NZ500886A - Enteric coated oral formulation comprising omeprazole and optionally an alkaline reacting compound and preparation where the light transmission at cloud point comprises the HPMC dissolved in a concentration of 1.2% (w/w) in a mixed solution of phosphate buffer 0.235M and pH 1.2 - Google Patents
Enteric coated oral formulation comprising omeprazole and optionally an alkaline reacting compound and preparation where the light transmission at cloud point comprises the HPMC dissolved in a concentration of 1.2% (w/w) in a mixed solution of phosphate buffer 0.235M and pH 1.2Info
- Publication number
- NZ500886A NZ500886A NZ500886A NZ50088698A NZ500886A NZ 500886 A NZ500886 A NZ 500886A NZ 500886 A NZ500886 A NZ 500886A NZ 50088698 A NZ50088698 A NZ 50088698A NZ 500886 A NZ500886 A NZ 500886A
- Authority
- NZ
- New Zealand
- Prior art keywords
- omeprazole
- hpmc
- cloud point
- core material
- low viscosity
- Prior art date
Links
- SUBDBMMJDZJVOS-UHFFFAOYSA-N 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole Chemical compound N=1C2=CC(OC)=CC=C2NC=1S(=O)CC1=NC=C(C)C(OC)=C1C SUBDBMMJDZJVOS-UHFFFAOYSA-N 0.000 title claims abstract description 95
- 229960000381 omeprazole Drugs 0.000 title claims abstract description 89
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 title claims abstract description 88
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 title claims abstract description 88
- 239000000203 mixture Substances 0.000 title claims abstract description 42
- 238000009472 formulation Methods 0.000 title claims abstract description 28
- 150000001875 compounds Chemical class 0.000 title claims abstract description 23
- 230000005540 biological transmission Effects 0.000 title claims description 21
- 239000011259 mixed solution Substances 0.000 title claims description 17
- 239000008363 phosphate buffer Substances 0.000 title claims description 12
- 238000002360 preparation method Methods 0.000 title description 4
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims abstract description 87
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims abstract description 87
- 239000010410 layer Substances 0.000 claims abstract description 61
- 239000011162 core material Substances 0.000 claims abstract description 45
- 239000002702 enteric coating Substances 0.000 claims abstract description 39
- 238000009505 enteric coating Methods 0.000 claims abstract description 39
- 239000011230 binding agent Substances 0.000 claims abstract description 27
- 239000004480 active ingredient Substances 0.000 claims abstract description 20
- 159000000011 group IA salts Chemical class 0.000 claims abstract description 20
- 238000004519 manufacturing process Methods 0.000 claims abstract description 11
- 239000008203 oral pharmaceutical composition Substances 0.000 claims abstract description 11
- 238000011282 treatment Methods 0.000 claims abstract description 8
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 7
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 7
- 201000010099 disease Diseases 0.000 claims abstract description 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims abstract description 5
- 235000011468 Albizia julibrissin Nutrition 0.000 claims description 17
- 241001070944 Mimosa Species 0.000 claims description 17
- 239000012530 fluid Substances 0.000 claims description 17
- 230000002496 gastric effect Effects 0.000 claims description 16
- 238000000034 method Methods 0.000 claims description 13
- 239000013543 active substance Substances 0.000 claims description 11
- 238000000576 coating method Methods 0.000 claims description 11
- 239000011248 coating agent Substances 0.000 claims description 9
- 239000000470 constituent Substances 0.000 claims description 8
- 239000003795 chemical substances by application Substances 0.000 claims description 7
- 238000011049 filling Methods 0.000 claims description 4
- 239000007864 aqueous solution Substances 0.000 claims description 3
- 239000003814 drug Substances 0.000 claims description 3
- 229920003145 methacrylic acid copolymer Polymers 0.000 claims description 3
- -1 hydroxypropyl Chemical group 0.000 claims description 2
- 159000000003 magnesium salts Chemical group 0.000 claims 2
- 229940117841 methacrylic acid copolymer Drugs 0.000 claims 1
- 210000004211 gastric acid Anatomy 0.000 abstract description 5
- 230000002265 prevention Effects 0.000 abstract description 2
- 239000008188 pellet Substances 0.000 description 15
- 229920000642 polymer Polymers 0.000 description 11
- 239000000126 substance Substances 0.000 description 11
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 11
- 230000002378 acidificating effect Effects 0.000 description 7
- 239000007853 buffer solution Substances 0.000 description 6
- 239000000463 material Substances 0.000 description 6
- 239000004014 plasticizer Substances 0.000 description 6
- 150000003839 salts Chemical class 0.000 description 6
- 239000000243 solution Substances 0.000 description 6
- 239000000654 additive Substances 0.000 description 5
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical class OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 4
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 4
- 239000002552 dosage form Substances 0.000 description 4
- 239000000825 pharmaceutical preparation Substances 0.000 description 4
- 235000000346 sugar Nutrition 0.000 description 4
- 102000004190 Enzymes Human genes 0.000 description 3
- 108090000790 Enzymes Proteins 0.000 description 3
- 241000124008 Mammalia Species 0.000 description 3
- 239000002253 acid Substances 0.000 description 3
- 230000015556 catabolic process Effects 0.000 description 3
- 229920002678 cellulose Polymers 0.000 description 3
- 235000010980 cellulose Nutrition 0.000 description 3
- 239000011247 coating layer Substances 0.000 description 3
- 238000006731 degradation reaction Methods 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 239000000945 filler Substances 0.000 description 3
- 210000004051 gastric juice Anatomy 0.000 description 3
- 238000010438 heat treatment Methods 0.000 description 3
- 239000004615 ingredient Substances 0.000 description 3
- 239000011777 magnesium Substances 0.000 description 3
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 description 3
- 239000003960 organic solvent Substances 0.000 description 3
- 229940127557 pharmaceutical product Drugs 0.000 description 3
- 238000002798 spectrophotometry method Methods 0.000 description 3
- 239000004094 surface-active agent Substances 0.000 description 3
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical class OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 2
- 239000004141 Sodium laurylsulphate Substances 0.000 description 2
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 229940069428 antacid Drugs 0.000 description 2
- 239000003159 antacid agent Substances 0.000 description 2
- 239000011575 calcium Substances 0.000 description 2
- 229910052791 calcium Inorganic materials 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 239000003086 colorant Substances 0.000 description 2
- 230000007423 decrease Effects 0.000 description 2
- 230000003111 delayed effect Effects 0.000 description 2
- 230000027119 gastric acid secretion Effects 0.000 description 2
- 208000021302 gastroesophageal reflux disease Diseases 0.000 description 2
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 description 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 2
- 230000002401 inhibitory effect Effects 0.000 description 2
- 239000000395 magnesium oxide Substances 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 230000007935 neutral effect Effects 0.000 description 2
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 description 2
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 description 2
- 238000005191 phase separation Methods 0.000 description 2
- 239000000049 pigment Substances 0.000 description 2
- 229920001223 polyethylene glycol Polymers 0.000 description 2
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 2
- 239000007921 spray Substances 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- 150000008163 sugars Chemical class 0.000 description 2
- HBAQYPYDRFILMT-UHFFFAOYSA-N 8-[3-(1-cyclopropylpyrazol-4-yl)-1H-pyrazolo[4,3-d]pyrimidin-5-yl]-3-methyl-3,8-diazabicyclo[3.2.1]octan-2-one Chemical class C1(CC1)N1N=CC(=C1)C1=NNC2=C1N=C(N=C2)N1C2C(N(CC1CC2)C)=O HBAQYPYDRFILMT-UHFFFAOYSA-N 0.000 description 1
- 229940121819 ATPase inhibitor Drugs 0.000 description 1
- GUBGYTABKSRVRQ-DCSYEGIMSA-N Beta-Lactose Chemical compound OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-DCSYEGIMSA-N 0.000 description 1
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical class [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 1
- 229920000623 Cellulose acetate phthalate Polymers 0.000 description 1
- PTHCMJGKKRQCBF-UHFFFAOYSA-N Cellulose, microcrystalline Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC)C(CO)O1 PTHCMJGKKRQCBF-UHFFFAOYSA-N 0.000 description 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
- PYGXAGIECVVIOZ-UHFFFAOYSA-N Dibutyl decanedioate Chemical compound CCCCOC(=O)CCCCCCCCC(=O)OCCCC PYGXAGIECVVIOZ-UHFFFAOYSA-N 0.000 description 1
- JIGUQPWFLRLWPJ-UHFFFAOYSA-N Ethyl acrylate Chemical compound CCOC(=O)C=C JIGUQPWFLRLWPJ-UHFFFAOYSA-N 0.000 description 1
- 208000007882 Gastritis Diseases 0.000 description 1
- 208000018522 Gastrointestinal disease Diseases 0.000 description 1
- 239000001828 Gelatine Substances 0.000 description 1
- 206010019375 Helicobacter infections Diseases 0.000 description 1
- 208000028861 Helicobacter pylori infectious disease Diseases 0.000 description 1
- 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 description 1
- 241001082241 Lythrum hyssopifolia Species 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 description 1
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 1
- 229910020038 Mg6Al2 Inorganic materials 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- 201000004681 Psoriasis Diseases 0.000 description 1
- 229920001800 Shellac Polymers 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 208000007107 Stomach Ulcer Diseases 0.000 description 1
- 208000025865 Ulcer Diseases 0.000 description 1
- 206010046274 Upper gastrointestinal haemorrhage Diseases 0.000 description 1
- 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 1
- 150000007513 acids Chemical class 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 239000000362 adenosine triphosphatase inhibitor Substances 0.000 description 1
- 239000004411 aluminium Substances 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 235000010210 aluminium Nutrition 0.000 description 1
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 description 1
- 229910021502 aluminium hydroxide Inorganic materials 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 159000000013 aluminium salts Chemical class 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 230000001458 anti-acid effect Effects 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 239000002518 antifoaming agent Substances 0.000 description 1
- 239000002216 antistatic agent Substances 0.000 description 1
- 239000007900 aqueous suspension Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 235000011116 calcium hydroxide Nutrition 0.000 description 1
- 239000007963 capsule composition Substances 0.000 description 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-N carbonic acid Chemical class OC(O)=O BVKZGUZCCUSVTD-UHFFFAOYSA-N 0.000 description 1
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 description 1
- 229920003123 carboxymethyl cellulose sodium Polymers 0.000 description 1
- 229940063834 carboxymethylcellulose sodium Drugs 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 229920002301 cellulose acetate Polymers 0.000 description 1
- 229920006217 cellulose acetate butyrate Polymers 0.000 description 1
- 229940081734 cellulose acetate phthalate Drugs 0.000 description 1
- 229960000541 cetyl alcohol Drugs 0.000 description 1
- 229920001688 coating polymer Polymers 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 230000001276 controlling effect Effects 0.000 description 1
- 229940031954 dibutyl sebacate Drugs 0.000 description 1
- 238000009792 diffusion process Methods 0.000 description 1
- 239000002270 dispersing agent Substances 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 208000000718 duodenal ulcer Diseases 0.000 description 1
- 206010013864 duodenitis Diseases 0.000 description 1
- 201000006549 dyspepsia Diseases 0.000 description 1
- 239000007938 effervescent tablet Substances 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 201000000052 gastrinoma Diseases 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 229940071676 hydroxypropylcellulose Drugs 0.000 description 1
- 229920000639 hydroxypropylmethylcellulose acetate succinate Polymers 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 230000004968 inflammatory condition Effects 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 239000002563 ionic surfactant Substances 0.000 description 1
- 238000004811 liquid chromatography Methods 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- VTHJTEIRLNZDEV-UHFFFAOYSA-L magnesium dihydroxide Chemical class [OH-].[OH-].[Mg+2] VTHJTEIRLNZDEV-UHFFFAOYSA-L 0.000 description 1
- 235000012254 magnesium hydroxide Nutrition 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- MQEUGMWHWPYFDD-UHFFFAOYSA-N magnesium;6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1h-benzimidazole Chemical class [Mg].N=1C2=CC(OC)=CC=C2NC=1S(=O)CC1=NC=C(C)C(OC)=C1C MQEUGMWHWPYFDD-UHFFFAOYSA-N 0.000 description 1
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- FYFFGSSZFBZTAH-UHFFFAOYSA-N methylaminomethanetriol Chemical compound CNC(O)(O)O FYFFGSSZFBZTAH-UHFFFAOYSA-N 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 150000007522 mineralic acids Chemical class 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 230000004899 motility Effects 0.000 description 1
- 239000002736 nonionic surfactant Substances 0.000 description 1
- 239000006186 oral dosage form Substances 0.000 description 1
- 239000008184 oral solid dosage form Substances 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 235000005985 organic acids Nutrition 0.000 description 1
- 229920000620 organic polymer Polymers 0.000 description 1
- 239000006179 pH buffering agent Substances 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- PNJWIWWMYCMZRO-UHFFFAOYSA-N pent‐4‐en‐2‐one Natural products CC(=O)CC=C PNJWIWWMYCMZRO-UHFFFAOYSA-N 0.000 description 1
- 229940124531 pharmaceutical excipient Drugs 0.000 description 1
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 description 1
- 150000003022 phthalic acids Chemical class 0.000 description 1
- 229940068917 polyethylene glycols Drugs 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 229940068965 polysorbates Drugs 0.000 description 1
- 229940100467 polyvinyl acetate phthalate Drugs 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 238000011321 prophylaxis Methods 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 230000003248 secreting effect Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 239000004208 shellac Substances 0.000 description 1
- 229940113147 shellac Drugs 0.000 description 1
- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 description 1
- 235000013874 shellac Nutrition 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 238000005563 spheronization Methods 0.000 description 1
- 238000001694 spray drying Methods 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 239000007916 tablet composition Substances 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 239000004408 titanium dioxide Substances 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- 125000005591 trimellitate group Chemical group 0.000 description 1
- 230000036269 ulceration Effects 0.000 description 1
- 229920002554 vinyl polymer Polymers 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
- A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
-
- 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
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
Landscapes
- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE9702000A SE9702000D0 (sv) | 1997-05-28 | 1997-05-28 | New pharmaceutical formulation |
| PCT/SE1998/000922 WO1998053803A1 (en) | 1997-05-28 | 1998-05-18 | Pharmaceutical formulation of omeprazole |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| NZ500886A true NZ500886A (en) | 2001-11-30 |
Family
ID=20407122
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NZ500886A NZ500886A (en) | 1997-05-28 | 1998-05-18 | Enteric coated oral formulation comprising omeprazole and optionally an alkaline reacting compound and preparation where the light transmission at cloud point comprises the HPMC dissolved in a concentration of 1.2% (w/w) in a mixed solution of phosphate buffer 0.235M and pH 1.2 |
Country Status (40)
Families Citing this family (50)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6699885B2 (en) * | 1996-01-04 | 2004-03-02 | The Curators Of The University Of Missouri | Substituted benzimidazole dosage forms and methods of using same |
| US6645988B2 (en) | 1996-01-04 | 2003-11-11 | Curators Of The University Of Missouri | Substituted benzimidazole dosage forms and method of using same |
| US6489346B1 (en) | 1996-01-04 | 2002-12-03 | The Curators Of The University Of Missouri | Substituted benzimidazole dosage forms and method of using same |
| US5840737A (en) | 1996-01-04 | 1998-11-24 | The Curators Of The University Of Missouri | Omeprazole solution and method for using same |
| US6096340A (en) | 1997-11-14 | 2000-08-01 | Andrx Pharmaceuticals, Inc. | Omeprazole formulation |
| US6174548B1 (en) * | 1998-08-28 | 2001-01-16 | Andrx Pharmaceuticals, Inc. | Omeprazole formulation |
| KR100627614B1 (ko) * | 1998-04-20 | 2006-09-25 | 에자이 가부시키가이샤 | 안정화된 벤즈이미다졸계 화합물 함유 조성물로 이루어지는 의약제제 |
| SE9803772D0 (sv) | 1998-11-05 | 1998-11-05 | Astra Ab | Pharmaceutical formulation |
| SE9902386D0 (sv) * | 1999-06-22 | 1999-06-22 | Astra Ab | New formulation |
| US6245913B1 (en) | 1999-06-30 | 2001-06-12 | Wockhardt Europe Limited | Synthetic procedure for 5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methylthio]-IH-benzimidazole hydrochloride and its conversion to omeprazole |
| ES2168043B1 (es) | 1999-09-13 | 2003-04-01 | Esteve Labor Dr | Forma farmaceutica solida oral de liberacion modificada que contiene un compuesto de bencimidazol labil en medio acido. |
| CN1197574C (zh) | 1999-10-20 | 2005-04-20 | 卫材株式会社 | 稳定苯并咪唑化合物的方法 |
| US20040092511A1 (en) * | 1999-12-10 | 2004-05-13 | Billstein Stephan Anthony | Pharmaceutical combinations and their use in treating gastrointestinal and abdominal viscera disorders |
| US20020192299A1 (en) * | 2000-12-28 | 2002-12-19 | Rajneesh Taneja | Pharmaceutical compositions of a non-enteric coated proton pump inhibitor with a carbonate salt and bicarbonate salt combination |
| JP2002234842A (ja) * | 2001-02-09 | 2002-08-23 | Kyowa Yakuhin Kogyo Kk | 内服腸溶性製剤 |
| US20040006111A1 (en) * | 2002-01-25 | 2004-01-08 | Kenneth Widder | Transmucosal delivery of proton pump inhibitors |
| US20040082618A1 (en) * | 2002-07-03 | 2004-04-29 | Rajneesh Taneja | Liquid dosage forms of acid labile drugs |
| FR2843121B3 (fr) | 2002-08-02 | 2004-09-10 | Rhodia Chimie Sa | Agent ignifugeant, procede de preparation et l'utilisation de cet agent |
| US20040121004A1 (en) * | 2002-12-20 | 2004-06-24 | Rajneesh Taneja | Dosage forms containing a PPI, NSAID, and buffer |
| US20070243251A1 (en) * | 2002-12-20 | 2007-10-18 | Rajneesh Taneja | Dosage Forms Containing A PPI, NSAID, and Buffer |
| US20040146558A1 (en) * | 2003-01-28 | 2004-07-29 | Kyowa Pharmaceutical Co., Ltd. | Oral enteric-coated preparation |
| RU2359671C2 (ru) * | 2003-01-29 | 2009-06-27 | Такеда Фармасьютикал Компани Лимитед | Способ получения препарата с покрытием |
| UA86015C2 (ru) * | 2003-01-29 | 2009-03-25 | Такеда Фармасьютикал Компани Лимитед | Способ получения твердой лекарственной формы с покрытием |
| US7976853B2 (en) | 2003-01-29 | 2011-07-12 | Takeda Pharmaceutical Company Limited | Process for producing coated preparation |
| JP4567340B2 (ja) * | 2003-01-29 | 2010-10-20 | 武田薬品工業株式会社 | 被覆製剤の製造方法 |
| EP1603537A4 (en) * | 2003-02-20 | 2009-11-04 | Santarus Inc | NOVEL FORMULATION, ANTICIPATED COMPLEX IMMEDIATE RELEASE FOR A FAST AND CONTINUOUS SUPPRESSION OF MAGIC ACID |
| US20050042277A1 (en) * | 2003-07-17 | 2005-02-24 | Irukulla Srinivas | Pharmaceutical compositions having a swellable coating |
| US8993599B2 (en) | 2003-07-18 | 2015-03-31 | Santarus, Inc. | Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them |
| US20070292498A1 (en) * | 2003-11-05 | 2007-12-20 | Warren Hall | Combinations of proton pump inhibitors, sleep aids, buffers and pain relievers |
| CN1311824C (zh) * | 2004-04-21 | 2007-04-25 | 常州市第四制药厂有限公司 | 奥美拉唑肠溶微粒制剂及制备方法 |
| US8815916B2 (en) * | 2004-05-25 | 2014-08-26 | Santarus, Inc. | Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them |
| US8906940B2 (en) | 2004-05-25 | 2014-12-09 | Santarus, Inc. | Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them |
| DE602005013372D1 (de) * | 2005-07-29 | 2009-04-30 | Rottapharm Spa | Kombination aus Itriglumid und PPI zur Behandlung von gastrointestinalen- und assozierten Krankheiten |
| WO2007138606A2 (en) * | 2006-06-01 | 2007-12-06 | Dexcel Pharma Technologies Ltd. | Multiple unit pharmaceutical formulation |
| KR101436516B1 (ko) * | 2007-07-23 | 2014-09-02 | 주식회사태평양제약 | 코팅된 펠렛을 함유하는 현탁정 및 이의 제조방법 |
| AU2008304033B2 (en) * | 2007-09-28 | 2014-05-01 | Ctc Bio, Inc. | Pharmaceutical composition containing esomeprazole |
| CN101980701A (zh) * | 2008-03-28 | 2011-02-23 | 菲尔若国际公司 | 用于预防心血管疾病的胶囊 |
| DK2334378T3 (da) | 2008-08-19 | 2014-07-07 | Xenoport Inc | Prodrugs af methylhydrogenfumarat, farmaceutiske sammensætninger deraf og fremgangsmåder til anvendelse |
| US20140348915A9 (en) | 2012-08-22 | 2014-11-27 | Xenoport, Inc. | Oral Dosage Forms of Methyl Hydrogen Fumarate and Prodrugs Thereof |
| JP2015527372A (ja) | 2012-08-22 | 2015-09-17 | ゼノポート，インコーポレイティド | 副作用を低減させるモノメチルフマレートおよびそのプロドラッグの投与方法 |
| CN102961356A (zh) * | 2012-12-11 | 2013-03-13 | 山西云鹏制药有限公司 | 一种含奥美拉唑的蓝色肠溶片剂的制备方法 |
| WO2014160633A1 (en) | 2013-03-24 | 2014-10-02 | Xenoport, Inc. | Pharmaceutical compositions of dimethyl fumarate |
| TW201516020A (zh) | 2013-09-06 | 2015-05-01 | Xenoport Inc | （ｎ，ｎ－二乙基胺甲醯基）甲基（２ｅ）丁－２－烯－１，４－二酸甲酯之晶形、合成方法及用途 |
| US20150079180A1 (en) * | 2013-09-18 | 2015-03-19 | Xenoport, Inc. | Nanoparticle compositions of dimethyl fumarate |
| US9999672B2 (en) | 2014-03-24 | 2018-06-19 | Xenoport, Inc. | Pharmaceutical compositions of fumaric acid esters |
| US20170042806A1 (en) | 2015-04-29 | 2017-02-16 | Dexcel Pharma Technologies Ltd. | Orally disintegrating compositions |
| US10076494B2 (en) | 2016-06-16 | 2018-09-18 | Dexcel Pharma Technologies Ltd. | Stable orally disintegrating pharmaceutical compositions |
| JPWO2021153525A1 (OSRAM) | 2020-01-27 | 2021-08-05 | ||
| KR102432084B1 (ko) | 2021-11-16 | 2022-08-12 | 알리코제약(주) | S-오메프라졸을 함유하는 안정성이 개선되고 소형화된 정제 |
| WO2024075017A1 (en) | 2022-10-04 | 2024-04-11 | Zabirnyk Arsenii | Inhibition of aortic valve calcification |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE7804231L (sv) * | 1978-04-14 | 1979-10-15 | Haessle Ab | Magsyrasekretionsmedel |
| SE8301182D0 (sv) * | 1983-03-04 | 1983-03-04 | Haessle Ab | Novel compounds |
| GB2189698A (en) * | 1986-04-30 | 1987-11-04 | Haessle Ab | Coated omeprazole tablets |
| YU48263B (sh) * | 1991-06-17 | 1997-09-30 | Byk Gulden Lomberg Chemische Fabrik Gmbh. | Postupak za dobijanje farmaceutskog preparata na bazi pantoprazola |
| JPH05255088A (ja) * | 1991-11-05 | 1993-10-05 | Yoshitomi Pharmaceut Ind Ltd | 抗潰瘍剤含有製剤 |
| JP2669446B2 (ja) * | 1992-03-23 | 1997-10-27 | 信越化学工業株式会社 | 医薬品コーティング液用原料粉粒体 |
| FR2692146B1 (fr) * | 1992-06-16 | 1995-06-02 | Ethypharm Sa | Compositions stables de microgranules d'omeprazole gastro-protégés et leur procédé d'obtention. |
| JPH0733659A (ja) * | 1992-07-17 | 1995-02-03 | Yoshitomi Pharmaceut Ind Ltd | 抗潰瘍剤含有製剤 |
| SE9301830D0 (sv) * | 1993-05-28 | 1993-05-28 | Ab Astra | New compounds |
| SE9302395D0 (sv) * | 1993-07-09 | 1993-07-09 | Ab Astra | New pharmaceutical formulation |
| SE9302396D0 (sv) * | 1993-07-09 | 1993-07-09 | Ab Astra | A novel compound form |
| CZ289804B6 (cs) * | 1994-07-08 | 2002-04-17 | Astrazeneca Ab | Multijednotková tabletovaná dávková forma I |
| SE9500422D0 (sv) * | 1995-02-06 | 1995-02-06 | Astra Ab | New oral pharmaceutical dosage forms |
-
1997
- 1997-05-28 SE SE9702000A patent/SE9702000D0/xx unknown
-
1998
- 1998-05-14 AR ARP980102246A patent/AR012698A1/es not_active Application Discontinuation
- 1998-05-14 HR HR980260A patent/HRP980260B1/xx not_active IP Right Cessation
- 1998-05-15 TW TW87107541A patent/TW575435B/zh not_active IP Right Cessation
- 1998-05-15 MA MA25077A patent/MA26497A1/fr unknown
- 1998-05-18 DZ DZ980104A patent/DZ2494A1/xx active
- 1998-05-18 ID IDW991448A patent/ID24654A/id unknown
- 1998-05-18 DE DE69812089T patent/DE69812089T2/de not_active Expired - Lifetime
- 1998-05-18 EP EP98924700A patent/EP0984773B1/en not_active Expired - Lifetime
- 1998-05-18 JP JP50056299A patent/JP4649001B2/ja not_active Expired - Fee Related
- 1998-05-18 RS YUP-608/99A patent/RS49629B/sr unknown
- 1998-05-18 ES ES98924700T patent/ES2195342T3/es not_active Expired - Lifetime
- 1998-05-18 AU AU76803/98A patent/AU722879B2/en not_active Ceased
- 1998-05-18 PT PT98924700T patent/PT984773E/pt unknown
- 1998-05-18 NZ NZ500886A patent/NZ500886A/en not_active IP Right Cessation
- 1998-05-18 SK SK1590-99A patent/SK286625B6/sk not_active IP Right Cessation
- 1998-05-18 BR BR9809484-0A patent/BR9809484A/pt not_active Application Discontinuation
- 1998-05-18 RU RU99126869/14A patent/RU2207121C2/ru not_active IP Right Cessation
- 1998-05-18 SI SI9830433T patent/SI0984773T1/xx unknown
- 1998-05-18 AT AT98924700T patent/ATE234078T1/de active
- 1998-05-18 CN CN98805564A patent/CN1123338C/zh not_active Expired - Fee Related
- 1998-05-18 WO PCT/SE1998/000922 patent/WO1998053803A1/en not_active Ceased
- 1998-05-18 EE EEP199900540A patent/EE03903B1/xx not_active IP Right Cessation
- 1998-05-18 CA CA002290531A patent/CA2290531C/en not_active Expired - Lifetime
- 1998-05-18 KR KR1019997011083A patent/KR100540721B1/ko not_active Expired - Fee Related
- 1998-05-18 US US09/077,717 patent/US6090827A/en not_active Expired - Lifetime
- 1998-05-18 DK DK98924700T patent/DK0984773T3/da active
- 1998-05-18 ZA ZA984178A patent/ZA984178B/xx unknown
- 1998-05-18 TR TR1999/02890T patent/TR199902890T2/xx unknown
- 1998-05-18 IL IL13289598A patent/IL132895A0/xx not_active IP Right Cessation
- 1998-05-18 UA UA99116247A patent/UA71541C2/uk unknown
- 1998-05-18 PL PL98337237A patent/PL194634B1/pl unknown
- 1998-05-18 HU HU0002182A patent/HU229154B1/hu not_active IP Right Cessation
- 1998-05-18 CZ CZ0420299A patent/CZ298972B6/cs not_active IP Right Cessation
- 1998-05-21 TN TNTNSN98068A patent/TNSN98068A1/fr unknown
- 1998-05-25 EG EG56898A patent/EG24044A/xx active
- 1998-05-27 MY MYPI98002355A patent/MY122298A/en unknown
- 1998-07-19 SA SA98190304A patent/SA98190304B1/ar unknown
-
1999
- 1999-11-11 IS IS5245A patent/IS2856B/is unknown
- 1999-11-26 NO NO19995809A patent/NO328100B1/no not_active IP Right Cessation
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