KR20230008190A - 수용성 원료의약품의 약학적 과립화제 - Google Patents

수용성 원료의약품의 약학적 과립화제 Download PDF

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Publication number
KR20230008190A
KR20230008190A KR1020227042936A KR20227042936A KR20230008190A KR 20230008190 A KR20230008190 A KR 20230008190A KR 1020227042936 A KR1020227042936 A KR 1020227042936A KR 20227042936 A KR20227042936 A KR 20227042936A KR 20230008190 A KR20230008190 A KR 20230008190A
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South Korea
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weight
granulating agent
agent
wet
granulating
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Korean (ko)
Inventor
지아-닝 시앙
새미 카라보르니
윌리엄 더블유 시앙
다니엘 엠 카나팩스
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엑스더블유파마 리미티드
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Publication of KR20230008190A publication Critical patent/KR20230008190A/ko
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/223Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of alpha-aminoacids
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1611Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
KR1020227042936A 2020-06-18 2021-06-17 수용성 원료의약품의 약학적 과립화제 Pending KR20230008190A (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063040780P 2020-06-18 2020-06-18
US63/040,780 2020-06-18
PCT/US2021/037830 WO2021257832A1 (en) 2020-06-18 2021-06-17 Pharmaceutical granulations of water-soluble active pharmaceutical ingredients

Publications (1)

Publication Number Publication Date
KR20230008190A true KR20230008190A (ko) 2023-01-13

Family

ID=76859782

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020227042936A Pending KR20230008190A (ko) 2020-06-18 2021-06-17 수용성 원료의약품의 약학적 과립화제

Country Status (9)

Country Link
US (2) US11357734B2 (https=)
EP (1) EP4167966A1 (https=)
JP (2) JP7659580B2 (https=)
KR (1) KR20230008190A (https=)
CN (1) CN115803017A (https=)
AU (1) AU2021293941B2 (https=)
CA (1) CA3183185A1 (https=)
TW (1) TWI834044B (https=)
WO (1) WO2021257832A1 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2021292406B2 (en) 2020-06-18 2024-03-14 XWPharma Ltd. Controlled release granulations of water-soluble active pharmaceutical ingredients
CN116261451A (zh) 2020-07-24 2023-06-13 凯瑞康宁生物工程有限公司 γ-羟基丁酸衍生物的药物组合物和药物动力学
KR20230058151A (ko) 2020-10-05 2023-05-02 엑스더블유파마 리미티드 감마-하이드록시부티르산 유도체의 변형된 방출 조성물
EP4588471A3 (en) 2021-03-19 2025-09-24 XWPharma Ltd. Pharmacokinetics of combined release formulations of a gamma-hydroxybutyric acid derivative
US20240092727A1 (en) * 2022-09-06 2024-03-21 XWPharma Ltd. Crystalline 4-((l-valyl)oxy)butanoic acid
TW202519199A (zh) 2023-07-31 2025-05-16 凱瑞康寧生技股份有限公司 γ-羥基丁酸衍生物之醫藥組合物

Family Cites Families (53)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6458772B1 (en) 1909-10-07 2002-10-01 Medivir Ab Prodrugs
DE852392C (de) 1944-08-30 1952-10-13 Hoechst Ag Verfahren zur Darstellung von Selencyanverbindungen bzw. Selenazolen von aromatischen Aminen
FR2492258A1 (fr) 1980-10-17 1982-04-23 Pharmindustrie Nouveau medicament a base d'amino-2 trifluoromethoxy-6 benzothiazole
ES2061442T3 (es) 1985-10-14 1994-12-16 Nippon Zoki Pharmaceutical Co Peptidos.
FR2662695A1 (fr) 1990-06-05 1991-12-06 Rhone Poulenc Sante Amino-2 polyfluoroalcoxy-6 benzoselenazoles, leur preparation et les medicaments les contenant.
FR2699077B1 (fr) 1992-12-16 1995-01-13 Rhone Poulenc Rorer Sa Application d'anticonvulsivants dans le traitement de lésions neurologiques liées à des traumatismes.
IT1266565B1 (it) 1993-07-22 1997-01-09 Ct Lab Farm Srl Composizioni farmaceutiche a rilascio controllato a base di uno o piu' sali farmaceuticamente accettabili dell'acido gamma-idrossi-butirrico.
WO1999051613A1 (en) 1998-04-03 1999-10-14 Medivir Ab Prodrugs of phosphorous-containing pharmaceuticals
WO2001019321A2 (en) 1999-09-15 2001-03-22 Elan Pharmaceuticals, Inc. Methods for treating neuropathic pain using hetreoarylmethanesulfonamides
GB0002952D0 (en) 2000-02-09 2000-03-29 Pharma Mar Sa Process for producing kahalalide F compounds
FR2824477B1 (fr) * 2001-05-09 2005-09-09 Ethypharm Lab Prod Ethiques Granules enrobes a base d'inhibiteur de l'enzyme de conversion de l'anfiotensine, leur procede de preparation et comprimes orodispersibles contenant les granules enrobes
JP2004059452A (ja) 2002-07-25 2004-02-26 Asahi Glass Co Ltd ペンタフルオロサルファー置換ベンズイミダゾール化合物およびその製造方法
EP1610797A1 (en) 2003-03-27 2006-01-04 Boehringer Ingelheim International GmbH Antiviral combination of nevirapine and a further antiretroviral compound
KR101148734B1 (ko) * 2003-10-10 2012-07-05 에띠빠흠 징코 빌로바 추출물을 포함하는 서방형 미세과립 및 이것을 제조하는 방법
UA83416C2 (en) 2004-02-13 2008-07-10 Баниу Фармасьютикал Ко., Лтд. Fused ring 4-oxopyrimidine derivative
MY144903A (en) 2004-06-17 2011-11-30 Novartis Ag Pyrrolopyridine derivatives and their use as crth2 antagonists
EP1621187A1 (en) * 2004-07-26 2006-02-01 AstraZeneca AB Pharmaceutical multiparticulate tablet formulations and process for their preparation
US8193211B2 (en) 2004-09-30 2012-06-05 Supernus Pharmaceuticals, Inc. Controlled release compositions of gamma-hydroxybutyrate
WO2006038226A2 (en) * 2004-10-08 2006-04-13 Rubicon Research Pvt. Ltd. Process for making a highly compressible controlled delivery compositions of metformin
EP1679076A1 (en) 2005-01-06 2006-07-12 Medivir Ab Compounds useful in the treatment of HIV
US20080175873A1 (en) 2005-06-02 2008-07-24 Biovail Laboratories International S.R.L. Modified release composition of at least one form of venlafaxine
US7960561B2 (en) 2005-06-21 2011-06-14 Neurosearch A/S 2-(phenylamino) benzimidazole derivatives and their use as modulators of small-conductance calcium-activated potassium channels
US20070134315A1 (en) * 2005-12-08 2007-06-14 Viera Michael L Orally administrable extended release pellet and tablet formulations of a highly water soluble compound
EP2051735B1 (en) 2006-07-17 2012-08-29 Ramot, at Tel Aviv University Ltd. Conjugates comprising a psychotropic drug or a gaba agonist and an organic acid and their use treating pain and other cns disorders
ITTO20070665A1 (it) 2007-09-24 2009-03-25 Rottapharm Spa Derivati amidinici, tioureici e guanidinici di 2-amminobenzotiazoli e amminobenzotiazine, nuovi agenti farmacologici per il trattamento delle patologie neurodegenerative.
EP2268281A4 (en) 2008-02-15 2012-05-02 Abbott Lab THIENOPYRROLES AND PYRROLOTHIAZOLES AS NEW THERAPEUTIC AGENTS
LT2278975T (lt) 2008-05-07 2016-11-25 Cardioxyl Pharmaceuticals Inc. Nauji nitrozo junginiai kaip nitroksilo donorai, ir jų panaudojimo būdas
US8778398B2 (en) * 2008-11-04 2014-07-15 Jazz Pharmaceuticals, Inc. Immediate release formulations and dosage forms of gamma-hydroxybutyrate
FR2938431B1 (fr) * 2008-11-14 2013-12-20 Debregeas Et Associes Pharma Nouvelle composition a base d'acide gamma-hydroxybutyrique
CA2759251C (en) 2009-04-23 2017-01-03 Concert Pharmaceuticals, Inc. 4-hydroxybutyric acid analogs
KR101632318B1 (ko) 2009-11-05 2016-06-27 재단법인 의약바이오컨버젼스연구단 벤조헤테로사이클 유도체 또는 이의 약학적으로 허용가능한 염을 유효성분으로 포함하는 암 예방 및 치료용 조성물
WO2011084846A1 (en) 2010-01-07 2011-07-14 Alkermes, Inc. Quaternary ammonium salt prodrugs
MX391660B (es) 2010-03-24 2025-03-21 Jazz Pharmaceuticals Inc Formas de dosis de liberacion controlada para substancias de farmaco de alta dosis, solubles en agua e higroscopicas
CN102946869B (zh) * 2010-05-04 2016-08-03 爵士制药有限公司 γ-羟基丁酸的速释制剂及剂型
FR2971422B1 (fr) 2011-02-11 2016-05-20 Debregeas Et Associes Pharma Granules d'acide gamma-hydroxybutyrique
ES2804540T3 (es) 2011-02-14 2021-02-08 Concert Pharmaceuticals Inc Análogos deuterados de ácido 4–hidroxibutírico
US9428490B2 (en) 2011-07-29 2016-08-30 Karyopharm Therapeutics Inc. Nuclear transport modulators and uses thereof
WO2013163244A1 (en) 2012-04-26 2013-10-31 Bristol-Myers Squibb Company Imidazothiadiazole derivatives as protease activated receptor 4 (par4) inhibitors for treating platelet aggregation
US20150210624A1 (en) 2012-08-22 2015-07-30 Concert Pharmaceuticals, Inc. Deuterated 4-hydroxybutyric acid analogs
US20160068463A1 (en) 2012-11-14 2016-03-10 Metabolix, Inc. Production of salts of 4-hydroxybutyrate using biobased raw materials
US20160016916A1 (en) 2013-03-15 2016-01-21 Karyopharm Therapeutics Inc. Exo Olefin-Containing Nuclear Transport Modulators and Uses Thereof
WO2014205393A1 (en) 2013-06-21 2014-12-24 Karyopharm Therapeutics Inc. Nuclear transport modulators and uses thereof
WO2015057884A1 (en) 2013-10-16 2015-04-23 The Regents Of The University Of California Methods for treating seizure disorders and pain
ITMI20132041A1 (it) 2013-12-06 2015-06-07 Ct Lab Farm Srl Derivati dell'acido gamma-idrossibutirrico, loro preparazione e loro uso medico.
US10398662B1 (en) * 2015-02-18 2019-09-03 Jazz Pharma Ireland Limited GHB formulation and method for its manufacture
WO2017049470A1 (en) 2015-09-23 2017-03-30 Xw Laboratories Inc. Prodrugs of gamma-hydroxybutyric acid, compositions and uses thereof
CN113061089A (zh) 2015-09-23 2021-07-02 凯瑞康宁生物工程(武汉)有限公司 γ-羟基丁酸的前药及其组合物和用途
UY37341A (es) 2016-07-22 2017-11-30 Flamel Ireland Ltd Formulaciones de gamma-hidroxibutirato de liberación modificada con farmacocinética mejorada
US11602530B2 (en) 2016-11-28 2023-03-14 Biogen Ma Inc. CRM1 inhibitors for treating epilepsy
EA201992116A1 (ru) 2017-03-08 2020-01-29 СИНРКС ФАРМА, ЭлЭлСи Фармацевтические составы флороглюцинола и триметилфлороглюцинола
JP7349428B2 (ja) 2017-12-20 2023-09-22 フラメル アイルランド リミテッド 改善された安定性を有するパッケージされた修飾放出ガンマ-ヒドロキシブチラート製剤
CN113473980A (zh) 2019-03-01 2021-10-01 弗拉梅尔爱尔兰有限公司 在进食状态下具有改善的药代动力学的γ-羟基丁酸酯组合物
CN116261451A (zh) 2020-07-24 2023-06-13 凯瑞康宁生物工程有限公司 γ-羟基丁酸衍生物的药物组合物和药物动力学

Also Published As

Publication number Publication date
JP2023537192A (ja) 2023-08-31
JP7659580B2 (ja) 2025-04-09
CN115803017A (zh) 2023-03-14
EP4167966A1 (en) 2023-04-26
US11357734B2 (en) 2022-06-14
TWI834044B (zh) 2024-03-01
US20220323366A1 (en) 2022-10-13
JP2025029042A (ja) 2025-03-05
CA3183185A1 (en) 2021-12-23
AU2021293941A1 (en) 2023-01-19
JP7824387B2 (ja) 2026-03-04
AU2021293941B2 (en) 2024-03-28
WO2021257832A1 (en) 2021-12-23
US20210393537A1 (en) 2021-12-23
TW202203903A (zh) 2022-02-01

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