CA3055116C - Orodispersible tablet containing burlulipase and pharmaceutical composition produced therefrom - Google Patents
Orodispersible tablet containing burlulipase and pharmaceutical composition produced therefrom Download PDFInfo
- 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
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
- A61K9/20—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
- 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
- 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)
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)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Zoology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- General Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Wood Science & Technology (AREA)
- Botany (AREA)
- Dispersion Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Non-Alcoholic Beverages (AREA)
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 (https=) |
| EP (1) | EP3525769B1 (https=) |
| JP (2) | JP7208146B2 (https=) |
| CN (1) | CN110612098B (https=) |
| CA (1) | CA3055116C (https=) |
| DE (1) | DE102017104472A1 (https=) |
| ES (1) | ES2880602T3 (https=) |
| PL (1) | PL3525769T3 (https=) |
| WO (1) | WO2018158459A1 (https=) |
Families Citing this family (5)
| 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 |
| US20240000705A1 (en) * | 2020-09-17 | 2024-01-04 | Catalent U.K. Swindon Zydis Limited | Use of surfactant with high molecular weight fish gelatin based dosage formulations to improve flow characteristics |
| 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 |
| 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)
| 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 |
| ES2059986T3 (es) | 1989-03-08 | 1994-11-16 | Simon Lodewijk Scharpe | Una composicion para el tratamiento de la insuficiencia exocrina del pancreas, y el uso de dicha composicion. |
| ATE175117T1 (de) | 1991-07-01 | 1999-01-15 | Basf Ag | Verwendung von lipasen zur herstellung von arzneimitteln |
| GB9908014D0 (en) | 1999-04-08 | 1999-06-02 | Scherer Corp R P | Pharmaceutical compositions |
| US6740339B1 (en) | 1999-06-18 | 2004-05-25 | 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 |
| HRP20041152B1 (hr) | 2002-05-07 | 2008-01-31 | Ferring B.V. | Farmaceutske formulacije |
| 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 |
| CA2560613C (en) | 2004-03-22 | 2015-11-24 | Solvay Pharmaceuticals Gmbh | Oral pharmaceutical compositions of lipase-containing products, in particular of pancreatin, containing surfactants |
| WO2006044529A1 (en) | 2004-10-14 | 2006-04-27 | Altus Pharmaceuticals Inc. | Compositions containing lipase; protease and amylase for treating pancreatic insufficiency |
| ATE398444T1 (de) | 2004-10-28 | 2008-07-15 | Pantec Ag | Herstellung einer rasch zerfallendenden festen darreichungsform ausgehend von einem pulver und einem gefriertrocknungsschritt |
| EP2328609A1 (en) | 2008-08-26 | 2011-06-08 | Cystic Fibrosis Foundation Therapeutics, Inc. | Rapidly disintegrating tablets comprising lipase, amylase, and protease |
| ES2488407T3 (es) * | 2009-01-29 | 2014-08-27 | Nordmark Arzneimittel Gmbh & Co. Kg | Preparación farmacéutica que contiene lipasa de origen bacteriano |
| DE102009006594A1 (de) * | 2009-01-29 | 2010-08-05 | 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 |
-
2017
- 2017-03-03 DE DE102017104472.8A patent/DE102017104472A1/de not_active Withdrawn
-
2018
- 2018-03-05 CA CA3055116A patent/CA3055116C/en active Active
- 2018-03-05 JP JP2019547658A patent/JP7208146B2/ja active Active
- 2018-03-05 PL PL18711039T patent/PL3525769T3/pl unknown
- 2018-03-05 CN CN201880019225.8A patent/CN110612098B/zh active Active
- 2018-03-05 ES ES18711039T patent/ES2880602T3/es active Active
- 2018-03-05 EP EP18711039.0A patent/EP3525769B1/de active Active
- 2018-03-05 WO PCT/EP2018/055285 patent/WO2018158459A1/de not_active Ceased
- 2018-03-05 US US16/490,549 patent/US11464834B2/en active Active
-
2022
- 2022-09-22 JP JP2022151344A patent/JP2022184994A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| EP3525769B1 (de) | 2021-05-12 |
| ES2880602T3 (es) | 2021-11-25 |
| PL3525769T3 (pl) | 2021-10-25 |
| JP7208146B2 (ja) | 2023-01-18 |
| CN110612098A (zh) | 2019-12-24 |
| DE102017104472A1 (de) | 2018-09-06 |
| JP2022184994A (ja) | 2022-12-13 |
| CN110612098B (zh) | 2022-05-13 |
| WO2018158459A1 (de) | 2018-09-07 |
| JP2020509052A (ja) | 2020-03-26 |
| CA3055116A1 (en) | 2018-09-07 |
| EP3525769A1 (de) | 2019-08-21 |
| US20200009232A1 (en) | 2020-01-09 |
| US11464834B2 (en) | 2022-10-11 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20220928 |
|
| MPN | Maintenance fee for patent paid |
Free format text: FEE DESCRIPTION TEXT: MF (PATENT, 7TH ANNIV.) - STANDARD Year of fee payment: 7 |
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| U00 | Fee paid |
Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED Effective date: 20250225 |
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| U11 | Full renewal or maintenance fee paid |
Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT DETERMINED COMPLIANT Effective date: 20250225 Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL Effective date: 20250225 |
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| MPN | Maintenance fee for patent paid |
Free format text: FEE DESCRIPTION TEXT: MF (PATENT, 8TH ANNIV.) - STANDARD Year of fee payment: 8 |
|
| U00 | Fee paid |
Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED Effective date: 20260224 |
|
| U11 | Full renewal or maintenance fee paid |
Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL Effective date: 20260224 |