SK285964B6 - Liečivý prípravok obsahujúci fexofenadín hydrochlorid a spôsob jeho prípravy - Google Patents
Liečivý prípravok obsahujúci fexofenadín hydrochlorid a spôsob jeho prípravy Download PDFInfo
- Publication number
- SK285964B6 SK285964B6 SK1779-2002A SK17792002A SK285964B6 SK 285964 B6 SK285964 B6 SK 285964B6 SK 17792002 A SK17792002 A SK 17792002A SK 285964 B6 SK285964 B6 SK 285964B6
- Authority
- SK
- Slovakia
- Prior art keywords
- weight
- tablet
- fexofenadine hydrochloride
- amount
- mixture
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 100
- 229960000354 fexofenadine hydrochloride Drugs 0.000 title claims abstract description 33
- 238000002360 preparation method Methods 0.000 title claims abstract description 33
- RRJFVPUCXDGFJB-UHFFFAOYSA-N Fexofenadine hydrochloride Chemical compound Cl.C1=CC(C(C)(C(O)=O)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 RRJFVPUCXDGFJB-UHFFFAOYSA-N 0.000 title claims abstract description 32
- 238000000034 method Methods 0.000 title claims abstract description 24
- 239000013543 active substance Substances 0.000 claims abstract description 13
- 150000003077 polyols Chemical class 0.000 claims abstract description 11
- 229920005862 polyol Polymers 0.000 claims abstract description 10
- 239000007884 disintegrant Substances 0.000 claims abstract description 7
- 239000002706 dry binder Substances 0.000 claims abstract description 5
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 60
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims description 36
- 235000013539 calcium stearate Nutrition 0.000 claims description 33
- 239000008116 calcium stearate Substances 0.000 claims description 33
- 229920002472 Starch Polymers 0.000 claims description 28
- 235000019698 starch Nutrition 0.000 claims description 28
- 239000008107 starch Substances 0.000 claims description 28
- 239000000377 silicon dioxide Substances 0.000 claims description 17
- 239000011734 sodium Substances 0.000 claims description 16
- 229910052708 sodium Inorganic materials 0.000 claims description 16
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 15
- 239000002245 particle Substances 0.000 claims description 14
- 239000003814 drug Substances 0.000 claims description 13
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 12
- 239000004480 active ingredient Substances 0.000 claims description 11
- 235000010355 mannitol Nutrition 0.000 claims description 11
- 239000000126 substance Substances 0.000 claims description 10
- 239000002775 capsule Substances 0.000 claims description 9
- 238000004090 dissolution Methods 0.000 claims description 8
- 229940126601 medicinal product Drugs 0.000 claims description 6
- 150000001720 carbohydrates Chemical class 0.000 claims description 5
- 239000000945 filler Substances 0.000 claims description 5
- 239000008187 granular material Substances 0.000 claims description 5
- 239000000843 powder Substances 0.000 claims description 5
- 238000007580 dry-mixing Methods 0.000 claims description 4
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 4
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 4
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 4
- 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 description 4
- 239000008188 pellet Substances 0.000 claims description 4
- 239000003607 modifier Substances 0.000 claims description 3
- 235000014633 carbohydrates Nutrition 0.000 claims description 2
- 239000000654 additive Substances 0.000 abstract 1
- 239000000314 lubricant Substances 0.000 abstract 1
- 235000000346 sugar Nutrition 0.000 abstract 1
- 150000008163 sugars Chemical class 0.000 abstract 1
- 229940032147 starch Drugs 0.000 description 27
- 229910002016 Aerosil® 200 Inorganic materials 0.000 description 26
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 description 23
- 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 22
- 159000000000 sodium salts Chemical class 0.000 description 14
- 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 12
- 235000014443 Pyrus communis Nutrition 0.000 description 11
- 238000002156 mixing Methods 0.000 description 11
- 238000003756 stirring Methods 0.000 description 11
- 229930195725 Mannitol Natural products 0.000 description 9
- 239000000594 mannitol Substances 0.000 description 9
- 238000005550 wet granulation Methods 0.000 description 9
- 229940079593 drug Drugs 0.000 description 8
- 238000009472 formulation Methods 0.000 description 8
- 239000007909 solid dosage form Substances 0.000 description 7
- 239000003795 chemical substances by application Substances 0.000 description 5
- 229940079832 sodium starch glycolate Drugs 0.000 description 5
- 239000008109 sodium starch glycolate Substances 0.000 description 5
- 229920003109 sodium starch glycolate Polymers 0.000 description 5
- 239000002552 dosage form Substances 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 2
- -1 Hydroxypropyl Chemical group 0.000 description 2
- 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 2
- 229930006000 Sucrose Natural products 0.000 description 2
- 230000000172 allergic effect Effects 0.000 description 2
- 208000010668 atopic eczema Diseases 0.000 description 2
- 239000001913 cellulose Substances 0.000 description 2
- 229920002678 cellulose Polymers 0.000 description 2
- 235000010980 cellulose Nutrition 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 229960003592 fexofenadine Drugs 0.000 description 2
- RWTNPBWLLIMQHL-UHFFFAOYSA-N fexofenadine Chemical compound C1=CC(C(C)(C(O)=O)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 RWTNPBWLLIMQHL-UHFFFAOYSA-N 0.000 description 2
- 238000011049 filling Methods 0.000 description 2
- 239000007903 gelatin capsule 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
- 229940080313 sodium starch Drugs 0.000 description 2
- 239000005720 sucrose Substances 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 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 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 1
- 229920002785 Croscarmellose sodium Polymers 0.000 description 1
- 108010010803 Gelatin Proteins 0.000 description 1
- 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 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- 206010039085 Rhinitis allergic Diseases 0.000 description 1
- 240000008042 Zea mays Species 0.000 description 1
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 description 1
- 235000002017 Zea mays subsp mays Nutrition 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
- 208000026935 allergic disease Diseases 0.000 description 1
- 201000010105 allergic rhinitis Diseases 0.000 description 1
- 229910000019 calcium carbonate Inorganic materials 0.000 description 1
- 229960003563 calcium carbonate Drugs 0.000 description 1
- 235000010216 calcium carbonate Nutrition 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 description 1
- 150000007942 carboxylates Chemical class 0.000 description 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 235000005822 corn Nutrition 0.000 description 1
- 229960001681 croscarmellose sodium Drugs 0.000 description 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 238000007908 dry granulation Methods 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 235000011852 gelatine desserts Nutrition 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 229960001375 lactose Drugs 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 229940057948 magnesium stearate Drugs 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- 229940124531 pharmaceutical excipient Drugs 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SK1779-2002A SK285964B6 (sk) | 2002-12-13 | 2002-12-13 | Liečivý prípravok obsahujúci fexofenadín hydrochlorid a spôsob jeho prípravy |
| CZ2003-3277A CZ304912B6 (cs) | 2002-12-13 | 2003-12-01 | Léčivý přípravek obsahující fexofenadin-hydrochlorid a způsob jeho přípravy |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SK1779-2002A SK285964B6 (sk) | 2002-12-13 | 2002-12-13 | Liečivý prípravok obsahujúci fexofenadín hydrochlorid a spôsob jeho prípravy |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| SK17792002A3 SK17792002A3 (sk) | 2004-08-03 |
| SK285964B6 true SK285964B6 (sk) | 2007-12-06 |
Family
ID=32653845
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SK1779-2002A SK285964B6 (sk) | 2002-12-13 | 2002-12-13 | Liečivý prípravok obsahujúci fexofenadín hydrochlorid a spôsob jeho prípravy |
Country Status (2)
| Country | Link |
|---|---|
| CZ (1) | CZ304912B6 (cs) |
| SK (1) | SK285964B6 (cs) |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10044776A1 (de) * | 2000-09-09 | 2002-04-04 | Wolfgang Richter | Zweigeteilte Pressschnecke |
| US20030021849A1 (en) * | 2001-04-09 | 2003-01-30 | Ben-Zion Dolitzky | Polymorphs of fexofenadine hydrochloride |
| US6960357B2 (en) * | 2001-05-25 | 2005-11-01 | Mistral Pharma Inc. | Chemical delivery device |
-
2002
- 2002-12-13 SK SK1779-2002A patent/SK285964B6/sk not_active IP Right Cessation
-
2003
- 2003-12-01 CZ CZ2003-3277A patent/CZ304912B6/cs not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| CZ20033277A3 (en) | 2004-07-14 |
| SK17792002A3 (sk) | 2004-08-03 |
| CZ304912B6 (cs) | 2015-01-21 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MM4A | Patent lapsed due to non-payment of maintenance fees |
Effective date: 20191213 |