CA3089172A1 - Process to reduce endotoxin in gelatin - Google Patents

Process to reduce endotoxin in gelatin Download PDF

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Publication number
CA3089172A1
CA3089172A1 CA3089172A CA3089172A CA3089172A1 CA 3089172 A1 CA3089172 A1 CA 3089172A1 CA 3089172 A CA3089172 A CA 3089172A CA 3089172 A CA3089172 A CA 3089172A CA 3089172 A1 CA3089172 A1 CA 3089172A1
Authority
CA
Canada
Prior art keywords
gelatin
solution
endotoxin
salt
salt solution
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
CA3089172A
Other languages
English (en)
French (fr)
Inventor
Yik Teng WONG
Khojasteh SHIRKHANI
Ami POWE
Sarah Stewart
Charli SMARDON
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.)
Catalent UK Swindon Zydis Ltd
Original Assignee
Catalent UK Swindon Zydis Ltd
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
Application filed by Catalent UK Swindon Zydis Ltd filed Critical Catalent UK Swindon Zydis Ltd
Publication of CA3089172A1 publication Critical patent/CA3089172A1/en
Pending legal-status Critical Current

Links

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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09H—PREPARATION OF GLUE OR GELATINE
    • C09H3/00—Isolation of glue or gelatine from raw materials, e.g. by extracting, by heating
    • C09H3/02—Purification of solutions of gelatine
    • 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
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/513—Organic macromolecular compounds; Dendrimers
    • A61K9/5169—Proteins, e.g. albumin, gelatin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J41/00—Anion exchange; Use of material as anion exchangers; Treatment of material for improving the anion exchange properties
    • B01J41/08—Use of material as anion exchangers; Treatment of material for improving the anion exchange properties
    • B01J41/12—Macromolecular compounds
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J47/00—Ion-exchange processes in general; Apparatus therefor
    • B01J47/014—Ion-exchange processes in general; Apparatus therefor in which the adsorbent properties of the ion-exchanger are involved, e.g. recovery of proteins or other high-molecular compounds
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J47/00—Ion-exchange processes in general; Apparatus therefor
    • B01J47/12—Ion-exchange processes in general; Apparatus therefor characterised by the use of ion-exchange material in the form of ribbons, filaments, fibres or sheets, e.g. membranes

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Nanotechnology (AREA)
  • Optics & Photonics (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
CA3089172A 2018-03-08 2019-03-07 Process to reduce endotoxin in gelatin Pending CA3089172A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862640394P 2018-03-08 2018-03-08
US62/640,394 2018-03-08
PCT/IB2019/000234 WO2019171173A1 (en) 2018-03-08 2019-03-07 Process to reduce endotoxin in gelatin

Publications (1)

Publication Number Publication Date
CA3089172A1 true CA3089172A1 (en) 2019-09-12

Family

ID=66668957

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3089172A Pending CA3089172A1 (en) 2018-03-08 2019-03-07 Process to reduce endotoxin in gelatin

Country Status (11)

Country Link
US (2) US10988638B2 (https=)
EP (1) EP3761956B1 (https=)
JP (1) JP7431741B2 (https=)
CN (1) CN111902129A (https=)
AU (1) AU2019229784A1 (https=)
BR (1) BR112020015253A2 (https=)
CA (1) CA3089172A1 (https=)
ES (1) ES2982045T3 (https=)
IL (1) IL277009B2 (https=)
MX (1) MX2020009112A (https=)
WO (1) WO2019171173A1 (https=)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102793584B1 (ko) 2016-12-31 2025-04-09 바이오엑셀 테라퓨틱스 인코포레이티드 불안의 치료를 위한 설하 덱스메데토미딘의 용도
PL3813802T3 (pl) 2018-06-27 2025-04-22 Bioxcel Therapeutics, Inc. Formulacje błony zawierające deksmedetomidynę i sposoby ich wytwarzania
EP3999058A4 (en) 2019-07-19 2023-05-03 Bioxcel Therapeutics, Inc. NON-SEDATIVE DEXMEDETOMIDINE-BASED TREATMENT REGIMEN
HUE056569T2 (hu) 2019-07-31 2022-02-28 Catalent Uk Swindon Zydis Ltd Sûrûség-áramlásmérõ gyógyászati készítmény adagolásához
CN111286276A (zh) * 2020-03-26 2020-06-16 吉林大学 一种林蛙皮明胶的制备方法
WO2022103638A1 (en) 2020-11-16 2022-05-19 Orcosa Inc. Cannabinoids in the treatment of autism spectrum disorder
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans
CN113607903B (zh) * 2021-07-30 2024-03-15 振德医疗用品股份有限公司 一种检测含有正电荷聚合物细菌内毒素的方法
EP4501129A4 (en) 2022-03-30 2026-03-11 Toray Industries PROCESS FOR THE PRODUCTION OF GELATIN OR A CONCENTRATED GELATIN SOLUTION
US11806334B1 (en) 2023-01-12 2023-11-07 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens
NL2038119B1 (en) * 2024-07-02 2026-01-16 Sentryx B V A method for purifying a gelatin

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB211423A (en) 1923-10-06 1924-02-21 Leopold Seeger Improved means for locking nuts
GB1548022A (en) 1976-10-06 1979-07-04 Wyeth John & Brother Ltd Pharmaceutial dosage forms
CA1097233A (en) 1977-07-20 1981-03-10 George K. E. Gregory Packages
US4374063A (en) 1981-09-28 1983-02-15 General Foods Corporation Process for the preparation and purification of gelatin and pyrogen-free gelatin so prepared
IE53696B1 (en) 1981-12-02 1989-01-18 Wyeth John & Brother Ltd Solid shaped articles
JP3039966B2 (ja) * 1990-07-20 2000-05-08 新田ゼラチン株式会社 ゼラチンのイオン性不純物除去方法
ATE187733T1 (de) * 1994-02-07 2000-01-15 Qiagen Gmbh Verfahren zur herstellung endotoxinfreier oder an endotoxin abgereicherter nucleinsäuren und/oder oligonucleotide für die gentherapie
US5616689A (en) * 1994-07-13 1997-04-01 Collagen Corporation Method of controlling structure stability of collagen fibers produced form solutions or dispersions treated with sodium hydroxide for infectious agent deactivation
GB9908014D0 (en) 1999-04-08 1999-06-02 Scherer Corp R P Pharmaceutical compositions
IL149459A0 (en) * 1999-11-12 2002-11-10 Fibrogen Inc Recombinant gelatins
DE10010342A1 (de) * 2000-03-06 2001-09-20 Merck Patent Gmbh Verfahren zur Abreicherung von Endotoxinen
JP4762785B2 (ja) * 2005-06-02 2011-08-31 西川ゴム工業株式会社 ゼラチンスポンジ
JP5328077B2 (ja) * 2006-02-10 2013-10-30 エア・ウォーター株式会社 低エンドトキシン化ゼラチンの製造方法
JP4404866B2 (ja) * 2006-03-03 2010-01-27 ゼライス株式会社 エンドトキシン含有量を低減したゼラチンの製造方法および低エンドトキシンゼラチン
JP4099541B2 (ja) 2006-07-19 2008-06-11 ゼライス株式会社 ペプチド精製物の製造方法
JP2010520320A (ja) * 2007-02-28 2010-06-10 リポクセン テクノロジーズ リミテッド ポリシアル酸におけるエンドトキシンの低減
WO2009154440A1 (en) * 2008-06-19 2009-12-23 Bender Analytical Holding B.V. Method for removing impurities from biopolymer material
US10548839B2 (en) 2010-03-16 2020-02-04 Wei Tian Process of manufacturing a lyophilized fast dissolving, multi-phasic dosage form
CN102423721B (zh) * 2011-08-18 2013-07-24 浙江工业大学 一种磁性阴离子交换剂及其作为内毒素吸附介质的应用
US20140142200A1 (en) 2012-11-16 2014-05-22 Eyegenix LLC Keratoprosthesis
CN104370997B (zh) * 2014-09-24 2018-07-31 陈辉 去除生物制品中细菌内毒素的试剂盒、方法及其生物制品的制备方法

Also Published As

Publication number Publication date
AU2019229784A1 (en) 2020-08-13
WO2019171173A1 (en) 2019-09-12
JP2021516685A (ja) 2021-07-08
IL277009A (en) 2020-10-29
CN111902129A (zh) 2020-11-06
JP7431741B2 (ja) 2024-02-15
ES2982045T3 (es) 2024-10-14
RU2020132925A (ru) 2022-04-08
MX2020009112A (es) 2020-10-01
US20190276707A1 (en) 2019-09-12
US20210207003A1 (en) 2021-07-08
IL277009B1 (en) 2024-02-01
US10988638B2 (en) 2021-04-27
EP3761956A1 (en) 2021-01-13
IL277009B2 (en) 2024-06-01
EP3761956C0 (en) 2024-06-12
BR112020015253A2 (pt) 2020-12-08
EP3761956B1 (en) 2024-06-12

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Effective date: 20220915