CA3055116C - Orodispersible tablet containing burlulipase and pharmaceutical composition produced therefrom - Google Patents

Orodispersible tablet containing burlulipase and pharmaceutical composition produced therefrom Download PDF

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Publication number
CA3055116C
CA3055116C CA3055116A CA3055116A CA3055116C CA 3055116 C CA3055116 C CA 3055116C CA 3055116 A CA3055116 A CA 3055116A CA 3055116 A CA3055116 A CA 3055116A CA 3055116 C CA3055116 C CA 3055116C
Authority
CA
Canada
Prior art keywords
burlulipase
orodispersible
orodispersible tablet
tablet according
activity
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
CA3055116A
Other languages
English (en)
French (fr)
Other versions
CA3055116A1 (en
Inventor
Richard Fuhrherr
Jan Ludemann
Lisa Garrett
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.)
Nordmark Pharma GmbH
Original Assignee
Nordmark Pharma GmbH
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 Nordmark Pharma GmbH filed Critical Nordmark Pharma GmbH
Publication of CA3055116A1 publication Critical patent/CA3055116A1/en
Application granted granted Critical
Publication of CA3055116C publication Critical patent/CA3055116C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2068Compounds of unknown constitution, e.g. material from plants or animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/465Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K47/46Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • 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
    • A61K9/0056Mouth 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/107Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y301/00Hydrolases acting on ester bonds (3.1)
    • C12Y301/01Carboxylic ester hydrolases (3.1.1)
    • C12Y301/01003Triacylglycerol lipase (3.1.1.3)

Landscapes

  • 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)
CA3055116A 2017-03-03 2018-03-05 Orodispersible tablet containing burlulipase and pharmaceutical composition produced therefrom Active CA3055116C (en)

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
CA3055116A1 CA3055116A1 (en) 2018-09-07
CA3055116C true CA3055116C (en) 2023-07-11

Family

ID=61628314

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3055116A Active CA3055116C (en) 2017-03-03 2018-03-05 Orodispersible tablet containing burlulipase and pharmaceutical composition produced therefrom

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

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
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
DE602005009677D1 (de) 2004-03-22 2008-10-23 Solvay Pharm Gmbh Orale pharmazeutische zusammensetzungen von produkten mit lipase, insbesondere von pankreatin, mit tensiden
HUE031245T2 (en) 2004-10-14 2017-06-28 Lilly Co Eli Preparations containing lipase, protease and amylase for the treatment of pancreatic insufficiency
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
DE102009006594A1 (de) 2009-01-29 2010-08-05 Nordmark Arzneimittel Gmbh & Co. Kg Pharmazeutisches Präparat
EP2786761A1 (de) * 2009-01-29 2014-10-08 Nordmark Arzneimittel GmbH & Co.KG Pharmazeutisches Präparat
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

Also Published As

Publication number Publication date
EP3525769A1 (de) 2019-08-21
PL3525769T3 (pl) 2021-10-25
CN110612098B (zh) 2022-05-13
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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