JP7208146B2 - ブルルリパーゼを含有する口腔内分散性錠剤を生産する方法およびブルルリパーゼを含む液体医薬組成物を生産する方法。 - Google Patents
ブルルリパーゼを含有する口腔内分散性錠剤を生産する方法およびブルルリパーゼを含む液体医薬組成物を生産する方法。 Download PDFInfo
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- JP7208146B2 JP7208146B2 JP2019547658A JP2019547658A JP7208146B2 JP 7208146 B2 JP7208146 B2 JP 7208146B2 JP 2019547658 A JP2019547658 A JP 2019547658A JP 2019547658 A JP2019547658 A JP 2019547658A JP 7208146 B2 JP7208146 B2 JP 7208146B2
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- Prior art keywords
- lipase
- burr
- orodispersible tablet
- orodispersible
- producing
- 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.)
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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)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2022151344A JP2022184994A (ja) | 2017-03-03 | 2022-09-22 | ブルルリパーゼを含有する口腔内分散性錠剤、ブルルリパーゼを含む液体医薬組成物を調製する方法および口腔内分散性錠剤を生産するプロセス |
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 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022151344A Division JP2022184994A (ja) | 2017-03-03 | 2022-09-22 | ブルルリパーゼを含有する口腔内分散性錠剤、ブルルリパーゼを含む液体医薬組成物を調製する方法および口腔内分散性錠剤を生産するプロセス |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2020509052A JP2020509052A (ja) | 2020-03-26 |
| JP2020509052A5 JP2020509052A5 (https=) | 2021-04-15 |
| JP7208146B2 true JP7208146B2 (ja) | 2023-01-18 |
Family
ID=61628314
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019547658A Active JP7208146B2 (ja) | 2017-03-03 | 2018-03-05 | ブルルリパーゼを含有する口腔内分散性錠剤を生産する方法およびブルルリパーゼを含む液体医薬組成物を生産する方法。 |
| JP2022151344A Pending JP2022184994A (ja) | 2017-03-03 | 2022-09-22 | ブルルリパーゼを含有する口腔内分散性錠剤、ブルルリパーゼを含む液体医薬組成物を調製する方法および口腔内分散性錠剤を生産するプロセス |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022151344A Pending JP2022184994A (ja) | 2017-03-03 | 2022-09-22 | ブルルリパーゼを含有する口腔内分散性錠剤、ブルルリパーゼを含む液体医薬組成物を調製する方法および口腔内分散性錠剤を生産するプロセス |
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 |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2006502972A (ja) | 2002-05-07 | 2006-01-26 | フェリング ベスローテン フェンノートシャップ | デスモプレシンの口腔内分散性医薬製剤 |
Family Cites Families (17)
| 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 |
| 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
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2006502972A (ja) | 2002-05-07 | 2006-01-26 | フェリング ベスローテン フェンノートシャップ | デスモプレシンの口腔内分散性医薬製剤 |
Non-Patent Citations (8)
| Title |
|---|
| Badgujar, B. P., Mundada, A. S.,The technologies used for developing orally disintegrating tablets: a review,Acta Pharmaceutica,2011年,Vol.61, No.2,p.117-139,doi:10.2478/v10007-011-0020-8 |
| ClinicalTrials.gov Identifier: NCT01710644,Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis,[online],2016年06月07日,[retrieved on 2021.05.07],Retrieved from the Internet:<URL:https://clinicaltrials.gov/ct2/show/NCT01710644> |
| Heubi, J. E. et al.,Safety and Efficacy of a Novel Microbial Lipase in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis: A Randomized Controlled Clinical Trial,The Journal of Pediatrics,2016年,Vol.176,p.156-161,doi:10.1016/j.jpeds.2016.05.049 |
| Kristensen, H. G.,WHO guideline development of paediatric medicines: points to consider in pharmaceutical development,International Journal of Pharmaceutics,2012年,Vol.435, No.2,p.134-135,doi:10.1016/j.ijpharm.2012.05.054 |
| Stoltenberg, I., Breitkreutz, J.,Orally disintegrating mini-tablets (ODMTs) - a novel solid oral dosage form for paediatric use,European Journal of Pharmaceutics and Biopharmaceutics,2011年,Vol.78, No.3,p.462-469,doi:10.1016/j.ejpb.2011.02.005 |
| Sznitowska, M. et al.,The physical characteristics of lyophilized tablets containing a model drug in different chemical forms and concentrations,Acta Poloniae Pharmaceutica,2005年,Vol.62, No.1,p.25-29 |
| 井阪 久美子,熊坂 治,小児用剤形と服薬アドヒアランス―OD錠・チュアブル錠の小児への適応を視野に入れて―,薬局,2013年,第64巻,第10号,p.2641-2649 |
| 米子 真記,海外の指針等における小児の製剤開発,薬局,2013年,第64巻,第10号,p.2619-2623 |
Also Published As
| Publication number | Publication date |
|---|---|
| EP3525769B1 (de) | 2021-05-12 |
| ES2880602T3 (es) | 2021-11-25 |
| PL3525769T3 (pl) | 2021-10-25 |
| 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 |
| CA3055116C (en) | 2023-07-11 |
| US20200009232A1 (en) | 2020-01-09 |
| US11464834B2 (en) | 2022-10-11 |
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