ZA200404880B - Pharmaceutical compositions comprising metformine and glibenclamide for the treatment of type-II diabetes mellitus. - Google Patents
Pharmaceutical compositions comprising metformine and glibenclamide for the treatment of type-II diabetes mellitus. Download PDFInfo
- Publication number
- ZA200404880B ZA200404880B ZA200404880A ZA200404880A ZA200404880B ZA 200404880 B ZA200404880 B ZA 200404880B ZA 200404880 A ZA200404880 A ZA 200404880A ZA 200404880 A ZA200404880 A ZA 200404880A ZA 200404880 B ZA200404880 B ZA 200404880B
- Authority
- ZA
- South Africa
- Prior art keywords
- glibenclamide
- metformin
- layer
- pharmaceutical formulations
- formulations according
- Prior art date
Links
- ZNNLBTZKUZBEKO-UHFFFAOYSA-N glyburide Chemical compound COC1=CC=C(Cl)C=C1C(=O)NCCC1=CC=C(S(=O)(=O)NC(=O)NC2CCCCC2)C=C1 ZNNLBTZKUZBEKO-UHFFFAOYSA-N 0.000 title claims description 160
- 229960004580 glibenclamide Drugs 0.000 title claims description 157
- XZWYZXLIPXDOLR-UHFFFAOYSA-N metformin Chemical compound CN(C)C(=N)NC(N)=N XZWYZXLIPXDOLR-UHFFFAOYSA-N 0.000 title claims description 135
- 239000008194 pharmaceutical composition Substances 0.000 title claims description 28
- 238000011282 treatment Methods 0.000 title claims description 10
- 208000001072 type 2 diabetes mellitus Diseases 0.000 title description 5
- 229960003105 metformin Drugs 0.000 claims description 121
- 239000003826 tablet Substances 0.000 claims description 98
- 239000000203 mixture Substances 0.000 claims description 74
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 57
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 49
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 claims description 34
- 238000002360 preparation method Methods 0.000 claims description 33
- 239000007942 layered tablet Substances 0.000 claims description 30
- 239000008119 colloidal silica Substances 0.000 claims description 29
- 239000004480 active ingredient Substances 0.000 claims description 27
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 26
- 235000019359 magnesium stearate Nutrition 0.000 claims description 25
- 239000011734 sodium Substances 0.000 claims description 21
- 239000011777 magnesium Substances 0.000 claims description 20
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 20
- TZBAVQKIEKDGFH-UHFFFAOYSA-N n-[2-(diethylamino)ethyl]-1-benzothiophene-2-carboxamide;hydrochloride Chemical compound [Cl-].C1=CC=C2SC(C(=O)NCC[NH+](CC)CC)=CC2=C1 TZBAVQKIEKDGFH-UHFFFAOYSA-N 0.000 claims description 19
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 17
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 17
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 17
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.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 WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 claims description 14
- 239000004407 iron oxides and hydroxides Substances 0.000 claims description 14
- JEIPFZHSYJVQDO-UHFFFAOYSA-N iron(III) oxide Inorganic materials O=[Fe]O[Fe]=O JEIPFZHSYJVQDO-UHFFFAOYSA-N 0.000 claims description 14
- 229960001021 lactose monohydrate Drugs 0.000 claims description 14
- 239000000377 silicon dioxide Substances 0.000 claims description 14
- 238000009472 formulation Methods 0.000 claims description 13
- 229910002012 Aerosil® Inorganic materials 0.000 claims description 12
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 12
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 12
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 12
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 12
- 239000004094 surface-active agent Substances 0.000 claims description 12
- 239000002270 dispersing agent Substances 0.000 claims description 11
- MOTZDAYCYVMXPC-UHFFFAOYSA-N dodecyl hydrogen sulfate Chemical class CCCCCCCCCCCCOS(O)(=O)=O MOTZDAYCYVMXPC-UHFFFAOYSA-N 0.000 claims description 11
- 229920002785 Croscarmellose sodium Polymers 0.000 claims description 9
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical group [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 9
- 239000004141 Sodium laurylsulphate Substances 0.000 claims description 9
- 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 claims description 9
- 229960005168 croscarmellose Drugs 0.000 claims description 9
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 claims description 9
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 9
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 8
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 8
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 8
- 206010012601 diabetes mellitus Diseases 0.000 claims description 8
- 229960001375 lactose Drugs 0.000 claims description 8
- 239000008101 lactose Substances 0.000 claims description 8
- 150000003839 salts Chemical class 0.000 claims description 8
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 7
- 239000000244 polyoxyethylene sorbitan monooleate Chemical class 0.000 claims description 7
- 229940068968 polysorbate 80 Drugs 0.000 claims description 7
- 229920000053 polysorbate 80 Chemical class 0.000 claims description 7
- 239000000454 talc Substances 0.000 claims description 7
- 229910052623 talc Inorganic materials 0.000 claims description 7
- FLKPEMZONWLCSK-UHFFFAOYSA-N diethyl phthalate Chemical compound CCOC(=O)C1=CC=CC=C1C(=O)OCC FLKPEMZONWLCSK-UHFFFAOYSA-N 0.000 claims description 6
- 229920002472 Starch Polymers 0.000 claims description 5
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 5
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 5
- 239000008107 starch Substances 0.000 claims description 5
- 235000019698 starch Nutrition 0.000 claims description 5
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical group OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 4
- 239000001828 Gelatine Substances 0.000 claims description 4
- 235000010980 cellulose Nutrition 0.000 claims description 4
- 229920002678 cellulose Polymers 0.000 claims description 4
- 239000001913 cellulose Substances 0.000 claims description 4
- 229920000159 gelatin Polymers 0.000 claims description 4
- 235000019322 gelatine Nutrition 0.000 claims description 4
- 235000011187 glycerol Nutrition 0.000 claims description 4
- 229960003511 macrogol Drugs 0.000 claims description 4
- 239000011248 coating agent Substances 0.000 claims description 2
- 238000000576 coating method Methods 0.000 claims description 2
- 150000004682 monohydrates Chemical class 0.000 claims description 2
- 229920001223 polyethylene glycol Polymers 0.000 claims description 2
- 229910021653 sulphate ion Inorganic materials 0.000 claims description 2
- 229910002016 Aerosil® 200 Inorganic materials 0.000 claims 4
- 229920003084 Avicel® PH-102 Polymers 0.000 claims 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 2
- 241000206607 Porphyra umbilicalis Species 0.000 claims 2
- 229910052708 sodium Inorganic materials 0.000 claims 2
- BPQQTUXANYXVAA-UHFFFAOYSA-N Orthosilicate Chemical compound [O-][Si]([O-])([O-])[O-] BPQQTUXANYXVAA-UHFFFAOYSA-N 0.000 claims 1
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 claims 1
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 claims 1
- 238000004090 dissolution Methods 0.000 description 23
- 238000000034 method Methods 0.000 description 12
- 239000003814 drug Substances 0.000 description 11
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Substances N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 11
- 229940079593 drug Drugs 0.000 description 10
- OETHQSJEHLVLGH-UHFFFAOYSA-N metformin hydrochloride Chemical compound Cl.CN(C)C(=N)N=C(N)N OETHQSJEHLVLGH-UHFFFAOYSA-N 0.000 description 10
- 239000000243 solution Substances 0.000 description 10
- 239000008187 granular material Substances 0.000 description 9
- 238000002474 experimental method Methods 0.000 description 8
- 229920002261 Corn starch Polymers 0.000 description 7
- 239000008120 corn starch Substances 0.000 description 7
- 238000005469 granulation Methods 0.000 description 7
- 230000003179 granulation Effects 0.000 description 7
- 238000002156 mixing Methods 0.000 description 7
- 229940123208 Biguanide Drugs 0.000 description 6
- 150000004283 biguanides Chemical class 0.000 description 6
- 238000007906 compression Methods 0.000 description 6
- 230000006835 compression Effects 0.000 description 6
- 229940125396 insulin Drugs 0.000 description 6
- 238000004519 manufacturing process Methods 0.000 description 6
- 102000004877 Insulin Human genes 0.000 description 5
- 108090001061 Insulin Proteins 0.000 description 5
- 210000004027 cell Anatomy 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 229960004329 metformin hydrochloride Drugs 0.000 description 5
- 230000009467 reduction Effects 0.000 description 5
- 238000010521 absorption reaction Methods 0.000 description 4
- 238000004040 coloring Methods 0.000 description 4
- DDRJAANPRJIHGJ-UHFFFAOYSA-N creatinine Chemical compound CN1CC(=O)NC1=N DDRJAANPRJIHGJ-UHFFFAOYSA-N 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- 229920000623 Cellulose acetate phthalate Polymers 0.000 description 3
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 3
- 229940081734 cellulose acetate phthalate Drugs 0.000 description 3
- 150000001875 compounds Chemical class 0.000 description 3
- 238000007922 dissolution test Methods 0.000 description 3
- 238000001035 drying Methods 0.000 description 3
- 230000003628 erosive effect Effects 0.000 description 3
- 229940095884 glucophage Drugs 0.000 description 3
- 239000008103 glucose Substances 0.000 description 3
- HCEQQASHRRPQFE-UHFFFAOYSA-N 5-chloro-n-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-2-methoxybenzamide;3-(diaminomethylidene)-1,1-dimethylguanidine;hydrochloride Chemical compound Cl.CN(C)C(=N)N=C(N)N.COC1=CC=C(Cl)C=C1C(=O)NCCC1=CC=C(S(=O)(=O)NC(=O)NC2CCCCC2)C=C1 HCEQQASHRRPQFE-UHFFFAOYSA-N 0.000 description 2
- 206010022489 Insulin Resistance Diseases 0.000 description 2
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
- 239000000654 additive Substances 0.000 description 2
- 238000011260 co-administration Methods 0.000 description 2
- 229940109239 creatinine Drugs 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 238000009509 drug development Methods 0.000 description 2
- 229940112611 glucovance Drugs 0.000 description 2
- 230000002440 hepatic effect Effects 0.000 description 2
- 239000000314 lubricant Substances 0.000 description 2
- 239000011812 mixed powder Substances 0.000 description 2
- 229940127017 oral antidiabetic Drugs 0.000 description 2
- 210000000496 pancreas Anatomy 0.000 description 2
- 230000002093 peripheral effect Effects 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- LLJFMFZYVVLQKT-UHFFFAOYSA-N 1-cyclohexyl-3-[4-[2-(7-methoxy-4,4-dimethyl-1,3-dioxo-2-isoquinolinyl)ethyl]phenyl]sulfonylurea Chemical compound C=1C(OC)=CC=C(C(C2=O)(C)C)C=1C(=O)N2CCC(C=C1)=CC=C1S(=O)(=O)NC(=O)NC1CCCCC1 LLJFMFZYVVLQKT-UHFFFAOYSA-N 0.000 description 1
- RKWGIWYCVPQPMF-UHFFFAOYSA-N Chloropropamide Chemical compound CCCNC(=O)NS(=O)(=O)C1=CC=C(Cl)C=C1 RKWGIWYCVPQPMF-UHFFFAOYSA-N 0.000 description 1
- 101100533387 Homo sapiens SCGB1D1 gene Proteins 0.000 description 1
- 102100028659 Secretoglobin family 1D member 1 Human genes 0.000 description 1
- JLRGJRBPOGGCBT-UHFFFAOYSA-N Tolbutamide Chemical compound CCCCNC(=O)NS(=O)(=O)C1=CC=C(C)C=C1 JLRGJRBPOGGCBT-UHFFFAOYSA-N 0.000 description 1
- 206010067584 Type 1 diabetes mellitus Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 229940127003 anti-diabetic drug Drugs 0.000 description 1
- 239000003472 antidiabetic agent Substances 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 210000000227 basophil cell of anterior lobe of hypophysis Anatomy 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 229960001761 chlorpropamide Drugs 0.000 description 1
- 238000002648 combination therapy Methods 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000003292 diminished effect Effects 0.000 description 1
- 238000010494 dissociation reaction Methods 0.000 description 1
- 230000005593 dissociations 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
- 238000011156 evaluation Methods 0.000 description 1
- 230000029142 excretion Effects 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 229960001381 glipizide Drugs 0.000 description 1
- ZJJXGWJIGJFDTL-UHFFFAOYSA-N glipizide Chemical compound C1=NC(C)=CN=C1C(=O)NCCC1=CC=C(S(=O)(=O)NC(=O)NC2CCCCC2)C=C1 ZJJXGWJIGJFDTL-UHFFFAOYSA-N 0.000 description 1
- 229960003468 gliquidone Drugs 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 201000001421 hyperglycemia Diseases 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 238000011221 initial treatment Methods 0.000 description 1
- 229910052742 iron Inorganic materials 0.000 description 1
- 230000003907 kidney function Effects 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 208000030159 metabolic disease Diseases 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 239000002207 metabolite Substances 0.000 description 1
- 239000003538 oral antidiabetic agent Substances 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 238000010422 painting Methods 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000003285 pharmacodynamic effect Effects 0.000 description 1
- ICFJFFQQTFMIBG-UHFFFAOYSA-N phenformin Chemical compound NC(=N)NC(=N)NCCC1=CC=CC=C1 ICFJFFQQTFMIBG-UHFFFAOYSA-N 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 238000009097 single-agent therapy Methods 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 229960005371 tolbutamide Drugs 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
Classifications
-
- 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
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
-
- 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
- A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
-
- 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
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- 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)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Endocrinology (AREA)
- Emergency Medicine (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT2001FI000230A ITFI20010230A1 (it) | 2001-11-29 | 2001-11-29 | Composizioni farmaceutiche per il trattamento del diabete mellito di tipo ii |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ZA200404880B true ZA200404880B (en) | 2005-07-29 |
Family
ID=11442301
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ZA200404880A ZA200404880B (en) | 2001-11-29 | 2004-06-21 | Pharmaceutical compositions comprising metformine and glibenclamide for the treatment of type-II diabetes mellitus. |
Country Status (40)
| Country | Link |
|---|---|
| US (1) | US20050053661A1 (de) |
| EP (1) | EP1458364B1 (de) |
| JP (1) | JP4474162B2 (de) |
| KR (1) | KR20040079898A (de) |
| CN (1) | CN1596103B (de) |
| AR (1) | AR037407A1 (de) |
| AT (1) | ATE387190T1 (de) |
| AU (1) | AU2002358061B2 (de) |
| BR (1) | BR0214403A (de) |
| CA (1) | CA2466677A1 (de) |
| CO (1) | CO5590906A2 (de) |
| CY (1) | CY1107966T1 (de) |
| DE (1) | DE60225331T2 (de) |
| DK (1) | DK1458364T3 (de) |
| EA (1) | EA006766B1 (de) |
| EG (1) | EG24124A (de) |
| ES (1) | ES2302862T3 (de) |
| HK (1) | HK1069974A1 (de) |
| HN (1) | HN2002000341A (de) |
| HR (1) | HRP20040501A2 (de) |
| HU (1) | HUP0402154A3 (de) |
| IL (1) | IL162143A0 (de) |
| IT (1) | ITFI20010230A1 (de) |
| MA (1) | MA27087A1 (de) |
| MX (1) | MXPA04004974A (de) |
| MY (1) | MY141243A (de) |
| NO (1) | NO20042713L (de) |
| NZ (1) | NZ533779A (de) |
| PA (1) | PA8559801A1 (de) |
| PE (1) | PE20030580A1 (de) |
| PL (1) | PL206016B1 (de) |
| PT (1) | PT1458364E (de) |
| RS (1) | RS50937B (de) |
| SI (1) | SI1458364T1 (de) |
| SV (1) | SV2004001415A (de) |
| TN (1) | TNSN04095A1 (de) |
| UA (1) | UA81615C2 (de) |
| UY (1) | UY27549A1 (de) |
| WO (1) | WO2003045355A1 (de) |
| ZA (1) | ZA200404880B (de) |
Families Citing this family (30)
| Publication number | Priority date | Publication date | Assignee | Title |
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| PL362687A1 (en) * | 2001-01-12 | 2004-11-02 | Sun Pharmaceutical Industries Limited | Spaced drug delivery system |
| WO2003105809A1 (en) | 2002-06-17 | 2003-12-24 | Themis Laboratories Private Limited | Multilayer tablets containing thiazolidinedione and biguanides and methods for producing them |
| US7785627B2 (en) | 2002-09-20 | 2010-08-31 | Watson Pharmaceuticals, Inc. | Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative |
| US9060941B2 (en) | 2002-09-20 | 2015-06-23 | Actavis, Inc. | Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative |
| PT2316456T (pt) | 2003-04-29 | 2017-09-05 | Orexigen Therapeutics Inc | Composições para afetar a perda de peso compreendendo naltrexona e bupropion |
| UY29445A1 (es) * | 2005-03-30 | 2006-10-02 | Generex Pharm Inc | Composiciones para la transmisión transmucosa oral de la metformina |
| TWI471145B (zh) * | 2005-06-13 | 2015-02-01 | Bristol Myers Squibb & Gilead Sciences Llc | 單一式藥學劑量型 |
| ES2344440T3 (es) * | 2006-11-09 | 2010-08-26 | Orexigen Therapeutics, Inc. | Formulaciones farmaceuticas en capas que comprenden una capa intermedia de disolucion rapida. |
| ITMI20062254A1 (it) * | 2006-11-24 | 2008-05-25 | Acraf | Uso di un acido metossi-alcanoico dell'indazolo per preparare una composizione farmaceutca |
| US20110144145A1 (en) | 2008-05-30 | 2011-06-16 | Orexigen Therapeutics, Inc. | Methods for treating visceral fat conditions |
| CA2638240C (en) | 2008-08-29 | 2010-02-02 | Alexander Macgregor | Method of treating dysglycemia and glucose excursions |
| CN102724878A (zh) | 2010-01-11 | 2012-10-10 | 奥雷西根治疗公司 | 在重度抑郁症患者中提供体重减轻疗法的方法 |
| RU2483717C2 (ru) * | 2010-11-22 | 2013-06-10 | Открытое акционерное общество "Химико-фармацевтический комбинат "АКРИХИН" (ОАО "АКРИХИН") | Фармацевтическая композиция для лечения диабета (варианты) |
| BR112013017411B1 (pt) | 2011-01-07 | 2022-03-22 | Anji Pharma (Us) Llc | Uso de uma composição compreendendo metformina ou um sal da mesma |
| US11759441B2 (en) | 2011-01-07 | 2023-09-19 | Anji Pharmaceuticals Inc. | Biguanide compositions and methods of treating metabolic disorders |
| US8796338B2 (en) | 2011-01-07 | 2014-08-05 | Elcelyx Therapeutics, Inc | Biguanide compositions and methods of treating metabolic disorders |
| WO2013103384A1 (en) | 2012-01-06 | 2013-07-11 | Elcelyx Therapeutics, Inc. | Biguanide compositions and methods of treating metabolic disorders |
| US11974971B2 (en) | 2011-01-07 | 2024-05-07 | Anji Pharmaceuticals Inc. | Compositions and methods for treating metabolic disorders |
| US9572784B2 (en) | 2011-01-07 | 2017-02-21 | Elcelyx Therapeutics, Inc. | Compositions comprising statins, biguanides and further agents for reducing cardiometabolic risk |
| US9211263B2 (en) | 2012-01-06 | 2015-12-15 | Elcelyx Therapeutics, Inc. | Compositions and methods of treating metabolic disorders |
| US9480663B2 (en) | 2011-01-07 | 2016-11-01 | Elcelyx Therapeutics, Inc. | Biguanide compositions and methods of treating metabolic disorders |
| EA033067B1 (ru) | 2012-01-06 | 2019-08-30 | Элселикс Терапьютикс, Инк. | Способ лечения метаболических расстройств у пациента, имеющего противопоказание к назначению бигуанидного соединения |
| PE20150358A1 (es) | 2012-06-06 | 2015-04-06 | Orexigen Therapeutics Inc | Metodos para el tratamiento del sobrepeso y de la obesidad |
| EP3219318A4 (de) | 2014-11-11 | 2018-07-11 | Shionogi & Co., Ltd. | Mehrschichtige tablette mit einem gegenüber licht instabilen wirkstoff |
| KR101750690B1 (ko) * | 2015-10-28 | 2017-06-27 | 주식회사 종근당 | 메트포르민 및 로베글리타존을 포함하는 약제학적 조성물 |
| CN105596339A (zh) * | 2015-12-23 | 2016-05-25 | 青岛海之源智能技术有限公司 | 一种二甲双胍阿昔莫司复方组合物及制备方法 |
| CN110128305A (zh) * | 2019-05-10 | 2019-08-16 | 天津大学 | 二甲双胍-甲苯磺丁脲新盐型、其制备方法及医药用途 |
| JP2021120357A (ja) * | 2020-01-30 | 2021-08-19 | サンノーバ株式会社 | 錠剤 |
| GB2599950A (en) * | 2020-10-16 | 2022-04-20 | Zentiva Ks | Pharmaceutical compositions with low amounts of nitrosamine impurities and methods for producing the same |
| CN113143940A (zh) * | 2020-12-30 | 2021-07-23 | 成都恒瑞制药有限公司 | 一种抗糖尿病药物组合物的制备方法 |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2347531A1 (de) * | 1973-09-21 | 1975-04-30 | Hoechst Ag | Arzneizubereitungen zur oralen diabetes-behandlung |
| IT1276130B1 (it) * | 1995-11-14 | 1997-10-27 | Gentili Ist Spa | Associazione glibenclamide-metformina, composizioni farmaceutiche che la contengono e loro uso nel trattamento del diabete mellito di tipo |
| KR100620935B1 (ko) * | 1998-03-19 | 2006-09-13 | 브리스톨-마이어스스퀴브컴파니 | 용해도가 높은 약물에 대한 2상 서방성 전달 시스템과 방법 |
| DE69818444T2 (de) * | 1998-07-15 | 2004-05-06 | Merck Santé | Tabletten enthaltend eine Kombination von Glibenclamid und Metformin |
| US6780432B1 (en) * | 2000-05-01 | 2004-08-24 | Aeropharm Technology, Inc. | Core formulation |
| PL362687A1 (en) * | 2001-01-12 | 2004-11-02 | Sun Pharmaceutical Industries Limited | Spaced drug delivery system |
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2001
- 2001-11-29 IT IT2001FI000230A patent/ITFI20010230A1/it unknown
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2002
- 2002-11-22 AR ARP020104498A patent/AR037407A1/es unknown
- 2002-11-25 MY MYPI20024393A patent/MY141243A/en unknown
- 2002-11-26 PE PE2002001140A patent/PE20030580A1/es not_active Application Discontinuation
- 2002-11-26 UY UY27549A patent/UY27549A1/es not_active Application Discontinuation
- 2002-11-27 EG EG2002111281A patent/EG24124A/xx active
- 2002-11-28 SV SV2002001415A patent/SV2004001415A/es not_active Application Discontinuation
- 2002-11-29 CN CN028236920A patent/CN1596103B/zh not_active Expired - Fee Related
- 2002-11-29 MX MXPA04004974A patent/MXPA04004974A/es active IP Right Grant
- 2002-11-29 AT AT02791739T patent/ATE387190T1/de not_active IP Right Cessation
- 2002-11-29 DE DE60225331T patent/DE60225331T2/de not_active Expired - Lifetime
- 2002-11-29 KR KR10-2004-7006874A patent/KR20040079898A/ko not_active Application Discontinuation
- 2002-11-29 PL PL369851A patent/PL206016B1/pl not_active IP Right Cessation
- 2002-11-29 HN HN2002000341A patent/HN2002000341A/es unknown
- 2002-11-29 ES ES02791739T patent/ES2302862T3/es not_active Expired - Lifetime
- 2002-11-29 CA CA002466677A patent/CA2466677A1/en not_active Abandoned
- 2002-11-29 US US10/497,022 patent/US20050053661A1/en not_active Abandoned
- 2002-11-29 BR BR0214403-4A patent/BR0214403A/pt not_active IP Right Cessation
- 2002-11-29 UA UA20040504085A patent/UA81615C2/ru unknown
- 2002-11-29 EA EA200400664A patent/EA006766B1/ru not_active IP Right Cessation
- 2002-11-29 PT PT02791739T patent/PT1458364E/pt unknown
- 2002-11-29 EP EP02791739A patent/EP1458364B1/de not_active Expired - Lifetime
- 2002-11-29 JP JP2003546858A patent/JP4474162B2/ja not_active Expired - Lifetime
- 2002-11-29 IL IL16214302A patent/IL162143A0/xx not_active IP Right Cessation
- 2002-11-29 HU HU0402154A patent/HUP0402154A3/hu unknown
- 2002-11-29 DK DK02791739T patent/DK1458364T3/da active
- 2002-11-29 WO PCT/EP2002/013497 patent/WO2003045355A1/en active IP Right Grant
- 2002-11-29 PA PA20028559801A patent/PA8559801A1/es unknown
- 2002-11-29 SI SI200230693T patent/SI1458364T1/sl unknown
- 2002-11-29 NZ NZ533779A patent/NZ533779A/en not_active IP Right Cessation
- 2002-11-29 AU AU2002358061A patent/AU2002358061B2/en not_active Ceased
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2004
- 2004-05-24 MA MA27696A patent/MA27087A1/fr unknown
- 2004-05-28 RS YUP-473/04A patent/RS50937B/sr unknown
- 2004-05-28 TN TNP2004000095A patent/TNSN04095A1/en unknown
- 2004-06-04 HR HRP20040501 patent/HRP20040501A2/hr not_active Application Discontinuation
- 2004-06-21 ZA ZA200404880A patent/ZA200404880B/en unknown
- 2004-06-28 NO NO20042713A patent/NO20042713L/no not_active Application Discontinuation
- 2004-06-29 CO CO04061363A patent/CO5590906A2/es not_active Application Discontinuation
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2005
- 2005-03-18 HK HK05102373A patent/HK1069974A1/xx not_active IP Right Cessation
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