EP3814386A1 - NOUVELLE HYDROXYPROPYL-ß-CYCLODEXTRINE ET SON PROCÉDÉ DE PRÉPARATION - Google Patents

NOUVELLE HYDROXYPROPYL-ß-CYCLODEXTRINE ET SON PROCÉDÉ DE PRÉPARATION

Info

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
Application number
EP19752213.9A
Other languages
German (de)
English (en)
French (fr)
Inventor
Clothilde Buffe
Joël DELATTRE
Vincent Wiatz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Roquette Freres SA
Original Assignee
Roquette Freres SA
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
Priority claimed from FR1855952A external-priority patent/FR3083234B1/fr
Application filed by Roquette Freres SA filed Critical Roquette Freres SA
Publication of EP3814386A1 publication Critical patent/EP3814386A1/fr
Pending legal-status Critical Current

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08BPOLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0006Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid
    • C08B37/0009Homoglycans, 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
    • C08B37/0012Cyclodextrin [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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/724Cyclodextrins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs 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)
EP19752213.9A 2018-06-29 2019-06-28 NOUVELLE HYDROXYPROPYL-ß-CYCLODEXTRINE ET SON PROCÉDÉ DE PRÉPARATION Pending EP3814386A1 (fr)

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)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
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

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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