KR950002759A - New Omeprazole Oral Formulations - Google Patents
New Omeprazole Oral Formulations Download PDFInfo
- Publication number
- KR950002759A KR950002759A KR1019930012649A KR930012649A KR950002759A KR 950002759 A KR950002759 A KR 950002759A KR 1019930012649 A KR1019930012649 A KR 1019930012649A KR 930012649 A KR930012649 A KR 930012649A KR 950002759 A KR950002759 A KR 950002759A
- Authority
- KR
- South Korea
- Prior art keywords
- omeprazole
- phthalate
- coating layer
- dosage form
- oral dosage
- 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.)
- Ceased
Links
- 229960000381 omeprazole Drugs 0.000 title claims abstract 13
- 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 11
- 239000000203 mixture Substances 0.000 title claims abstract 8
- 238000009472 formulation Methods 0.000 title claims abstract 5
- 239000011247 coating layer Substances 0.000 claims abstract 7
- 239000003814 drug Substances 0.000 claims abstract 6
- 229920000642 polymer Polymers 0.000 claims abstract 6
- 229940079593 drug Drugs 0.000 claims abstract 5
- 230000002378 acidificating effect Effects 0.000 claims abstract 3
- 239000000654 additive Substances 0.000 claims abstract 3
- 230000000996 additive effect Effects 0.000 claims abstract 3
- 239000004014 plasticizer Substances 0.000 claims abstract 3
- 239000003381 stabilizer Substances 0.000 claims abstract 3
- 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 claims abstract 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims abstract 2
- 229930195725 Mannitol Natural products 0.000 claims abstract 2
- 239000011230 binding agent Substances 0.000 claims abstract 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims abstract 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims abstract 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims abstract 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims abstract 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims abstract 2
- 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 2
- 239000000594 mannitol Substances 0.000 claims abstract 2
- 235000010355 mannitol Nutrition 0.000 claims abstract 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract 2
- 239000006186 oral dosage form Substances 0.000 claims 6
- -1 hydroxypropylmethyl Omeprazole Chemical compound 0.000 claims 4
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims 3
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims 2
- 229920000623 Cellulose acetate phthalate Polymers 0.000 claims 2
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 claims 2
- IYKJEILNJZQJPU-UHFFFAOYSA-N acetic acid;butanedioic acid Chemical compound CC(O)=O.OC(=O)CCC(O)=O IYKJEILNJZQJPU-UHFFFAOYSA-N 0.000 claims 2
- 239000000783 alginic acid Substances 0.000 claims 2
- 229920000615 alginic acid Polymers 0.000 claims 2
- 235000010443 alginic acid Nutrition 0.000 claims 2
- 229960001126 alginic acid Drugs 0.000 claims 2
- 150000004781 alginic acids Chemical class 0.000 claims 2
- 229920002301 cellulose acetate Polymers 0.000 claims 2
- 229940081734 cellulose acetate phthalate Drugs 0.000 claims 2
- PPQREHKVAOVYBT-UHFFFAOYSA-H dialuminum;tricarbonate Chemical compound [Al+3].[Al+3].[O-]C([O-])=O.[O-]C([O-])=O.[O-]C([O-])=O PPQREHKVAOVYBT-UHFFFAOYSA-H 0.000 claims 2
- DOIRQSBPFJWKBE-UHFFFAOYSA-N dibutyl phthalate Chemical compound CCCCOC(=O)C1=CC=CC=C1C(=O)OCCCC DOIRQSBPFJWKBE-UHFFFAOYSA-N 0.000 claims 2
- FLKPEMZONWLCSK-UHFFFAOYSA-N diethyl phthalate Chemical compound CCOC(=O)C1=CC=CC=C1C(=O)OCC FLKPEMZONWLCSK-UHFFFAOYSA-N 0.000 claims 2
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol group Chemical group C(CCCCCCCCCCCCCCC)O BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 claims 2
- 229920003132 hydroxypropyl methylcellulose phthalate Polymers 0.000 claims 2
- 229940031704 hydroxypropyl methylcellulose phthalate Drugs 0.000 claims 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- 229920003145 methacrylic acid copolymer Polymers 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 claims 2
- 229940100467 polyvinyl acetate phthalate Drugs 0.000 claims 2
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 claims 2
- LWIHDJKSTIGBAC-UHFFFAOYSA-K tripotassium phosphate Chemical compound [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 claims 2
- LCTORNIWLGOBPB-GASJEMHNSA-N (3r,4s,5s,6r)-2-amino-6-(hydroxymethyl)oxane-2,3,4,5-tetrol Chemical compound NC1(O)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O LCTORNIWLGOBPB-GASJEMHNSA-N 0.000 claims 1
- ZNQVEEAIQZEUHB-UHFFFAOYSA-N 2-ethoxyethanol Chemical compound CCOCCO ZNQVEEAIQZEUHB-UHFFFAOYSA-N 0.000 claims 1
- ZUGAOYSWHHGDJY-UHFFFAOYSA-K 5-hydroxy-2,8,9-trioxa-1-aluminabicyclo[3.3.2]decane-3,7,10-trione Chemical compound [Al+3].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O ZUGAOYSWHHGDJY-UHFFFAOYSA-K 0.000 claims 1
- YUXIBTJKHLUKBD-UHFFFAOYSA-N Dibutyl succinate Chemical compound CCCCOC(=O)CCC(=O)OCCCC YUXIBTJKHLUKBD-UHFFFAOYSA-N 0.000 claims 1
- MBBZMMPHUWSWHV-BDVNFPICSA-N N-methylglucamine Chemical group CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO MBBZMMPHUWSWHV-BDVNFPICSA-N 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 229920002125 Sokalan® Polymers 0.000 claims 1
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims 1
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 claims 1
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical group [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 claims 1
- ILRRQNADMUWWFW-UHFFFAOYSA-K aluminium phosphate Chemical compound O1[Al]2OP1(=O)O2 ILRRQNADMUWWFW-UHFFFAOYSA-K 0.000 claims 1
- 229940118662 aluminum carbonate Drugs 0.000 claims 1
- 229910000019 calcium carbonate Inorganic materials 0.000 claims 1
- FNAQSUUGMSOBHW-UHFFFAOYSA-H calcium citrate Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O.[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O FNAQSUUGMSOBHW-UHFFFAOYSA-H 0.000 claims 1
- 239000001354 calcium citrate Substances 0.000 claims 1
- 239000001506 calcium phosphate Substances 0.000 claims 1
- 229910000389 calcium phosphate Inorganic materials 0.000 claims 1
- 235000011010 calcium phosphates Nutrition 0.000 claims 1
- 159000000007 calcium salts Chemical class 0.000 claims 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims 1
- 235000013539 calcium stearate Nutrition 0.000 claims 1
- 239000008116 calcium stearate Substances 0.000 claims 1
- 229960000541 cetyl alcohol Drugs 0.000 claims 1
- 229940001468 citrate Drugs 0.000 claims 1
- 229960002097 dibutylsuccinate Drugs 0.000 claims 1
- 235000013870 dimethyl polysiloxane Nutrition 0.000 claims 1
- 239000004205 dimethyl polysiloxane Substances 0.000 claims 1
- 239000001087 glyceryl triacetate Substances 0.000 claims 1
- 235000013773 glyceryl triacetate Nutrition 0.000 claims 1
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 claims 1
- 239000001095 magnesium carbonate Substances 0.000 claims 1
- 229910000021 magnesium carbonate Inorganic materials 0.000 claims 1
- VTHJTEIRLNZDEV-UHFFFAOYSA-L magnesium dihydroxide Chemical compound [OH-].[OH-].[Mg+2] VTHJTEIRLNZDEV-UHFFFAOYSA-L 0.000 claims 1
- 239000000347 magnesium hydroxide Substances 0.000 claims 1
- 229910001862 magnesium hydroxide Inorganic materials 0.000 claims 1
- 239000000395 magnesium oxide Substances 0.000 claims 1
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 claims 1
- 235000012245 magnesium oxide Nutrition 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 claims 1
- GOQYKNQRPGWPLP-UHFFFAOYSA-N n-heptadecyl alcohol Natural products CCCCCCCCCCCCCCCCCO GOQYKNQRPGWPLP-UHFFFAOYSA-N 0.000 claims 1
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 claims 1
- 239000004584 polyacrylic acid Substances 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 239000001508 potassium citrate Substances 0.000 claims 1
- 229960002635 potassium citrate Drugs 0.000 claims 1
- QEEAPRPFLLJWCF-UHFFFAOYSA-K potassium citrate (anhydrous) Chemical compound [K+].[K+].[K+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O QEEAPRPFLLJWCF-UHFFFAOYSA-K 0.000 claims 1
- 235000011082 potassium citrates Nutrition 0.000 claims 1
- 229910000160 potassium phosphate Inorganic materials 0.000 claims 1
- 235000011009 potassium phosphates Nutrition 0.000 claims 1
- 159000000001 potassium salts Chemical class 0.000 claims 1
- 229940114930 potassium stearate Drugs 0.000 claims 1
- ANBFRLKBEIFNQU-UHFFFAOYSA-M potassium;octadecanoate Chemical compound [K+].CCCCCCCCCCCCCCCCCC([O-])=O ANBFRLKBEIFNQU-UHFFFAOYSA-M 0.000 claims 1
- RUOJZAUFBMNUDX-UHFFFAOYSA-N propylene carbonate Chemical compound CC1COC(=O)O1 RUOJZAUFBMNUDX-UHFFFAOYSA-N 0.000 claims 1
- 239000001509 sodium citrate Substances 0.000 claims 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims 1
- 235000011083 sodium citrates Nutrition 0.000 claims 1
- 239000001488 sodium phosphate Substances 0.000 claims 1
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 1
- 235000011008 sodium phosphates Nutrition 0.000 claims 1
- 159000000000 sodium salts Chemical class 0.000 claims 1
- 229940012831 stearyl alcohol Drugs 0.000 claims 1
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 claims 1
- 229960002622 triacetin Drugs 0.000 claims 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims 1
- 235000013337 tricalcium citrate Nutrition 0.000 claims 1
- 239000001069 triethyl citrate Substances 0.000 claims 1
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 claims 1
- 235000013769 triethyl citrate Nutrition 0.000 claims 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 1
- 239000011248 coating agent Substances 0.000 abstract 2
- 238000000576 coating method Methods 0.000 abstract 2
- 238000007796 conventional method Methods 0.000 abstract 2
- 239000012530 fluid Substances 0.000 abstract 2
- 239000010410 layer Substances 0.000 abstract 2
- 230000015556 catabolic process Effects 0.000 abstract 1
- 238000006731 degradation reaction Methods 0.000 abstract 1
- 230000002496 gastric effect Effects 0.000 abstract 1
- 210000004051 gastric juice Anatomy 0.000 abstract 1
- 230000000968 intestinal effect Effects 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 239000002356 single layer Substances 0.000 abstract 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
본 발명은 오메프라졸을 함유하는 새로운 안정화 경구 약제에 관한 것이다.The present invention relates to a novel stabilized oral medicament containing omeprazole.
본 발명의 경구 제형은 약물로서 오메프라졸, 약물안정화제, 히드록시프로필셀룰로스나 히드록시프로필메틸셀룰로스에서 선택된 결합제, 부형제로서 만니톨을 함유하는 약물함유층에 산성 폴리머, 염기성 폴리머, 알카리성 첨가물, 가소제를 함유하는 알칼리성 조성물을 도포한 단일코팅층으로 이루어진다.The oral formulation of the present invention comprises an acidic polymer, a basic polymer, an alkaline additive, and a plasticizer in a drug-containing layer containing omeprazole, a drug stabilizer, a binder selected from hydroxypropylcellulose or hydroxypropylmethylcellulose, and mannitol as an excipient. It consists of a single coating layer coated with an alkaline composition.
본 발명에 의하여 제공되는 새로운 오메프라졸 경구 제형은 종래의 방법의 2층 코팅이 아닌, 위액에 녹지도 않고 위액을 통과시키지 않으면서 장액에서는 신속하게 녹는 알칼리성 조성물을 단층 코팅함으로써, 오메프라졸의 분해가 일어나지 않으면서도 기존의 방법에 비해 제조공정이나 작업시간이 짧고 수율이 높은 새로운 오메프라졸 경구 제형이다.The new omeprazole oral formulation provided by the present invention is not a two-layer coating of the conventional method, but is a single layer coating of an alkaline composition that dissolves rapidly in the intestinal fluid without dissolving in gastric juice and without passing gastric fluid, so that no degradation of omeprazole occurs. In addition, it is a new omeprazole oral formulation with shorter manufacturing process or working time and higher yield than the conventional method.
Description
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음Since this is an open matter, no full text was included.
Claims (7)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1019930012649A KR950002759A (en) | 1993-07-06 | 1993-07-06 | New Omeprazole Oral Formulations |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1019930012649A KR950002759A (en) | 1993-07-06 | 1993-07-06 | New Omeprazole Oral Formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| KR950002759A true KR950002759A (en) | 1995-02-16 |
Family
ID=67142782
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| KR1019930012649A Ceased KR950002759A (en) | 1993-07-06 | 1993-07-06 | New Omeprazole Oral Formulations |
Country Status (1)
| Country | Link |
|---|---|
| KR (1) | KR950002759A (en) |
-
1993
- 1993-07-06 KR KR1019930012649A patent/KR950002759A/en not_active Ceased
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| A201 | Request for examination | ||
| PA0109 | Patent application |
Patent event code: PA01091R01D Comment text: Patent Application Patent event date: 19930706 |
|
| PA0201 | Request for examination |
Patent event code: PA02012R01D Patent event date: 19930706 Comment text: Request for Examination of Application |
|
| PG1501 | Laying open of application | ||
| E902 | Notification of reason for refusal | ||
| PE0902 | Notice of grounds for rejection |
Comment text: Notification of reason for refusal Patent event date: 19960726 Patent event code: PE09021S01D |
|
| E601 | Decision to refuse application | ||
| PE0601 | Decision on rejection of patent |
Patent event date: 19961009 Comment text: Decision to Refuse Application Patent event code: PE06012S01D Patent event date: 19960726 Comment text: Notification of reason for refusal Patent event code: PE06011S01I |