JP2006514688A - ゲル安定化ナノパーティクル活性物質組成物 - Google Patents
ゲル安定化ナノパーティクル活性物質組成物 Download PDFInfo
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- JP2006514688A JP2006514688A JP2005503259A JP2005503259A JP2006514688A JP 2006514688 A JP2006514688 A JP 2006514688A JP 2005503259 A JP2005503259 A JP 2005503259A JP 2005503259 A JP2005503259 A JP 2005503259A JP 2006514688 A JP2006514688 A JP 2006514688A
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- gelatin
- chloride
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- 239000013543 active substance Substances 0.000 title claims abstract description 283
- 239000002105 nanoparticle Substances 0.000 title claims abstract description 152
- 239000000203 mixture Substances 0.000 title claims description 343
- 229920000159 gelatin Polymers 0.000 claims abstract description 226
- 235000019322 gelatine Nutrition 0.000 claims abstract description 226
- 108010010803 Gelatin Proteins 0.000 claims abstract description 225
- 235000011852 gelatine desserts Nutrition 0.000 claims abstract description 225
- 239000008273 gelatin Substances 0.000 claims abstract description 224
- 239000002245 particle Substances 0.000 claims abstract description 154
- 239000002552 dosage form Substances 0.000 claims abstract description 133
- 239000007787 solid Substances 0.000 claims abstract description 92
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 65
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 9
- 238000001879 gelation Methods 0.000 claims abstract description 9
- 229940014259 gelatin Drugs 0.000 claims description 222
- 238000009472 formulation Methods 0.000 claims description 135
- 239000003381 stabilizer Substances 0.000 claims description 80
- DKYWVDODHFEZIM-UHFFFAOYSA-N ketoprofen Chemical compound OC(=O)C(C)C1=CC=CC(C(=O)C=2C=CC=CC=2)=C1 DKYWVDODHFEZIM-UHFFFAOYSA-N 0.000 claims description 79
- 229960000991 ketoprofen Drugs 0.000 claims description 79
- -1 antibiotic Substances 0.000 claims description 58
- 239000003814 drug Substances 0.000 claims description 56
- 238000000034 method Methods 0.000 claims description 56
- 229940079593 drug Drugs 0.000 claims description 45
- 239000000126 substance Substances 0.000 claims description 30
- CMWTZPSULFXXJA-UHFFFAOYSA-N Naproxen Natural products C1=C(C(C)C(O)=O)C=CC2=CC(OC)=CC=C21 CMWTZPSULFXXJA-UHFFFAOYSA-N 0.000 claims description 29
- 229960002009 naproxen Drugs 0.000 claims description 29
- CMWTZPSULFXXJA-VIFPVBQESA-N naproxen Chemical compound C1=C([C@H](C)C(O)=O)C=CC2=CC(OC)=CC=C21 CMWTZPSULFXXJA-VIFPVBQESA-N 0.000 claims description 29
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 29
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 29
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 29
- 239000011149 active material Substances 0.000 claims description 27
- 239000002872 contrast media Substances 0.000 claims description 19
- 239000007909 solid dosage form Substances 0.000 claims description 18
- 239000007788 liquid Substances 0.000 claims description 17
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 16
- 235000015872 dietary supplement Nutrition 0.000 claims description 16
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 15
- 239000000499 gel Substances 0.000 claims description 15
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 15
- 150000003839 salts Chemical class 0.000 claims description 15
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 15
- 125000002091 cationic group Chemical group 0.000 claims description 13
- 239000000463 material Substances 0.000 claims description 13
- 239000011159 matrix material Substances 0.000 claims description 13
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 12
- 235000013305 food Nutrition 0.000 claims description 12
- 229920000642 polymer Polymers 0.000 claims description 12
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims description 11
- 239000000227 bioadhesive Substances 0.000 claims description 11
- 238000013270 controlled release Methods 0.000 claims description 11
- 229960000878 docusate sodium Drugs 0.000 claims description 11
- 238000002156 mixing Methods 0.000 claims description 11
- APSBXTVYXVQYAB-UHFFFAOYSA-M sodium docusate Chemical compound [Na+].CCCCC(CC)COC(=O)CC(S([O-])(=O)=O)C(=O)OCC(CC)CCCC APSBXTVYXVQYAB-UHFFFAOYSA-M 0.000 claims description 11
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 claims description 10
- 238000010521 absorption reaction Methods 0.000 claims description 9
- VLKZOEOYAKHREP-UHFFFAOYSA-N n-Hexane Chemical compound CCCCCC VLKZOEOYAKHREP-UHFFFAOYSA-N 0.000 claims description 9
- 229920001223 polyethylene glycol Polymers 0.000 claims description 8
- 230000036186 satiety Effects 0.000 claims description 8
- 235000019627 satiety Nutrition 0.000 claims description 8
- NLXLAEXVIDQMFP-UHFFFAOYSA-N Ammonia chloride Chemical compound [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 claims description 7
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 7
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 7
- 241001465754 Metazoa Species 0.000 claims description 7
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 7
- 239000002202 Polyethylene glycol Substances 0.000 claims description 7
- 239000002253 acid Substances 0.000 claims description 7
- 235000019441 ethanol Nutrition 0.000 claims description 7
- 239000008299 semisolid dosage form Substances 0.000 claims description 7
- DKGAVHZHDRPRBM-UHFFFAOYSA-N Tert-Butanol Chemical compound CC(C)(C)O DKGAVHZHDRPRBM-UHFFFAOYSA-N 0.000 claims description 6
- 229960000686 benzalkonium chloride Drugs 0.000 claims description 6
- 235000010980 cellulose Nutrition 0.000 claims description 6
- 229920002678 cellulose Polymers 0.000 claims description 6
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 6
- 239000000194 fatty acid Substances 0.000 claims description 6
- 229930195729 fatty acid Natural products 0.000 claims description 6
- 229960003174 lansoprazole Drugs 0.000 claims description 6
- MJIHNNLFOKEZEW-UHFFFAOYSA-N lansoprazole Chemical compound CC1=C(OCC(F)(F)F)C=CN=C1CS(=O)C1=NC2=CC=CC=C2N1 MJIHNNLFOKEZEW-UHFFFAOYSA-N 0.000 claims description 6
- 150000003904 phospholipids Chemical class 0.000 claims description 6
- 229940124597 therapeutic agent Drugs 0.000 claims description 6
- AISMNBXOJRHCIA-UHFFFAOYSA-N trimethylazanium;bromide Chemical compound Br.CN(C)C AISMNBXOJRHCIA-UHFFFAOYSA-N 0.000 claims description 6
- UHOVQNZJYSORNB-UHFFFAOYSA-N Benzene Chemical compound C1=CC=CC=C1 UHOVQNZJYSORNB-UHFFFAOYSA-N 0.000 claims description 5
- 229920002307 Dextran Polymers 0.000 claims description 5
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 claims description 5
- 229910019142 PO4 Inorganic materials 0.000 claims description 5
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 5
- 235000010443 alginic acid Nutrition 0.000 claims description 5
- 229920000615 alginic acid Polymers 0.000 claims description 5
- 239000000730 antalgic agent Substances 0.000 claims description 5
- 239000001913 cellulose Substances 0.000 claims description 5
- 235000008216 herbs Nutrition 0.000 claims description 5
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 claims description 5
- 239000010452 phosphate Substances 0.000 claims description 5
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 5
- 235000021317 phosphate Nutrition 0.000 claims description 5
- 238000002360 preparation method Methods 0.000 claims description 5
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims description 4
- YJHSJERLYWNLQL-UHFFFAOYSA-N 2-hydroxyethyl(dimethyl)azanium;chloride Chemical compound Cl.CN(C)CCO YJHSJERLYWNLQL-UHFFFAOYSA-N 0.000 claims description 4
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 claims description 4
- 244000215068 Acacia senegal Species 0.000 claims description 4
- 241000416162 Astragalus gummifer Species 0.000 claims description 4
- 229920000084 Gum arabic Polymers 0.000 claims description 4
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims description 4
- 229920001615 Tragacanth Polymers 0.000 claims description 4
- XTXRWKRVRITETP-UHFFFAOYSA-N Vinyl acetate Chemical compound CC(=O)OC=C XTXRWKRVRITETP-UHFFFAOYSA-N 0.000 claims description 4
- 235000010489 acacia gum Nutrition 0.000 claims description 4
- 239000000205 acacia gum Substances 0.000 claims description 4
- 229940072056 alginate Drugs 0.000 claims description 4
- 150000001412 amines Chemical class 0.000 claims description 4
- 235000019270 ammonium chloride Nutrition 0.000 claims description 4
- JBIROUFYLSSYDX-UHFFFAOYSA-M benzododecinium chloride Chemical compound [Cl-].CCCCCCCCCCCC[N+](C)(C)CC1=CC=CC=C1 JBIROUFYLSSYDX-UHFFFAOYSA-M 0.000 claims description 4
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 4
- 229940107161 cholesterol Drugs 0.000 claims description 4
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 claims description 4
- MYSWGUAQZAJSOK-UHFFFAOYSA-N ciprofloxacin Chemical compound C12=CC(N3CCNCC3)=C(F)C=C2C(=O)C(C(=O)O)=CN1C1CC1 MYSWGUAQZAJSOK-UHFFFAOYSA-N 0.000 claims description 4
- WHBIGIKBNXZKFE-UHFFFAOYSA-N delavirdine Chemical compound CC(C)NC1=CC=CN=C1N1CCN(C(=O)C=2NC3=CC=C(NS(C)(=O)=O)C=C3C=2)CC1 WHBIGIKBNXZKFE-UHFFFAOYSA-N 0.000 claims description 4
- DDXLVDQZPFLQMZ-UHFFFAOYSA-M dodecyl(trimethyl)azanium;chloride Chemical compound [Cl-].CCCCCCCCCCCC[N+](C)(C)C DDXLVDQZPFLQMZ-UHFFFAOYSA-M 0.000 claims description 4
- 235000013399 edible fruits Nutrition 0.000 claims description 4
- 150000004665 fatty acids Chemical class 0.000 claims description 4
- OVBPIULPVIDEAO-LBPRGKRZSA-N folic acid Chemical compound C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-LBPRGKRZSA-N 0.000 claims description 4
- HICYUNOFRYFIMG-UHFFFAOYSA-N n,n-dimethyl-1-naphthalen-1-ylmethanamine;hydrochloride Chemical compound [Cl-].C1=CC=C2C(C[NH+](C)C)=CC=CC2=C1 HICYUNOFRYFIMG-UHFFFAOYSA-N 0.000 claims description 4
- 235000018102 proteins Nutrition 0.000 claims description 4
- 102000004169 proteins and genes Human genes 0.000 claims description 4
- 108090000623 proteins and genes Proteins 0.000 claims description 4
- BNRNXUUZRGQAQC-UHFFFAOYSA-N sildenafil Chemical compound CCCC1=NN(C)C(C(N2)=O)=C1N=C2C(C(=CC=1)OCC)=CC=1S(=O)(=O)N1CCN(C)CC1 BNRNXUUZRGQAQC-UHFFFAOYSA-N 0.000 claims description 4
- 235000010487 tragacanth Nutrition 0.000 claims description 4
- 239000000196 tragacanth Substances 0.000 claims description 4
- 229940116362 tragacanth Drugs 0.000 claims description 4
- 239000011782 vitamin Substances 0.000 claims description 4
- 229940088594 vitamin Drugs 0.000 claims description 4
- 229930003231 vitamin Natural products 0.000 claims description 4
- KGIGUEBEKRSTEW-UHFFFAOYSA-N 2-vinylpyridine Chemical compound C=CC1=CC=CC=N1 KGIGUEBEKRSTEW-UHFFFAOYSA-N 0.000 claims description 3
- LZZYPRNAOMGNLH-UHFFFAOYSA-M Cetrimonium bromide Chemical compound [Br-].CCCCCCCCCCCCCCCC[N+](C)(C)C LZZYPRNAOMGNLH-UHFFFAOYSA-M 0.000 claims description 3
- 229920001661 Chitosan Polymers 0.000 claims description 3
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 claims description 3
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 3
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 3
- 235000019485 Safflower oil Nutrition 0.000 claims description 3
- 235000021355 Stearic acid Nutrition 0.000 claims description 3
- NJSSICCENMLTKO-HRCBOCMUSA-N [(1r,2s,4r,5r)-3-hydroxy-4-(4-methylphenyl)sulfonyloxy-6,8-dioxabicyclo[3.2.1]octan-2-yl] 4-methylbenzenesulfonate Chemical compound C1=CC(C)=CC=C1S(=O)(=O)O[C@H]1C(O)[C@@H](OS(=O)(=O)C=2C=CC(C)=CC=2)[C@@H]2OC[C@H]1O2 NJSSICCENMLTKO-HRCBOCMUSA-N 0.000 claims description 3
- 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 3
- NIXOWILDQLNWCW-UHFFFAOYSA-N acrylic acid group Chemical group C(C=C)(=O)O NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 3
- 229940035676 analgesics Drugs 0.000 claims description 3
- 125000000129 anionic group Chemical group 0.000 claims description 3
- 230000000507 anthelmentic effect Effects 0.000 claims description 3
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims description 3
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- 229940078456 calcium stearate Drugs 0.000 claims description 3
- YMKDRGPMQRFJGP-UHFFFAOYSA-M cetylpyridinium chloride Chemical group [Cl-].CCCCCCCCCCCCCCCC[N+]1=CC=CC=C1 YMKDRGPMQRFJGP-UHFFFAOYSA-M 0.000 claims description 3
- 229960001927 cetylpyridinium chloride Drugs 0.000 claims description 3
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims description 3
- 239000003246 corticosteroid Substances 0.000 claims description 3
- 235000011187 glycerol Nutrition 0.000 claims description 3
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- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 claims description 3
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 3
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- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 claims description 3
- 150000002632 lipids Chemical class 0.000 claims description 3
- XKBGEWXEAPTVCK-UHFFFAOYSA-M methyltrioctylammonium chloride Chemical compound [Cl-].CCCCCCCC[N+](C)(CCCCCCCC)CCCCCCCC XKBGEWXEAPTVCK-UHFFFAOYSA-M 0.000 claims description 3
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 3
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- ROSDSFDQCJNGOL-UHFFFAOYSA-N protonated dimethyl amine Natural products CNC ROSDSFDQCJNGOL-UHFFFAOYSA-N 0.000 claims description 3
- 150000003856 quaternary ammonium compounds Chemical class 0.000 claims description 3
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- FPJHWYCPAOPVIV-VOZMEZHOSA-N (2R,3S,4R,5R,6R)-6-[(2R,3R,4R,5R,6R)-5-acetamido-2-(hydroxymethyl)-6-methoxy-3-sulfooxyoxan-4-yl]oxy-4,5-dihydroxy-3-methoxyoxane-2-carboxylic acid Chemical compound CO[C@@H]1O[C@H](CO)[C@H](OS(O)(=O)=O)[C@H](O[C@@H]2O[C@H]([C@@H](OC)[C@H](O)[C@H]2O)C(O)=O)[C@H]1NC(C)=O FPJHWYCPAOPVIV-VOZMEZHOSA-N 0.000 claims description 2
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- QAQSNXHKHKONNS-UHFFFAOYSA-N 1-ethyl-2-hydroxy-4-methyl-6-oxopyridine-3-carboxamide Chemical compound CCN1C(O)=C(C(N)=O)C(C)=CC1=O QAQSNXHKHKONNS-UHFFFAOYSA-N 0.000 claims description 2
- DBRHJJQHHSOXCQ-UHFFFAOYSA-N 2,2-dihydroxyethyl(methyl)azanium;chloride Chemical compound [Cl-].C[NH2+]CC(O)O DBRHJJQHHSOXCQ-UHFFFAOYSA-N 0.000 claims description 2
- UEJJHQNACJXSKW-UHFFFAOYSA-N 2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione Chemical compound O=C1C2=CC=CC=C2C(=O)N1C1CCC(=O)NC1=O UEJJHQNACJXSKW-UHFFFAOYSA-N 0.000 claims description 2
- SGTNSNPWRIOYBX-UHFFFAOYSA-N 2-(3,4-dimethoxyphenyl)-5-{[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino}-2-(propan-2-yl)pentanenitrile Chemical compound C1=C(OC)C(OC)=CC=C1CCN(C)CCCC(C#N)(C(C)C)C1=CC=C(OC)C(OC)=C1 SGTNSNPWRIOYBX-UHFFFAOYSA-N 0.000 claims description 2
- FEBUJFMRSBAMES-UHFFFAOYSA-N 2-[(2-{[3,5-dihydroxy-2-(hydroxymethyl)-6-phosphanyloxan-4-yl]oxy}-3,5-dihydroxy-6-({[3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}methyl)oxan-4-yl)oxy]-3,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl phosphinite Chemical compound OC1C(O)C(O)C(CO)OC1OCC1C(O)C(OC2C(C(OP)C(O)C(CO)O2)O)C(O)C(OC2C(C(CO)OC(P)C2O)O)O1 FEBUJFMRSBAMES-UHFFFAOYSA-N 0.000 claims description 2
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
Abstract
Description
ナノパーティクル活性物質組成物は、米国特許第5,145,684号(「‘684特許」)に最初に記載されたもので、非架橋表面安定剤を表面に吸収または会合させた難溶性の活性物質からなる粒子である。‘684特許には、上記のナノパーティクル活性物質組成物の製造方法も記載されている。ナノパーティクル組成物は、粒径が小さくなり、その結果表面積が増加すると、投与後に組成物が迅速に溶解し、吸収されるので望ましい。
により本明細書に組み入れる。さらに、2002年1月31日に公開された「制御放出ナノパーティクル組成物」(Controlled Release Nanoparticulate Compositions)に関する米国特許出願第20020012675 A1号、および2002年12月12日に公開された国際出願第WO 02/098565号には、ナノパーティクル活性物質組成物について記載されており、これらを特に参照により本明細書に組み入れる。
最近では、医薬製品は3つの個体の群、乳児、小児および成人用に設計される。乳児の必要とするものは2から12歳の子供とは異なり、また、子供の必要とするものは成人とは異なる。さらに、高齢者の集団の必要とするものは他の成人とは異なる。他の薬物送達型を必要とする個体の別のカテゴリーは、慢性の投与計画を受けている患者である。錠剤または丸剤の投与の繰り返しは毎日の投与計画を必要とする患者にとって問題となりやすい。そこで、さまざまな患者の集団のための代替の剤形が必要とされている。
ゼラチン薬物送達システムは、子供、高齢者、および慢性の投薬を受けている患者のいずれにおいても投与の容易さを達成するのに役立つであろう。しかしながら、上記の投与システムは十分な安定性およびバイオアベイラビリティーを示さなければならない。十分なバイオアベイラビリティーおよび活性物質の安定性がなくては、投与の容易さは薬物治療のプロセスにおける1つの段階に過ぎない。先行技術のゼラチン剤形は、バイオアベイラビリティーと活性物質の安定性の組合せというこの2つの必要性を解決することができなかった。
本発明は、驚くべき、予期しなかった新規のナノパーティクル活性物質のゼラチン固体または半固体投与製剤の発見に関する。新規の剤形は、固体または半固体ゲル中に過剰な水を保持するのに十分なゲル化を示すゲル形成物質を含む。
さらに、ゼラチン固体または半固体剤形ナノパーティクル活性物質製剤は、投与が容易で、活性物質の安定性が改善され、溶解性が改善された活性物質剤形を提供する、少なくとも1つのゲル形成物質を含む。ゼラチン固体または半固体投与製剤はまた、活性物質成分の再分散性が増大し、それにより薬理的に許容されるバイオアベイラビリティーを達成している。
本発明は、驚くべき、予期しなかった新規の固体または半固体ゼラチン剤形の発見に関する。
A. ゼラチン剤形の再分散性プロファイル
本発明の固体または半固体ナノパーティクル活性物質ゼラチン剤形は、固体または半固体活性物質剤形中に過剰な水を保持するのに十分なゲル化を示し、これにより活性物質の迅速な再分散が可能になる。上記の迅速な再分散は、好ましくは活性物質のバイオアベイラビリティーの増加と相関する。先行技術のゼラチン製剤は安定性を考慮したために水、または十分な量の水を含むことができなかったので、これは意義深い。ゼラチン剤形中に存在する水が不十分であると、活性物質のin vivoの再分散性がわずかしか、または全くないために、投与後に十分に活性物質の溶解および血流中への吸収がおこなわれない。
本発明の固体または半固体ゼラチン剤形に関する典型的な利点は、薬物投与と活性物質の体内への出現の間の時間の遅延が小さくなることである。この遅延時間は通常剤形の崩壊およびその後の活性物質の分布と関連する。
本発明の別の態様において、本発明のナノパーティクル活性物質のゼラチン剤形は増大したバイオアベイラビリティーを有するので、同じ活性物質の従来の非ナノパーティクル剤形と比較して活性物質の投与量を減らすことができ、その結果、活性物質に付随する毒性を減少させることができる。
固体または半固体経口ゼラチン剤形の製造には活性物質を可溶化する必要がない。先行技術のゼラチン剤形は活性物質の可溶化を必要としたので、これは意義深いことである。このような活性物質の可溶化は、活性物質の薬物動態学的および薬理的特性を変える可能性があるので、望ましくない。たとえば、可溶化の後に活性物質が沈殿すると、活性物質の凝固状態の改変が起こる可能性があり(すなわち、活性物質がアモルファス型か結晶型か)、それが水性の状態における活性物質の安定性に影響を与える可能性があり、また、それがどの程度の量の活性物質が固体の状態に戻ったかに影響を与える可能性がある。
その投与の容易さのために、本発明の組成物は、小児、老人、および嚥下困難の患者、ならびに慢性の投薬を必要とする患者に特有の必要性に対して特に有用である。固体または半固体ゼラチン活性物質送達製剤は、それらの投与の容易さ、利便性、および患者に優しい性質のために有益である。人口の35%から50%、特に小児および老人の患者が錠剤および硬ゼラチンカプセルを飲み込むのを困難であると感じていると推定される。本発明の固体または半固体ゼラチン活性物質送達製剤は、投与すると剤形が「融ける」ので、錠剤またはカプセルを丸ごと飲み込む必要がなくなる。
本発明はまた、好ましくは、哺乳類被験体に投与された時に、望まれる薬物動態プロファイルを有するナノパーティクル活性物質のゼラチン剤形を提供する。ゼラチン剤形の望ましい薬物動態プロファイルは、好ましくは、(1) 投与後に哺乳類被験体の血漿中でアッセイした場合の活性物質のTmaxが、同じ活性物質の従来の非ナノパーティクル剤形を同じ投与量で投与した場合のTmaxよりも好ましくは小さいこと;(2) 投与後に哺乳類被験体の血漿中でアッセイした場合の活性物質のCmaxが、同じ活性物質の従来の非ナノパーティクル剤形を同じ投与量で投与した場合のCmaxよりも好ましくは大きいこと;および/または(3) 投与後に哺乳類被験体の血漿中でアッセイした場合の活性物質のAUCが、同じ活性物質の従来の非ナノパーティクル剤形を同じ投与量で投与した場合のAUCよりも好ましくは大きいことを含むが、これらに限定されない。
本発明のさらに別の実施形態において、本発明のゼラチン剤形は、同じまたは異なる活性物質の複数のナノパーティクル活性物質組成物を含む。活性物質が同一である場合には、組成物は、たとえば、活性物質の粒径または活性物質の投与量が異なっている。さらに、ゼラチン剤形は1つ以上の可溶化された、または従来のマイクロパーティクル粒径の活性物質を含んでもよい。
本発明は、ヒトに投与された場合に、活性物質の薬物動態プロファイルが好ましくは組成物を摂取した被験体の満腹か空腹かの状態により実質的に影響されないようなナノパーティクル活性物質のゼラチン剤形を包含する。これは、ゼラチン剤形が満腹の状態で投与された場合と空腹の状態で投与された場合とで、吸収される活性物質の量または活性物質の吸収速度に実質的な差異がないことを意味する。
本発明のナノパーティクル活性物質の生物付着性ゼラチン剤形は、下に詳細に記載する少なくとも1つのカチオン性表面安定剤を含む。ナノパーティクル活性物質の生物付着性ゼラチン剤形は、粘膜のような生物表面に優れた生物付着を示す。生物付着という用語は、2つの生物の表面の間、または生物の表面および合成表面の間のすべての親和的相互作用を指す。生物付着性ナノパーティクル活性物質の場合には、生物付着の用語は、ナノパーティクル活性物質と生物基質(すなわち、胃腸ムチン、肺組織、鼻粘膜等)の間の付着を表現するために用いられる。たとえば、「カチオン性表面安定剤を有する生物付着性ナノパーティクル組成物」に関する米国特許第6,428,814号を参照されたい。上記文献を特に参照により本明細書に組み入れる。
固体または半固体ゼラチン剤形に製剤する前の出発ナノパーティクル活性物質組成物は、約2ミクロン未満の有効平均粒径を有する少なくとも1つの活性物質、および活性物質の表面に吸収されたまたは会合した少なくとも1つの表面安定剤を含む。
本発明は非常にさまざまな活性物質を用いて実施することができる。活性物質は好ましくは難溶性で、少なくとも1つの液体媒体に分散可能である。有用な液体分散媒体には、水、塩水溶液、ベニバナ油、ならびにエタノール、t-ブタノール、ヘキサン、およびグリコールのような溶媒が含まれるが、これらに限定されない。「難溶性」という用語は、活性物質が液体の分散媒体中で、約30mg/ml未満、好ましくは約20mg/ml未満、好ましくは約10mg/ml未満、およびより好ましくは約1mg/ml未満の溶解度を有することを意味する。2つ以上の活性物質を組み合わせて用いることができる。
表面安定剤の選択は些末なことではなく、望ましい製剤を実現するためには通常多くの実験を必要とする。
(i) R1-R4はいずれもCH3ではない;
(ii) R1-R4のうち1つがCH3である;
(iii) R1-R4のうち3つがCH3である;
(iv) R1-R4のすべてがCH3である;
(v) R1-R4のうち2つがCH3であり、R1-R4のうち1つがC6H5CH2であり、R1-R4のうち1つが炭素原子7個以下のアルキル鎖である;
(vi) R1-R4のうち2つがCH3であり、R1-R4のうち1つがC6H5CH2であり、R1-R4のうち1つが炭素原子19個以上のアルキル鎖である;
(vii) R1-R4のうち2つがCH3であり、R1-R4のうち1つがC6H5(CH2)n基(式中、n>1)である;
(viii) R1-R4のうち2つがCH3であり、R1-R4のうち1つがC6H5CH2であり、R1-R4のうち1つが少なくとも1個のヘテロ原子を含む;
(ix) R1-R4のうち2つがCH3であり、R1-R4のうち1つがC6H5CH2であり、R1-R4のうち1つが少なくとも1個のハロゲンを含む;
(x) R1-R4のうち2つがCH3であり、R1-R4のうち1つがC6H5CH2であり、R1-R4のうち1つが少なくとも1個の環状部分を含む;
(xi) R1-R4のうち2つがCH3であり、R1-R4のうち1つがフェニル環である;または
(xii) R1-R4のうち2つがCH3であり、R1-R4のうち2つが純粋に脂肪族の部分である。
本明細書において、粒径は、当業者に公知の従来の粒径測定技術により測定される重量平均粒径に基づいて決定される。上記の技術には、たとえば、沈降場流動分画、光子相関分光分析、光散乱、およびディスク遠心分離(disk centrifugation)が含まれる。
ゲル形成物質は、天然、半合成、または合成のゼラチン、または化学または物理ゲルであってよい。本発明の製剤には少なくとも1つの天然または合成のゲル形成物質が用いられる。
本発明の医薬組成物は、1つ以上の結合剤、充填剤、滑沢剤、懸濁剤、甘味料、香味料、保存料、緩衝剤、湿潤剤、崩壊剤、発泡剤、および他の賦形剤を含んでいてもよい。上記の賦形剤は当業者に公知である。
本発明のゼラチン剤形におけるナノパーティクル活性物質組成物の相対的な量はさまざまであってよく、たとえば、送達のために選択された活性物質および表面安定剤、活性物質および表面安定剤の融点、活性物質および表面安定剤の水溶性、活性薬物および表面安定剤の水溶液の表面張力等に依存し得る。活性物質は治療効果を引き出すのに十分ないかなる量で存在してもよい。
本発明の別の態様において、ナノパーティクル活性物質の固体または半固体ゼラチン剤形を製造する方法を提供する。上記方法は、(1) 少なくとも1つの活性物質および少なくとも1つの表面安定剤のナノパーティクル活性物質組成物で、活性物質が約2000nm未満の有効平均粒径を有するもの、および(2) 固体または半固体剤形中に過剰な水を保持するのに十分なゲル化を示し、ナノパーティクル活性物質組成物を取り囲む固体剤形マトリックスを形成する、少なくとも1つのゲル形成物質を混合することを含む。上記方法は活性物質の可溶化を含まない。この組成物は、ゼラチン固体剤形組成物を患者に投与した際に再分散が達成されるような固体剤形の製剤を形成するために用いられる。
固体または半固体剤形への製剤に用いられるナノパーティクル分散物を得るための活性物質の磨砕は、少なくとも1つの活性物質の粒子を、活性物質が難溶性である液体の分散媒体に分散させた後、粉砕媒体の存在下で機械的手段を適用して活性物質の粒径を所望の有効平均粒径に減少させることを含む。分散媒体は、たとえば、水、ベニバナ油、エタノール、t-ブタノール、グリセリン、ポリエチレングリコール(PEG)、ヘキサン、またはグリコールである。
活性物質ナノパーティクル組成物を製造するためのホモジナイゼーション法の例は、「ナノパーティクルを含む治療用組成物を製造する方法」(Process of Preparing Therapeutic Compositions Containing Nanoparticles)に関する米国特許第5,510,118号に記載されている。
本発明は、活性物質、特に水難溶性の活性物質の迅速なアベイラビリティーおよび投与の容易さを必要としているヒトおよび動物を含む被験体を治療する方法を提供する。上記方法は、被験体に有効量のナノパーティクル活性物質の固体または半固体ゼラチン剤形を投与することを含む。投与されると、ゼラチン剤形は融解し、成分のナノパーティクル活性物質粒子は再分散する。
本実施例の目的は、鎮痛作用を有する化合物Aのナノパーティクルゼラチン製剤を製造することであった。
この実施例の目的はナノパーティクルケトプロフェンゼラチン製剤を製造することであった。ケトプロフェンは有名な非ステロイド抗炎症薬(NSAID)である。
本実施例の目的はさまざまな固体または半固体ナノパーティクルナプロキセンゼラチン投与製剤の再分散特性を比較することであった。ナプロキセンは有名な抗炎症、鎮痛、および解熱薬である。
この実施例の目的は実施例1の方法により製造された半固体ゼラチンナノパーティクル化合物A投与製剤の再分散特性を研究することであった。
この実施例の目的は実施例2の方法により製造された半固体ゼラチンナノパーティクルケトプロフェン投与製剤の再分散特性を研究することであった。
この実施例の目的は、空腹のビ−グル犬に経口投与した場合のナノパーティクルケトプロフェンゼラチン製剤のin vivoのパフォーマンスを評価することであった。
(b) 4匹のイヌには、用量50mgのケトプロフェンのナノパーティクル結晶分散物(NCD)を投与した;
(c) 4匹のイヌには、用量50mgのケトプロフェンの5%軟経口ゼラチン製剤を投与した;および
(d) 4匹のイヌには、用量50mgのケトプロフェンの20%硬経口ゼラチン製剤を投与した。
この実施例の目的は、空腹のビ−グル犬に口腔投与された場合のナノパーティクルケトプロフェンゼラチン製剤のin vivoにおけるパフォーマンスを評価することであった。この研究に用いられたケトプロフェン製剤は実施例6と同じであった。
(b) 4匹のイヌには、用量50mgのケトプロフェンのナノパーティクル結晶分散物(NCD)を投与した;
(c) 4匹のイヌには、用量50mgのケトプロフェンの5%軟経口ゼラチン製剤を投与した;および
(d) 4匹のイヌには、用量50mgのケトプロフェンの20%硬経口ゼラチン製剤を投与した。
Claims (46)
- 固体または半固体ゼラチン組成物であって、
(a) 組成物に加える前に約2000nm未満の有効平均粒径を有する少なくとも1つの活性物質;
(b) 少なくとも1つの表面安定剤;および
(c) 固体または半固体状態に過剰な水を保持するのに十分なゲル化を示す、少なくとも1つのゲル形成物質
を含む組成物。 - 少なくとも1つの活性物質の濃度が、他の賦形剤を含まない、少なくとも1つの活性物質および少なくとも1つの表面安定剤を合わせた総重量に基づく重量で、約99.5%から約0.001%、約95%から約0.1%、および約90%から約0.5%からなる群より選択される、請求項1記載の組成物。
- 少なくとも1つの表面安定剤の濃度が、他の賦形剤を含まない、少なくとも1つの活性物質および少なくとも1つの表面安定剤を合わせた総乾燥重量に基づく重量で、約0.5%から約99.999%、約5.0%から約99.9%、および約10%から約99.5%からなる群より選択される、請求項1または2記載の組成物。
- 少なくとも1つのゲル形成物質の濃度が、活性物質、少なくとも1つの表面安定剤、および少なくとも1つのゲル形成物質の総重量に基づく重量で、約0.5%から約60%、約3%から約40%、および約5%から約20 %からなる群より選択される、請求項1から3のいずれか1項記載の組成物。
- 組成物中に存在する水の量が、組成物の総重量に基づいて、約5%から約97%、約20%から約95%、約30%から約92%、約45%から約90%、および約65%から約85%からなる群より選択される、請求項1から4のいずれか1項記載の組成物。
- ゲル形成物質が、天然のゼラチン、半合成ゼラチン、および合成ゼラチンからなる群より選択される、請求項1から5のいずれか1項記載の組成物。
- ゲル形成物質が、藻類由来のもの、植物由来のもの、微生物由来のもの、および動物由来のものからなる群より選択される天然のゼラチンである、請求項6記載の組成物。
- ゲル形成物質が、寒天、ファーセレラン、アルギン酸塩、カラギーナン、植物抽出物、アラビアゴム、トラガカント、カラヤ、ガティシードガム、グアーガム、ローカストビーンガム、キサンタン、プルラン、スクレログルカン、カードラン、デキストラン、ジェラン、キチン、キトサン、コンドロイチン硫酸、デルマタン硫酸、へパレイン、ケラタン硫酸、およびヒアルロン酸からなる群より選択される天然のゼラチンである、請求項7記載の組成物。
- ゲル形成物質が、架橋してゲルを形成する複合基を有する水溶性ポリマーである、請求項6記載の組成物。
- 水溶性ポリマーが、アクリル酸、メタクリル酸、アクリルアミド、N-アルキルアクリルアミド、メタクリルアミド、ビニルピロリドン、メタクリル酸メチル、メタクリル酸ヒドロキシエチル、およびビニルピリジンからなる群より選択される、請求項9記載の組成物。
- 複合基が、N,N’-メチレンビスアクリルアミドおよびタンパク質からなる群より選択される、請求項9記載の組成物。
- 活性物質粒子の有効平均粒径が、約1900nm未満、約1800nm未満、約1700nm未満、約1600nm未満、約1500nm未満、約1400nm未満、約1300nm未満、約1200nm未満、約1100nm未満、約1000nm未満、約900nm未満、約800nm未満、約700nm未満、約600nm未満、約500nm未満、約400nm未満、約300nm未満、約250nm未満、約200nm未満、約100nm未満、約75nm未満、および約50nm未満からなる群より選択される、請求項1から11のいずれか1項記載の組成物。
- 少なくとも約70%、少なくとも約90%、または少なくとも約95%の活性物質粒子が有効平均粒径よりも小さい粒径を有する、請求項1から12記載の組成物。
- ゼラチンナノパーティクル組成物が、幾何学的形、動物の形、数字の形、キャラクターの形、およびアルファベットの形からなる群より選択される形に型で成形されたものである、請求項1から13のいずれか1項記載の組成物。
- 組成物が、経口、直腸、腟内、局所(local)、口腔内、および局所(topical)投与からなる群より選択される投与用に製剤化された、請求項1から14のいずれか1項記載の組成物。
- 速効性製剤、制御放出製剤、口腔内即崩壊製剤、遅延放出製剤、持続放出製剤、パルス放出製剤、ならびに速効性および制御放出の混合型製剤からなる群より選択される剤形に製剤化された、請求項1から15のいずれか1項記載の組成物。
- 組成物がさらに1つ以上の薬学的に許容される賦形剤、担体またはそれらの組合せを含む、請求項1から16のいずれか1項記載の組成物。
- 少なくとも1つの活性物質が、結晶粒子、半結晶粒子、半アモルファス粒子、アモルファス粒子、およびそれらの混合物からなる群より選択される形である、請求項1から17のいずれか1項記載の組成物。
- 少なくとも1つの活性物質が、少なくとも1つの液体媒体中で難溶性であり、ここで、「難溶性」とは、液体媒体中で、約30mg/ml未満、約20mg/ml未満、約10mg/ml未満、および約1mg/ml未満からなる群より選択される溶解度であると定義される、請求項1から18のいずれか1項記載の組成物。
- 液体媒体が、水、ベニバナ油、エタノール、t-ブタノール、グリセリン、ポリエチレングリコール(PEG)、ヘキサン、およびグリコールからなる群より選択される、請求項19記載の組成物。
- 少なくとも1つの活性物質が、塩または他の適当な物質とコンジュゲートすることにより少なくとも1つの液体媒体中で難溶性にされたものである、請求項1から20のいずれか1項記載の組成物。
- 少なくとの1つの活性物質が、COX-2阻害剤、抗癌剤、NSAIDS、タンパク質、ペプチド、栄養補給食品、抗肥満薬、コルチコステロイド、エラスターゼ阻害剤、鎮痛薬、抗真菌薬、腫瘍治療薬、制吐薬、鎮痛薬、心血管薬、抗炎症薬、駆虫薬、抗不整脈薬、抗生物質、抗凝血薬、抗うつ薬、抗糖尿病薬、抗てんかん薬、抗ヒスタミン薬、抗高血圧薬、抗ムスカリン薬、抗マイコバクテリア薬、抗腫瘍薬、免疫抑制剤、抗甲状腺薬、抗ウイルス薬、抗不安薬、鎮静薬、収斂薬、ベータアドレナリン受容体遮断薬、血液製品および代替物、強心薬、造影剤、鎮咳薬、診断薬、診断用造影剤、利尿薬、ドパミン作動薬、止血薬、免疫薬、脂質調節薬、筋弛緩薬、副交感神経作動薬、上皮小体カルシトニンおよびビホスホネート、プロスタグランジン、放射性医薬品、性ホルモン、抗アレルギー薬、興奮薬および食欲抑制薬、交感神経作動薬、甲状腺薬、血管拡張薬、キサンチン、ざ瘡薬、アルファヒドロキシ製剤、嚢胞性線維症治療薬、喘息治療薬、気腫治療薬、呼吸困難症候群治療薬、慢性気管支炎治療薬、慢性閉塞性肺疾患治療薬、臓器移植拒絶治療薬、結核および他の肺の感染の治療薬、および後天性免疫不全症候群に伴う呼吸障害治療薬からなる群より選択される、請求項1から21のいずれか1項記載の組成物。
- 栄養補給食品が、栄養補助食品、ビタミン、ミネラル、薬草、体に医学的または薬学的効果を有するヒーリングフード、葉酸、脂肪酸、果物および野菜の抽出物、ビタミン補助食品、ミネラル補助食品、ホスファチジルセリン、リポ酸、メラトニン、グルコサミン/コンドロイチン、薬用アロエ、グーグル、グルタミン、アミノ酸、緑茶、リコペン、そのままの食物、食品添加物、薬草、植物栄養素、抗酸化剤、果物のフラボノイド成分、マツヨイグサ油、亜麻仁、魚および海獣油、ならびにプロバイオティクスからなる群より選択される、請求項22記載の組成物。
- 活性物質が、アシクロビル、アルプラゾラム、アルトレタミン、アミロライド、アミオダロン、メシル酸ベンズトロピン、ブプロピオン、カベルゴリン、カンデサルタン、セリバスタチン、クロルプロマジン、シプロフロキサシン、シサプリド、クラリスロマイシン、クロニジン、クロピドグレル、シクロベンザプリン、シプロヘプタジン、デラビルジン、デスモプレッシン、ジルチアゼム、ジピリダモール、ドラセトロン、マレイン酸エナラプリル、エナラプリラート、ファモチジン、フェロジピン、フラゾリドン、グリピジド、イルベサルタン、ケトコナゾール、ランソプラゾール、ロラタジン、ロキサピン、メベンダゾール、メルカプトプリン、乳酸ミルリノン、ミノサイクリン、ミトキサントロン、メシル酸ネルフィナビル、ニモジピン、ノルフロキサシン、オランザピン、オメプラゾール、ペンシクロビル、ピモジド、タコリムス、クアゼパム、ラロキシフェン、リファブチン、リファンピン、リスペリドン、リザトリプタン、サキナビル、セルトラリン、シルデナフィル、アセチルスルフイソキサゾール、テマゼパム、チアベンダゾール、チオグアニン、トランドラプリル、トリアムテレン、トリメトレキセート、トログリタゾン、トロバフロキサシン、ベラパミル、硫酸ビンブラスチン、ミコフェノレート、アトバクオン、プログアニル、セフタジジム、セフロキシム、エトポシド、テルビナフィン、サリドマイド、フルコナゾール、アムサクリン、ダカルバジン、テニポシド、およびアセチルサリチル酸塩からなる群より選択される、請求項1から21のいずれか1項記載の組成物。
- 活性物質が、鎮痛薬、ケトプロフェン、およびナプロキセンからなる群より選択される、請求項1から22のいずれか1項記載の組成物。
- 少なくとも2つの表面安定剤を含む、請求項1から25のいずれか1項記載の組成物。
- 表面安定剤が、イオン性表面安定剤、アニオン性表面安定剤、カチオン性表面安定剤、非イオン性表面安定剤、および両性イオン性表面安定剤からなる群より選択される、請求項1から26のいずれか1項記載の組成物。
- 少なくとの1つの表面安定剤が、塩化セチルピリジニウム、ゼラチン、カゼイン、ホスファチド、デキストラン、グリセロール、アラビアゴム、コレステロール、トラガカント、ステアリン酸、塩化ベンザルコニウム、ステアリン酸カルシウム、モノステアリン酸グリセロール、セトステアリルアルコール、セトマクロゴール乳化ワックス、ソルビタンエステル、ポリオキシエチレンアルキルエーテル、ポリオキシエチレンひまし油誘導体、ポリオキシエチレンソルビタン脂肪酸エステル、ポリエチレングリコール、ドデシルトリメチルアンモニウムブロミド、ポリオキシエチレンステアレート、コロイド二酸化ケイ素、リン酸塩、ドデシル硫酸ナトリウム、カルボキシメチルセルロースカルシウム、ヒドロキシプロピルセルロース、ヒプロメロース(hypromellose)、カルボキシメチルセルロースナトリウム、メチルセルロース、ヒドロキシエチルセルロース、ヒプロメロースフタレート、非結晶セルロース、ケイ酸マグネシウムアルミニウム、トリエタノールアミン、ポリビニルアルコール、ポリビニルピロリドン、エチレンオキシドおよびホルムアルデヒドとの4-(1,1,3,3-テトラメチルブチル)フェノールポリマー、ポロキサマー、ポロキサミン、荷電したリン脂質、スルホコハク酸ジオクチル、スルホコハク酸ナトリウムのジアルキルエステル、ラウリル硫酸ナトリウム、アルキルアリールポリエーテルスルホネート、ステアリン酸スクロースおよびジステアリン酸スクロースの混合物、p-イソノニルフェノキシポリ-(グリシドール)、デカノイル-N-メチルグルカミド;n-デシルβ-D-グルコピラノシド;n-デシルβ-D-マルトピラノシド;n-ドデシルβ-D-グルコピラノシド;n-ドデシルβ-D-マルトシド;ヘプタノイル-N-メチルグルカミド;n-ヘプチル-β-D-グルコピラノシド;n-ヘプチルβ-D-チオグルコシド;n-ヘキシルβ-D-グルコピラノシド;ノナノイル-N-メチルグルカミド;n-ノイルβ-D-グルコピラノシド;オクタノイル-N-メチルグルカミド;n-オクチル-β-D-グルコピラノシド;オクチルβ-D-チオグルコピラノシド;リゾチーム、PEG-リン脂質、PEG-コレステロール、PEG-コレステロール誘導体、PEG-ビタミンA、ならびに酢酸ビニルおよびビニルピロリドンのランダムコポリマーからなる群より選択される、請求項1から27のいずれか1項記載の組成物。
- 少なくとも1つのカチオン性表面安定剤が、ポリマー、生体高分子、多糖、セルロース誘導体、アルギン酸塩、非高分子化合物、リン脂質、カチオン性脂質、ポリメチルメタクリレートトリメチルアンモニウムブロミド、スルホニウム化合物、ポリビニルピロリドン-2-ジメチルアミノエチルメタクリレートジメチル硫酸、ヘキサデシルトリメチルアンモニウムブロミド、ホスホニウム化合物、第4アンモニウム化合物、ベンジル-ジ(2-クロロエチル)エチルアンモニウムブロミド、ヤシトリメチルアンモニウムクロリド、ヤシトリメチルアンモニウムブロミド、ヤシメチルジヒドロキシエチルアンモニウムクロリド、ヤシメチルジヒドロキシエチルアンモニウムブロミド、デシルトリエチルアンモニウムクロリド、デシルジメチルヒドロキシエチルアンモニウムクロリド、デシルジメチルヒドロキシエチルアンモニウムクロリドブロミド、C12-15ジメチルヒドロキシエチルアンモニウムクロリド、C12-15ジメチルヒドロキシエチルアンモニウムクロリドブロミド、ヤシジメチルヒドロキシエチルアンモニウムクロリド、ヤシジメチルヒドロキシエチルアンモニウムブロミド、ミリスチルトリメチルアンモニウムメチルスルフェート、ラウリルジメチルベンジルアンモニウムクロリド、ラウリルジメチルベンジルアンモニウムブロミド、ラウリルジメチル(エテノキシ)4アンモニウムクロリド、ラウリルジメチル(エテノキシ)4アンモニウムブロミド、N-アルキル(C12-18)ジメチルベンジルアンモニウムクロリド、N-アルキル(C14-18)ジメチルベンジルアンモニウムクロリド、N-テトラデシリドメチルベンジルアンモニウムクロリド一水和物、ジメチルジデシルアンモニウムクロリド、N-アルキルおよび(C12-14)ジメチル1-ナフチルメチルアンモニウムクロリド、トリメチルアンモニウムハロゲン化物、アルキル-トリメチルアンモニウム塩、ジアルキルジメチルアンモニウム塩、ラウリルトリメチルアンモニウムクロリド、エトキシル化アルキルアミドアルキルジアルキルアンモニウム塩、エトキシル化トリアルキルアンモニウム塩、ジアルキルベンゼンジアルキルアンモニウムクロリド、N-ジデシルジメチルアンモニウムクロリド、N-テトラデシルジメチルベンジルアンモニウムクロリド一水和物、N-アルキル(C12-14)ジメチル1-ナフチルメチルアンモニウムクロリド、ドデシルジメチルベンジルアンモニウムクロリド、ジアルキルベンゼンアルキルアンモニウムクロリド、ラウリルトリメチルアンモニウムクロリド、アルキルベンジルメチルアンモニウムクロリド、アルキルベンジルジメチルアンモニウムブロミド、C12トリメチルアンモニウムブロミド、C15トリメチルアンモニウムブロミド、C17トリメチルアンモニウムブロミド、ドデシルベンジルトリエチルアンモニウムクロリド、ポリ-ジアリルジメチルアンモニウムクロリド(DADMAC)、ジメチルアンモニウムクロリド、アルキルジメチルアンモニウムハロゲン化物、トリセチルメチルアンモニウムクロリド、デシルトリメチルアンモニウムブロミド、ドデシルトリエチルアンモニウムブロミド、テトラデシルトリメチルアンモニウムブロミド、メチルトリオクチルアンモニウムクロリド、POLYQUAT 10(商標)、テトラブチルアンモニウムブロミド、ベンジルトリメチルアンモニウムブロミド、コリンエステル、塩化ベンザルコニウム、ステアルアルコニウムクロリド化合物、セチルピリジニウムブロミド、セチルピリジニウムクロリド、第4ポリオキシエチルアルキルアミンのハロゲン化物塩、MIRAPOL(商標)、ALKAQUAT(商標)、アルキルピリジニウム塩;アミン、アミン塩、アミンオキシド、イミドアゾリニウム塩、プロトン化第4アクリルアミド、メチル化第4ポリマー、およびカチオングアールからなる群より選択される、請求項27記載の組成物。
- 組成物が生物付着性(bioadhesive)である、請求項27または29記載の組成物。
- 活性物質のTmaxが、投与後に哺乳類被験体の血漿においてアッセイした場合、同じ薬物の非ナノパーティクル剤形を同じ投与量で投与した場合のTmaxよりも小さい、請求項1から30のいずれか1項記載の組成物。
- Tmaxが、同じ投与量で投与した同じ薬物の非ナノパーティクル製剤が示すTmaxの約90%以下、約80%以下、約70%以下、約60%以下、約50%以下、約30%以下、約25%以下、約20%以下、約15%以下、および約10%以下からなる群より選択される、請求項31記載の組成物。
- 活性物質のCmaxが、投与後に哺乳類被験体の血漿においてアッセイした場合、同じ薬物の非ナノパーティクル剤形を同じ投与量で投与した場合のCmaxよりも大きい、請求項1から32のいずれか1項記載の組成物。
- Cmaxが、同じ投与量で投与した同じ薬物の非ナノパーティクル製剤が示すCmaxよりも、少なくとも約10%大きい、少なくとも約20%大きい、少なくとも約30%大きい、少なくとも約40%大きい、少なくとも約50%大きい、少なくとも約60%大きい、少なくとも約70%大きい、少なくとも約80%大きい、少なくとも約90%大きい、および少なくとも約100%大きいからなる群より選択される、請求項33記載の組成物。
- 活性物質のAUCが、投与後に哺乳類被験体の血漿においてアッセイした場合、同じ薬物の従来の非ナノパーティクル剤形を同じ投与量で投与した場合のAUCよりも大きい、請求項1から34のいずれか1項記載の組成物。
- AUCが、同じ投与量で投与した同じ薬物の非ナノパーティクル製剤が示すAUCよりも、少なくとも約10%大きい、少なくとも約20%大きい、少なくとも約30%大きい、少なくとも約40%大きい、少なくとも約50%大きい、少なくとも約60%大きい、少なくとも約70%大きい、少なくとも約80%大きい、少なくとも約90%大きい、および少なくとも約100%大きいからなる群より選択される、請求項35記載の組成物。
- 満腹状態で投与した場合に、空腹状態で投与した場合と比較して、吸収レベルが顕著に異ならない、請求項1から36のいずれか1項記載の組成物。
- 本発明の活性物質組成物を満腹状態で投与した場合の、空腹状態で投与した場合に対する吸収の差異が、約100%未満、約90%未満、約80%未満、約70%未満、約60%未満、約50%未満、約40%未満、約30%未満、約25%未満、約20%未満、約15%未満、約10%未満、約5%未満、および約3%未満からなる群より選択される、請求項37記載の組成物。
- ヒトに投与される場合、空腹状態の被験体への組成物の投与が、満腹状態の被験体への組成物の投与と生物学的に同等である、請求項1から38のいずれか1項記載の組成物。
- ヒトに投与される場合の「生物学的な同等」が、CmaxおよびAUCの両方に対して0.80と1.25の間の90%信頼区間により確立される、請求項39記載の組成物。
- ヒトに投与される場合の「生物学的な同等」が、AUCに対して0.80と1.25の間の90% 信頼区間、およびCmaxに対して0.70と1.43の間の90%信頼区間により確立される、請求項39記載の組成物。
- 投与された際に、活性物質粒子が、約2000nm未満、約1900nm未満、約1800nm未満、約1700nm未満、約1600nm未満、約1500nm未満、約1400nm未満、約1300nm未満、約1200nm未満、約1100nm未満、約1000nm未満、約900nm未満、約800nm未満、約700nm未満、約600nm未満、約500nm未満、約400nm未満、約300nm未満、約250nm未満、約200nm未満、約150nm未満、約100nm未満、約75nm未満、および約50nm未満からなる群より選択される有効平均粒径を有するように組成物が再分散する、請求項1から41のいずれか1項記載の組成物。
- 活性物質粒子が、約2ミクロン未満、約1900nm未満、約1800nm未満、約1700nm未満、約1600nm未満、約1500nm未満、約1400nm未満、約1300nm未満、約1200nm未満、約1100nm未満、約1000nm未満、約900nm未満、約800nm未満、約700nm未満、約600nm未満、約500nm未満、約400nm未満、約300nm未満、約250nm未満、約200nm未満、約150nm未満、約100nm未満、約75nm未満、および約50nm未満からなる群より選択される有効平均粒径を有するように、組成物が生体関連媒体中に再分散する、請求項1から42のいずれか1項記載の組成物。
- 請求項1から43のいずれか1項記載の固体または半固体ゼラチン組成物を製造する方法であって、
(a) (i) 少なくとも1つの活性物質および少なくとも1つの表面安定剤を含むナノパーティクル活性物質組成物で、活性物質が約2000nm未満の有効平均粒径を有するもの、および
(ii) 固体または半固体剤形中に過剰な水を保持するのに十分なゲル化を示し、ナノパーティクル活性物質組成物を取り囲む固体または半固体剤形マトリックスを形成する、少なくとも1つのゲル形成物質
を混合すること;および
(b) 前記少なくとも1つの活性物質を可溶化する過程を含まずに、固体の投与製剤を形成すること
を含む方法。 - 被験体に有効量の請求項1から43のいずれか1項記載のゼラチン組成物を投与することを含む被験体を治療する方法であって、上記組成物が、
(a) 剤形に加える前に約2000nm未満の有効平均粒径を有する少なくとも1つの活性物質;
(b) 少なくとも1つの表面安定剤;および
(c) 固体または半固体状態に過剰な水を保持するのに十分なゲル化を示す、少なくとも1つのゲル形成物質
を含む方法。 - 投与時に被験体が空腹である、請求項45記載の方法。
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WO2002098565A1 (en) | 2001-06-05 | 2002-12-12 | Elan Pharma International Limited | System and method for milling materials |
US6949256B2 (en) * | 2002-01-18 | 2005-09-27 | Banner Pharmacaps, Inc. | Non-gelatin capsule shell formulation |
DE10244504A1 (de) | 2002-09-25 | 2004-04-08 | Capsulution Nanoscience Ag | Schnellfreisetzende Darreichungsform mit schwerlöslichem Wirkstoff |
US20060088590A1 (en) * | 2004-10-22 | 2006-04-27 | Banner Pharmacaps, Inc. | Non-blooming gelatin and non-gelatin formulations |
WO2007050975A2 (en) * | 2005-10-26 | 2007-05-03 | Banner Pharmacaps, Inc. | Hydrophilic vehicle-based dual controlled release matrix system as capsule fill |
US20070148248A1 (en) * | 2005-12-22 | 2007-06-28 | Banner Pharmacaps, Inc. | Gastric reflux resistant dosage forms |
-
2003
- 2003-09-11 AT AT03816299T patent/ATE487470T1/de active
- 2003-09-11 DE DE60334924T patent/DE60334924D1/de not_active Expired - Lifetime
- 2003-09-11 CA CA2498207A patent/CA2498207C/en not_active Expired - Fee Related
- 2003-09-11 PT PT03816299T patent/PT1553927E/pt unknown
- 2003-09-11 SI SI200331901T patent/SI1553927T1/sl unknown
- 2003-09-11 US US10/659,706 patent/US7713551B2/en active Active
- 2003-09-11 DK DK03816299.6T patent/DK1553927T3/da active
- 2003-09-11 WO PCT/US2003/028380 patent/WO2005000265A2/en active Application Filing
- 2003-09-11 AU AU2003304237A patent/AU2003304237A1/en not_active Abandoned
- 2003-09-11 JP JP2005503259A patent/JP4878839B2/ja not_active Expired - Fee Related
- 2003-09-11 EP EP03816299A patent/EP1553927B9/en not_active Expired - Lifetime
- 2003-09-11 ES ES03816299T patent/ES2355723T3/es not_active Expired - Lifetime
-
2010
- 2010-11-26 CY CY20101101084T patent/CY1110949T1/el unknown
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2008260708A (ja) * | 2007-04-11 | 2008-10-30 | Ohkura Pharmaceutical Co Ltd | ベンズイソキサゾール誘導体の経口ゼリー状医薬組成物 |
JP2017019847A (ja) * | 2010-04-14 | 2017-01-26 | アヤンダ グループ エーエス | 経口医薬分散組成物 |
US10966926B2 (en) | 2010-04-14 | 2021-04-06 | Vitux Group As | Oral pharmaceutical dispersion compositions |
JP2014510778A (ja) * | 2011-04-11 | 2014-05-01 | アヤンダ グループ エーエス | 経口医薬分散組成物 |
WO2013035423A1 (ja) * | 2011-09-09 | 2013-03-14 | 東洋カプセル株式会社 | カンデサルタンシレキセチル含有医薬組成物 |
JPWO2013035423A1 (ja) * | 2011-09-09 | 2015-03-23 | 東洋カプセル株式会社 | カンデサルタンシレキセチル含有医薬組成物 |
WO2016108507A3 (ko) * | 2014-12-31 | 2016-08-25 | 건일제약 주식회사 | 멜라토닌 및 설트랄린을 포함하는 경구용 복합정제 |
Also Published As
Publication number | Publication date |
---|---|
AU2003304237A8 (en) | 2005-01-13 |
CA2498207C (en) | 2012-03-13 |
EP1553927B1 (en) | 2010-11-10 |
US20050031691A1 (en) | 2005-02-10 |
US7713551B2 (en) | 2010-05-11 |
EP1553927A2 (en) | 2005-07-20 |
PT1553927E (pt) | 2010-11-22 |
DE60334924D1 (de) | 2010-12-23 |
SI1553927T1 (sl) | 2010-12-31 |
WO2005000265A2 (en) | 2005-01-06 |
AU2003304237A1 (en) | 2005-01-13 |
ATE487470T1 (de) | 2010-11-15 |
WO2005000265A3 (en) | 2005-05-12 |
EP1553927B9 (en) | 2011-09-21 |
ES2355723T3 (es) | 2011-03-30 |
DK1553927T3 (da) | 2011-01-31 |
CY1110949T1 (el) | 2015-06-10 |
JP4878839B2 (ja) | 2012-02-15 |
CA2498207A1 (en) | 2005-01-06 |
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