MX385449B - Polimorfo de neridronato de sodio y procedimiento de preparación del mismo. - Google Patents
Polimorfo de neridronato de sodio y procedimiento de preparación del mismo.Info
- Publication number
- MX385449B MX385449B MX2020010744A MX2020010744A MX385449B MX 385449 B MX385449 B MX 385449B MX 2020010744 A MX2020010744 A MX 2020010744A MX 2020010744 A MX2020010744 A MX 2020010744A MX 385449 B MX385449 B MX 385449B
- Authority
- MX
- Mexico
- Prior art keywords
- sodium neridronate
- range
- polymorph
- sodium
- neridronate
- Prior art date
Links
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
- A61K31/66—Phosphorus compounds
- A61K31/662—Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
- A61K31/663—Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
- A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
- A61P5/20—Drugs for disorders of the endocrine system of the parathyroid hormones for decreasing, blocking or antagonising the activity of PTH
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
- C07F9/00—Compounds containing elements of Groups 5 or 15 of the Periodic Table
- C07F9/02—Phosphorus compounds
- C07F9/025—Purification; Separation; Stabilisation; Desodorisation of organo-phosphorus compounds
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
- C07F9/00—Compounds containing elements of Groups 5 or 15 of the Periodic Table
- C07F9/02—Phosphorus compounds
- C07F9/28—Phosphorus compounds with one or more P—C bonds
- C07F9/38—Phosphonic acids [RP(=O)(OH)2]; Thiophosphonic acids ; [RP(=X1)(X2H)2(X1, X2 are each independently O, S or Se)]
- C07F9/3804—Phosphonic acids [RP(=O)(OH)2]; Thiophosphonic acids ; [RP(=X1)(X2H)2(X1, X2 are each independently O, S or Se)] not used, see subgroups
- C07F9/3839—Polyphosphonic acids
- C07F9/3873—Polyphosphonic acids containing nitrogen substituent, e.g. N.....H or N-hydrocarbon group which can be substituted by halogen or nitro(so), N.....O, N.....S, N.....C(=X)- (X =O, S), N.....N, N...C(=X)...N (X =O, S)
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Physical Education & Sports Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Rheumatology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- Epidemiology (AREA)
- Oncology (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Immunology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
La presente invención se refiere a un nuevo polimorfo cristalino hemihidratado de sal sódica del ácido neridrónico, y a un nuevo procedimiento para la preparación del mismo que comprende los pasos de: 1) disolver neridronato de sodio sólido en cualquier forma cristalina en agua, a una temperatura en el intervalo de 70 a 90°C, para obtener una solución acuosa de neridronato de sodio; 2) agregar un solvente seleccionado del grupo que consiste en etanol, 1-propanol y 2-propanol a la solución acuosa obtenida en el paso (1), de modo que la relación final de volumen de agua:solvente esté en el intervalo de 1:0.5 a 1:1, obteniendo así una suspensión; 3) colocar la suspensión obtenida en el paso (2) bajo agitación mecánica, a una temperatura en el intervalo de 60 a 95°C; 4) recuperar la forma F cristalina hemihidratada del neridronato de sodio formada en el paso anterior (3); la forma F cristalina hemihidratada de neridronato de sodio, particularmente estable, puede emplearse en la preparación de formas farmacéuticas orales sólidas para usarse en el tratamiento de trastornos musculoesqueléticos y del metabolismo del calcio.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP18166508.4A EP3553067A1 (en) | 2018-04-10 | 2018-04-10 | Polymorph of sodium neridronate and preparation process thereof |
| PCT/EP2019/059026 WO2019197437A1 (en) | 2018-04-10 | 2019-04-10 | Polymorph of sodium neridronate and preparation process thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| MX2020010744A MX2020010744A (es) | 2021-08-19 |
| MX385449B true MX385449B (es) | 2025-03-18 |
Family
ID=62495533
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2020010744A MX385449B (es) | 2018-04-10 | 2019-04-10 | Polimorfo de neridronato de sodio y procedimiento de preparación del mismo. |
Country Status (18)
| Country | Link |
|---|---|
| US (1) | US10815257B2 (es) |
| EP (2) | EP3553067A1 (es) |
| JP (1) | JP7042359B2 (es) |
| CN (1) | CN112204043B (es) |
| AU (1) | AU2019250339B2 (es) |
| CA (2) | CA3096316C (es) |
| CY (1) | CY1125059T1 (es) |
| DK (1) | DK3774823T3 (es) |
| ES (1) | ES2908072T3 (es) |
| HR (1) | HRP20220248T1 (es) |
| HU (1) | HUE058239T2 (es) |
| LT (1) | LT3774823T (es) |
| MX (1) | MX385449B (es) |
| PL (1) | PL3774823T3 (es) |
| PT (1) | PT3774823T (es) |
| SI (1) | SI3774823T1 (es) |
| SM (1) | SMT202200166T1 (es) |
| WO (1) | WO2019197437A1 (es) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT201900008391A1 (it) * | 2019-06-07 | 2020-12-07 | Abiogen Pharma Spa | Procedimento di preparazione del polimorfo f di sodio neridronato |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3032871A1 (de) * | 1980-09-01 | 1982-04-15 | Vysoká škola chemicko-technologická Praha, Praha | 6-amino-1-hydroxyhexyliden-diphosphonsaeure, ihre salze und ein verfahren zur herstellung derselben |
| US4304734A (en) * | 1980-10-16 | 1981-12-08 | Vysoka Skola Chemicko-Technologicka | 6-Amino-1-hydroxyhexylidene diphosphonic acid, salts and a process for production thereof |
| US4639338A (en) * | 1984-08-06 | 1987-01-27 | Ciba-Geigy Corporation | Preparation of crystalline disodium 3-amino-1-hydroxypropane-1,1-diphosphonate pentahydrate |
| IT1246992B (it) | 1991-01-08 | 1994-12-12 | Gentili Ist Spa | Procedimento per la preparazione di acidi difosfonici e loro sali |
| AU2003233569A1 (en) | 2002-05-17 | 2003-12-02 | Teva Pharmaceutical Industries Ltd. | Use of certain diluents for making bisphosphonic acids |
| CA2656053A1 (en) | 2006-07-03 | 2008-01-10 | Generics [Uk] Limited | Novel process for the preparation of bisphosphonic acids |
| CN101125863B (zh) | 2007-08-31 | 2011-07-27 | 浙江新东港药业股份有限公司 | 一种阿仑膦酸新的制备方法 |
| WO2010035664A1 (ja) | 2008-09-24 | 2010-04-01 | 田辺三菱製薬株式会社 | ビスホスホン酸誘導体の製法 |
| CN104072538A (zh) | 2014-07-10 | 2014-10-01 | 陕西汉江药业集团股份有限公司 | 一种双膦酸盐类药物的合成方法 |
-
2018
- 2018-04-10 EP EP18166508.4A patent/EP3553067A1/en not_active Withdrawn
-
2019
- 2019-04-10 PL PL19721990T patent/PL3774823T3/pl unknown
- 2019-04-10 CA CA3096316A patent/CA3096316C/en active Active
- 2019-04-10 US US16/379,873 patent/US10815257B2/en active Active
- 2019-04-10 SI SI201930170T patent/SI3774823T1/sl unknown
- 2019-04-10 WO PCT/EP2019/059026 patent/WO2019197437A1/en not_active Ceased
- 2019-04-10 ES ES19721990T patent/ES2908072T3/es active Active
- 2019-04-10 HR HRP20220248TT patent/HRP20220248T1/hr unknown
- 2019-04-10 CN CN201980035619.7A patent/CN112204043B/zh active Active
- 2019-04-10 CA CA3126088A patent/CA3126088C/en active Active
- 2019-04-10 EP EP19721990.0A patent/EP3774823B1/en active Active
- 2019-04-10 JP JP2020555444A patent/JP7042359B2/ja active Active
- 2019-04-10 HU HUE19721990A patent/HUE058239T2/hu unknown
- 2019-04-10 LT LTEPPCT/EP2019/059026T patent/LT3774823T/lt unknown
- 2019-04-10 DK DK19721990.0T patent/DK3774823T3/da active
- 2019-04-10 SM SM20220166T patent/SMT202200166T1/it unknown
- 2019-04-10 PT PT197219900T patent/PT3774823T/pt unknown
- 2019-04-10 MX MX2020010744A patent/MX385449B/es unknown
- 2019-04-10 AU AU2019250339A patent/AU2019250339B2/en active Active
-
2022
- 2022-03-02 CY CY20221100179T patent/CY1125059T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| LT3774823T (lt) | 2022-03-10 |
| CA3096316A1 (en) | 2019-10-17 |
| JP2021512939A (ja) | 2021-05-20 |
| CY1125059T1 (el) | 2024-02-16 |
| CN112204043B (zh) | 2023-11-17 |
| AU2019250339A1 (en) | 2020-11-26 |
| CA3126088C (en) | 2023-09-12 |
| US10815257B2 (en) | 2020-10-27 |
| MX2020010744A (es) | 2021-08-19 |
| EP3553067A1 (en) | 2019-10-16 |
| JP7042359B2 (ja) | 2022-03-25 |
| AU2019250339B2 (en) | 2021-07-15 |
| HUE058239T2 (hu) | 2022-07-28 |
| EP3774823B1 (en) | 2021-12-08 |
| EP3774823A1 (en) | 2021-02-17 |
| ES2908072T3 (es) | 2022-04-27 |
| CA3126088A1 (en) | 2019-10-17 |
| PL3774823T3 (pl) | 2022-05-02 |
| DK3774823T3 (da) | 2022-02-14 |
| CN112204043A (zh) | 2021-01-08 |
| PT3774823T (pt) | 2022-02-28 |
| SMT202200166T1 (it) | 2022-05-12 |
| HRP20220248T1 (hr) | 2022-04-29 |
| CA3096316C (en) | 2022-02-22 |
| US20190308999A1 (en) | 2019-10-10 |
| SI3774823T1 (sl) | 2022-04-29 |
| WO2019197437A1 (en) | 2019-10-17 |
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