ES2880602T3 - Comprimido orodispersable que contiene burlulipasa y composición farmacéutica preparada a partir de ella - Google Patents
Comprimido orodispersable que contiene burlulipasa y composición farmacéutica preparada a partir de ella Download PDFInfo
- Publication number
- ES2880602T3 ES2880602T3 ES18711039T ES18711039T ES2880602T3 ES 2880602 T3 ES2880602 T3 ES 2880602T3 ES 18711039 T ES18711039 T ES 18711039T ES 18711039 T ES18711039 T ES 18711039T ES 2880602 T3 ES2880602 T3 ES 2880602T3
- Authority
- ES
- Spain
- Prior art keywords
- burlulipase
- orodispersible tablet
- orodispersible
- tablet according
- 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.)
- Active
Links
- 229950002931 burlulipase Drugs 0.000 title claims abstract description 124
- 239000008194 pharmaceutical composition Substances 0.000 title claims description 19
- 239000007788 liquid Substances 0.000 claims description 36
- 239000003814 drug Substances 0.000 claims description 34
- 239000002671 adjuvant Substances 0.000 claims description 30
- 108090001060 Lipase Proteins 0.000 claims description 29
- 102000004882 Lipase Human genes 0.000 claims description 28
- 239000004367 Lipase Substances 0.000 claims description 27
- 235000019421 lipase Nutrition 0.000 claims description 27
- 238000011282 treatment Methods 0.000 claims description 26
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 18
- 238000000034 method Methods 0.000 claims description 18
- 229940079593 drug Drugs 0.000 claims description 17
- 108010010803 Gelatin Proteins 0.000 claims description 16
- 229920000159 gelatin Polymers 0.000 claims description 16
- 239000008273 gelatin Substances 0.000 claims description 16
- 235000019322 gelatine Nutrition 0.000 claims description 16
- 235000011852 gelatine desserts Nutrition 0.000 claims description 16
- 239000007864 aqueous solution Substances 0.000 claims description 14
- 239000011230 binding agent Substances 0.000 claims description 14
- 230000001079 digestive effect Effects 0.000 claims description 14
- 241000251468 Actinopterygii Species 0.000 claims description 13
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 13
- 230000008569 process Effects 0.000 claims description 11
- 201000003883 Cystic fibrosis Diseases 0.000 claims description 10
- 230000002265 prevention Effects 0.000 claims description 10
- 102000004169 proteins and genes Human genes 0.000 claims description 10
- 108090000623 proteins and genes Proteins 0.000 claims description 10
- 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 9
- 229930195725 Mannitol Natural products 0.000 claims description 9
- 208000035475 disorder Diseases 0.000 claims description 9
- 201000007089 exocrine pancreatic insufficiency Diseases 0.000 claims description 9
- 239000000594 mannitol Substances 0.000 claims description 9
- 235000010355 mannitol Nutrition 0.000 claims description 9
- 238000004519 manufacturing process Methods 0.000 claims description 8
- 239000002253 acid Substances 0.000 claims description 7
- 239000003795 chemical substances by application Substances 0.000 claims description 4
- 235000011121 sodium hydroxide Nutrition 0.000 claims description 4
- 238000004090 dissolution Methods 0.000 claims description 2
- 230000007812 deficiency Effects 0.000 claims 3
- 239000004094 surface-active agent Substances 0.000 claims 1
- 239000003826 tablet Substances 0.000 description 104
- 230000000694 effects Effects 0.000 description 36
- 239000000243 solution Substances 0.000 description 32
- 238000002360 preparation method Methods 0.000 description 25
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 19
- 108010019160 Pancreatin Proteins 0.000 description 17
- 229940055695 pancreatin Drugs 0.000 description 17
- 239000000203 mixture Substances 0.000 description 16
- 238000004108 freeze drying Methods 0.000 description 15
- 229940040461 lipase Drugs 0.000 description 15
- 230000002366 lipolytic effect Effects 0.000 description 15
- 239000000839 emulsion Substances 0.000 description 13
- 239000000725 suspension Substances 0.000 description 13
- 102000004190 Enzymes Human genes 0.000 description 12
- 108090000790 Enzymes Proteins 0.000 description 12
- 229940088598 enzyme Drugs 0.000 description 12
- 102000013142 Amylases Human genes 0.000 description 10
- 108010065511 Amylases Proteins 0.000 description 10
- 108091005804 Peptidases Proteins 0.000 description 10
- 239000004365 Protease Substances 0.000 description 10
- 235000019418 amylase Nutrition 0.000 description 10
- 239000003381 stabilizer Substances 0.000 description 8
- 208000035467 Pancreatic insufficiency Diseases 0.000 description 7
- 210000000496 pancreas Anatomy 0.000 description 7
- 238000011084 recovery Methods 0.000 description 7
- 238000003860 storage Methods 0.000 description 7
- 239000004382 Amylase Substances 0.000 description 6
- 206010033645 Pancreatitis Diseases 0.000 description 6
- UYXTWWCETRIEDR-UHFFFAOYSA-N Tributyrin Chemical group CCCC(=O)OCC(OC(=O)CCC)COC(=O)CCC UYXTWWCETRIEDR-UHFFFAOYSA-N 0.000 description 6
- 102000035195 Peptidases Human genes 0.000 description 5
- 102100037486 Reverse transcriptase/ribonuclease H Human genes 0.000 description 5
- 239000002775 capsule Substances 0.000 description 5
- 102000038379 digestive enzymes Human genes 0.000 description 5
- 108091007734 digestive enzymes Proteins 0.000 description 5
- 239000004615 ingredient Substances 0.000 description 5
- 241000134107 Burkholderia plantarii Species 0.000 description 4
- 241000282887 Suidae Species 0.000 description 4
- 229940025131 amylases Drugs 0.000 description 4
- 230000001580 bacterial effect Effects 0.000 description 4
- 201000010099 disease Diseases 0.000 description 4
- 235000013305 food Nutrition 0.000 description 4
- 238000002156 mixing Methods 0.000 description 4
- 238000003825 pressing Methods 0.000 description 4
- 239000000047 product Substances 0.000 description 4
- 150000003839 salts Chemical class 0.000 description 4
- 238000003756 stirring Methods 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
- 208000016222 Pancreatic disease Diseases 0.000 description 3
- 206010033649 Pancreatitis chronic Diseases 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
- 230000037406 food intake Effects 0.000 description 3
- 235000012054 meals Nutrition 0.000 description 3
- 239000000825 pharmaceutical preparation Substances 0.000 description 3
- 235000019419 proteases Nutrition 0.000 description 3
- 229910002012 Aerosil® Inorganic materials 0.000 description 2
- ZHNUHDYFZUAESO-UHFFFAOYSA-N Formamide Chemical compound NC=O ZHNUHDYFZUAESO-UHFFFAOYSA-N 0.000 description 2
- 229920003085 Kollidon® CL Polymers 0.000 description 2
- 229920000168 Microcrystalline cellulose Polymers 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
- 239000000654 additive Substances 0.000 description 2
- 150000001413 amino acids Chemical group 0.000 description 2
- 238000003556 assay Methods 0.000 description 2
- 235000013361 beverage Nutrition 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
- 238000007906 compression Methods 0.000 description 2
- 230000006835 compression Effects 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
- 239000007919 dispersible tablet Substances 0.000 description 2
- 239000003995 emulsifying agent Substances 0.000 description 2
- 238000000855 fermentation Methods 0.000 description 2
- 230000004151 fermentation Effects 0.000 description 2
- 238000007710 freezing Methods 0.000 description 2
- 230000008014 freezing Effects 0.000 description 2
- 235000011389 fruit/vegetable juice Nutrition 0.000 description 2
- 210000004051 gastric juice Anatomy 0.000 description 2
- 210000001035 gastrointestinal tract Anatomy 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 235000019626 lipase activity Nutrition 0.000 description 2
- 239000006193 liquid solution Substances 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 2
- 239000008108 microcrystalline cellulose Substances 0.000 description 2
- 229940016286 microcrystalline cellulose Drugs 0.000 description 2
- 210000000214 mouth Anatomy 0.000 description 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 239000007921 spray Substances 0.000 description 2
- 230000006641 stabilisation Effects 0.000 description 2
- 238000011105 stabilization Methods 0.000 description 2
- 210000002784 stomach Anatomy 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 239000000758 substrate Substances 0.000 description 2
- 150000005846 sugar alcohols Chemical class 0.000 description 2
- BHKKSKOHRFHHIN-MRVPVSSYSA-N 1-[[2-[(1R)-1-aminoethyl]-4-chlorophenyl]methyl]-2-sulfanylidene-5H-pyrrolo[3,2-d]pyrimidin-4-one Chemical compound N[C@H](C)C1=C(CN2C(NC(C3=C2C=CN3)=O)=S)C=CC(=C1)Cl BHKKSKOHRFHHIN-MRVPVSSYSA-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
- 206010016654 Fibrosis Diseases 0.000 description 1
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 1
- 241001465754 Metazoa Species 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
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 206010041969 Steatorrhoea Diseases 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 229940008474 alka-seltzer Drugs 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 235000012206 bottled water Nutrition 0.000 description 1
- 239000001110 calcium chloride Substances 0.000 description 1
- 229910001628 calcium chloride Inorganic materials 0.000 description 1
- XAAHAAMILDNBPS-UHFFFAOYSA-L calcium hydrogenphosphate dihydrate Chemical compound O.O.[Ca+2].OP([O-])([O-])=O XAAHAAMILDNBPS-UHFFFAOYSA-L 0.000 description 1
- 235000011132 calcium sulphate Nutrition 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 229920003086 cellulose ether Polymers 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 230000001055 chewing effect Effects 0.000 description 1
- 235000015165 citric acid Nutrition 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 238000000748 compression moulding Methods 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
- 230000003247 decreasing effect Effects 0.000 description 1
- 239000003599 detergent Substances 0.000 description 1
- 235000019700 dicalcium phosphate Nutrition 0.000 description 1
- 229940079919 digestives enzyme preparation Drugs 0.000 description 1
- 208000016097 disease of metabolism Diseases 0.000 description 1
- 239000007884 disintegrant Substances 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 239000008298 dragée Substances 0.000 description 1
- 239000003651 drinking water Substances 0.000 description 1
- 210000001198 duodenum Anatomy 0.000 description 1
- 239000002702 enteric coating Substances 0.000 description 1
- 238000009505 enteric coating Methods 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
- 230000004761 fibrosis Effects 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 230000004907 flux Effects 0.000 description 1
- 235000010855 food raising agent Nutrition 0.000 description 1
- -1 for example Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 235000012470 frozen dough Nutrition 0.000 description 1
- 235000015203 fruit juice Nutrition 0.000 description 1
- 229910021485 fumed silica Inorganic materials 0.000 description 1
- 230000002538 fungal effect Effects 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 210000003736 gastrointestinal content Anatomy 0.000 description 1
- 238000003304 gavage Methods 0.000 description 1
- 230000002068 genetic effect Effects 0.000 description 1
- 210000004907 gland Anatomy 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 230000000415 inactivating effect Effects 0.000 description 1
- 230000002779 inactivation Effects 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 239000008297 liquid dosage form Substances 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 208000015486 malignant pancreatic neoplasm Diseases 0.000 description 1
- 208000030159 metabolic disease Diseases 0.000 description 1
- 230000037323 metabolic rate Effects 0.000 description 1
- 239000012569 microbial contaminant Substances 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
- 239000003921 oil Substances 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
- 208000024691 pancreas disease Diseases 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
- 210000001819 pancreatic juice Anatomy 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
- 239000000546 pharmaceutical excipient 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
- 229920003124 powdered cellulose Polymers 0.000 description 1
- 235000019814 powdered cellulose Nutrition 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 238000009877 rendering Methods 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
- 239000007909 solid dosage form Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 108010079522 solysime Proteins 0.000 description 1
- 238000001694 spray drying Methods 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 208000001162 steatorrhea Diseases 0.000 description 1
- 238000009475 tablet pressing Methods 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 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
- 239000002351 wastewater Substances 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
- 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)
- 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)
- Gastroenterology & Hepatology (AREA)
- General Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Biochemistry (AREA)
- Immunology (AREA)
- Botany (AREA)
- Dispersion Chemistry (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Oil, Petroleum & Natural Gas (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 (2)
| 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 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2880602T3 true ES2880602T3 (es) | 2021-11-25 |
Family
ID=61628314
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES18711039T Active ES2880602T3 (es) | 2017-03-03 | 2018-03-05 | Comprimido orodispersable que contiene burlulipasa y composición farmacéutica preparada a partir de ella |
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 |
| WO2022103639A1 (en) | 2020-11-16 | 2022-05-19 | Orcosa Inc. | Methods of treating autoimmune or inflammatory conditions with cannabidiol or its derivatives/analogs |
| 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 |
| 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. |
| CA2110497C (en) | 1991-07-01 | 2005-04-19 | Reinhard Braatz | Use of bacterial lipases for producing drugs for maldigestion therapy |
| GB9908014D0 (en) | 1999-04-08 | 1999-06-02 | Scherer Corp R P | Pharmaceutical compositions |
| CA2374760A1 (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 |
| 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 |
| PT1809320E (pt) | 2004-10-14 | 2010-10-25 | Altus Pharmaceuticals Inc | Composições contendo lipase, protease e amilase para o tratamento de insuficiência pancreática |
| KR101379297B1 (ko) | 2004-10-28 | 2014-04-10 | 팬택 아게 | 고 다공성, 속해성 고형 투여 형태 및 분말 제조 및동결건조 단계를 포함하는 그의 제조 방법 |
| EP2328609A1 (en) | 2008-08-26 | 2011-06-08 | 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 |
| BRPI0922653B8 (pt) | 2009-01-29 | 2021-05-25 | Nordmark Arzneimittel Gmbh & Co Kg | uso de uma lipase bacteriana do tipo pseudomonas em solução aquosa |
| 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 EP EP18711039.0A patent/EP3525769B1/de active Active
- 2018-03-05 WO PCT/EP2018/055285 patent/WO2018158459A1/de not_active Ceased
- 2018-03-05 ES ES18711039T patent/ES2880602T3/es active Active
- 2018-03-05 CN CN201880019225.8A patent/CN110612098B/zh 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 PL PL18711039T patent/PL3525769T3/pl unknown
- 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 |
|---|---|
| PL3525769T3 (pl) | 2021-10-25 |
| CN110612098A (zh) | 2019-12-24 |
| EP3525769B1 (de) | 2021-05-12 |
| EP3525769A1 (de) | 2019-08-21 |
| CA3055116A1 (en) | 2018-09-07 |
| US20200009232A1 (en) | 2020-01-09 |
| CN110612098B (zh) | 2022-05-13 |
| JP2020509052A (ja) | 2020-03-26 |
| US11464834B2 (en) | 2022-10-11 |
| JP2022184994A (ja) | 2022-12-13 |
| JP7208146B2 (ja) | 2023-01-18 |
| CA3055116C (en) | 2023-07-11 |
| WO2018158459A1 (de) | 2018-09-07 |
| DE102017104472A1 (de) | 2018-09-06 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| ES2880602T3 (es) | Comprimido orodispersable que contiene burlulipasa y composición farmacéutica preparada a partir de ella | |
| ES2614157T3 (es) | Composiciones que contienen lipasa, proteasa y amilasa para el tratamiento de la insuficiencia pancreática | |
| ES2236738T3 (es) | Composicion para mejorar la digestibilidad y la utilizacion de nutrientes. | |
| KR101670016B1 (ko) | 안정한 소화 효소 조성물 | |
| US10596235B2 (en) | Pharmaceutical preparation | |
| US20080166334A1 (en) | Combination enzyme for cystic fibrosis | |
| CN108187033A (zh) | 肠溶包衣的低强度胰脂肪酶制剂 | |
| KR20030074625A (ko) | 삶의 질을 개선하는 의약 및 식품 및 그 제조방법 | |
| TW201113052A (en) | Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency | |
| JP7554807B2 (ja) | 消化障害の予防および／または処置用の医薬組成物およびそれを製造する方法、並びにそれを含む医薬製品 | |
| US20230138700A1 (en) | Combined animal-derived and synthetically produced pancreatic enzyme replacement therapy | |
| CA3055118C (en) | Pharmaceutical composition comprising pancreatin and a lipase-containing coating | |
| ES2924573A1 (es) | Sistema de administracion en multiples sitios para administracion diferencial en el tracto gastrointestinal | |
| JP2014193909A (ja) | 医薬調製物 |