ZA200603656B - Controlled-release pharmaceutical formulation - Google Patents
Controlled-release pharmaceutical formulation Download PDFInfo
- Publication number
- ZA200603656B ZA200603656B ZA200603656A ZA200603656A ZA200603656B ZA 200603656 B ZA200603656 B ZA 200603656B ZA 200603656 A ZA200603656 A ZA 200603656A ZA 200603656 A ZA200603656 A ZA 200603656A ZA 200603656 B ZA200603656 B ZA 200603656B
- Authority
- ZA
- South Africa
- Prior art keywords
- pharmaceutical formulation
- formulation according
- coating
- polymer
- pellet
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims description 26
- 238000013270 controlled release Methods 0.000 title claims description 17
- 239000008188 pellet Substances 0.000 claims description 38
- 238000000576 coating method Methods 0.000 claims description 34
- 239000011248 coating agent Substances 0.000 claims description 33
- 229920000642 polymer Polymers 0.000 claims description 26
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 26
- 239000013543 active substance Substances 0.000 claims description 25
- 239000006185 dispersion Substances 0.000 claims description 23
- 239000000203 mixture Substances 0.000 claims description 23
- DRHKJLXJIQTDTD-OAHLLOKOSA-N Tamsulosine Chemical compound CCOC1=CC=CC=C1OCCN[C@H](C)CC1=CC=C(OC)C(S(N)(=O)=O)=C1 DRHKJLXJIQTDTD-OAHLLOKOSA-N 0.000 claims description 18
- 229960002613 tamsulosin Drugs 0.000 claims description 18
- 238000000034 method Methods 0.000 claims description 17
- 238000002360 preparation method Methods 0.000 claims description 13
- 238000009472 formulation Methods 0.000 claims description 11
- 238000001125 extrusion Methods 0.000 claims description 8
- 238000005563 spheronization Methods 0.000 claims description 8
- 229920001577 copolymer Polymers 0.000 claims description 6
- 239000004094 surface-active agent Substances 0.000 claims description 6
- 206010004446 Benign prostatic hyperplasia Diseases 0.000 claims description 5
- JIGUQPWFLRLWPJ-UHFFFAOYSA-N Ethyl acrylate Chemical compound CCOC(=O)C=C JIGUQPWFLRLWPJ-UHFFFAOYSA-N 0.000 claims description 5
- 208000004403 Prostatic Hyperplasia Diseases 0.000 claims description 5
- PNJWIWWMYCMZRO-UHFFFAOYSA-N pent‐4‐en‐2‐one Natural products CC(=O)CC=C PNJWIWWMYCMZRO-UHFFFAOYSA-N 0.000 claims description 5
- 239000003814 drug Substances 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 4
- 238000005469 granulation Methods 0.000 claims description 4
- 230000003179 granulation Effects 0.000 claims description 4
- 150000003839 salts Chemical class 0.000 claims description 4
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 claims description 3
- 229920003145 methacrylic acid copolymer Polymers 0.000 claims description 3
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 3
- 229920013820 alkyl cellulose Polymers 0.000 claims description 2
- 239000002775 capsule Substances 0.000 claims description 2
- 239000004615 ingredient Substances 0.000 claims description 2
- 229920000058 polyacrylate Polymers 0.000 claims description 2
- 125000000129 anionic group Chemical group 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 9
- 239000008108 microcrystalline cellulose Substances 0.000 description 9
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 9
- 229940016286 microcrystalline cellulose Drugs 0.000 description 9
- 239000000454 talc Substances 0.000 description 9
- 229910052623 talc Inorganic materials 0.000 description 9
- 239000000725 suspension Substances 0.000 description 6
- 229920003163 Eudragit® NE 30 D Polymers 0.000 description 5
- ZZIZZTHXZRDOFM-UHFFFAOYSA-N 2-(2-ethoxyphenoxy)ethyl-[1-(4-methoxy-3-sulfamoylphenyl)propan-2-yl]azanium;chloride Chemical compound Cl.CCOC1=CC=CC=C1OCCNC(C)CC1=CC=C(OC)C(S(N)(=O)=O)=C1 ZZIZZTHXZRDOFM-UHFFFAOYSA-N 0.000 description 4
- 230000036470 plasma concentration Effects 0.000 description 4
- 229960003198 tamsulosin hydrochloride Drugs 0.000 description 4
- 229920003138 Eudragit® L 30 D-55 Polymers 0.000 description 3
- 229920003153 Eudragit® NE polymer Polymers 0.000 description 3
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 3
- 239000004141 Sodium laurylsulphate Substances 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 125000005395 methacrylic acid group Chemical group 0.000 description 3
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 3
- 230000001225 therapeutic effect Effects 0.000 description 3
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 description 2
- 239000001856 Ethyl cellulose Substances 0.000 description 2
- 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 description 2
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 230000001419 dependent effect Effects 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 150000002148 esters Chemical class 0.000 description 2
- 235000019325 ethyl cellulose Nutrition 0.000 description 2
- 229920001249 ethyl cellulose Polymers 0.000 description 2
- -1 fatty acid esters Chemical class 0.000 description 2
- 125000000524 functional group Chemical group 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 2
- 229920000136 polysorbate Polymers 0.000 description 2
- 229950008882 polysorbate Drugs 0.000 description 2
- 229920000053 polysorbate 80 Polymers 0.000 description 2
- 229940068968 polysorbate 80 Drugs 0.000 description 2
- DBMJMQXJHONAFJ-UHFFFAOYSA-N sodium;dodecyl sulfate;hydron Chemical compound [H+].[Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-N 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 239000003826 tablet Substances 0.000 description 2
- GUBGYTABKSRVRQ-UHFFFAOYSA-N 2-(hydroxymethyl)-6-[4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxane-3,4,5-triol Chemical compound OCC1OC(OC2C(O)C(O)C(O)OC2CO)C(O)C(O)C1O GUBGYTABKSRVRQ-UHFFFAOYSA-N 0.000 description 1
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 description 1
- 108060003345 Adrenergic Receptor Proteins 0.000 description 1
- 102000017910 Adrenergic receptor Human genes 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
- 229920001214 Polysorbate 60 Polymers 0.000 description 1
- NWGKJDSIEKMTRX-AAZCQSIUSA-N Sorbitan monooleate Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O NWGKJDSIEKMTRX-AAZCQSIUSA-N 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 206010047141 Vasodilatation Diseases 0.000 description 1
- LWZFANDGMFTDAV-BURFUSLBSA-N [(2r)-2-[(2r,3r,4s)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl] dodecanoate Chemical compound CCCCCCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O LWZFANDGMFTDAV-BURFUSLBSA-N 0.000 description 1
- 239000005557 antagonist Substances 0.000 description 1
- 239000007900 aqueous suspension Substances 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- OGHNVEJMJSYVRP-UHFFFAOYSA-N carvedilol Chemical compound COC1=CC=CC=C1OCCNCC(O)COC1=CC=CC2=C1C1=CC=CC=C1N2 OGHNVEJMJSYVRP-UHFFFAOYSA-N 0.000 description 1
- 230000009137 competitive binding Effects 0.000 description 1
- 239000007891 compressed tablet Substances 0.000 description 1
- 229940069210 coreg Drugs 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 235000014113 dietary fatty acids Nutrition 0.000 description 1
- 230000003292 diminished effect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000035475 disorder Diseases 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 239000000194 fatty acid Substances 0.000 description 1
- 229930195729 fatty acid Natural products 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 230000030136 gastric emptying Effects 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 239000012729 immediate-release (IR) formulation Substances 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 235000012054 meals Nutrition 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 230000027939 micturition Effects 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 230000001242 postsynaptic effect Effects 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 210000002307 prostate Anatomy 0.000 description 1
- 102000005962 receptors Human genes 0.000 description 1
- 108020003175 receptors Proteins 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 210000002460 smooth muscle Anatomy 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 229950006451 sorbitan laurate Drugs 0.000 description 1
- 235000011067 sorbitan monolaureate Nutrition 0.000 description 1
- 229950004959 sorbitan oleate Drugs 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 210000003932 urinary bladder Anatomy 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
- 230000024883 vasodilation Effects 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/18—Sulfonamides
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/08—Drugs for disorders of the urinary system of the prostate
Landscapes
- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Urology & Nephrology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SI200300317A SI21637A (sl) | 2003-12-23 | 2003-12-23 | Farmacevtska oblika z nadzorovanim sproščanjem |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ZA200603656B true ZA200603656B (en) | 2007-09-26 |
Family
ID=34709497
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ZA200603656A ZA200603656B (en) | 2003-12-23 | 2006-05-09 | Controlled-release pharmaceutical formulation |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US20070141149A1 (fr) |
| EP (1) | EP1699439A2 (fr) |
| JP (1) | JP2007516282A (fr) |
| CN (1) | CN1897923A (fr) |
| AR (1) | AR048138A1 (fr) |
| AU (1) | AU2004305422B2 (fr) |
| BR (1) | BRPI0418122A (fr) |
| CA (1) | CA2547586C (fr) |
| RU (1) | RU2447884C2 (fr) |
| SI (1) | SI21637A (fr) |
| WO (1) | WO2005060939A2 (fr) |
| ZA (1) | ZA200603656B (fr) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2006232696A (ja) * | 2005-02-23 | 2006-09-07 | Taisho Pharm Ind Ltd | 徐放性製剤 |
| JP5524624B2 (ja) * | 2007-11-16 | 2014-06-18 | 旭化成ケミカルズ株式会社 | 水系フィルムコーティング液、および、フィルムコーティング顆粒、ならびに、これを用いた錠剤 |
| KR101689688B1 (ko) * | 2008-11-18 | 2016-12-26 | 유씨비 파마, 에스.에이. | ２옥소１피롤리딘 유도체를 포함하는 지연 방출형 제형 |
| CN118284408A (zh) | 2021-10-25 | 2024-07-02 | 法玛利德尔公司 | 他达拉非经口混悬剂 |
| CN115300506A (zh) * | 2022-08-11 | 2022-11-08 | 南京红地生物科技有限公司 | 含有坦索罗辛和米拉贝隆的复方制剂及其制备方法 |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4772475A (en) * | 1985-03-08 | 1988-09-20 | Yamanouchi Pharmaceutical Co., Ltd. | Controlled-release multiple units pharmaceutical formulation |
| PH27186A (en) * | 1989-09-07 | 1993-04-16 | Ciba Geigy Ag | Double-coated granules of disodium pamidronate |
| US5041430A (en) * | 1989-09-18 | 1991-08-20 | Du Pont Mereck Pharmaceutical Company | Oral anticoagulant/platelet inhibitor low dose formulation |
| ZA919510B (en) * | 1990-12-05 | 1992-10-28 | Smithkline Beecham Corp | Pharmaceutical compositions |
| EP0520119A1 (fr) * | 1991-06-17 | 1992-12-30 | Spirig Ag Pharmazeutische Präparate | Composition à base de diclofenac pour l'administration orale |
| GB9117361D0 (en) * | 1991-08-12 | 1991-09-25 | Euro Celtique Sa | Oral dosage form |
| AU8604098A (en) * | 1997-08-01 | 1999-02-22 | Acushnet Company | Golf ball and method of making same |
| EA002806B1 (ru) * | 1997-09-11 | 2002-10-31 | Нюкомед Данмарк А/С | Многоединичные композиции с модифицированным высвобождением нестероидных противовоспалительных лекарственных веществ (nsaid) |
| US6602522B1 (en) * | 1997-11-14 | 2003-08-05 | Andrx Pharmaceuticals L.L.C. | Pharmaceutical formulation for acid-labile compounds |
| WO2001062195A1 (fr) * | 2000-02-24 | 2001-08-30 | Advancis Pharmaceutical Corporation | Compositions antibiotiques et antifongiques |
| US6610328B2 (en) * | 2000-02-24 | 2003-08-26 | Advancis Pharmaceutical Corp. | Amoxicillin-clarithromycin antibiotic composition |
| KR100530546B1 (ko) * | 2001-07-27 | 2005-11-23 | 아스텔라스세이야쿠 가부시키가이샤 | 구강내에서 신속하게 붕괴되는 정제용 서방성 미립자가함유된 조성물 및 그의 제조 방법 |
| KR20040081446A (ko) * | 2002-01-04 | 2004-09-21 | 아이박스 리서치, 인코포레이티드 | 글리피지드의 서방성을 위한 약물 전달 체계 |
| US7018658B2 (en) * | 2002-11-14 | 2006-03-28 | Synthon Bv | Pharmaceutical pellets comprising tamsulosin |
-
2003
- 2003-12-23 SI SI200300317A patent/SI21637A/sl not_active IP Right Cessation
-
2004
- 2004-12-21 AR ARP040104829A patent/AR048138A1/es not_active Application Discontinuation
- 2004-12-22 AU AU2004305422A patent/AU2004305422B2/en not_active Ceased
- 2004-12-22 CN CNA2004800388929A patent/CN1897923A/zh active Pending
- 2004-12-22 RU RU2006126786/15A patent/RU2447884C2/ru not_active IP Right Cessation
- 2004-12-22 BR BRPI0418122-0A patent/BRPI0418122A/pt not_active IP Right Cessation
- 2004-12-22 WO PCT/SI2004/000044 patent/WO2005060939A2/fr active Application Filing
- 2004-12-22 CA CA2547586A patent/CA2547586C/fr not_active Expired - Fee Related
- 2004-12-22 JP JP2006546934A patent/JP2007516282A/ja active Pending
- 2004-12-22 US US10/583,440 patent/US20070141149A1/en not_active Abandoned
- 2004-12-22 EP EP04809252A patent/EP1699439A2/fr not_active Ceased
-
2006
- 2006-05-09 ZA ZA200603656A patent/ZA200603656B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP1699439A2 (fr) | 2006-09-13 |
| SI21637A (sl) | 2005-06-30 |
| RU2447884C2 (ru) | 2012-04-20 |
| CA2547586C (fr) | 2012-12-04 |
| AR048138A1 (es) | 2006-04-05 |
| JP2007516282A (ja) | 2007-06-21 |
| BRPI0418122A (pt) | 2007-04-17 |
| AU2004305422A1 (en) | 2005-07-07 |
| RU2006126786A (ru) | 2008-01-27 |
| WO2005060939A3 (fr) | 2005-12-29 |
| CN1897923A (zh) | 2007-01-17 |
| WO2005060939A2 (fr) | 2005-07-07 |
| CA2547586A1 (fr) | 2005-07-07 |
| US20070141149A1 (en) | 2007-06-21 |
| AU2004305422B2 (en) | 2010-12-23 |
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