JP7431741B2 - ゼラチン中のエンドトキシンを低減する方法 - Google Patents

ゼラチン中のエンドトキシンを低減する方法 Download PDF

Info

Publication number
JP7431741B2
JP7431741B2 JP2020546887A JP2020546887A JP7431741B2 JP 7431741 B2 JP7431741 B2 JP 7431741B2 JP 2020546887 A JP2020546887 A JP 2020546887A JP 2020546887 A JP2020546887 A JP 2020546887A JP 7431741 B2 JP7431741 B2 JP 7431741B2
Authority
JP
Japan
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.)
Active
Application number
JP2020546887A
Other languages
English (en)
Japanese (ja)
Other versions
JP2021516685A5 (https=
JP2021516685A (ja
JPWO2019171173A5 (https=
Inventor
イク・テン・ウォン
ホジャステ・シルカニ
アミ・ポウ
サラ・スチュアート
チャーリ・スマードン
Original Assignee
キャタレント・ユーケー・スウィンドン・ザイディス・リミテッド
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 キャタレント・ユーケー・スウィンドン・ザイディス・リミテッド filed Critical キャタレント・ユーケー・スウィンドン・ザイディス・リミテッド
Publication of JP2021516685A publication Critical patent/JP2021516685A/ja
Publication of JP2021516685A5 publication Critical patent/JP2021516685A5/ja
Publication of JPWO2019171173A5 publication Critical patent/JPWO2019171173A5/ja
Application granted granted Critical
Publication of JP7431741B2 publication Critical patent/JP7431741B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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
    • 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
    • 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)
JP2020546887A 2018-03-08 2019-03-07 ゼラチン中のエンドトキシンを低減する方法 Active JP7431741B2 (ja)

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 (4)

Publication Number Publication Date
JP2021516685A JP2021516685A (ja) 2021-07-08
JP2021516685A5 JP2021516685A5 (https=) 2022-03-15
JPWO2019171173A5 JPWO2019171173A5 (https=) 2022-03-15
JP7431741B2 true JP7431741B2 (ja) 2024-02-15

Family

ID=66668957

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2020546887A Active JP7431741B2 (ja) 2018-03-08 2019-03-07 ゼラチン中のエンドトキシンを低減する方法

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

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007211170A (ja) 2006-02-10 2007-08-23 Air Water Inc 低エンドトキシン化ゼラチンの製造方法
JP2007231225A (ja) 2006-03-03 2007-09-13 Jellice Co Ltd 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
JP2008024611A (ja) 2006-07-19 2008-02-07 Jellice Co Ltd ペプチド精製物の製造方法
US20140142200A1 (en) 2012-11-16 2014-05-22 Eyegenix LLC Keratoprosthesis

Family Cites Families (17)

* 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
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
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

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007211170A (ja) 2006-02-10 2007-08-23 Air Water Inc 低エンドトキシン化ゼラチンの製造方法
JP2007231225A (ja) 2006-03-03 2007-09-13 Jellice Co Ltd 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
US20080132682A1 (en) 2006-03-03 2008-06-05 Jellice Co., Ltd. Method for manufacturing gelatin with reduced endotoxin content and low endotoxin gelatin
JP2008024611A (ja) 2006-07-19 2008-02-07 Jellice Co Ltd ペプチド精製物の製造方法
US20140142200A1 (en) 2012-11-16 2014-05-22 Eyegenix LLC Keratoprosthesis

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
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
CA3089172A1 (en) 2019-09-12
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

Similar Documents

Publication Publication Date Title
JP7431741B2 (ja) ゼラチン中のエンドトキシンを低減する方法
AU2011227446B2 (en) Process of manufacturing a lyophilized fast dissolving, multi-phasic dosage form
KR20140088234A (ko) 안정성이 증진된 페닐에프린 액상 조성물
EP3532035B1 (en) Compositions of different densities for fast disintegrating multi-layer tablet
JP5388842B2 (ja) インフルエンザワクチン含有凍結乾燥製剤、及びその製造方法
CN116832147B (zh) Glp1多肽药物冻干闪释片及其制备方法
KR20170106460A (ko) 점막표면에서 활성제의 향상된 수송을 위한 저장성 하이드로겔 제제
EP4215186A1 (en) Treatment of celiac disease with tolerizing particles
EP2745839B1 (fr) Composition pharmaceutique sous la forme d'une suspension orale comprenant une fraction flavonoïque et de la gomme xanthane
CN103494780A (zh) 一种注射用加米霉素组合物冻干粉及制备方法
RU2788164C2 (ru) Процесс снижения содержания эндотоксина в желатине
HK40032225A (en) Process to reduce endotoxin in gelatin
CN115813867B (zh) 碳酸镧冻干片及其制备方法
CN108324688B (zh) 苯甲酸利扎曲普坦原位凝胶鼻喷剂
CN103070834B (zh) 含有埃索美拉唑的冻干粉针
EP3708153A1 (en) Solution preparation for aerosol inhalation of carbocisteine, and preparation method therefor
CN102258547B (zh) 榛叶黄酮提取物及其药物组合物
CN115054580A (zh) 大规格冻干口腔崩解片
Agrawal et al. Formulation, evaluation, and in vitro drug diffusion of niosomal gel of selected drug
EP2253329B1 (en) Ibuprofen lysinate oral suspension
CN110946960B (zh) 滋肾育胎丸在制备防治精子质量下降的药物中的应用
CN116763801A (zh) 一种注射用盐酸表柔比星及其制备方法
WO2026065704A1 (zh) 一种乳源外泌体口含糖及其制备方法
WO2025209335A1 (zh) 包含谷氨酰胺源物质的组合物及其用途
CN102188364A (zh) 载药类脂微粒的制备方法

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20210326

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20210326

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20220307

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20220307

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20221227

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20230130

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230419

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20230724

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20231020

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20240122

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20240202

R150 Certificate of patent or registration of utility model

Ref document number: 7431741

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150