EP3814386A1 - NOUVELLE HYDROXYPROPYL-ß-CYCLODEXTRINE ET SON PROCÉDÉ DE PRÉPARATION - Google Patents
NOUVELLE HYDROXYPROPYL-ß-CYCLODEXTRINE ET SON PROCÉDÉ DE PRÉPARATIONInfo
- Publication number
- EP3814386A1 EP3814386A1 EP19752213.9A EP19752213A EP3814386A1 EP 3814386 A1 EP3814386 A1 EP 3814386A1 EP 19752213 A EP19752213 A EP 19752213A EP 3814386 A1 EP3814386 A1 EP 3814386A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- substance
- less
- equal
- ppm
- hrboϋ
- Prior art date
- Legal status (The legal status 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 status listed.)
- Pending
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
- C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
- C08B37/0006—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid
- C08B37/0009—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid alpha-D-Glucans, e.g. polydextrose, alternan, glycogen; (alpha-1,4)(alpha-1,6)-D-Glucans; (alpha-1,3)(alpha-1,4)-D-Glucans, e.g. isolichenan or nigeran; (alpha-1,4)-D-Glucans; (alpha-1,3)-D-Glucans, e.g. pseudonigeran; Derivatives thereof
- C08B37/0012—Cyclodextrin [CD], e.g. cycle with 6 units (alpha), with 7 units (beta) and with 8 units (gamma), large-ring cyclodextrin or cycloamylose with 9 units or more; Derivatives thereof
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/724—Cyclodextrins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- 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
-
- 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
- A61P3/06—Antihyperlipidemics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
Definitions
- the propylene oxide: anhydroglucose molar ratio used is chosen from a range going from 0.70: 1.00 to 0.86: 1.00;
- This chloride content can be conventionally determined by a person skilled in the art by potentiometric titration of an h ⁇ CD solution using a silver nitrate solution of known concentration.
- the HPpCD according to the invention has a pH in a range from 5.0 to 7.5; said pH being measured on the basis of a solution of HP CD consisting of 2 g of dry HP CD, 98 g of distilled water and 0.3 ml of a potassium chloride solution at 225 g / L .
- the propylene oxide: anhydroglucose molar ratio used is greater than or equal to 0.75: 1.00, preferably greater than or equal to 0.80: 1.00, preferably greater than or equal to 0.82: 1.00, preferably greater than or equal to 0.84: 1.00, preferably equal to 0.85: 1, 00.
- the invention also relates to the use of an HRbO ⁇ according to the invention as an excipient, and / or for encapsulating a substance, and / or solubilizing a substance in an aqueous medium, and / or for improving the chemical stability of a substance , and / or to improve the delivery of a substance to and through biological membranes, and / or to increase the physical stability of a substance, and / or to formulate a substance from a liquid form to a pulverulent form , and / or to prevent interactions of a substance with another substance, and / or to reduce local irritation after topical or oral administration of a substance, and / or to prevent absorption of a substance by level of certain tissues such as the skin, and / or to obtain a prolonged release of a substance, and / or to mask the taste of a substance, in particular its bitterness, and / or to mask the smell of a substance , and / or for mo identify the bioavailability of a substance.
- these substances are lipophilic compounds or carriers of at least one lipophilic group.
- the bleaching step was carried out by treatment with active charcoal for 1 h at 70 ° C.
- the medium was then filtered through a bag filter and then a cartridge filter 1 ⁇ m then 0.22 ⁇ m.
- the membrane purification step was carried out using a nanofiltration module equipped with a membrane having a cutoff threshold of less than 800 Da, at a pressure of less than 35 bars and at a temperature of more than 45 ° C. .
- the propanediol content of the retentate was checked by HPLC assay. The nanofiltration operation was stopped as soon as a propanediol content of less than 0.1% by weight on dry product was reached.
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Diabetes (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Inorganic Chemistry (AREA)
- Materials Engineering (AREA)
- Polymers & Plastics (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biochemistry (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hospice & Palliative Care (AREA)
- Cardiology (AREA)
- Psychiatry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Polysaccharides And Polysaccharide Derivatives (AREA)
- Medicinal Preparation (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Cosmetics (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Steroid Compounds (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR1855952A FR3083234B1 (fr) | 2018-06-29 | 2018-06-29 | Nouvelles hydroxypropyl-beta-cyclodextrines et leurs procedes de preparation |
| FR1902375 | 2019-03-08 | ||
| PCT/FR2019/051602 WO2020002851A1 (fr) | 2018-06-29 | 2019-06-28 | NOUVELLE HYDROXYPROPYL-β-CYCLODEXTRINE ET SON PROCÉDÉ DE PRÉPARATION |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP3814386A1 true EP3814386A1 (fr) | 2021-05-05 |
Family
ID=67551566
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP19752213.9A Pending EP3814386A1 (fr) | 2018-06-29 | 2019-06-28 | NOUVELLE HYDROXYPROPYL-ß-CYCLODEXTRINE ET SON PROCÉDÉ DE PRÉPARATION |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US12522670B2 (https=) |
| EP (1) | EP3814386A1 (https=) |
| JP (2) | JP7581055B2 (https=) |
| KR (1) | KR102912248B1 (https=) |
| CN (1) | CN112334494A (https=) |
| CA (1) | CA3104568A1 (https=) |
| IL (1) | IL279845A (https=) |
| MX (1) | MX2020013689A (https=) |
| SG (1) | SG11202013126QA (https=) |
| WO (1) | WO2020002851A1 (https=) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP7607935B2 (ja) | 2019-01-03 | 2025-01-06 | サイクラリティ・セラピューティクス・インコーポレイテッド | シクロデキストリン二量体、それらの組成物、及びそれらの使用 |
| WO2023156966A1 (en) | 2022-02-18 | 2023-08-24 | Beren Therapeutics P.B.C. | Compositions of hydroxypropyl-beta-cyclodextrin and methods of purifying the same |
| JP2024064599A (ja) * | 2022-10-28 | 2024-05-14 | 国立大学法人 熊本大学 | 細胞内コレステロール輸送障害に起因する疾患又は障害の治療、予防又は改善用組成物 |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3346123A1 (de) * | 1983-12-21 | 1985-06-27 | Janssen Pharmaceutica, N.V., Beerse | Pharmazeutische praeparate von in wasser schwerloeslichen oder instabilen arzneistoffen und verfahren zu ihrer herstellung |
| HK1009335A1 (en) * | 1989-04-03 | 1999-05-28 | Janssen Pharmaceutica N.V. | Regioselective substitutions in cyclodextrins |
| US5096893A (en) | 1989-04-03 | 1992-03-17 | The United States Of America As Represented By The Department Of Health And Human Services | Regioselective substitutions in cyclodextrins |
| KR920008700A (ko) * | 1990-10-29 | 1992-05-28 | 이헌조 | 데크의 테이프 삽입유무 표시방법 |
| DE19505263A1 (de) * | 1995-02-16 | 1996-08-22 | Consortium Elektrochem Ind | Verfahren zur Reinigung von wasserlöslichen Cyclodextrinderivaten |
| CN1155888A (zh) * | 1995-06-08 | 1997-07-30 | 火箭兄弟公司 | 粉状羟丙基-β-环糊精组合物和其制备方法 |
| FR2735136B1 (fr) * | 1995-06-08 | 1997-08-14 | Roquette Freres | Composition pulverulente d'hydroxypropyl-betacyclodextrine et son procede de preparation. |
| FR2738149B1 (fr) * | 1995-09-06 | 1997-11-14 | Chauvin Lab Sa | Collyre a base d'indometacine pret a l'emploi |
| US5744154A (en) | 1995-09-06 | 1998-04-28 | Laboratoire Chauvin S.A. | Ready-to-use indomethacin-based eye lotion |
| EP1655034A1 (en) | 2004-10-10 | 2006-05-10 | Université de Liège | Use of cyclodextrin for treatment and prevention of bronchial inflammatory diseases. |
| WO2012037117A1 (en) | 2010-09-13 | 2012-03-22 | Bev-Rx, Inc. | Aqueous drug delivery system comprising off - flavor masking agent |
| CN102558394B (zh) * | 2010-12-07 | 2014-11-12 | 石药集团中奇制药技术(石家庄)有限公司 | 羟丙基-β-环糊精的制备方法 |
| CN102040675B (zh) * | 2010-12-22 | 2012-10-03 | 石药集团中诺药业(石家庄)有限公司 | 一种羟丙基-β-环糊精的制备方法 |
| US8791269B2 (en) | 2011-07-01 | 2014-07-29 | Fondazione Istituto Insubrico Di Ricerca Per La Vita | Complex of amorphous tomoxiprole and cyclodextrin with fast dissolution rate and process for the preparation thereof |
| FR3014694B1 (fr) * | 2013-12-13 | 2016-11-11 | Roquette Freres | Compositions a base de methyl-cyclodextrines pour le traitement et/ou la prevention de maladies par augmentation du taux de cholesterol-hdl |
| CA2988529A1 (en) | 2015-06-10 | 2016-12-15 | Vtesse, Inc. | Hydroxypropyl beta-cyclodextrin compositions and methods |
| CN108034010A (zh) * | 2017-12-29 | 2018-05-15 | 山东滨州智源生物科技有限公司 | 一种羟丙基环糊精的绿色制备方法 |
-
2019
- 2019-06-28 MX MX2020013689A patent/MX2020013689A/es unknown
- 2019-06-28 US US17/255,153 patent/US12522670B2/en active Active
- 2019-06-28 WO PCT/FR2019/051602 patent/WO2020002851A1/fr not_active Ceased
- 2019-06-28 SG SG11202013126QA patent/SG11202013126QA/en unknown
- 2019-06-28 CN CN201980044053.4A patent/CN112334494A/zh active Pending
- 2019-06-28 EP EP19752213.9A patent/EP3814386A1/fr active Pending
- 2019-06-28 JP JP2020573107A patent/JP7581055B2/ja active Active
- 2019-06-28 KR KR1020207037131A patent/KR102912248B1/ko active Active
- 2019-06-28 CA CA3104568A patent/CA3104568A1/fr active Pending
-
2020
- 2020-12-29 IL IL279845A patent/IL279845A/en unknown
-
2024
- 2024-08-07 JP JP2024130931A patent/JP2024150779A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| US12522670B2 (en) | 2026-01-13 |
| JP2024150779A (ja) | 2024-10-23 |
| KR20210027279A (ko) | 2021-03-10 |
| IL279845A (en) | 2021-03-01 |
| JP2021529243A (ja) | 2021-10-28 |
| SG11202013126QA (en) | 2021-02-25 |
| JP7581055B2 (ja) | 2024-11-12 |
| KR102912248B1 (ko) | 2026-01-15 |
| US20210253746A1 (en) | 2021-08-19 |
| WO2020002851A1 (fr) | 2020-01-02 |
| MX2020013689A (es) | 2021-05-12 |
| CA3104568A1 (fr) | 2020-01-02 |
| CN112334494A (zh) | 2021-02-05 |
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Legal Events
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| STAA | Information on the status of an ep patent application or granted ep patent |
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| PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
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| STAA | Information on the status of an ep patent application or granted ep patent |
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| 17P | Request for examination filed |
Effective date: 20201222 |
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| AK | Designated contracting states |
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| DAV | Request for validation of the european patent (deleted) | ||
| DAX | Request for extension of the european patent (deleted) | ||
| STAA | Information on the status of an ep patent application or granted ep patent |
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| 17Q | First examination report despatched |
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