DE102017104472A1 - Schmelztablette enthaltend Burlulipase und daraus hergestellte pharmazeutische Zusammensetzung - Google Patents
Schmelztablette enthaltend Burlulipase und daraus hergestellte pharmazeutische Zusammensetzung Download PDFInfo
- Publication number
- DE102017104472A1 DE102017104472A1 DE102017104472.8A DE102017104472A DE102017104472A1 DE 102017104472 A1 DE102017104472 A1 DE 102017104472A1 DE 102017104472 A DE102017104472 A DE 102017104472A DE 102017104472 A1 DE102017104472 A1 DE 102017104472A1
- Authority
- DE
- Germany
- Prior art keywords
- burlulipase
- orodispersible
- tablet according
- orodispersible tablet
- treatment
- 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.)
- Withdrawn
Links
- 229950002931 burlulipase Drugs 0.000 title claims abstract description 113
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 19
- 239000007788 liquid Substances 0.000 claims abstract description 36
- 239000003814 drug Substances 0.000 claims abstract description 34
- 238000011282 treatment Methods 0.000 claims abstract description 28
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 22
- 201000007089 exocrine pancreatic insufficiency Diseases 0.000 claims abstract description 12
- 201000003883 Cystic fibrosis Diseases 0.000 claims abstract description 11
- 239000000243 solution Substances 0.000 claims description 35
- 108090001060 Lipase Proteins 0.000 claims description 26
- 102000004882 Lipase Human genes 0.000 claims description 25
- 239000004367 Lipase Substances 0.000 claims description 24
- 235000019421 lipase Nutrition 0.000 claims description 24
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 21
- 238000002360 preparation method Methods 0.000 claims description 21
- 229940079593 drug Drugs 0.000 claims description 17
- 239000000839 emulsion Substances 0.000 claims description 17
- 229920000159 gelatin Polymers 0.000 claims description 17
- 235000019322 gelatine Nutrition 0.000 claims description 17
- 239000000725 suspension Substances 0.000 claims description 17
- 108010010803 Gelatin Proteins 0.000 claims description 16
- 239000008273 gelatin Substances 0.000 claims description 16
- 235000011852 gelatine desserts Nutrition 0.000 claims description 16
- 238000004108 freeze drying Methods 0.000 claims description 15
- 239000000203 mixture Substances 0.000 claims description 15
- 241000251468 Actinopterygii Species 0.000 claims description 14
- 239000007864 aqueous solution Substances 0.000 claims description 14
- 239000011230 binding agent Substances 0.000 claims description 13
- 238000000034 method Methods 0.000 claims description 13
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 10
- 229930195725 Mannitol Natural products 0.000 claims description 10
- 239000000594 mannitol Substances 0.000 claims description 10
- 235000010355 mannitol Nutrition 0.000 claims description 10
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 10
- 230000008569 process Effects 0.000 claims description 9
- 102000004169 proteins and genes Human genes 0.000 claims description 9
- 108090000623 proteins and genes Proteins 0.000 claims description 9
- 230000002265 prevention Effects 0.000 claims description 8
- 239000002253 acid Substances 0.000 claims description 7
- 239000007884 disintegrant Substances 0.000 claims description 5
- 238000004090 dissolution Methods 0.000 claims description 5
- 201000006549 dyspepsia Diseases 0.000 claims description 5
- 235000011121 sodium hydroxide Nutrition 0.000 claims description 5
- 238000007710 freezing Methods 0.000 claims description 3
- 230000008014 freezing Effects 0.000 claims description 3
- 238000011049 filling Methods 0.000 claims description 2
- 238000009472 formulation Methods 0.000 claims description 2
- 208000027219 Deficiency disease Diseases 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 230000001079 digestive effect Effects 0.000 abstract description 10
- 235000013361 beverage Nutrition 0.000 abstract description 4
- 230000000694 effects Effects 0.000 description 28
- 108010019160 Pancreatin Proteins 0.000 description 17
- 229940055695 pancreatin Drugs 0.000 description 17
- 229940040461 lipase Drugs 0.000 description 14
- 102000004190 Enzymes Human genes 0.000 description 10
- 108090000790 Enzymes Proteins 0.000 description 10
- 229940088598 enzyme Drugs 0.000 description 10
- 102000013142 Amylases Human genes 0.000 description 9
- 108010065511 Amylases Proteins 0.000 description 9
- 108091005804 Peptidases Proteins 0.000 description 9
- 239000004365 Protease Substances 0.000 description 9
- 235000019418 amylase Nutrition 0.000 description 9
- 238000004519 manufacturing process Methods 0.000 description 9
- 239000003381 stabilizer Substances 0.000 description 8
- 210000000496 pancreas Anatomy 0.000 description 7
- 238000003860 storage Methods 0.000 description 7
- 206010033645 Pancreatitis Diseases 0.000 description 6
- 239000004382 Amylase Substances 0.000 description 5
- 102000035195 Peptidases Human genes 0.000 description 5
- UYXTWWCETRIEDR-UHFFFAOYSA-N Tributyrin Chemical group CCCC(=O)OCC(OC(=O)CCC)COC(=O)CCC UYXTWWCETRIEDR-UHFFFAOYSA-N 0.000 description 5
- 239000002775 capsule Substances 0.000 description 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 5
- 235000012054 meals Nutrition 0.000 description 5
- 238000011084 recovery Methods 0.000 description 5
- 238000003756 stirring Methods 0.000 description 5
- 241000134107 Burkholderia plantarii Species 0.000 description 4
- 102100037486 Reverse transcriptase/ribonuclease H Human genes 0.000 description 4
- 229940025131 amylases Drugs 0.000 description 4
- 230000001580 bacterial effect Effects 0.000 description 4
- 102000038379 digestive enzymes Human genes 0.000 description 4
- 108091007734 digestive enzymes Proteins 0.000 description 4
- 201000010099 disease Diseases 0.000 description 4
- 239000004615 ingredient Substances 0.000 description 4
- 230000002366 lipolytic effect Effects 0.000 description 4
- 239000000047 product Substances 0.000 description 4
- 150000003839 salts Chemical class 0.000 description 4
- 235000000346 sugar Nutrition 0.000 description 4
- 150000008163 sugars Chemical class 0.000 description 4
- 241001453380 Burkholderia Species 0.000 description 3
- 208000000668 Chronic Pancreatitis Diseases 0.000 description 3
- 208000035467 Pancreatic insufficiency Diseases 0.000 description 3
- 206010033649 Pancreatitis chronic Diseases 0.000 description 3
- 241000282887 Suidae Species 0.000 description 3
- 239000002671 adjuvant Substances 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 238000004132 cross linking Methods 0.000 description 3
- 238000000855 fermentation Methods 0.000 description 3
- 230000004151 fermentation Effects 0.000 description 3
- 230000037406 food intake Effects 0.000 description 3
- 235000019626 lipase activity Nutrition 0.000 description 3
- 229940126601 medicinal product Drugs 0.000 description 3
- 239000000843 powder Substances 0.000 description 3
- 239000007787 solid Substances 0.000 description 3
- 230000006641 stabilisation Effects 0.000 description 3
- 238000011105 stabilization Methods 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 239000000758 substrate Substances 0.000 description 3
- ZHNUHDYFZUAESO-UHFFFAOYSA-N Formamide Chemical compound NC=O ZHNUHDYFZUAESO-UHFFFAOYSA-N 0.000 description 2
- 208000016222 Pancreatic disease Diseases 0.000 description 2
- 206010033647 Pancreatitis acute Diseases 0.000 description 2
- 241000589516 Pseudomonas Species 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 239000012072 active phase Substances 0.000 description 2
- 201000003229 acute pancreatitis Diseases 0.000 description 2
- 150000001413 amino acids Chemical group 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 description 2
- 238000002425 crystallisation Methods 0.000 description 2
- 230000008025 crystallization Effects 0.000 description 2
- 239000012228 culture supernatant Substances 0.000 description 2
- 239000003995 emulsifying agent Substances 0.000 description 2
- 239000002702 enteric coating Substances 0.000 description 2
- 238000009505 enteric coating Methods 0.000 description 2
- 235000011389 fruit/vegetable juice Nutrition 0.000 description 2
- 210000004051 gastric juice Anatomy 0.000 description 2
- 210000003736 gastrointestinal content Anatomy 0.000 description 2
- 210000001035 gastrointestinal tract Anatomy 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 239000000155 melt Substances 0.000 description 2
- 210000000214 mouth Anatomy 0.000 description 2
- 235000016709 nutrition Nutrition 0.000 description 2
- 230000035764 nutrition Effects 0.000 description 2
- 210000001819 pancreatic juice Anatomy 0.000 description 2
- 238000003825 pressing Methods 0.000 description 2
- 235000019419 proteases Nutrition 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 239000007921 spray Substances 0.000 description 2
- 210000002784 stomach Anatomy 0.000 description 2
- 150000005846 sugar alcohols Chemical class 0.000 description 2
- BUHVIAUBTBOHAG-FOYDDCNASA-N (2r,3r,4s,5r)-2-[6-[[2-(3,5-dimethoxyphenyl)-2-(2-methylphenyl)ethyl]amino]purin-9-yl]-5-(hydroxymethyl)oxolane-3,4-diol Chemical compound COC1=CC(OC)=CC(C(CNC=2C=3N=CN(C=3N=CN=2)[C@H]2[C@@H]([C@H](O)[C@@H](CO)O2)O)C=2C(=CC=CC=2)C)=C1 BUHVIAUBTBOHAG-FOYDDCNASA-N 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 241000589513 Burkholderia cepacia Species 0.000 description 1
- 241000589638 Burkholderia glumae Species 0.000 description 1
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 description 1
- 206010010356 Congenital anomaly Diseases 0.000 description 1
- 206010012735 Diarrhoea Diseases 0.000 description 1
- XRHVZWWRFMCBAZ-UHFFFAOYSA-L Endothal-disodium Chemical compound [Na+].[Na+].C1CC2C(C([O-])=O)C(C(=O)[O-])C1O2 XRHVZWWRFMCBAZ-UHFFFAOYSA-L 0.000 description 1
- 102100031375 Endothelial lipase Human genes 0.000 description 1
- 239000001828 Gelatine Substances 0.000 description 1
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 1
- 208000026350 Inborn Genetic disease Diseases 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- 229920000881 Modified starch Polymers 0.000 description 1
- 102000019280 Pancreatic lipases Human genes 0.000 description 1
- 108050006759 Pancreatic lipases Proteins 0.000 description 1
- 206010061902 Pancreatic neoplasm Diseases 0.000 description 1
- 108010067035 Pancrelipase Proteins 0.000 description 1
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 1
- 240000005384 Rhizopus oryzae Species 0.000 description 1
- 206010041969 Steatorrhoea Diseases 0.000 description 1
- 208000018756 Variant Creutzfeldt-Jakob disease Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 229940008474 alka-seltzer Drugs 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 238000013475 authorization Methods 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 208000005881 bovine spongiform encephalopathy Diseases 0.000 description 1
- 239000001110 calcium chloride Substances 0.000 description 1
- 229910001628 calcium chloride Inorganic materials 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 235000010980 cellulose Nutrition 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000001055 chewing effect Effects 0.000 description 1
- 235000015165 citric acid Nutrition 0.000 description 1
- 239000000356 contaminant Substances 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 238000005238 degreasing Methods 0.000 description 1
- 239000003599 detergent Substances 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 229940079919 digestives enzyme preparation Drugs 0.000 description 1
- 208000016097 disease of metabolism Diseases 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000035622 drinking Effects 0.000 description 1
- 239000003651 drinking water Substances 0.000 description 1
- 235000020188 drinking water Nutrition 0.000 description 1
- 238000004945 emulsification Methods 0.000 description 1
- 230000002255 enzymatic effect Effects 0.000 description 1
- 238000002641 enzyme replacement therapy Methods 0.000 description 1
- 210000003499 exocrine gland Anatomy 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 235000015203 fruit juice Nutrition 0.000 description 1
- 230000002538 fungal effect Effects 0.000 description 1
- 208000016361 genetic disease Diseases 0.000 description 1
- 210000004907 gland Anatomy 0.000 description 1
- 230000002779 inactivation Effects 0.000 description 1
- 238000010348 incorporation Methods 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 239000008297 liquid dosage form Substances 0.000 description 1
- 239000012669 liquid formulation Substances 0.000 description 1
- 239000006193 liquid solution Substances 0.000 description 1
- 208000015486 malignant pancreatic neoplasm Diseases 0.000 description 1
- 208000030159 metabolic disease Diseases 0.000 description 1
- 239000012569 microbial contaminant Substances 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 235000013336 milk Nutrition 0.000 description 1
- 239000008267 milk Substances 0.000 description 1
- 210000004080 milk Anatomy 0.000 description 1
- 239000012452 mother liquor Substances 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 235000015205 orange juice Nutrition 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 235000005985 organic acids Nutrition 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 239000006174 pH buffer Substances 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 229950010604 pancreas powder Drugs 0.000 description 1
- 201000002528 pancreatic cancer Diseases 0.000 description 1
- 208000008443 pancreatic carcinoma Diseases 0.000 description 1
- 229940116369 pancreatic lipase Drugs 0.000 description 1
- 210000004923 pancreatic tissue Anatomy 0.000 description 1
- 229940045258 pancrelipase Drugs 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- 229940124531 pharmaceutical excipient Drugs 0.000 description 1
- 229960000502 poloxamer Drugs 0.000 description 1
- 229920001983 poloxamer Polymers 0.000 description 1
- 229920000191 poly(N-vinyl pyrrolidone) Polymers 0.000 description 1
- 229950008882 polysorbate Drugs 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 239000000523 sample Substances 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- PERKCQYZRBLRLO-UHFFFAOYSA-M sodium;2-acetyloxybenzoic acid;hydrogen carbonate;2-hydroxypropane-1,2,3-tricarboxylic acid Chemical compound [Na+].OC([O-])=O.CC(=O)OC1=CC=CC=C1C(O)=O.OC(=O)CC(O)(C(O)=O)CC(O)=O PERKCQYZRBLRLO-UHFFFAOYSA-M 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000001694 spray drying Methods 0.000 description 1
- 208000001162 steatorrhea Diseases 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 238000007864 suspending Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 230000032258 transport Effects 0.000 description 1
- 238000001291 vacuum drying Methods 0.000 description 1
- 230000003612 virological effect Effects 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
Classifications
-
- 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)
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)
Priority Applications (10)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| 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 |
| ES18711039T ES2880602T3 (es) | 2017-03-03 | 2018-03-05 | Comprimido orodispersable que contiene burlulipasa y composición farmacéutica preparada a partir de ella |
| CN201880019225.8A CN110612098B (zh) | 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 |
| CA3055116A CA3055116C (en) | 2017-03-03 | 2018-03-05 | Orodispersible tablet containing burlulipase and pharmaceutical composition produced therefrom |
| JP2019547658A 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。 |
| PL18711039T PL3525769T3 (pl) | 2017-03-03 | 2018-03-05 | Tabletka ulegająca rozpadowi w jamie ustnej zawierająca burlulipazę i wytworzona z niej kompozycja farmaceutyczna |
| US16/490,549 US11464834B2 (en) | 2017-03-03 | 2018-03-05 | Orodispersible tablet containing burlulipase and pharmaceutical composition produced therefrom |
| EP18711039.0A EP3525769B1 (de) | 2017-03-03 | 2018-03-05 | Schmelztablette enthaltend burlulipase und daraus hergestellte pharmazeutische zusammensetzung |
| 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 (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102017104472.8A DE102017104472A1 (de) | 2017-03-03 | 2017-03-03 | Schmelztablette enthaltend Burlulipase und daraus hergestellte pharmazeutische Zusammensetzung |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DE102017104472A1 true DE102017104472A1 (de) | 2018-09-06 |
Family
ID=61628314
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE102017104472.8A Withdrawn DE102017104472A1 (de) | 2017-03-03 | 2017-03-03 | Schmelztablette enthaltend Burlulipase und daraus hergestellte pharmazeutische Zusammensetzung |
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) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102023200788A1 (de) | 2023-01-31 | 2024-08-01 | Technische Universität Braunschweig - Körperschaft des öffentlichen Rechts | Festes Lyophilisat und Verfahren zur Herstellung |
Families Citing this family (4)
| 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 |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000061117A1 (en) | 1999-04-08 | 2000-10-19 | R.P. Scherer Corporation | Fast-dispersing dosage forms containing fish gelatin |
| US6740339B1 (en) | 1999-06-18 | 2004-05-25 | Takeda Chemical Industries, Ltd. | Quickly disintegrating solid preparations |
| WO2010025126A1 (en) | 2008-08-26 | 2010-03-04 | Cystic Fibrosis Foundation Therapeutics, Inc. | Rapidly disintegrating tablets comprising lipase, amylase, and protease |
| WO2010085975A1 (de) | 2009-01-29 | 2010-08-05 | Nordmark Arzneimittel Gmbh & Co. Kg | Pharmazeutisches präparat enthaltend lipase bakteriellen ursprungs |
| DE102015114857A1 (de) | 2015-09-04 | 2017-03-09 | Nordmark Arzneimittel Gmbh & Co. Kg | Getränk, enthaltend eine pharmazeutische Zusammensetzung |
Family Cites Families (13)
| 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 |
| 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 |
| 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 |
-
2017
- 2017-03-03 DE DE102017104472.8A patent/DE102017104472A1/de not_active Withdrawn
-
2018
- 2018-03-05 CN CN201880019225.8A patent/CN110612098B/zh active Active
- 2018-03-05 US US16/490,549 patent/US11464834B2/en active Active
- 2018-03-05 EP EP18711039.0A patent/EP3525769B1/de active Active
- 2018-03-05 PL PL18711039T patent/PL3525769T3/pl unknown
- 2018-03-05 ES ES18711039T patent/ES2880602T3/es active Active
- 2018-03-05 JP JP2019547658A patent/JP7208146B2/ja active Active
- 2018-03-05 CA CA3055116A patent/CA3055116C/en active Active
- 2018-03-05 WO PCT/EP2018/055285 patent/WO2018158459A1/de not_active Ceased
-
2022
- 2022-09-22 JP JP2022151344A patent/JP2022184994A/ja active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000061117A1 (en) | 1999-04-08 | 2000-10-19 | R.P. Scherer Corporation | Fast-dispersing dosage forms containing fish gelatin |
| US6740339B1 (en) | 1999-06-18 | 2004-05-25 | Takeda Chemical Industries, Ltd. | Quickly disintegrating solid preparations |
| WO2010025126A1 (en) | 2008-08-26 | 2010-03-04 | Cystic Fibrosis Foundation Therapeutics, Inc. | Rapidly disintegrating tablets comprising lipase, amylase, and protease |
| WO2010085975A1 (de) | 2009-01-29 | 2010-08-05 | Nordmark Arzneimittel Gmbh & Co. Kg | Pharmazeutisches präparat enthaltend lipase bakteriellen ursprungs |
| DE102015114857A1 (de) | 2015-09-04 | 2017-03-09 | Nordmark Arzneimittel Gmbh & Co. Kg | Getränk, enthaltend eine pharmazeutische Zusammensetzung |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102023200788A1 (de) | 2023-01-31 | 2024-08-01 | Technische Universität Braunschweig - Körperschaft des öffentlichen Rechts | Festes Lyophilisat und Verfahren zur Herstellung |
Also Published As
| Publication number | Publication date |
|---|---|
| EP3525769A1 (de) | 2019-08-21 |
| PL3525769T3 (pl) | 2021-10-25 |
| CN110612098B (zh) | 2022-05-13 |
| 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 |
| 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 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| EP3525769B1 (de) | Schmelztablette enthaltend burlulipase und daraus hergestellte pharmazeutische zusammensetzung | |
| DE502007010071C5 (de) | Verwendung einer zusammensetzung aus mineralstoffen und gegebenenfalls acetogenen und/oder butyrogenen bakterien zur vermeidung oder reduzierung von gasbildung im dickdarm eines säugetiers und dadurch bedingter abdominaler beschwerden | |
| AU2013267357C1 (en) | Methods of treating celiac disease | |
| EP2391382B1 (de) | Pharmazeutisches präparat enthaltend lipase bakteriellen ursprungs | |
| WO2002060474A2 (de) | Gemische von enzymen aus pilzen und deren verwendung zur behandlung der maldigestion | |
| AU2016213722A1 (en) | Solid dispersion of rifaximin | |
| CN104739848A (zh) | L-阿拉伯糖与塔格糖的组合物及其制备方法和药物应用 | |
| DE102009006594A1 (de) | Pharmazeutisches Präparat | |
| KR102095536B1 (ko) | 천연물 추출물의 용출률 및 붕해성이 개선된 경구용 제제 | |
| DE69004301T2 (de) | Mischung zur Behandlung der von exokrinen Insuffizienz der Bauchspeicheldrüse und die Verwendung der genannten Mischung. | |
| EP3589275A1 (de) | Pharmazeutische zusammensetzung umfassend pankreatin und einen lipasehaltigen überzug | |
| DE102017104501A1 (de) | Pharmazeutische Zusammensetzung umfassend einen Träger und einen Überzug enthaltend wenigstens eine Lipase | |
| RU2014050C1 (ru) | Офтальмологическое средство и способ его получения | |
| DE10111165A1 (de) | Verwendung von Hyaluronsäure-Uroniden zur Behandlung von entzündlichen Vorgängen | |
| US11452687B2 (en) | Oral medicament comprising an osmotic laxative incorporated into a matrix based on plant fats with reduced doses of macrogol | |
| JPH11302170A (ja) | トコフェロール含有製剤 | |
| EP3423035B1 (de) | Wässrige lösung von burlulipase umfassend kalziumionen | |
| RU2276985C1 (ru) | Фармацевтическая композиция для лечения заболеваний поджелудочной железы и расстройств пищеварения, связанных с заболеванием печени | |
| TW201639598A (zh) | 延遲崩解性粒子組成物 | |
| HK1204450B (en) | Methods of treating celiac disease |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| R163 | Identified publications notified | ||
| R081 | Change of applicant/patentee |
Owner name: NORDMARK PHARMA GMBH, DE Free format text: FORMER OWNER: NORDMARK ARZNEIMITTEL GMBH & CO. KG, 25436 UETERSEN, DE |
|
| R082 | Change of representative |
Representative=s name: RGTH RICHTER GERBAULET THIELEMANN HOFMANN PATE, DE |
|
| R119 | Application deemed withdrawn, or ip right lapsed, due to non-payment of renewal fee |