unknown
- 2021-03-24 HR HRP20240284TT patent/HRP20240284T1/hr unknown
- 2021-03-24 WO PCT/EP2021/057555 patent/WO2021191268A1/fr not_active Ceased
- 2021-03-24 FI FIEP21712892.5T patent/FI4125825T3/fi active
- 2021-03-24 HU HUE21712892A patent/HUE065414T2/hu unknown
- 2021-03-24 CN CN202180037889.9A patent/CN115697311B/zh active Active
- 2021-03-24 CR CR20220527A patent/CR20220527A/es unknown
- 2021-03-24 DK DK21712892.5T patent/DK4125825T3/da active
- 2021-03-24 MX MX2022011737A patent/MX2022011737A/es unknown
- 2021-03-24 RS RS20240227A patent/RS65226B1/sr unknown
- 2021-03-24 LT LTEPPCT/EP2021/057555T patent/LT4125825T/lt unknown
- 2021-03-24 PE PE2022002070A patent/PE20221832A1/es unknown
- 2021-03-24 EP EP21712892.5A patent/EP4125825B1/fr active Active
- 2021-03-24 ES ES21712892T patent/ES2973785T3/es active Active
- 2021-03-24 PL PL21712892.5T patent/PL4125825T3/pl unknown
- 2021-03-24 SI SI202130114T patent/SI4125825T1/sl unknown
- 2021-03-24 JP JP2022558004A patent/JP7735301B2/ja active Active
- 2021-03-24 BR BR112022018366A patent/BR112022018366A2/pt unknown
- 2021-03-24 UA UAA202203961A patent/UA129276C2/uk unknown
- 2021-03-24 MA MA59146A patent/MA59146B1/fr unknown
- 2021-03-24 PT PT217128925T patent/PT4125825T/pt unknown
- 2021-03-24 SM SM20240158T patent/SMT202400158T1/it unknown
- 2021-03-24 KR KR1020227032023A patent/KR102979874B1/ko active Active
- 2021-03-24 AU AU2021243600A patent/AU2021243600B2/en active Active
- 2021-03-24 PH PH1/2022/552521A patent/PH12022552521A1/en unknown
- 2021-09-30 JO JOJO/P/2022/0229A patent/JOP20220229A1/ar 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
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| RU2404982C2 (ru) | Применение соединений пирролохинолина для уничтожения клинически латентных микроорганизмов | |
| US20220218670A1 (en) | Methods of treating diseases characterised by vasoconstriction | |
| EP4706757A3 (fr) | Dérivés de l'acide 2-((2,3-dihydrobenzo[b [1,4 dioxan-5-yl)pipéridin-1-yl)méthyl)-1-((oxétan-2-yl)méthyl)-1h-benzo[d!imidazole-6-carboxylique et composés similaires | |
| Stockis et al. | Brivaracetam and carbamazepine interaction in healthy subjects and in vitro | |
| US20090176831A1 (en) | Compounds and Methods for Treating Cancer and Diseases of the Central Nervous System | |
| TWI583380B (zh) | 免疫抑制性調配物 | |
| US20110319459A1 (en) | Compounds and Methods for Treating Cancer and Diseases of the Central Nervous System | |
| RU2000116011A (ru) | Пероральная фармацевтическая лекарственная форма с продолжительным высвобождением | |
| BG102669A (bg) | Метод за лечение и фармацевтичен състав | |
| TW201345568A (zh) | 包含囊封於硬膠囊中之多單位球形錠（ｍｕｓｔ）的複合調配物及製備其之方法 | |
| NZ514554A (en) | NR2B subunit selective NMDA receptor antagonists for treatment of depression, hearing and vision loss, and neurological damage | |
| JP2011098965A5 (fr) | ||
| Sanchez et al. | Advances in the discovery of heterocyclic-based drugs against Alzheimer’s disease | |
| US20240016791A1 (en) | Iloperidone metabolite for use in the treatment of psychiatric disorders | |
| JP2025163142A (ja) | Ｃｘｃｒ７アンタゴニストのｓ１ｐ１受容体調節剤との合剤 | |
| CO2022013621A2 (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 | |
| Ishigooka et al. | Post‐hoc analysis investigating the safety and efficacy of brexpiprazole in Japanese patients with schizophrenia who were switched from other antipsychotics in a long‐term study (Secondary Publication) | |
| RU2326664C2 (ru) | Производные бензотиазол-4,7-диона и бензоксазол-4,7-диона, их получение и терапевтическое применение | |
| Malhotra et al. | Effects of the moderate CYP3A4 inhibitor, fluconazole, on the pharmacokinetics of fesoterodine in healthy subjects | |
| Li et al. | An open‐label study to assess the effect of itraconazole and rifampin on parsaclisib pharmacokinetics when administered orally in healthy participants | |
| Takeuchi et al. | Effectiveness of the repeated administration of scopolamine ointment on clozapine‐induced hypersalivation in patients with treatment‐resistant schizophrenia: A preliminary study | |
| Moen | Telmisartan/amlodipine: single-pill combination in hypertension | |
| Li et al. | Quality by Design Approach for Development and Characterization of Granisetron Hydrochloride-Loaded Orodispersible Films | |
| JP2013177351A (ja) | Ｐｇｄ２拮抗剤及びロイコトリエン拮抗剤からなる喘息治療剤 | |
| WO2016126115A2 (fr) | Composition pharmaceutique comprenant de la pitavastatine ou un sel pharmaceutiquement acceptable de celle-ci, et du valsartan ou un sel pharmaceutiquement acceptable de celui-ci |