CA1292913C - Preparation pharmaceutique a liberation continue contenant des granules a plusieurs couches - Google Patents

Preparation pharmaceutique a liberation continue contenant des granules a plusieurs couches

Info

Publication number: CA1292913C
Authority: CA; Canada
Prior art keywords: layer; release; particles; slow; rapid
Prior art date: 1986-10-21
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Expired - Lifetime

Application number

CA000521013A

Other languages

English (en)

Inventor

Sumio Watanabe

Ichiro Yamakawa

Hidenobu Ando

Nobutaka Noda

Yasuo Miyake

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

Eisai R&D Management Co Ltd

Original Assignee

Eisai Co Ltd

Priority date (The priority date 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 date listed.)

1986-10-21

Filing date

1986-10-21

Publication date

1991-12-10

1986-10-21 Application filed by Eisai Co Ltd filed Critical Eisai Co Ltd

1986-10-21 Priority to CA000521013A priority Critical patent/CA1292913C/fr

1991-12-10 Application granted granted Critical

1991-12-10 Publication of CA1292913C publication Critical patent/CA1292913C/fr

2008-12-10 Anticipated expiration legal-status Critical

Status Expired - Lifetime legal-status Critical Current

Links

239000008187 granular material Substances 0.000 title claims abstract description 55
238000013268 sustained release Methods 0.000 title description 3
239000012730 sustained-release form Substances 0.000 title description 3
239000000825 pharmaceutical preparation Substances 0.000 title 1
229910052751 metal Inorganic materials 0.000 claims abstract description 12
239000002184 metal Substances 0.000 claims abstract description 12
QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims abstract description 12
239000000203 mixture Substances 0.000 claims description 26
239000001856 Ethyl cellulose Substances 0.000 claims description 14
ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 14
235000019325 ethyl cellulose Nutrition 0.000 claims description 14
229920001249 ethyl cellulose Polymers 0.000 claims description 14
229920001800 Shellac Polymers 0.000 claims description 13
239000004208 shellac Substances 0.000 claims description 13
235000013874 shellac Nutrition 0.000 claims description 13
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 claims description 13
229940113147 shellac Drugs 0.000 claims description 13
CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims description 12
239000008116 calcium stearate Substances 0.000 claims description 11
235000013539 calcium stearate Nutrition 0.000 claims description 11
HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 6
239000001993 wax Substances 0.000 claims description 5
239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 3
235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 3
229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 3
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 3
235000019359 magnesium stearate Nutrition 0.000 claims description 3
230000002035 prolonged effect Effects 0.000 abstract description 3
239000002245 particle Substances 0.000 description 73
VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 20
LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 19
238000004090 dissolution Methods 0.000 description 16
239000004615 ingredient Substances 0.000 description 15
239000003826 tablet Substances 0.000 description 14
239000000454 talc Substances 0.000 description 12
229910052623 talc Inorganic materials 0.000 description 12
239000000523 sample Substances 0.000 description 11
YQSHYGCCYVPRDI-UHFFFAOYSA-N (4-propan-2-ylphenyl)methanamine Chemical compound CC(C)C1=CC=C(CN)C=C1 YQSHYGCCYVPRDI-UHFFFAOYSA-N 0.000 description 10
229960003782 dextromethorphan hydrobromide Drugs 0.000 description 10
238000000034 method Methods 0.000 description 10
239000000377 silicon dioxide Substances 0.000 description 10
229920002261 Corn starch Polymers 0.000 description 9
239000008120 corn starch Substances 0.000 description 9
235000019441 ethanol Nutrition 0.000 description 9
229960002819 diprophylline Drugs 0.000 description 8
KSCFJBIXMNOVSH-UHFFFAOYSA-N dyphylline Chemical compound O=C1N(C)C(=O)N(C)C2=C1N(CC(O)CO)C=N2 KSCFJBIXMNOVSH-UHFFFAOYSA-N 0.000 description 8
238000009472 formulation Methods 0.000 description 6
229930006000 Sucrose Natural products 0.000 description 5
150000001875 compounds Chemical class 0.000 description 4
230000006378 damage Effects 0.000 description 4
238000007922 dissolution test Methods 0.000 description 4
239000003814 drug Substances 0.000 description 4
230000000694 effects Effects 0.000 description 4
239000000463 material Substances 0.000 description 4
239000004200 microcrystalline wax Substances 0.000 description 4
235000019808 microcrystalline wax Nutrition 0.000 description 4
-1 octyl decyl Chemical group 0.000 description 4
230000001681 protective effect Effects 0.000 description 4
244000215068 Acacia senegal Species 0.000 description 3
229920000084 Gum arabic Polymers 0.000 description 3
239000002202 Polyethylene glycol Substances 0.000 description 3
239000000205 acacia gum Substances 0.000 description 3
235000010489 acacia gum Nutrition 0.000 description 3
239000003405 delayed action preparation Substances 0.000 description 3
235000014113 dietary fatty acids Nutrition 0.000 description 3
239000000194 fatty acid Substances 0.000 description 3
229930195729 fatty acid Natural products 0.000 description 3
239000007902 hard capsule Substances 0.000 description 3
238000001727 in vivo Methods 0.000 description 3
238000010030 laminating Methods 0.000 description 3
239000007788 liquid Substances 0.000 description 3
238000002156 mixing Methods 0.000 description 3
229920001223 polyethylene glycol Polymers 0.000 description 3
238000003860 storage Methods 0.000 description 3
239000005720 sucrose Substances 0.000 description 3
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
229920002153 Hydroxypropyl cellulose Polymers 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
238000002835 absorbance Methods 0.000 description 2
230000015572 biosynthetic process Effects 0.000 description 2
239000011248 coating agent Substances 0.000 description 2
238000000576 coating method Methods 0.000 description 2
239000007891 compressed tablet Substances 0.000 description 2
238000007906 compression Methods 0.000 description 2
230000006835 compression Effects 0.000 description 2
239000001863 hydroxypropyl cellulose Substances 0.000 description 2
235000010977 hydroxypropyl cellulose Nutrition 0.000 description 2
230000000977 initiatory effect Effects 0.000 description 2
229920000609 methyl cellulose Polymers 0.000 description 2
239000001923 methylcellulose Substances 0.000 description 2
238000002360 preparation method Methods 0.000 description 2
230000002459 sustained effect Effects 0.000 description 2
RLYOPPJABLAKCZ-UHFFFAOYSA-N 2-butoxycarbonylbenzenecarboperoxoic acid Chemical compound CCCCOC(=O)C1=CC=CC=C1C(=O)OO RLYOPPJABLAKCZ-UHFFFAOYSA-N 0.000 description 1
RHLJLALHBZGAFM-UHFFFAOYSA-N Bunazosinum Chemical compound C1CN(C(=O)CCC)CCCN1C1=NC(N)=C(C=C(OC)C(OC)=C2)C2=N1 RHLJLALHBZGAFM-UHFFFAOYSA-N 0.000 description 1
VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
CPELXLSAUQHCOX-UHFFFAOYSA-N Hydrogen bromide Chemical compound Br CPELXLSAUQHCOX-UHFFFAOYSA-N 0.000 description 1
MKXZASYAUGDDCJ-SZMVWBNQSA-N LSM-2525 Chemical compound C1CCC[C@H]2[C@@]3([H])N(C)CC[C@]21C1=CC(OC)=CC=C1C3 MKXZASYAUGDDCJ-SZMVWBNQSA-N 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
FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
DYWNLSQWJMTVGJ-KUSKTZOESA-N Phenylpropanolamine hydrochloride Chemical compound Cl.C[C@H](N)[C@H](O)C1=CC=CC=C1 DYWNLSQWJMTVGJ-KUSKTZOESA-N 0.000 description 1
235000021355 Stearic acid Nutrition 0.000 description 1
XTXRWKRVRITETP-UHFFFAOYSA-N Vinyl acetate Chemical compound CC(=O)OC=C XTXRWKRVRITETP-UHFFFAOYSA-N 0.000 description 1
238000007605 air drying Methods 0.000 description 1
230000004888 barrier function Effects 0.000 description 1
IUGQFMIATSVYLK-UHFFFAOYSA-N benzyl 2-(4-hydroxyphenyl)acetate Chemical compound C1=CC(O)=CC=C1CC(=O)OCC1=CC=CC=C1 IUGQFMIATSVYLK-UHFFFAOYSA-N 0.000 description 1
239000011230 binding agent Substances 0.000 description 1
230000000903 blocking effect Effects 0.000 description 1
229960002467 bunazosin Drugs 0.000 description 1
229960003612 bunazosin hydrochloride Drugs 0.000 description 1
239000002775 capsule Substances 0.000 description 1
229920002678 cellulose Polymers 0.000 description 1
239000001913 cellulose Substances 0.000 description 1
235000010980 cellulose Nutrition 0.000 description 1
239000013068 control sample Substances 0.000 description 1
235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 description 1
229960001985 dextromethorphan Drugs 0.000 description 1
239000003480 eluent Substances 0.000 description 1
238000011049 filling Methods 0.000 description 1
239000001341 hydroxy propyl starch Substances 0.000 description 1
235000013828 hydroxypropyl starch Nutrition 0.000 description 1
150000002500 ions Chemical class 0.000 description 1
238000004898 kneading Methods 0.000 description 1
239000008101 lactose Substances 0.000 description 1
229910052749 magnesium Inorganic materials 0.000 description 1
239000011777 magnesium Substances 0.000 description 1
238000004519 manufacturing process Methods 0.000 description 1
238000000465 moulding Methods 0.000 description 1
OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
239000008188 pellet Substances 0.000 description 1
239000000546 pharmaceutical excipient Substances 0.000 description 1
229960002305 phenylpropanolamine hydrochloride Drugs 0.000 description 1
239000002904 solvent Substances 0.000 description 1
238000005507 spraying Methods 0.000 description 1
239000008117 stearic acid Substances 0.000 description 1
238000005728 strengthening Methods 0.000 description 1
235000015112 vegetable and seed oil Nutrition 0.000 description 1
239000008158 vegetable oil Substances 0.000 description 1
238000005303 weighing Methods 0.000 description 1
230000004584 weight gain Effects 0.000 description 1
235000019786 weight gain Nutrition 0.000 description 1

Landscapes

Medicinal Preparation (AREA)

CA000521013A 1986-10-21 1986-10-21 Preparation pharmaceutique a liberation continue contenant des granules a plusieurs couches Expired - Lifetime CA1292913C (fr)

Priority Applications (1)

Application Number	Priority Date	Filing Date	Title
CA000521013A CA1292913C (fr)	1986-10-21	1986-10-21	Preparation pharmaceutique a liberation continue contenant des granules a plusieurs couches

Applications Claiming Priority (1)

Application Number	Priority Date	Filing Date	Title
CA000521013A CA1292913C (fr)	1986-10-21	1986-10-21	Preparation pharmaceutique a liberation continue contenant des granules a plusieurs couches

Publications (1)

Publication Number	Publication Date
CA1292913C true CA1292913C (fr)	1991-12-10

Family

ID=4134188

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
CA000521013A Expired - Lifetime CA1292913C (fr)	1986-10-21	1986-10-21	Preparation pharmaceutique a liberation continue contenant des granules a plusieurs couches

Country Status (1)

Country	Link
CA (1)	CA1292913C (fr)

1986
- 1986-10-21 CA CA000521013A patent/CA1292913C/fr not_active Expired - Lifetime

Legal Events

Date	Code	Title	Description
2008-12-10	MKEX	Expiry

Publication	Publication Date	Title
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EP1524967B1 (fr)	2008-03-12	Preparation pharmaceutique contenant un compose de benzimidazole melange a de la cellulose microcristalline et procede pour sa preparation
CA1292913C (fr)	1991-12-10	Preparation pharmaceutique a liberation continue contenant des granules a plusieurs couches
CA2433915C (fr)	2010-04-20	Forme posologique orale a liberation regulee amelioree
JPH0710756A (ja)	1995-01-13	塩酸ニカルジピン徐放製剤
HK1072195B (en)	2008-05-23	Pharmaceutical preparation containing a benzimidazole compound mixed with microcrystalline cellulose and a method for its preparation
AU2002253907A1 (en)	2002-08-19	Improved controlled release oral dosage form