JP4647893B2 - 非水性結腸下剤処方物 - Google Patents
非水性結腸下剤処方物 Download PDFInfo
- Publication number
- JP4647893B2 JP4647893B2 JP2003297910A JP2003297910A JP4647893B2 JP 4647893 B2 JP4647893 B2 JP 4647893B2 JP 2003297910 A JP2003297910 A JP 2003297910A JP 2003297910 A JP2003297910 A JP 2003297910A JP 4647893 B2 JP4647893 B2 JP 4647893B2
- Authority
- JP
- Japan
- Prior art keywords
- laxative
- phosphate
- magnesium
- kit
- salt
- 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.)
- Expired - Lifetime
Links
- 239000000203 mixture Substances 0.000 title claims description 126
- 230000002475 laxative effect Effects 0.000 title claims description 80
- 239000008141 laxative Substances 0.000 title claims description 69
- 238000009472 formulation Methods 0.000 title claims description 48
- 230000000112 colonic effect Effects 0.000 title description 13
- 150000003839 salts Chemical class 0.000 claims description 51
- MHJAJDCZWVHCPF-UHFFFAOYSA-L dimagnesium phosphate Chemical compound [Mg+2].OP([O-])([O-])=O MHJAJDCZWVHCPF-UHFFFAOYSA-L 0.000 claims description 27
- 229940075110 dibasic magnesium phosphate Drugs 0.000 claims description 21
- 230000037396 body weight Effects 0.000 claims description 19
- 238000000034 method Methods 0.000 claims description 19
- 239000011777 magnesium Substances 0.000 claims description 18
- QQFLQYOOQVLGTQ-UHFFFAOYSA-L magnesium;dihydrogen phosphate Chemical compound [Mg+2].OP(O)([O-])=O.OP(O)([O-])=O QQFLQYOOQVLGTQ-UHFFFAOYSA-L 0.000 claims description 14
- 239000002270 dispersing agent Substances 0.000 claims description 11
- 230000001939 inductive effect Effects 0.000 claims description 11
- 239000011230 binding agent Substances 0.000 claims description 10
- 229940035053 monobasic magnesium phosphate Drugs 0.000 claims description 10
- 239000000872 buffer Substances 0.000 claims description 7
- 239000011734 sodium Substances 0.000 claims description 7
- 229940095060 magnesium tartrate Drugs 0.000 claims description 6
- MUZDLCBWNVUYIR-ZVGUSBNCSA-L magnesium;(2r,3r)-2,3-dihydroxybutanedioate Chemical compound [Mg+2].[O-]C(=O)[C@H](O)[C@@H](O)C([O-])=O MUZDLCBWNVUYIR-ZVGUSBNCSA-L 0.000 claims description 6
- AVTYONGGKAJVTE-OLXYHTOASA-L potassium L-tartrate Chemical compound [K+].[K+].[O-]C(=O)[C@H](O)[C@@H](O)C([O-])=O AVTYONGGKAJVTE-OLXYHTOASA-L 0.000 claims description 6
- 239000001472 potassium tartrate Substances 0.000 claims description 6
- 229940111695 potassium tartrate Drugs 0.000 claims description 6
- 235000011005 potassium tartrates Nutrition 0.000 claims description 6
- 239000001433 sodium tartrate Substances 0.000 claims description 6
- 229960002167 sodium tartrate Drugs 0.000 claims description 6
- 235000011004 sodium tartrates Nutrition 0.000 claims description 6
- 239000013061 administrable dose form Substances 0.000 claims description 5
- 229910052749 magnesium Inorganic materials 0.000 claims description 5
- 239000007903 gelatin capsule Substances 0.000 claims description 2
- HELHAJAZNSDZJO-OLXYHTOASA-L sodium L-tartrate Chemical compound [Na+].[Na+].[O-]C(=O)[C@H](O)[C@@H](O)C([O-])=O HELHAJAZNSDZJO-OLXYHTOASA-L 0.000 claims description 2
- 235000002639 sodium chloride Nutrition 0.000 description 54
- 229910019142 PO4 Inorganic materials 0.000 description 19
- 235000021317 phosphate Nutrition 0.000 description 19
- 238000002360 preparation method Methods 0.000 description 19
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 19
- 150000001875 compounds Chemical class 0.000 description 18
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 15
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 14
- 210000001072 colon Anatomy 0.000 description 14
- GVALZJMUIHGIMD-UHFFFAOYSA-H magnesium phosphate Chemical compound [Mg+2].[Mg+2].[Mg+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O GVALZJMUIHGIMD-UHFFFAOYSA-H 0.000 description 14
- 239000010452 phosphate Substances 0.000 description 14
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 12
- 230000000694 effects Effects 0.000 description 12
- 241000792859 Enema Species 0.000 description 11
- 239000007920 enema Substances 0.000 description 11
- 239000002202 Polyethylene glycol Substances 0.000 description 10
- 229920001223 polyethylene glycol Polymers 0.000 description 10
- 239000007864 aqueous solution Substances 0.000 description 9
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 9
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical class OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 8
- 239000011780 sodium chloride Substances 0.000 description 8
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 7
- PMZURENOXWZQFD-UHFFFAOYSA-L Sodium Sulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 description 7
- 239000002775 capsule Substances 0.000 description 7
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 7
- 239000008108 microcrystalline cellulose Substances 0.000 description 7
- 229940016286 microcrystalline cellulose Drugs 0.000 description 7
- 230000003204 osmotic effect Effects 0.000 description 7
- 150000003013 phosphoric acid derivatives Chemical class 0.000 description 7
- 239000000243 solution Substances 0.000 description 7
- 235000019640 taste Nutrition 0.000 description 7
- 239000004135 Bone phosphate Substances 0.000 description 6
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 6
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 6
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 description 6
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical class OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 6
- 239000003792 electrolyte Substances 0.000 description 6
- 229940079360 enema for constipation Drugs 0.000 description 6
- KJFMBFZCATUALV-UHFFFAOYSA-N phenolphthalein Chemical compound C1=CC(O)=CC=C1C1(C=2C=CC(O)=CC=2)C2=CC=CC=C2C(=O)O1 KJFMBFZCATUALV-UHFFFAOYSA-N 0.000 description 6
- -1 phosphate anion Chemical class 0.000 description 6
- 239000001103 potassium chloride Substances 0.000 description 6
- 235000011164 potassium chloride Nutrition 0.000 description 6
- 239000001488 sodium phosphate Substances 0.000 description 6
- 229910000162 sodium phosphate Inorganic materials 0.000 description 6
- 235000011008 sodium phosphates Nutrition 0.000 description 6
- 229910052938 sodium sulfate Inorganic materials 0.000 description 6
- 235000011152 sodium sulphate Nutrition 0.000 description 6
- 239000000126 substance Substances 0.000 description 6
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 5
- 230000008901 benefit Effects 0.000 description 5
- 229940095399 enema Drugs 0.000 description 5
- 230000002496 gastric effect Effects 0.000 description 5
- 210000000936 intestine Anatomy 0.000 description 5
- 239000000600 sorbitol Substances 0.000 description 5
- 229960002920 sorbitol Drugs 0.000 description 5
- 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 description 4
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 4
- 239000001768 carboxy methyl cellulose Substances 0.000 description 4
- 239000012530 fluid Substances 0.000 description 4
- 230000001965 increasing effect Effects 0.000 description 4
- 239000007788 liquid Substances 0.000 description 4
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 description 4
- 239000001095 magnesium carbonate Substances 0.000 description 4
- 229910000021 magnesium carbonate Inorganic materials 0.000 description 4
- 239000004337 magnesium citrate Substances 0.000 description 4
- 229960005336 magnesium citrate Drugs 0.000 description 4
- 235000002538 magnesium citrate Nutrition 0.000 description 4
- 229910000401 monomagnesium phosphate Inorganic materials 0.000 description 4
- 235000019785 monomagnesium phosphate Nutrition 0.000 description 4
- 239000002736 nonionic surfactant Substances 0.000 description 4
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 4
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 4
- PVGBHEUCHKGFQP-UHFFFAOYSA-N sodium;n-[5-amino-2-(4-aminophenyl)sulfonylphenyl]sulfonylacetamide Chemical compound [Na+].CC(=O)NS(=O)(=O)C1=CC(N)=CC=C1S(=O)(=O)C1=CC=C(N)C=C1 PVGBHEUCHKGFQP-UHFFFAOYSA-N 0.000 description 4
- PLSARIKBYIPYPF-UHFFFAOYSA-H trimagnesium dicitrate Chemical compound [Mg+2].[Mg+2].[Mg+2].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O.[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O PLSARIKBYIPYPF-UHFFFAOYSA-H 0.000 description 4
- CDOUZKKFHVEKRI-UHFFFAOYSA-N 3-bromo-n-[(prop-2-enoylamino)methyl]propanamide Chemical compound BrCCC(=O)NCNC(=O)C=C CDOUZKKFHVEKRI-UHFFFAOYSA-N 0.000 description 3
- 241001116389 Aloe Species 0.000 description 3
- KHOITXIGCFIULA-UHFFFAOYSA-N Alophen Chemical compound C1=CC(OC(=O)C)=CC=C1C(C=1N=CC=CC=1)C1=CC=C(OC(C)=O)C=C1 KHOITXIGCFIULA-UHFFFAOYSA-N 0.000 description 3
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 3
- 239000010369 Cascara Substances 0.000 description 3
- 235000006693 Cassia laevigata Nutrition 0.000 description 3
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 3
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical class OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 3
- 241000556215 Frangula purshiana Species 0.000 description 3
- JLVVSXFLKOJNIY-UHFFFAOYSA-N Magnesium ion Chemical compound [Mg+2] JLVVSXFLKOJNIY-UHFFFAOYSA-N 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 3
- 241000522641 Senna Species 0.000 description 3
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Chemical class [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 description 3
- 239000000853 adhesive Substances 0.000 description 3
- 230000001070 adhesive effect Effects 0.000 description 3
- 235000011399 aloe vera Nutrition 0.000 description 3
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 description 3
- 229960004977 anhydrous lactose Drugs 0.000 description 3
- 229960000503 bisacodyl Drugs 0.000 description 3
- 229910000019 calcium carbonate Inorganic materials 0.000 description 3
- DWKPZOZZBLWFJX-UHFFFAOYSA-L calcium;1,4-bis(2-ethylhexoxy)-1,4-dioxobutane-2-sulfonate Chemical compound [Ca+2].CCCCC(CC)COC(=O)CC(S([O-])(=O)=O)C(=O)OCC(CC)CCCC.CCCCC(CC)COC(=O)CC(S([O-])(=O)=O)C(=O)OCC(CC)CCCC DWKPZOZZBLWFJX-UHFFFAOYSA-L 0.000 description 3
- 229940071704 cascara sagrada Drugs 0.000 description 3
- 239000004359 castor oil Substances 0.000 description 3
- 235000019438 castor oil Nutrition 0.000 description 3
- 229960001777 castor oil Drugs 0.000 description 3
- 230000008859 change Effects 0.000 description 3
- QBPFLULOKWLNNW-UHFFFAOYSA-N chrysazin Chemical compound O=C1C2=CC=CC(O)=C2C(=O)C2=C1C=CC=C2O QBPFLULOKWLNNW-UHFFFAOYSA-N 0.000 description 3
- 150000001860 citric acid derivatives Chemical class 0.000 description 3
- 238000002052 colonoscopy Methods 0.000 description 3
- 229960001577 dantron Drugs 0.000 description 3
- 229940061607 dibasic sodium phosphate Drugs 0.000 description 3
- 235000019329 dioctyl sodium sulphosuccinate Nutrition 0.000 description 3
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 3
- 239000002552 dosage form Substances 0.000 description 3
- 230000009977 dual effect Effects 0.000 description 3
- 230000037406 food intake Effects 0.000 description 3
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 3
- UOVKYUCEFPSRIJ-UHFFFAOYSA-D hexamagnesium;tetracarbonate;dihydroxide;pentahydrate Chemical compound O.O.O.O.O.[OH-].[OH-].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[Mg+2].[O-]C([O-])=O.[O-]C([O-])=O.[O-]C([O-])=O.[O-]C([O-])=O UOVKYUCEFPSRIJ-UHFFFAOYSA-D 0.000 description 3
- 239000004615 ingredient Substances 0.000 description 3
- 230000000968 intestinal effect Effects 0.000 description 3
- 229940031958 magnesium carbonate hydroxide Drugs 0.000 description 3
- 229940096405 magnesium cation Drugs 0.000 description 3
- VTHJTEIRLNZDEV-UHFFFAOYSA-L magnesium dihydroxide Chemical compound [OH-].[OH-].[Mg+2] VTHJTEIRLNZDEV-UHFFFAOYSA-L 0.000 description 3
- 239000000347 magnesium hydroxide Substances 0.000 description 3
- 229910001862 magnesium hydroxide Inorganic materials 0.000 description 3
- OVGXLJDWSLQDRT-UHFFFAOYSA-L magnesium lactate Chemical compound [Mg+2].CC(O)C([O-])=O.CC(O)C([O-])=O OVGXLJDWSLQDRT-UHFFFAOYSA-L 0.000 description 3
- 239000000626 magnesium lactate Substances 0.000 description 3
- 235000015229 magnesium lactate Nutrition 0.000 description 3
- 229960004658 magnesium lactate Drugs 0.000 description 3
- 159000000003 magnesium salts Chemical class 0.000 description 3
- 229920000609 methyl cellulose Polymers 0.000 description 3
- 239000001923 methylcellulose Substances 0.000 description 3
- 235000010981 methylcellulose Nutrition 0.000 description 3
- 229940045641 monobasic sodium phosphate Drugs 0.000 description 3
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 3
- 235000019799 monosodium phosphate Nutrition 0.000 description 3
- 230000004899 motility Effects 0.000 description 3
- 229940124513 senna glycoside Drugs 0.000 description 3
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 3
- 159000000000 sodium salts Chemical class 0.000 description 3
- 238000001356 surgical procedure Methods 0.000 description 3
- 230000002195 synergetic effect Effects 0.000 description 3
- 239000011975 tartaric acid Chemical class 0.000 description 3
- 235000002906 tartaric acid Nutrition 0.000 description 3
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 2
- CSNNHWWHGAXBCP-UHFFFAOYSA-L Magnesium sulfate Chemical compound [Mg+2].[O-][S+2]([O-])([O-])[O-] CSNNHWWHGAXBCP-UHFFFAOYSA-L 0.000 description 2
- 235000003421 Plantago ovata Nutrition 0.000 description 2
- 239000009223 Psyllium Substances 0.000 description 2
- 206010047700 Vomiting Diseases 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 239000000654 additive Substances 0.000 description 2
- 239000002671 adjuvant Substances 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000002405 diagnostic procedure Methods 0.000 description 2
- 229910000395 dimagnesium phosphate Inorganic materials 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 230000008030 elimination Effects 0.000 description 2
- 238000003379 elimination reaction Methods 0.000 description 2
- 239000007789 gas Substances 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
- 230000000622 irritating effect Effects 0.000 description 2
- 150000003893 lactate salts Chemical class 0.000 description 2
- 229940125722 laxative agent Drugs 0.000 description 2
- 229940091250 magnesium supplement Drugs 0.000 description 2
- 239000002480 mineral oil Substances 0.000 description 2
- 235000010446 mineral oil Nutrition 0.000 description 2
- LJCNRYVRMXRIQR-OLXYHTOASA-L potassium sodium L-tartrate Chemical compound [Na+].[K+].[O-]C(=O)[C@H](O)[C@@H](O)C([O-])=O LJCNRYVRMXRIQR-OLXYHTOASA-L 0.000 description 2
- 229940074439 potassium sodium tartrate Drugs 0.000 description 2
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- 229910052708 sodium Inorganic materials 0.000 description 2
- 235000011006 sodium potassium tartrate Nutrition 0.000 description 2
- 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 description 1
- 241000416162 Astragalus gummifer Species 0.000 description 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 1
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- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 description 1
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- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
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- 235000021311 artificial sweeteners Nutrition 0.000 description 1
- DKUUCFOULZBTQY-UHFFFAOYSA-N benzylbenzene hydrate Chemical compound C(C1=CC=CC=C1)C1=CC=CC=C1.O DKUUCFOULZBTQY-UHFFFAOYSA-N 0.000 description 1
- 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 description 1
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- 229940079356 contact laxatives Drugs 0.000 description 1
- 235000013681 dietary sucrose Nutrition 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
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- 229910012375 magnesium hydride Inorganic materials 0.000 description 1
- 239000004137 magnesium phosphate Substances 0.000 description 1
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- 229910000157 magnesium phosphate Inorganic materials 0.000 description 1
- 235000010994 magnesium phosphates Nutrition 0.000 description 1
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- 230000004048 modification Effects 0.000 description 1
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- 230000008693 nausea Effects 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 239000002357 osmotic agent Substances 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
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- 230000035699 permeability Effects 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 125000002467 phosphate group Chemical group [H]OP(=O)(O[H])O[*] 0.000 description 1
- 239000011574 phosphorus Substances 0.000 description 1
- 229910052698 phosphorus Inorganic materials 0.000 description 1
- 230000035479 physiological effects, processes and functions Effects 0.000 description 1
- 229920001983 poloxamer Polymers 0.000 description 1
- 229920001993 poloxamer 188 Polymers 0.000 description 1
- 229920000570 polyether Polymers 0.000 description 1
- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
- 210000000664 rectum Anatomy 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 210000000813 small intestine Anatomy 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/42—Phosphorus; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
-
- 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
-
- 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
- A61P1/10—Laxatives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Description
いくつかの医学的手順、例えば、結腸鏡検査、レントゲン検査および腸の手術を受ける患者の準備においては、直腸をできるだけ空にすることがしばしば、重要である。例えば、満足なエックス線写真を撮るためには、特に結腸からのガスの除去に関して、腸が十分に洗浄(cleanse)されていることが、しばしば、本質的である。結腸が、手術または診断手順(例えば、結腸鏡検査)のために予備的に準備される場合も条件は同様に適用される。この場合、糞便廃棄物を除去することも必要である。
(a)リン酸、硫酸および酒石酸のマグネシウム塩およびナトリウム塩、ならびにそれらの混合物からなる群から選択される下剤塩の非水性混合物を調製し、下剤処方物を形成する工程;
(b)該下剤処方物の経口投与可能な投薬形態を形成する工程;
(c)患者へ該処方物の下剤有効投薬量を経口投与する工程;および
(d)該投与された投薬量により便通を誘発させる工程、
を包含する患者の結腸の便通を誘発する、方法。
(a)Mg3(PO4)2、MgHPO4、Mg(H2PO4)2、MgSO4、MgCl2、Na2SO4、酒石酸ナトリウム、酒石酸カリウム、酒石酸マグネシウム、およびそれらの混合物からなる群から選択される下剤塩の非水性混合物を調製し、下剤処方物を形成する工程;
(b)該下剤処方物の経口投与可能な投薬形態を形成する工程;
(c)患者へ該処方物の下剤有効投薬量を経口投与する工程;および
(d)該投与された投薬量により便通を誘発させる工程、
を包含する患者の結腸の便通を誘発する、方法。
本発明は、Mg3(PO4)2、MgHPO4、Mg(H2PO4)2、MgSO4、MgCl2、Na2SO4、酒石酸ナトリウム、酒石酸カリウム、酒石酸マグネシウム、およびそれらの混合物からなる群から選択される塩の下剤活性量を含む、安定な非水性錠剤投薬形態の結腸下剤処方物に関する。1つの好ましい実施態様では、投薬処方物は、二塩基性リン酸マグネシウム(MgHPO4)を含む。好ましい実施態様では、この処方物は、有効量の下剤塩(好ましくは、二塩基性リン酸マグネシウム)を、体重1キログラム当たり約0.05〜約2.0グラム含み、この処方物は、錠剤またはカプセル形態で患者に簡便に投与され得る。好ましくは、下剤塩の患者への投薬量は、体重1キログラム当たり約0.1〜約1.2グラムの範囲内のリン酸マグネシウム塩であり、より好ましくは、体重1キログラム当たり約0.2〜0.7グラムの範囲内である。本発明に従う好ましい実施態様では、塩は、リン酸水素マグネシウム(二塩基性リン酸マグネシウム)であるか、またはリン酸水素マグネシウムとリン酸二水素マグネシウム(一塩基性リン酸マグネシウム)との混合物である。
用語「患者」は、本発明の組成物で処置が施される動物、好ましくはヒトを記述するために明細書全体にわたって使用される。特定の動物(例えば、ヒト患者)に対して特異的である状態を処置するために、この用語「患者」は特定の動物を意味する。本発明の記載におけるほとんどの場合では、用語「患者」は、ヒトの患者を意味する。
Claims (9)
- 患者の結腸の便通を誘発する方法における使用のためのキットであって、該キットは、Mg3(PO4)2、MgHPO4、Mg(H2PO4)2、MgSO4、MgCl2、Na2SO4、酒石酸ナトリウム、酒石酸カリウム、酒石酸マグネシウム、およびそれらの混合物からなる群から選択される下剤塩の非水性混合物の2用量を含み、該方法は、以下の工程:
(a)下剤処方物の経口投与可能な投薬形態を形成する工程;
(b)該患者へ2下剤有効用量の該処方物を経口投与する工程;および
(c)該投与された用量により便通を誘発させる工程、
を包含し、該経口投与可能な投薬形態が、ゼラチンカプセルおよび錠剤からなる群から選択される、
キット。 - 工程(a)が、緩衝剤、分散剤およびバインダーからなる群より選択される少なくとも1つのメンバーを前記下剤処方物に添加する工程をさらに含む、請求項1に記載のキット。
- 前記混合物が、二塩基性リン酸マグネシウム、一塩基性リン酸マグネシウム、およびそれらの混合物からなる群から選択される下剤塩を含む、請求項1に記載のキット。
- 前記下剤塩が、体重1キログラム当たり0.2グラム〜体重1キログラム当たり12.0グラムの範囲の量で含まれる二塩基性リン酸マグネシウムである、請求項3に記載のキット。
- 前記下剤塩が、体重1キログラム当たり0.2グラム〜体重1キログラム当たり12.0グラムの範囲の量で含まれる二塩基性リン酸マグネシウムと一塩基性リン酸マグネシウムとの混合物である、請求項3に記載のキット。
- 前記二塩基性リン酸マグネシウムが、体重1キログラム当たり0.2グラム〜体重1キログラム当たり0.7グラムの割合で投与される、請求項4に記載のキット。
- それぞれ2〜12個の錠剤の2用量を含む、請求項1に記載のキット。
- それぞれ4〜10個の錠剤の2用量を含む、請求項1に記載のキット。
- 前記用量が、2〜4時間離れて服用されることを指示する指示書をさらに備える、請求項2に記載のキット。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/829,080 US6162464A (en) | 1997-03-31 | 1997-03-31 | Non-aqueous colonic purgative formulations |
Related Parent Applications (1)
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JP54189598A Division JP3706147B2 (ja) | 1997-03-31 | 1998-03-30 | 非水性結腸下剤処方物 |
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JP2010257326A Division JP2011032291A (ja) | 1997-03-31 | 2010-11-17 | 非水性結腸下剤処方物 |
Publications (2)
Publication Number | Publication Date |
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JP2004043489A JP2004043489A (ja) | 2004-02-12 |
JP4647893B2 true JP4647893B2 (ja) | 2011-03-09 |
Family
ID=25253475
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
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JP54189598A Expired - Lifetime JP3706147B2 (ja) | 1997-03-31 | 1998-03-30 | 非水性結腸下剤処方物 |
JP2003297910A Expired - Lifetime JP4647893B2 (ja) | 1997-03-31 | 2003-08-21 | 非水性結腸下剤処方物 |
JP2010257326A Withdrawn JP2011032291A (ja) | 1997-03-31 | 2010-11-17 | 非水性結腸下剤処方物 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
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JP54189598A Expired - Lifetime JP3706147B2 (ja) | 1997-03-31 | 1998-03-30 | 非水性結腸下剤処方物 |
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JP2010257326A Withdrawn JP2011032291A (ja) | 1997-03-31 | 2010-11-17 | 非水性結腸下剤処方物 |
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US (1) | US6162464A (ja) |
EP (1) | EP0934071A4 (ja) |
JP (3) | JP3706147B2 (ja) |
KR (1) | KR20000016266A (ja) |
CN (1) | CN1225588A (ja) |
AU (1) | AU6591398A (ja) |
CA (1) | CA2256896C (ja) |
EA (1) | EA001443B1 (ja) |
NZ (1) | NZ332998A (ja) |
WO (1) | WO1998043654A1 (ja) |
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- 1998-03-30 EA EA199801086A patent/EA001443B1/ru not_active IP Right Cessation
- 1998-03-30 CA CA002256896A patent/CA2256896C/en not_active Expired - Lifetime
- 1998-03-30 CN CN98800569A patent/CN1225588A/zh active Pending
- 1998-03-30 JP JP54189598A patent/JP3706147B2/ja not_active Expired - Lifetime
- 1998-03-30 NZ NZ332998A patent/NZ332998A/xx not_active IP Right Cessation
- 1998-03-30 WO PCT/US1998/006224 patent/WO1998043654A1/en not_active Application Discontinuation
- 1998-03-30 AU AU65913/98A patent/AU6591398A/en not_active Abandoned
- 1998-03-30 KR KR1019980709839A patent/KR20000016266A/ko not_active Application Discontinuation
- 1998-03-30 EP EP98912121A patent/EP0934071A4/en not_active Withdrawn
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2003
- 2003-08-21 JP JP2003297910A patent/JP4647893B2/ja not_active Expired - Lifetime
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2010
- 2010-11-17 JP JP2010257326A patent/JP2011032291A/ja not_active Withdrawn
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Also Published As
Publication number | Publication date |
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EP0934071A1 (en) | 1999-08-11 |
WO1998043654A1 (en) | 1998-10-08 |
JP2011032291A (ja) | 2011-02-17 |
CA2256896C (en) | 2002-11-19 |
EA001443B1 (ru) | 2001-04-23 |
JP2000500160A (ja) | 2000-01-11 |
CN1225588A (zh) | 1999-08-11 |
JP3706147B2 (ja) | 2005-10-12 |
EA199801086A1 (ru) | 1999-06-24 |
AU6591398A (en) | 1998-10-22 |
US6162464A (en) | 2000-12-19 |
KR20000016266A (ko) | 2000-03-25 |
JP2004043489A (ja) | 2004-02-12 |
NZ332998A (en) | 2000-05-26 |
EP0934071A4 (en) | 2000-07-12 |
CA2256896A1 (en) | 1998-10-08 |
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