DK2470165T3 - Filmcoating-sammensætning fra faste pulverforbindelser - Google Patents
Filmcoating-sammensætning fra faste pulverforbindelser Download PDFInfo
- Publication number
- DK2470165T3 DK2470165T3 DK10749574.9T DK10749574T DK2470165T3 DK 2470165 T3 DK2470165 T3 DK 2470165T3 DK 10749574 T DK10749574 T DK 10749574T DK 2470165 T3 DK2470165 T3 DK 2470165T3
- Authority
- DK
- Denmark
- Prior art keywords
- powder formulation
- wax
- powder
- coating
- starch
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 58
- 150000001875 compounds Chemical class 0.000 title claims abstract description 24
- 239000000843 powder Substances 0.000 title claims description 62
- 239000007787 solid Substances 0.000 title claims description 26
- 239000007888 film coating Substances 0.000 title abstract description 22
- 238000009501 film coating Methods 0.000 title abstract description 22
- 230000002209 hydrophobic effect Effects 0.000 claims abstract description 25
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims abstract description 17
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims abstract description 17
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims abstract description 17
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims abstract description 17
- 239000004014 plasticizer Substances 0.000 claims abstract description 14
- 239000000049 pigment Substances 0.000 claims abstract description 9
- 229920002472 Starch Polymers 0.000 claims abstract description 8
- 235000019698 starch Nutrition 0.000 claims abstract description 8
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims abstract description 6
- 241001465754 Metazoa Species 0.000 claims abstract description 6
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims abstract description 6
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims abstract description 6
- 235000013311 vegetables Nutrition 0.000 claims abstract description 5
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims abstract description 4
- 238000009472 formulation Methods 0.000 claims description 25
- 239000001993 wax Substances 0.000 claims description 19
- 235000013871 bee wax Nutrition 0.000 claims description 14
- 239000012166 beeswax Substances 0.000 claims description 14
- 239000002245 particle Substances 0.000 claims description 14
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 9
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 9
- 235000019422 polyvinyl alcohol Nutrition 0.000 claims description 9
- 238000009826 distribution Methods 0.000 claims description 8
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical group CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 claims description 8
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 7
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 6
- 239000008107 starch Substances 0.000 claims description 6
- 238000002844 melting Methods 0.000 claims description 5
- 230000008018 melting Effects 0.000 claims description 5
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 claims description 4
- 239000001087 glyceryl triacetate Substances 0.000 claims description 4
- 235000013773 glyceryl triacetate Nutrition 0.000 claims description 4
- -1 guaranate Polymers 0.000 claims description 4
- 229960002622 triacetin Drugs 0.000 claims description 4
- 235000011187 glycerol Nutrition 0.000 claims description 3
- 229950008882 polysorbate Drugs 0.000 claims description 3
- 229920000136 polysorbate Polymers 0.000 claims description 3
- 239000004408 titanium dioxide Substances 0.000 claims description 3
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims description 2
- LDVVTQMJQSCDMK-UHFFFAOYSA-N 1,3-dihydroxypropan-2-yl formate Chemical group OCC(CO)OC=O LDVVTQMJQSCDMK-UHFFFAOYSA-N 0.000 claims description 2
- 241000283153 Cetacea Species 0.000 claims description 2
- 241000257303 Hymenoptera Species 0.000 claims description 2
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 2
- 229910052782 aluminium Inorganic materials 0.000 claims description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 2
- 229920001531 copovidone Polymers 0.000 claims description 2
- 229920000609 methyl cellulose Polymers 0.000 claims description 2
- 239000001923 methylcellulose Substances 0.000 claims description 2
- 235000010981 methylcellulose Nutrition 0.000 claims description 2
- 239000002480 mineral oil Substances 0.000 claims description 2
- 235000010446 mineral oil Nutrition 0.000 claims description 2
- 239000003605 opacifier Substances 0.000 claims description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 2
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 2
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 2
- 239000004922 lacquer Substances 0.000 claims 1
- 150000003626 triacylglycerols Chemical class 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 26
- 235000014113 dietary fatty acids Nutrition 0.000 abstract description 9
- 239000000194 fatty acid Substances 0.000 abstract description 9
- 229930195729 fatty acid Natural products 0.000 abstract description 9
- 239000003086 colorant Substances 0.000 abstract description 8
- 150000004665 fatty acids Chemical class 0.000 abstract description 8
- 229910052751 metal Inorganic materials 0.000 abstract description 8
- 239000002184 metal Substances 0.000 abstract description 8
- 150000003839 salts Chemical class 0.000 abstract description 8
- 150000002191 fatty alcohols Chemical class 0.000 abstract description 5
- 229920000881 Modified starch Polymers 0.000 abstract description 4
- 235000019426 modified starch Nutrition 0.000 abstract description 4
- 239000004354 Hydroxyethyl cellulose Substances 0.000 abstract description 2
- 235000015872 dietary supplement Nutrition 0.000 abstract description 2
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 abstract description 2
- 238000000576 coating method Methods 0.000 description 45
- 239000003826 tablet Substances 0.000 description 36
- 239000011248 coating agent Substances 0.000 description 32
- 238000000034 method Methods 0.000 description 21
- 230000004888 barrier function Effects 0.000 description 16
- 239000006185 dispersion Substances 0.000 description 15
- 235000019645 odor Nutrition 0.000 description 11
- 239000007909 solid dosage form Substances 0.000 description 11
- 239000000243 solution Substances 0.000 description 8
- 239000002552 dosage form Substances 0.000 description 7
- 239000002417 nutraceutical Substances 0.000 description 7
- 235000021436 nutraceutical agent Nutrition 0.000 description 7
- 230000008569 process Effects 0.000 description 7
- 239000003814 drug Substances 0.000 description 6
- 229920000642 polymer Polymers 0.000 description 6
- 229940079593 drug Drugs 0.000 description 5
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 4
- 239000000839 emulsion Substances 0.000 description 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 238000003801 milling Methods 0.000 description 4
- 239000001301 oxygen Substances 0.000 description 4
- 229910052760 oxygen Inorganic materials 0.000 description 4
- 238000004806 packaging method and process Methods 0.000 description 4
- 239000004480 active ingredient Substances 0.000 description 3
- 238000013459 approach Methods 0.000 description 3
- 230000015556 catabolic process Effects 0.000 description 3
- 239000007765 cera alba Substances 0.000 description 3
- 238000006731 degradation reaction Methods 0.000 description 3
- 238000004090 dissolution Methods 0.000 description 3
- 235000013305 food Nutrition 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 238000002156 mixing Methods 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- 238000003756 stirring Methods 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 238000009495 sugar coating Methods 0.000 description 3
- 229920000623 Cellulose acetate phthalate Polymers 0.000 description 2
- 244000303965 Cyamopsis psoralioides Species 0.000 description 2
- 239000001856 Ethyl cellulose Substances 0.000 description 2
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 2
- 229920002494 Zein Polymers 0.000 description 2
- 239000007864 aqueous solution Substances 0.000 description 2
- 229940081734 cellulose acetate phthalate Drugs 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- 229910000365 copper sulfate Inorganic materials 0.000 description 2
- ARUVKPQLZAKDPS-UHFFFAOYSA-L copper(II) sulfate Chemical compound [Cu+2].[O-][S+2]([O-])([O-])[O-] ARUVKPQLZAKDPS-UHFFFAOYSA-L 0.000 description 2
- 239000007771 core particle Substances 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 238000009505 enteric coating Methods 0.000 description 2
- 239000002702 enteric coating Substances 0.000 description 2
- 235000019325 ethyl cellulose Nutrition 0.000 description 2
- 229920001249 ethyl cellulose Polymers 0.000 description 2
- 235000019634 flavors Nutrition 0.000 description 2
- 238000000265 homogenisation Methods 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 235000019359 magnesium stearate Nutrition 0.000 description 2
- 230000000873 masking effect Effects 0.000 description 2
- 229940057917 medium chain triglycerides Drugs 0.000 description 2
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 description 2
- 239000003960 organic solvent Substances 0.000 description 2
- 230000035699 permeability Effects 0.000 description 2
- 239000000825 pharmaceutical preparation Substances 0.000 description 2
- 238000005507 spraying Methods 0.000 description 2
- 239000000454 talc Substances 0.000 description 2
- 229910052623 talc Inorganic materials 0.000 description 2
- 229920003169 water-soluble polymer Polymers 0.000 description 2
- 230000004584 weight gain Effects 0.000 description 2
- 235000019786 weight gain Nutrition 0.000 description 2
- 239000005019 zein Substances 0.000 description 2
- 229940093612 zein Drugs 0.000 description 2
- 240000002234 Allium sativum Species 0.000 description 1
- PNEYBMLMFCGWSK-UHFFFAOYSA-N Alumina Chemical compound [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 244000180278 Copernicia prunifera Species 0.000 description 1
- 235000010919 Copernicia prunifera Nutrition 0.000 description 1
- 229920002785 Croscarmellose sodium Polymers 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- CERQOIWHTDAKMF-UHFFFAOYSA-M Methacrylate Chemical compound CC(=C)C([O-])=O CERQOIWHTDAKMF-UHFFFAOYSA-M 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- 102000003979 Mineralocorticoid Receptors Human genes 0.000 description 1
- 108090000375 Mineralocorticoid Receptors Proteins 0.000 description 1
- 239000004368 Modified starch Substances 0.000 description 1
- 229920001800 Shellac Polymers 0.000 description 1
- SEQDDYPDSLOBDC-UHFFFAOYSA-N Temazepam Chemical compound N=1C(O)C(=O)N(C)C2=CC=C(Cl)C=C2C=1C1=CC=CC=C1 SEQDDYPDSLOBDC-UHFFFAOYSA-N 0.000 description 1
- 244000126014 Valeriana officinalis Species 0.000 description 1
- 235000013832 Valeriana officinalis Nutrition 0.000 description 1
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 1
- VJHCJDRQFCCTHL-UHFFFAOYSA-N acetic acid 2,3,4,5,6-pentahydroxyhexanal Chemical compound CC(O)=O.OCC(O)C(O)C(O)C(O)C=O VJHCJDRQFCCTHL-UHFFFAOYSA-N 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 238000004378 air conditioning Methods 0.000 description 1
- 235000010443 alginic acid Nutrition 0.000 description 1
- 239000000783 alginic acid Substances 0.000 description 1
- 229920000615 alginic acid Polymers 0.000 description 1
- 229960001126 alginic acid Drugs 0.000 description 1
- 150000004781 alginic acids Chemical class 0.000 description 1
- 239000007961 artificial flavoring substance Substances 0.000 description 1
- 239000008122 artificial sweetener Substances 0.000 description 1
- 235000021311 artificial sweeteners Nutrition 0.000 description 1
- 238000000889 atomisation Methods 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 239000003354 cholesterol ester transfer protein inhibitor Substances 0.000 description 1
- 229940125881 cholesteryl ester transfer protein inhibitor Drugs 0.000 description 1
- 239000008199 coating composition Substances 0.000 description 1
- 229960005168 croscarmellose Drugs 0.000 description 1
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 description 1
- 230000001186 cumulative effect Effects 0.000 description 1
- 125000003438 dodecyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])* 0.000 description 1
- 239000000975 dye Substances 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 238000004880 explosion Methods 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 235000004611 garlic Nutrition 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 239000007970 homogeneous dispersion Substances 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 229920013821 hydroxy alkyl cellulose Polymers 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
- 150000002734 metacrylic acid derivatives Chemical class 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 125000001421 myristyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- GOQYKNQRPGWPLP-UHFFFAOYSA-N n-heptadecyl alcohol Natural products CCCCCCCCCCCCCCCCCO GOQYKNQRPGWPLP-UHFFFAOYSA-N 0.000 description 1
- 235000021096 natural sweeteners Nutrition 0.000 description 1
- 239000008203 oral pharmaceutical composition Substances 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 125000000913 palmityl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 239000012188 paraffin wax Substances 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 239000011253 protective coating Substances 0.000 description 1
- VMXUWOKSQNHOCA-LCYFTJDESA-N ranitidine Chemical compound [O-][N+](=O)/C=C(/NC)NCCSCC1=CC=C(CN(C)C)O1 VMXUWOKSQNHOCA-LCYFTJDESA-N 0.000 description 1
- 229960000620 ranitidine Drugs 0.000 description 1
- 230000001953 sensory effect Effects 0.000 description 1
- 235000013874 shellac Nutrition 0.000 description 1
- 239000004208 shellac Substances 0.000 description 1
- 229940113147 shellac Drugs 0.000 description 1
- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 description 1
- 150000003385 sodium Chemical class 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000008347 soybean phospholipid Substances 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 125000004079 stearyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 239000000375 suspending agent Substances 0.000 description 1
- 229960003188 temazepam Drugs 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 235000016788 valerian Nutrition 0.000 description 1
- 229940038779 valerian root extract Drugs 0.000 description 1
- 239000001192 valeriana officinalis l. rhizome/root Substances 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
- 229910052725 zinc Inorganic materials 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
- A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
- A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
- A23G3/343—Products for covering, coating, finishing, decorating
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
- A23G2200/00—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF containing organic compounds, e.g. synthetic flavouring agents
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
- A23G2200/00—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF containing organic compounds, e.g. synthetic flavouring agents
- A23G2200/06—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF containing organic compounds, e.g. synthetic flavouring agents containing beet sugar or cane sugar if specifically mentioned or containing other carbohydrates, e.g. starches, gums, alcohol sugar, polysaccharides, dextrin or containing high or low amount of carbohydrate
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/288—Compounds of unknown constitution, e.g. material from plants or animals
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Medicinal Preparation (AREA)
- Paints Or Removers (AREA)
- General Preparation And Processing Of Foods (AREA)
Claims (10)
1. Formulering i pulverform omfattende: 1. en vandopløselig filmdanner, og ii. en fast pulverformig, hydrofob forbindelse i en mængde på fra 5 til 50 vægt% af den samlede formulering i pulverform, som omfatter et mikroniseret pulver af voks, - hvor voksen er afledt af enten en vegetabilsk kilde, en animalsk kilde eller en ikke-naturlig voks; og - hvor den faste, pulverformige, hydrofobe forbindelse har et smeltepunkt i området fra 55-90°C og en partikelstørrelse, dv90, i området fra 10 pm til 400 pm, hvor den volumenbaserede partikelstørrelsesfordeling måles ved hjælp af laserlys-diffraktion.
2. Formulering i pulverform ifølge krav 1, hvor den vandopløselige filmdanner er valgt fra gruppen bestående af hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, hydroxylethylcellulose, natriumcarboxymethylcellulose, polyvinylalkohol, copovidon, alginsyre, stivelse og stivelsesderivater, modificeret stivelse, guar og guar-derivater.
3. Formulering i pulverform ifølge krav 2, hvor den vandopløselige filmdanner omfatter hydroxypropylcellulose.
4. Formulering i pulverform ifølge krav 2, hvor den vandopløselige filmdanner omfatter hydroxypropylmethylcellulose.
5. Formulering i pulverform ifølge krav 1, hvor den faste, pulverformige, hydrofobe forbindelse omfatter et mikroniseret pulver af voks, hvor voksen er afledt fra en animalsk kilde valgt fra gruppen bestående af bier og hval.
6. Formulering i pulverform ifølge krav 5, hvor voksen er bivoks.
7. Formulering i pulverform ifølge krav 1, hvor formuleringen i pulverform yderligere omfatter et blødgøringsmiddel.
8. Formulering i pulverform ifølge krav 7, hvor blødgøringsmidlet er valgt fra gruppen bestående af triacetin, glycerin, mineralolie, acetyleret monoglycerid, triglycerider med mellemkæde, og polysorbat.
9. Formulering i pulverform ifølge krav 1, der yderligere omfatter et farvestof, hvor farvestoffet kan være en hvilken som helst fødevaregodkendt farve, et hvilket som helst fødevaregodkendt pigment, en hvilken som helst fødevaregodkendt opacifikator eller et hvilket som helst fødevaregodkendt farvestof.
10. Formulering i pulverform ifølge krav 9, hvor farvestoffet omfatter et pigment valgt fra gruppen bestående af aluminiumlak, jernoxid og titandioxid.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US23772009P | 2009-08-28 | 2009-08-28 | |
| PCT/US2010/046811 WO2011025881A1 (en) | 2009-08-28 | 2010-08-26 | Film coating composition from solid powder compounds |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2470165T3 true DK2470165T3 (da) | 2018-06-06 |
Family
ID=43066921
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10749574.9T DK2470165T3 (da) | 2009-08-28 | 2010-08-26 | Filmcoating-sammensætning fra faste pulverforbindelser |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US8968456B2 (da) |
| EP (1) | EP2470165B1 (da) |
| JP (2) | JP5795585B2 (da) |
| CN (1) | CN102481258B (da) |
| BR (1) | BR112012004372B1 (da) |
| CA (1) | CA2770212C (da) |
| DK (1) | DK2470165T3 (da) |
| ES (1) | ES2670808T3 (da) |
| HU (1) | HUE038033T2 (da) |
| MX (1) | MX2012001973A (da) |
| PL (1) | PL2470165T3 (da) |
| RU (1) | RU2563133C2 (da) |
| SI (1) | SI2470165T1 (da) |
| TR (1) | TR201807532T4 (da) |
| WO (1) | WO2011025881A1 (da) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011025881A1 (en) * | 2009-08-28 | 2011-03-03 | Hercules Incorporated | Film coating composition from solid powder compounds |
| WO2011143347A2 (en) * | 2010-05-11 | 2011-11-17 | Sensient Colors Llc | Film coating composition and methods of making and using the same |
| MX2011003856A (es) * | 2011-04-11 | 2012-10-24 | Univ Mexico Nacional Autonoma | Composicion de nanoparticulas lipidicas solidas para la conservacion prolongada por recubrimiento de frutas, verduras, semillas, cereales y/o alimentos frescos. |
| EP2631254A1 (en) | 2012-02-27 | 2013-08-28 | Cytec Surface Specialties, S.A. | Fluorinated water-oil repellency agents |
| EP2583986A1 (en) | 2011-10-17 | 2013-04-24 | Cytec Surface Specialties, S.A. | Fluorinated water-oil repellency agents |
| CN103432587B (zh) * | 2013-08-28 | 2014-10-29 | 天津爱勒易医药材料有限公司 | 一种环保型薄膜包衣预混剂及其制备方法 |
| MX377902B (es) * | 2016-08-04 | 2025-03-10 | Bpsi Holdings Llc | Recubrimientos faciles de tragar y sustratos recubiertos con estos |
| EP3740240A4 (en) * | 2018-02-19 | 2021-07-28 | Sensient Colors LLC | COMPOSITIONS FOR COATING EDIBLE SUBSTRATES AND PROCESS FOR THEIR MANUFACTURE AND USE |
Family Cites Families (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5535031A (en) * | 1978-09-04 | 1980-03-11 | Shin Etsu Chem Co Ltd | Enteric coating composition |
| JPS56122334A (en) | 1980-02-29 | 1981-09-25 | Chisso Corp | Liquid crystal 4-alkylcyclohexyl ester |
| US5077053A (en) | 1990-02-12 | 1991-12-31 | Warner-Lambert Company | Zein as a moisture barrier for sugarless edible compositions and method for preparing same |
| GB9414045D0 (en) | 1994-07-12 | 1994-08-31 | Berwind Pharma Service | Moisture barrier film coating composition, method, and coated form |
| EP0771339B1 (en) | 1994-07-12 | 2003-10-15 | BPSI Holdings, Inc. | Dry moisture barrier film coating composition, method of coating substrates using the same and pharmaceutical tablets coated therewith |
| UA74141C2 (uk) * | 1998-12-09 | 2005-11-15 | Дж.Д. Сірл Енд Ко. | Фармацевтична композиція на основі тонкоподрібненого еплеренону (варіанти), спосіб її одержання та спосіб лікування розладів, опосередкованих альдостероном (варіанти) |
| US6419956B1 (en) | 1999-12-30 | 2002-07-16 | Ancile Pharmaceuticals | Odor-masking coating for a pharmaceutical preparation |
| CA2359812C (en) * | 2000-11-20 | 2004-02-10 | The Procter & Gamble Company | Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures |
| GB0204772D0 (en) * | 2002-02-28 | 2002-04-17 | Phoqus Ltd | Pharmaceutical dosage forms |
| US20060217351A1 (en) | 2003-05-05 | 2006-09-28 | Brandt John T | Method for treating cardiovascular diseases |
| JP2004339162A (ja) * | 2003-05-16 | 2004-12-02 | Shin Etsu Chem Co Ltd | 難溶性薬物を含む医薬用固形製剤とその製造方法 |
| JP2006188490A (ja) | 2004-12-06 | 2006-07-20 | Freunt Ind Co Ltd | フィルムコーティング組成物、その皮膜および錠剤 |
| WO2006082500A1 (en) | 2005-02-03 | 2006-08-10 | Pfizer Products Inc. | Dosage forms providing controlled and immediate release of cholesteryl ester transfer protein inhibitors and immediate release of hmg-coa reductase inhibitors |
| EP2594272B1 (en) * | 2005-05-18 | 2018-07-11 | Horizon Orphan LLC | Aerosolized fluoroquinolones and uses thereof |
| CN100459978C (zh) * | 2006-04-28 | 2009-02-11 | 广东药学院 | 一种罗格列酮缓释片及其制备方法 |
| ES2392781T3 (es) * | 2007-09-27 | 2012-12-13 | Wockhardt Limited | Composiciones farmacéuticas de reína o diacereína |
| CN101896170A (zh) * | 2007-11-13 | 2010-11-24 | 赫尔克里士公司 | 用于营养品和药物剂型的水分散性肠溶衣配制物 |
| WO2011025881A1 (en) * | 2009-08-28 | 2011-03-03 | Hercules Incorporated | Film coating composition from solid powder compounds |
-
2010
- 2010-08-26 WO PCT/US2010/046811 patent/WO2011025881A1/en not_active Ceased
- 2010-08-26 BR BR112012004372-2A patent/BR112012004372B1/pt active IP Right Grant
- 2010-08-26 TR TR2018/07532T patent/TR201807532T4/tr unknown
- 2010-08-26 EP EP10749574.9A patent/EP2470165B1/en active Active
- 2010-08-26 DK DK10749574.9T patent/DK2470165T3/da active
- 2010-08-26 CN CN201080038588.XA patent/CN102481258B/zh active Active
- 2010-08-26 MX MX2012001973A patent/MX2012001973A/es active IP Right Grant
- 2010-08-26 ES ES10749574.9T patent/ES2670808T3/es active Active
- 2010-08-26 HU HUE10749574A patent/HUE038033T2/hu unknown
- 2010-08-26 PL PL10749574T patent/PL2470165T3/pl unknown
- 2010-08-26 CA CA2770212A patent/CA2770212C/en active Active
- 2010-08-26 RU RU2012111982/15A patent/RU2563133C2/ru active
- 2010-08-26 US US12/869,272 patent/US8968456B2/en active Active
- 2010-08-26 SI SI201031702T patent/SI2470165T1/en unknown
- 2010-08-26 JP JP2012526986A patent/JP5795585B2/ja active Active
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2015
- 2015-06-09 JP JP2015116621A patent/JP2015172070A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| EP2470165B1 (en) | 2018-04-18 |
| CA2770212C (en) | 2017-03-28 |
| US20110048281A1 (en) | 2011-03-03 |
| CN102481258B (zh) | 2015-06-17 |
| EP2470165A1 (en) | 2012-07-04 |
| BR112012004372A2 (pt) | 2016-03-15 |
| MX2012001973A (es) | 2012-04-11 |
| PL2470165T3 (pl) | 2018-09-28 |
| RU2563133C2 (ru) | 2015-09-20 |
| US8968456B2 (en) | 2015-03-03 |
| JP2013503180A (ja) | 2013-01-31 |
| CN102481258A (zh) | 2012-05-30 |
| RU2012111982A (ru) | 2013-10-10 |
| CA2770212A1 (en) | 2011-03-03 |
| ES2670808T3 (es) | 2018-06-01 |
| HUE038033T2 (hu) | 2018-10-29 |
| SI2470165T1 (en) | 2018-08-31 |
| BR112012004372B1 (pt) | 2020-06-02 |
| WO2011025881A1 (en) | 2011-03-03 |
| TR201807532T4 (tr) | 2018-06-21 |
| JP2015172070A (ja) | 2015-10-01 |
| JP5795585B2 (ja) | 2015-10-14 |
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