CN110612098B - 含有伯鲁酶的口腔分散片和由此生产的药物组合物 - Google Patents

含有伯鲁酶的口腔分散片和由此生产的药物组合物 Download PDF

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CN110612098B
CN110612098B CN201880019225.8A CN201880019225A CN110612098B CN 110612098 B CN110612098 B CN 110612098B CN 201880019225 A CN201880019225 A CN 201880019225A CN 110612098 B CN110612098 B CN 110612098B
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beryllase
orodispersible
orodispersible tablets
tablets according
aqueous solution
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CN110612098A (zh
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R·福赫勒
J·吕德曼
L·加勒特
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Normark Pharmaceutical Co ltd
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Normark Pharmaceutical Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2068—Compounds of unknown constitution, e.g. material from plants or 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/01—Carboxylic ester hydrolases (3.1.1)
    • C12Y301/01003—Triacylglycerol lipase (3.1.1.3)

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Botany (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Non-Alcoholic Beverages (AREA)
CN201880019225.8A 2017-03-03 2018-03-05 含有伯鲁酶的口腔分散片和由此生产的药物组合物 Active CN110612098B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102017104472.8 2017-03-03
DE102017104472.8A DE102017104472A1 (de) 2017-03-03 2017-03-03 Schmelztablette enthaltend Burlulipase und daraus hergestellte pharmazeutische Zusammensetzung
PCT/EP2018/055285 WO2018158459A1 (de) 2017-03-03 2018-03-05 Schmelztablette enthaltend burlulipase und daraus hergestellte pharmazeutische zusammensetzung

Publications (2)

Publication Number Publication Date
CN110612098A CN110612098A (zh) 2019-12-24
CN110612098B true CN110612098B (zh) 2022-05-13

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Country Status (9)

Country Link
US (1) US11464834B2 (enExample)
EP (1) EP3525769B1 (enExample)
JP (2) JP7208146B2 (enExample)
CN (1) CN110612098B (enExample)
CA (1) CA3055116C (enExample)
DE (1) DE102017104472A1 (enExample)
ES (1) ES2880602T3 (enExample)
PL (1) PL3525769T3 (enExample)
WO (1) WO2018158459A1 (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102017104480A1 (de) * 2017-03-03 2018-09-06 Nordmark Arzneimittel Gmbh & Co. Kg Wässrige Lösung von Burlulipase umfassend Kalziumionen
JP2023543710A (ja) * 2020-09-17 2023-10-18 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 流動特性を改善するための、高分子量魚ゼラチンに基づく投薬製剤を伴う、界面活性剤の使用
WO2022103634A1 (en) 2020-11-16 2022-05-19 Orcosa Inc. Improved use of cannabinoids in the treatment of epilepsy
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans
DE102023200788A1 (de) 2023-01-31 2024-08-01 Technische Universität Braunschweig - Körperschaft des öffentlichen Rechts Festes Lyophilisat und Verfahren zur Herstellung

Citations (4)

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Publication number Priority date Publication date Assignee Title
CN1394607A (zh) * 2002-08-07 2003-02-05 王登之 治疗心绞痛的黄杨宁口腔崩解片及其制备方法
CN101068565A (zh) * 2004-10-14 2007-11-07 阿尔特斯制药公司 治疗胰腺功能不全的包含脂酶、蛋白酶和淀粉酶的组合物
DE102009006594A1 (de) * 2009-01-29 2010-08-05 Nordmark Arzneimittel Gmbh & Co. Kg Pharmazeutisches Präparat
CN102231988A (zh) * 2009-01-29 2011-11-02 诺尔玛克药物有限责任及股份两合公司 细菌脂肪酶药物制剂

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DE1642654C3 (de) 1968-01-16 1979-11-29 Centre Europeen De Recherches Mauvernay, C.E.R.M., Riom Verfahren zur mikrobiologischen Herstellung eines stabilen gereinigten Lipase-Präparates und pharmazeutisches Mittel, welches dieses enthält
DE2638088C3 (de) 1976-08-24 1979-06-21 Deutsche Gold- Und Silber-Scheideanstalt Vormals Roessler, 6000 Frankfurt Verwendung von SuBmolkenpulver
DE69004301T2 (de) 1989-03-08 1994-03-24 Simon Lodewijk Scharpe Mischung zur Behandlung der von exokrinen Insuffizienz der Bauchspeicheldrüse und die Verwendung der genannten Mischung.
JP3593550B2 (ja) 1991-07-01 2004-11-24 ノルトマルク アルツナイミッテル ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コンパニー コマンディートゲゼルシャフト 医薬品製造のためのリパーゼの使用
GB9908014D0 (en) 1999-04-08 1999-06-02 Scherer Corp R P Pharmaceutical compositions
WO2000078292A1 (en) 1999-06-18 2000-12-28 Takeda Chemical Industries, Ltd. Quickly disintegrating solid preparations
US6588180B2 (en) 2001-02-02 2003-07-08 R. P. Scherer Technologies, Inc. Constricted neck blister pack and apparatus and method for making the same
AU2003233118B8 (en) 2002-05-07 2009-07-30 Ferring Bv Desmopressin in an orodispersible dosage form
DE602005009677D1 (de) 2004-03-22 2008-10-23 Solvay Pharm Gmbh Orale pharmazeutische zusammensetzungen von produkten mit lipase, insbesondere von pankreatin, mit tensiden
US8802145B2 (en) 2004-10-28 2014-08-12 Pantec Ag Highly porous, fast-disintegrating solid dosage form and its way of manufacturing comprising the preparation of a powder and a freezedrying step
WO2010025126A1 (en) 2008-08-26 2010-03-04 Cystic Fibrosis Foundation Therapeutics, Inc. Rapidly disintegrating tablets comprising lipase, amylase, and protease
WO2014166994A1 (en) 2013-04-09 2014-10-16 Danmarks Tekniske Universitet Nano-microdelivery systems for oral delivery of an active ingredient
CN104109662B (zh) 2014-06-23 2017-03-01 华中科技大学 一种固定化的洋葱伯克霍尔德菌脂肪酶及其制备方法
DE102015114857A1 (de) 2015-09-04 2017-03-09 Nordmark Arzneimittel Gmbh & Co. Kg Getränk, enthaltend eine pharmazeutische Zusammensetzung

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1394607A (zh) * 2002-08-07 2003-02-05 王登之 治疗心绞痛的黄杨宁口腔崩解片及其制备方法
CN101068565A (zh) * 2004-10-14 2007-11-07 阿尔特斯制药公司 治疗胰腺功能不全的包含脂酶、蛋白酶和淀粉酶的组合物
DE102009006594A1 (de) * 2009-01-29 2010-08-05 Nordmark Arzneimittel Gmbh & Co. Kg Pharmazeutisches Präparat
CN102231988A (zh) * 2009-01-29 2011-11-02 诺尔玛克药物有限责任及股份两合公司 细菌脂肪酶药物制剂

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Publication number Publication date
EP3525769A1 (de) 2019-08-21
PL3525769T3 (pl) 2021-10-25
CA3055116C (en) 2023-07-11
WO2018158459A1 (de) 2018-09-07
US11464834B2 (en) 2022-10-11
EP3525769B1 (de) 2021-05-12
ES2880602T3 (es) 2021-11-25
CA3055116A1 (en) 2018-09-07
DE102017104472A1 (de) 2018-09-06
JP7208146B2 (ja) 2023-01-18
JP2020509052A (ja) 2020-03-26
US20200009232A1 (en) 2020-01-09
JP2022184994A (ja) 2022-12-13
CN110612098A (zh) 2019-12-24

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