TWI400096B - 經控制釋放的水凝膠配方 - Google Patents
經控制釋放的水凝膠配方 Download PDFInfo
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- TWI400096B TWI400096B TW096132928A TW96132928A TWI400096B TW I400096 B TWI400096 B TW I400096B TW 096132928 A TW096132928 A TW 096132928A TW 96132928 A TW96132928 A TW 96132928A TW I400096 B TWI400096 B TW I400096B
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- polymer
- water
- insoluble polymer
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- 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
- A61K31/47—Quinolines; Isoquinolines
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- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
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- A—HUMAN NECESSITIES
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Description
本發明大致關於一種藥物組合物,例如以固體形式呈現的口服藥物配方。更具體地,本發明係關於一種長效性劑量組合物以及組合物中的載體與有效成分,例如含有藥物與載體材料之口服劑量配方的經控制釋放、持續釋放以及延長釋放藥物組合物。
將藥物以一預定速率傳輸,進而於長時間內使藥物濃度維持在所需療效,早已受到廣大注意。多數人都知道固體藥物配方需要每日口服三或四次。但口服配方服用次數仍待降低,例如降低至每日一次。此外,在藥物傳輸速率部份亦存有其他問題。舉例而言,已發現的立即釋放藥物配方會產生多種副作用,此係因在服用藥物後,立刻在血管或血漿中釋放的高藥物濃度所造成。
由於在藥物傳輸過程中,疏水性有效成分的水溶性較低且溶離(dissolution)速率較慢,目前挑戰將多種疏水性有效成分配製成延長釋放藥物之組合物。微粒製造方法(micronization)與乳劑已被提出可於體內提高表現。然而,這些方法具有諸多缺點,包含了穩定性、藥物沉澱與包裝問題。此外,為了配製疏水性有效成分的持久性釋放藥物組合物,而將聚合物加入的方式則常於其釋放曲線中呈現不利的初期驟增,進而導致較差、非恆定且常為非線
性的釋放速率。
因此,仍待配製出一種用於疏水性有效成分且經改善的經控制釋放配方,以及製備此種經控制釋放配方的方法。
本發明之實施例大致提供製備口服藥學組合物的藥物組合物與方法,例如疏水性有效成分的經控制釋放劑量組合物。於一實施例中,提供具有一或多個水凝膠材料或水膨脹聚合物的藥學組合物,並以一定比例與一釋放速率調節聚合物結合,以控制疏水性有效成分的體內與體外釋放速率。
於另一實施例中,藥學組合物可包含療效有效量的粉末狀疏水性藥物、一非交聯水膨脹單聚物以及一非凝膠不可溶聚合物,其中該非交聯水膨脹單聚物與該非凝膠不可溶聚合物以重量比約1:10至10:1結合。
於一實施例中,藥學組合物包含一粉末狀之非交聯水膨脹單聚物以及一粉末狀之非凝膠不可溶聚合物,其中該非交聯水膨脹單聚物與該非凝膠不可溶聚合物以重量比約1:10至10:1結合,且與一療效有效量的粉末狀疏水性藥物直接壓合。
於一實施例中,一經控制釋放之藥物組合物可包含一粉末狀非交聯水膨脹單聚物以及粉末狀非凝膠不可溶聚合物,其中該非交聯水膨脹單聚物與該非凝膠不可溶聚合物以重量比約1:10至10:1結合,且與一療效有效量的粉
末狀西洛他唑(cilostazol)直接壓合,該療效有效量為藥學組合物重量約1%至95%。
於一實施例中,一種經控制釋放之藥學組合物,可包含一粉末狀非交聯水膨脹單聚物,以及粉末狀非凝膠不可溶聚合物,其中該非交聯水膨脹單聚物與該非凝膠不可溶聚合物以重量比約1:10至10:1結合,且與一療效有效量的粉末狀甲磺酸多沙唑嗪(doxazosin mesylate)直接壓合,該療效有效量為該藥學組合物重量約1%至95%。
此外,一種施用一含有一療效有效量的粉末狀疏水性藥物之藥學組合物,可包含對一哺乳類動物施用一有效量的該藥學組合物,該藥學組合物包含一粉末狀之非交聯水膨脹單聚物;以及一粉末狀之非凝膠不可溶聚合物,其中該非交聯水膨脹單聚物與該非凝膠不可溶聚合物以重量比約1:10至10:1結合,且與該疏水性藥物直接壓合。
再則,更提供一種使用一藥物配方治療間歇性跛行的方法。對一哺乳類動物施用一有效量的該藥學組合物,該藥學組合物包含一粉末狀之非交聯水膨脹單聚物,以及一粉末狀之非凝膠不可溶聚合物,其中該非交聯水膨脹單聚物與該非凝膠不可溶聚合物以重量比約1:10至10:1結合,且與一療效有效量的粉末狀西洛他唑(cilostazol)直接壓合。
本發明提供一種具有至少一水膨脹水凝膠聚合物材料
的藥物組合物。於一實施例中,則獲得一水凝膠為主之藥物劑量系統,其可提供疏水性藥物之持續釋放。依據本發明一或多個實施例,此藥物組合物能夠提供經控制的釋放速率,舉例而言,疏水性有效成分大體上為零級釋放速率(zero-order release rate)。
於一實施例中,疏水性藥物之藥物組合物可包含一定比例的水凝膠材料與釋放速率調控聚合物,以達到所需的體外溶離(且最終達到所需的體內生物利用率)表現。水凝膠材料與釋放速率調控聚合物之重量比為1:20至20:1(例如為1:10至10:1)。
釋放速率調控聚合物可例如為非凝膠不可溶聚合物、疏水性聚合物、腸溶性聚合物(enteric polymer)等。此外,可包含一無毒性且藥物上可接受之穩定離子化化合物,以幫助水凝膠材料並修飾具療效之有效藥物的釋放速率。穩定離子化化合物可為例如溼潤劑(wetting agents)、界面活性劑(例如十二烷基硫酸鈉(sodium lauryl sulfate)、吐溫-20(tween-20)、吐溫-80(tween-80)、聚乙二醇(PEG)等),一賦型劑(例如稀釋液、黏結劑、釋放修飾劑、滑動劑與潤滑劑等)其中之一。
藥物配方之一例示可包含療效有效量的疏水性藥物、非交聯水膨脹單聚物水凝膠以及非凝膠不可溶聚合物。於此所述之疏水性藥物大致包含適度地低溶解於水中的有效藥學組合物,例如任何有機或無機化合物、或具有生物活性或藥理活性之物質,此物質於室溫水之溶解度低於約1 g/ml,例如低於100 mg/ml,或log P值大於2,或為酯溶性,或不吸附水等。
舉例而言,疏水性藥物可為難溶於水而欲用於口服的藥物有效化合物,但其普遍不易且不迅速地於消化道中分解。由於此疏水性性質,故常難以將疏水性藥物配製成能於體內呈現出良好生物利用率曲線的藥物。生物利用率低可能導致治療無效、需要使用較高劑量及/或不良的副作用。於此則提供作為例示之化合物。當知任一所述化合物其於室溫水中的溶解度,可輕易藉由快速的化學技術與工具(例如高效能液相層析法或光譜)而決定。
依據本發明可配製而得的疏水性藥物及其藥學上可接受鹽類,包含但不限於下述:消炎鎮痛劑:乙醯胺酚(acetaminophen)、阿洛普令(aloxiprin)、金諾芬(auranofin)、阿扎丙宗(azapropazone)、貝諾酯(benorylate)、塞来昔布(celecoxib)、二氟苯水楊酸(diflunisal)、伊托多雷(etodolac)、芬布芬(fenbufen)、非諾洛芬(fenoprofen)、氟比洛芬(flurbiprofen)、布洛芬(ibuprofen)、美洒辛(indomethacin)、酮基布洛芬(ketoprofen)、甲氯芬那酸(meclofenamic acid)、甲芬那酸(mefenamic acid)萘丁美酮(nabumetone)、萘普生(naproxen)、羥基保泰鬆(oxyphenbutazone)、苯丁唑(phenylbutazone)、吡羅昔康(piroxicam)、羅菲可西保(rofecoxib)、水楊醯胺(salicylamide)、水楊酸(salicylic acid)、舒林酸(sulindac);驅蟲劑(anthelmintics):阿苯達唑(albendazole)、羥萘苄芬寧(bephenium hydroxynaphthoate)、坎苯達唑(cambendazole)、雙氯酚(dichlorophen)、伊維菌素(ivermectin)、甲苯達唑(mebendazole)、奧沙尼奎(oxamniquine)、奧沙托引布奈(oxantel embonate)、奧芬達唑(oxfendazole)、吡喹酮(praziquantel)、雙羥萘酸噻嘧啶(pyrantel embonate)、噻苯咪唑(thiabendazole);抗心律不整劑(anti-arrhythmic agents):胺碘酮(amiodarone)、吡二丙胺(disopyramide)、氟卡尼(flecainide)、奎尼丁(quinidine)、抗細菌劑(anti-bacterial agents):苯耐胺(benethamine)、頭孢克羅(cefaclor)、西諾沙星(cinoxacin)、環丙沙星(ciprofloxacin)、克拉黴素(clarithromycin)、氯法齊明(clofazimine)、氯唑西林(cloxacillin)、地美環素(demeclocycline)、多西環素(doxycycline)、紅黴素(erythromycin)、乙硫異菸醯胺(ethionamide)、亞胺培南(imipenem)、奈啶酸(nalidixic acid)、硝基呋喃妥因錠(nitrofurantoin)、青黴素(penicillin)、利福平(rifampicin)、螺旋霉素(spiramycin)、苯甲醯磺胺(sulphabenzamide)、磺胺醋醯(sulphacetamide)、磺胺嘧啶(sulphadiazine)、周效磺胺(sulphadoxine)、磺胺異噁唑(sulphafurazole)、磺胺甲嘧啶(sulphamerazine)、磺胺甲基異噁唑(sulphamethoxazole)、磺胺吡啶(sulphapyridine)、四環黴素(tetracycline)、甲氧芐氨嘧啶(trimethoprim);抗凝血劑抗凝血劑(anti-coagulants):二苯駢呱哢醇(dicoumarol)、雙嘧達莫(dipyridamole)、醋硝香豆素(nicoumalone)、苯茚滿二酮(phenindione);抗憂鬱劑(anti-depressants):阿莫沙平(amoxapine)、馬普替林(maprotiline)、米安色林(mianserin)、去甲阿米替林(nortriptyline)、奧昔哌汀(oxypertine)、曲唑酮(trazodone)、三甲丙米嗪(trimipramine)、文拉法辛(venlafaxine);糖尿病治療藥品(anti-diabetics):乙醯苯磺醯環己脲(acetohexamide)、氯磺丙脲(chlorpropamide)、格列本脲(glibenclamide)、格列齊特(gliclazide)、格列吡嗪(glipizide)、氮雜庚環醯胺甲苯磺脲(tolazamide)、甲苯磺丁脲(tolbutamide);抗癲癇藥品(anti-epileptics):貝克拉胺(beclamide)、卡馬西平(carbamazepine)、氯硝西泮(clonazepam)、乙苯妥英(ethotoin)、美沙比妥(metharbital)、美芬妥英(methoin)、甲琥胺(methsuximide)、甲苯比妥(methylphenobarbitone)、奧卡西平(oxcarbazepine)、甲乙雙酮(paramethadione)、苯乙醯脲(phenacemide)、苯巴比妥(phenobarbital)、苯琥胺(phensuximide)、苯妥英(phenytoin)、撲癇酮(primidone)、舒噻美(sulthiame)、丙戊酸(valproic acid);抗黴菌劑(anti-fungal agents):兩性霉素(amphotericin)、布康唑(butoconazole)、克霉唑(clotrimazole)、益康唑(econazole)、氟康唑(fluconazole)、氟胞嘧啶(flucytosine)、灰黃霉素(griseofulvin)、伊曲康唑(itraconazole)、酮康唑(ketoconazole)、咪康唑(miconazole)、納他黴素(natamycin)、紐黴素(nystatin)、硫康唑(sulconazole)、特比萘芬(terbinafine)、特康唑(terconazole)、治可那唑(tioconazole)、十一烯酸(undecenoic acid);痛風治療劑(anti-gout agents):別嘌醇(allopurinol)、丙磺舒(probenecid)、苯磺唑酮(sulphinpyrazone);抗高血壓劑(anti-hypertensive agents):氨氯地平(amlodipine)、貝尼地平(benidipine)、達羅地平(darodipine)、二氮嗪(diazoxide)、地爾硫卓(dilitazem)、非洛地平(felodipine)、胍那芐(guanabenz)、依拉地平(isradipine)、甲基多巴(methyldopa)、米諾地爾(minoxidil)、尼卡地平(nicardipine)、硝苯地平(nifedipine)、尼莫地平(nimodipine)、酚苄明(phenoxybenzamine)、哌唑嗪(prazosin)、利舍平(reserpine)、特拉唑嗪(terazosin);抗瘧疾藥品(anti-malarials):阿莫地喹(amodiaquine)、氯喹寧(chloroquine)、氯丙胍(chlorproguanil)、鹵泛群(halofantrine)甲氟喹寧(mefloquine)氯胍(proguanil)、乙胺嘧啶(pyrimethamine)、喹寧(quinine);抗偏頭痛劑(anti-migraine agents):雙氫麥角胺(dihydroergotamine)、麥角胺(ergotamine)、美西麥角(methysergide)、苯噻啶(pizotifen)、舒馬曲坦(sumatriptan);抗蕈毒鹼劑(anti-muscarinic agents):阿托品(atropine)、苯海索(benzhexol)、比哌立登(biperiden)、普羅吩胺(ethopropazine)、莨菪鹼(hyoscyamine)、溴美噴酯(mepenzolate)、奧芬亞胺(oxyphencylcimine)、托品醯胺(tropicamide);抗腫瘤劑與免疫抑制劑(anti-neoplastic agents and immunosuppressants):氨魯米特(aminoglutethimide)、安吖啶(amsacrine)、硫唑嘌呤(azathioprine)、甲磺酸丁二醇二酯(busulphan)、苯丁酸氮芥(chlorambucil)、環孢靈(cyclosporin)、達卡巴嗪(dacarbazine)、雌莫司汀(estramustine)、依托泊苷(etoposide)、非那雄胺(finasteride)、洛莫司汀(lomustine)、美法崙(melphalan)、巰嘌呤(mercaptopurine)、甲氨蝶呤(methotrexate)、絲裂霉素(mitomycin)、米托坦(mitotane)、米托蒽醌(mitozantrone)、丙卡巴肼(procarbazine)、雷洛昔芬(raloxifene)、泰莫克斯芬(tamoxifen)、睾內酪(testolactone);抗帕金森氏症劑(anti-Parkinsonian agents):溴隱亭(bromocriptine)、麥角乙脲(lysuride);抗原蟲劑(anti-protazoal agents):苄硝唑(benznidazole)、氯碘羥喹(clioquinol)、地考喹酯(decoquinate)、双碘喹啉(diiodohydroxyquinoline)、二氯尼特(diloxanide)、二硝托胺(dinitolmide)、呋喃唑酮(furzolidone)、甲硝唑(metronidazole)、尼莫唑(nimorazole)、硝基呋喃(nitrofurazone)、奧哨唑(omidazole)、替硝唑(tinidazole);抗甲狀腺劑(anti-thyroid agents):卡比馬唑(carbimazole)、丙硫氧嘧啶(propylthiouracil);抗焦慮藥(anxiolytics)、鎮靜劑(sedatives)、助眠劑與抗精神病藥物(hypnotics and neuroleptics):阿洛巴比妥(allobarbitone)、布他比妥(allylbarbituric acid)、阿普唑侖(alprazolam)、異戊巴比妥(amylobarbitone)、巴比妥(barbitone)、苯他西泮(bentazepam)、滇西泮(bromazepam)、溴哌醇(bromperidol)、伯替唑他(brotizolam)、丁巴比妥(butobarbitone)、卡溴脲(carbromal)、丙醯奮乃靜(carphenazine)、氯氮卓(chlordiazepoxide)、氯美噻唑(chlormethiazole)、氯丙嗪(chlorpromazine)、氯巴占(clobazam)、氯噻西泮(clotiazepam)、氯氮平(clozapine)、環己巴比妥(cyclobarbitone)、地西泮(diazepam)、氟呱利多(droperidol)、環己炔胺(ethinamate)、氟乃尼松(flunanisone)、氟硝西泮(flunitrazepam)、三氟丙嗪(fluopromazine)、氟哌噻噸(flupenthixol)、氟奮乃靜(fluphenazine)、氟西泮(flurazepam)、氟哌啶醇(haloperidol)、勞拉西泮(lorazepam)、氯甲西泮(lormetazepam)、美達西泮(medazepam)、甲丙氨酯(meprobamate)、甲喹酮(methaqualone)、咪達唑侖(midazolam)、硝西泮(nitrazepam)、奧沙西泮(oxazepam)、戊巴比妥(pentobarbitone)、奮乃靜(perphenazine)、匹莫齊特(pimozide)、丙氯拉嗪(prochlorperazine)、舒必利(sulpiride)、替馬西泮(temazepam)、硫利達嗪(thioridazine)、三唑侖(triazolam)、佐匹克隆(zopiclone);β-受體阻斷劑(β-blockers):醋丁洛爾(acebutolol)、阿普洛爾(alprenolol)、阿替洛爾(atenolol)、拉貝洛爾(labetalol)、美托洛爾(metoprolol)、納多洛爾(nadolol)、氧烯洛爾(oxprenolol)、吲哚洛爾(pindolol)、普萘洛爾(propranolol);心肌收縮藥(cardiac Inotropic agents):氨力農(amrinone)、泮地黃毒苷(digitoxin)、地高辛(digoxin)、依諾昔酮(enoximone)、毛花苷C(lanatoside C)、甲地高辛(medigoxin);類固醇藥(corticosteroids):丙酸倍氯米松(beclomethasone)、倍他米松(betamethasone)、布地奈德(budesonide)、可的松(cortisone)、地思米松(desoxymethasone)、地塞米松(dexamethasone)、氟可龍(flucortolone)、氟氫可的松(fludrocortisone)、氟尼縮松(flunisolide)、氟替卡松(fluticasone)、氫化可的松(hydrocortisone)、甲潑尼龍(methylprednisolone)、潑尼松龍(prednisolone)、潑尼松(prednisone)、曲安西龍(triamcinolone);利尿劑(diuretics):乙醯唑胺(acetazolamide)、阿米洛利(amiloride)、阿米美啶(amisometradine)、苄氟噻嗪(bendroflumethiazide)、布美他尼(bumetanide)、氯苯塞(chlorothiazide)、氯噻酮(chlorthalidone)、依他尼酸(ethacrynic acid)、呋塞米(furosemide)、氫氯苯噻(hydrochlorothiazide)、美托拉腙(metolazone)、螺內酯(spironolactone)、氨苯蝶啶(triamterene);腸胃藥(gastro-intestinal agents):對氨水楊酸(aminosalicylic acid)、比沙可啶(bisacodyl)、西咪替丁(cimetidine)、西沙必利(cisapride)、地芬諾酯(diphenoxylate)、多潘立酮(domperidone)、法莫替丁(famotidine)、洛哌丁胺(loperamide)、美沙拉嗪(mesalazine)、尼扎替丁(nizatidine)、奧美拉唑(omeprazole)、昂丹司瓊(ondansetron)、雷尼替丁(ranitidine)、柳氮磺吡啶(sulphasalazine)、組胺H1受體拮抗劑(histamine H.sub.1-Receptor antagonists):阿伐斯汀(acrivastine)、阿司咪唑(astemizole)、桂利嗪(cinnarizine)、賽克利嗪(cyclizine)、賽庚啶(cyproheptadine)、茶苯海明(dimenhydrinate)、非索非那定(fexofenadine)、氟桂利嗪(flunarizine)、氯雷他定(loratadine)、美可洛嗪(meclozine)、奧沙米特(oxatomide);高脂質血症治療劑(lipid-regulating agents):阿托伐他汀(atorvastatin)、苯扎貝特(bezafibrate)、氯貝丁酯(clofibrate)、右旋甲狀腺素(dextrothyroxine)、非諾貝特(fenofibrate)、吉非貝齊(gemfibrozil)、洛伐他汀(lovastatin)、普羅布考(probucol)、辛伐他汀(simvastatin)、微纖維酸(fibrates)、非諾貝特(fenofibrates);硝酸鹽與其他抗心絞痛藥(nitrates and other anti-anginal agents):亞硝基戊烷(amyl nitrate)、硝基甘油(glyceryl trinitrate)、雙硝酸異山梨酯(isosorbide dinitrate)、單硝酸異山梨酯(isosorbide mononitrate)、四硝基季戊醇(pentaerythritol tetranitrate);營養補充劑(nutritional agents):β-胡蘿蔔素、維他命A、維他命B、維他命D、維他命E、維他命K;鎮痛劑(opioid analgesics):可待因(codeine)、右丙氧芬(dextropropyoxyphene)、二醋嗎啡(diamorphine)、二氫可待因(dihydrocodeine)、美普他酚(meptazinol)、美沙酮(methadone)、嗎啡(morphine)、納布啡(nalbuphine)、潘他唑新(pentazocine);血小板聚集抑制劑(platelet aggregation inhibitors):西洛他唑(cilostazol)、氯吡格雷(clopidogrel)、噻氯匹定(ticlopidine)、雙嘧達莫(dipyridamole)、阿斯匹靈(aspirin);呼吸治療藥(respiratory agents):孟魯司特(montelukast)、普崙司特(pranlukast)(CCN00401)、扎魯司特(zafirlukast)、齊留酮(zileuton);性荷爾蒙(sex hormones):氯米芬(clomiphene)、結合型雌激素(conjugated estrogens)、達那唑(danazol)、雌二醇(estradiol)、乙炔雌二醇(ethinyloestradiol)、美屈孕酮(medrogestone)、醋酸甲羥孕酮(medroxyprogesterone acetate)、美雌醇(mestranol)、甲睾酮(methyltestosterone)、炔諾酮(norethisterone)、諾孕酯(norgestimate)、炔諾孕酮(norgestrel)、黃体酮(progesterone)、司坦唑醇(stanozolol)、已烯雌酚(stiboestrol)、睾酮(testosterone)、7-甲基異炔諾酮(tibolone);興奮劑(stimulants):苯丙胺(amphetamine)、可卡因(cocaine)、硫酸右旋苯丙胺(dexamphetamine)、右芬氟拉明(dexfenfluramine)、氟拉明(fenfluramine)、馬吲哚(mazindol);甲狀腺製劑(thyroid agents):左甲狀腺素(levothyroxine)、其藥學上等效之鹽類其中之一。
其他利於實施本發明之生藥化合物包含,但不限於,西地那非(sildenafil(VIAGRATM
))、阿昔洛韋(acyclovir)、丙氧鳥苷(gancyclovir)、非所非那定(fexofenidine)、塞來考昔(celecoxib(CELEBREXTM
))、羅非考昔(rofecoxib (VIOXXTM
))、雄二酮(androstenedione)、氯喹(chloroquine)、鹽酸苯海拉明(diphenhydramine HCl)、丁螺環酮(buspirone)、甲磺酸多沙唑嗪(doxazosin mesylate)、氯雷他定(loratadine)、克羅米芬(clomiphine)、葡萄糖酸鋅(zinc gluconate)、醋酸鋅(zinc acetate)、氫化可的松(hydrocortisone)、華法林(warfarin)、茚地那韋(indinavir sulfate)、利多卡因(lidocaine)、諾弗卡因(novacaine)、雌二醇(estradiol)、醋酸炔諾酮(norethindrone acetate)、甲羥孕酮(medroxyprogesterone)、右芬氟拉明(dexfenfluramine)、右旋苯丙胺(dextroamphetamine)、多西環素(doxycycline)、沙利竇邁(thalidomide)、氟替卡松(fluticasone)、磷酸氟達拉濱(fludarabine phosphate)、依那西普(etanercept)、鹽酸二甲雙胍(metformin hydrochloride)、透明質酸鹽(hyaluronate)、四松鹽酸(tetrazocin hydrochloride),洛哌丁胺(loperamide)、伊玻蓋因(ibogaine)、氯硝西泮(clonazepam)、氯胺酮(ketamine)、拉米夫定(lamivudine(3TCTM
))、異維A酸(isotretinoin)、尼古丁(nicotine)、甲氟喹(mefloquine)、左氧氟沙星(levofloxacin)、阿托伐他汀(atorvastatin(LIPITORTM
))、硝酸咪康唑(miconazole nitrate(MONISTATTM
))、利托那
韋(ritonavir)、法莫替丁(famotidine)、辛伐他汀(simvastatin(ZOCORTM
))、鹽酸西布曲明單氫化物(sibutramine HCl monohydride)、氧氟沙星(ofloxacin)、蘭索拉唑(lansoprozole)、雷洛西芬(raloxifene(EVISTATM
))、扎那米偉(zanamivir(RELENZATM
))、磷酸奧塞米韋(oseltamivir phosphate)、4-苯基丁酸鈉鹽(4-phenylbutyric acid sodium salt)、氯丙嗪(chlorpromazine)、奈韋拉平(nevirapine)、齊多夫定(zidovudine)、鹽酸西替利嗪(cetirizine hydrochloride(ZYRTECTM
))、雙磷酸鹽類(bisphosphonates)例如帕米膦酸(pamidronate)與唑來磷酸(zoledronate)、硝苯地平(nifedipine)、非洛地平(felodipine)、其藥學上等效之鹽類與類似物。
疏水性藥物之一例示為西洛他唑(cilostazol)或其藥學上等效鹽類。疏水性藥物之另一例示為甲磺酸多沙唑嗪片(doxazosin mesylate)或其藥學上等效鹽類。西洛他唑抑制酸二酯酶III(phosphodiesterase III)並增加血小板中的環單磷酸腺苷(cyclic AMP),進而抑制血小板的聚集且使血管擴張。因此,西洛他唑能用於治療間歇性跛行(intermittent claudication)。血小板聚集抑制劑(例如西洛他唑)基本上係用於治療並預防動脈血栓。血小板經由聚集形成血栓,其於止住因血管受損造成的出血上扮演重要的角色。當血管內皮受損或血管變窄(例如動脈硬化)時,血小板會傾向聚集並引起血栓或栓塞的形成,導致局部缺血疾病,例如心肌梗塞、心絞痛、腦中風、周邊動脈疾病。因此,可施用血小板聚集抑制劑可以預防並治療與局部缺血之相關疾病。
其他血小板聚集抑制劑包含柳酸鹽(salicylates)、二磷酸腺苷抑制劑(adenosine diphosphate(ADP)inhibitors、醣蛋白IIb/IIIa拮抗劑(glycoprotein IIb/IIIa antagonists)、血小板源生長因子(platelet derived growth factor)、間接凝血酶抑制劑(indirect thrombin inhibitors)、環化腺苷酸磷酸二酯酶抑制劑(cAMP-phosphodiesterase inhibitors)以及消炎藥(anti-inflammatory agents)。阿斯匹靈為最早的抗血小板藥物(antiplatelet agents),且經由抑制環氧合酶(cyclooxygenase)而發揮功效。雙嘧達莫(dipyridamole)抑制腺嘌呤核苷(adenosine)的吸收,並增加環單磷酸腺(cyclic AMP)的量。結合雙密達莫(dipridamole)與阿斯匹靈的腦康平(AGGRENOXTM
),則利用與兩藥劑不同的機制來抑制血小板的聚集。氯吡多(clopidogrel)與噻氯匹定(ticlopidine)抑制二磷酸腺苷(adenosine diphosphate,ADP)結合至其血小板接受器,進而抑制血小板的聚集。氯吡格雷(clopidogrel)與噻氯匹定(ticlopidine)包含了中風、心肌梗塞、急性冠心症或其他血管性死亡的二次預防。研究用或較不常見之具潛力抗血小板凝聚劑包含納豆激酶(nattokinase)、洛曲非班(lotrafiban)、奧普烯醇(oprostenol)、雜環-取代之三環(terocyclic-substituted tricyclics)、阿昔單抗(abciximab)、埃替非巴肽(eptifibatide)、貝前列環素(beraprost):1氫-環戊並[b]苯並呋喃-5-丁酸(1H-Cyclopenta[b]benzofuran-5-butanoic acid)、2,3,3a,8b-四氫-2羥基-1-(3-羥基-4-甲基-1-辛烯-6-炔基(2,3,3a,8b-tetrahydro-2-hydroxy-1-(3-hydroxy-4-methyl-1-octen-6-ynyl);阿卡地新(acadesine):1H-咪唑-4-甲酰胺(1H-imidazole-4-carboxamide)、5-胺基-1-β-D-呋喃核糖基(5-amino-1-β-D-ribofuranosyl-);貝前列素鈉(beraprost sodium):1氫-環戊並[b]苯並呋喃-5-丁酸(1H-Cyclopenta[b]benzofuran-5-butanoic acid)、2,3,3a,8b-四氫-2羥基-1-(3-羥基-4-甲基-1-辛烯-6-炔基(2,3,3a,8b-tetrahydro-2-hydroxy-1-(3-hydroxy-4-methyl-1-octen-6-ynyl)單鈉鹽;西前列烯鈣(ciprostene calcium):正戊酸(pentanoic acid)、5-[(3aS,5R,6R,6aR)-六氫-5-羥基-6-[(1E,3S)-3-羥基-1-辛基]-3a-甲基-2(1H)-亞並環戊二烯基]鈣鹽(5-[(3aS,5R,6R,6aR)-hexahydro-5-hydroxy-6-[(1E,3S)-3-hydroxy-1-octenyl]-3a-methyl-2(1H)-pentalenylidene]-,calcium salt);伊他格雷(itazigrel):噻唑(thiazole)、4,5-雙(4-甲氧苯基)-2-(4-三氟甲基)(4,5-bis(4-methoxyphenyl)-2-(trifluoromethyl));利法利嗪(lifarizine):哌嗪(piperazine)、1-二苯甲基-4-[[5-甲基-2-(4-甲基苯基)-1H-咪唑-4-基]甲基]-)(1-(diphenylmethyl)-4-[[5-methyl-2-(4-methylphenyl)-1H-imidazol-4-yl]methyl]-);氧格雷酯(oxagrelate):6-酞嗪甲酸(6-phthalazine carboxylic acid)、3,4-二氫-1-羥甲基-5,7-二甲基-4-酮-乙基酯(3,4-dihydro-1-(hydroxymethyl)-5,7-dimethyl-4-oxo-ethyl ester)、其藥學上等效鹽類其中之一。
於此所使用之水凝膠為主的水膨脹聚合物與非凝膠不可溶聚合物係用以調整低水溶解度之有效藥學組合物的釋放速率與生物利用率。舉例而言,可使用離子性水凝膠聚合物,亦或是非離子性水凝膠聚合物(非離子性親水性水凝膠聚合物)。如一例示,可使用藥學適用單聚物水凝膠(例如由同一類型單體所聚合且未由兩個或多個不同類型之單體交聯而成的聚合物、聚合物具有相同的側鏈、非共聚物)。於一實施例中,藥學組合物可包含其重量約4%至80%的未交聯水膨脹單聚物。
未交聯水膨脹單聚物之例示包含羥丙基甲基纖維素(hydroxypropyl methylcellulose(HPMC),例如METHOCELTM
等)、藻酸鹽(alginate)、藻酸鈉(sodium alginate)、纖維素水凝膠(cellulose hydrogel)、聚乙烯吡咯烷酮(polyvinylpyrrolidone)、羥丙基纖維素(hydroxypropyl cellulose(HPC),例如KLUCELTM
等)、硝化纖維素(nitrocellulose)、羥基丙基甲基纖維素(hydroxypropyl ethylcellulose)、羥基丙基丁基纖維素(hydroxypropyl butylcellulose)、羥基丙基戊基纖維素(hydroxypropyl pentylcellulose)、甲基纖維素(methyl cellulose)、羥基乙基纖維素(hydroxyethyl cellulose)、烷基纖維素(alkyl celluloses)、羥烷基纖維素(hydroxyalkyl celluloses)、纖維素醚(cellulose ethers)、醋酸纖維素(cellulose acetate)、羧甲基纖維素(carboxymethyl cellulose),羧甲基纖維素鈉(sodium carboxymethyl cellulose)、羧甲基纖維素鈣(calcium carboxymethyl cellulose)、聚羥烷基丙烯酸甲酯(poly-hydroxyalkyl methacrylate)、聚甲基丙烯酸(polymethacrylic acid)、聚甲基丙烯酸甲酯(polymethylmethacrylate)、聚乙烯醇(poly vinyl alcohol)、聚丙烯酸鈉(sodium polyacrylic acid)、聚丙烯酸鈣(calcium polyacrylic acid)、聚丙烯酸(polyacrylic acid)、酸性羧基聚合物(acidic carboxy polymers)、聚羧乙烯(carboxypolymethylene)、羧乙烯聚合物(carboxyvinyl polymers)、羧基甲基醯胺(carboxymethylamide)、聚乙二醇(polyoxyethyleneglycols)、聚氧伸乙基(polyethylene oxide)及衍生物,其藥學上等效鹽類及其混合物,但不限於此。
於藥學組合物中所使用的非凝膠不可溶聚合物可為疏水性聚合物,其於所有的pH值範圍內皆不溶於水,以助於降低水膨脹水凝膠聚合物之親水性,進而以製備成疏水性藥物的口服劑型。
於藥學組合物中所使用的非凝膠不可溶聚合物可為腸溶性聚合物,其溶解度乃視pH值而定。舉例而言,可使用在酸性pH值下不溶而於較高pH值範圍下為可溶的腸溶性聚合物。腸溶性聚合物之一例示為EUDRAGITL100。
非凝膠不可溶聚合物之例示包含,疏水性聚合物(例如乙基纖維素(例如ETHOCELTM
等)、聚甲基丙烯酸聚合物(polymethyl acrylate polymer,例如聚丙烯酸樹脂EUDRAGIT®
NE、EUDRAGIT®
EC等)、非離子性聚合物、腸溶性聚合物(例如EUDRAGIT®
L等)、pH依賴型之不可溶聚合物及其衍生物、鹽類、及其混合物,但不限於此。不溶於水之聚合物其他例示包含纖維素衍生物(例如醋酸纖維素等)、聚醋酸乙烯酯(polyvinyl acetate,例如BASF公司生產之KOLLICOATTM SR30D)、丙烯酸乙酯(ethyl acrylate)與2-甲基丙烯酸甲酯(methylmethacrylate)為主之中性聚合物、丙烯酸酯與具有四級銨基之甲基丙烯酸酯的共聚物(例如EUDRAGIT®
NE、EUDRAGIT®
RS、EUDRAGIT®
RS30D、EUDRAGIT®
RL、EUDRAGIT®
RL30D與其類似者)、及其衍生物、鹽類與混合物,但不限於此。於一實施例中,藥學組合物可包含其重量約4%至80%的非凝膠不可溶聚合物。
於腸溶性聚合物之例示包含纖維素之酯類及其衍生物(例如纖維素乙酸酯苯甲酸酯(cellulose acetate phthalate)、羥丙基甲基纖維素鄰苯二甲酸酯(hydroxypropyl methyl cellulose)、羥丙基甲基纖維素琥珀酸酯(hydroxyproryl methylcellulose acetate succinate)及其類似者)、聚醋酸乙烯酞酸酯(polyvinyl acetate phthalate)、pH值敏感之甲基丙烯酸-甲基丙烯酸酯共聚物(pH-sensitive methacrylic acid-methamethacrylate
copolymers)與蟲膠(shellac)、及其衍生物、鹽類與其混合物,但不限於此。部份商業上可取得以使用腸溶性聚合物包含,例如由Rhom Pharma公司所製造以EUDRAGIT®
(1100、S100、L30D)商標名所販賣之甲基丙烯酸(methacrylic acid)共聚物、由Eastman Chemical Co.所製之纖維醋法酯(cellacefate)(纖維素乙酸酯苯甲酸酯(cellulose acetate phthalate)、由FMC Corp.所生產的水分散體(aquateric)水性腸溶性聚合物(例如作為水性分散液的纖維素乙酸酯苯甲酸酯)、由Shin Etsu K.K.所生產的AQOATTM
(例如作為水分散液的羥丙基甲基纖維素琥珀酸酯(hydroxypropyl methylcellulose acetate succinate或hypromellose acetate succinate))與其他腸溶性包覆材料。此腸溶性聚合物可作為乾性粉墨或水分散液。
於一實施例中,則提供一種修飾疏水性藥物之釋放速率的方法,該疏水性藥物使用可溶於水之水凝膠聚合物,以獲得經控制的釋放藥物配方(例如於體內與體外藥物溶離及/或生物利用率曲線呈現出例如持續釋放、恆定釋放、延長釋放或大致上為零級釋放等的配方。該方法可包含於藥物配方中,調整水溶性水凝膠聚合物與非凝膠不可溶聚合物之重量比,使其重量比約為1:10至10:1以獲得所需之釋放速率曲線。藥物配方之一例示包含水溶性水凝膠聚合物與非凝膠不可溶聚合物之重量比約為4:1。藥物配方之一例示包含水溶性水凝膠聚合物與非凝膠不可溶聚合物之重量比約為1:4。
此外,可獲得疏水性藥物之經控制釋放藥物溶離曲線。例如,可獲得疏水性藥物之體外恆定的藥物溶離曲線。於另一例示中,可獲得一藥物配方中疏水性藥物的零級藥物釋放曲線。
亦提供一種施用藥學組合物方法,該藥學組合物含有一療效有效量之粉末形式的疏水性藥物。於一實施例中,該方法包含對哺乳類動物施用一有效量的藥學組合物,該藥學組合物具有以重量比約10:1至1:10結合的非交聯水膨脹單聚物以及非凝膠疏水性聚合物,且非交聯水膨脹之單聚物以及非凝膠疏水性聚合物直接與一療效有效量的疏水性藥物壓合。
含有疏水性藥物的藥物配方可製備成口服劑型或固體劑型,例如藥錠、膠囊、藥袋等以及其他治療上可接受之形式。疏水性藥物可從粉末形式、微粒形式、細粒形式、顆粒形式等製備。含於配方中的疏水性藥物可為任一所需的療效有效劑量強度。於一實施例中,疏水性藥物約為藥學組合物重量的1%至95%。例如,製備西洛他唑藥錠的藥物配方可包含約100mg、200mg、300mg等的西洛他唑。
可使用現有之各式方法製備持續釋放或經控制釋放的藥物配方,例如呈藥錠或膠囊形式的各式延長釋放配方。一般而言,可使用濕式造粒或乾式造粒法。例如,形成延遲或持續釋放之配方的方法包含製備含有混合藥物的細粒,並將細粒壓合成藥錠。此外,藥錠可利用一延遲釋放覆層包覆。或者,可利用延遲釋放覆層包覆個別的細粒,
並將該些經包覆的細粒壓合成藥錠。除了形成含藥之細粒外,可使用分散劑改善疏水性藥物的溶解度與分散性,並將疏水性藥物製備成分散形式。
即使未形成細粒或分散形式,療效有效量的疏水性藥物已意外地發現可經由直接壓合製備成藥物配方。例如經由直接壓合,將疏水性藥物與水溶性水凝膠聚合物以及釋放速率調節聚合物製備成藥錠的方式,則提供了獲得所需之控制釋放速率曲線的有效方法。於一實施例中,則將療效有效量之粉末形式的疏水性藥物、適用量之粉末形式的未交聯水膨脹單聚物,以及適用量之粉末形式的非凝膠不可溶聚合物結合,並直接製備成所需的口服劑型,例如藥錠或膠囊。此外,含有口服劑型的疏水性藥物更可利用一外層覆層包覆。例如,若有需要,所製備的藥錠或膠囊可利用膜包覆或味遮層包覆,及/或腸溶性聚合物包覆。外層覆層亦可包含疏水性藥物、黏結劑、疏水性釋放修飾劑、潤滑劑、滑動劑、腸溶性聚合物等。
可選地,用以製備疏水性藥物之口服劑型的藥物配方亦可包含溼潤劑、界面活性劑、乳化劑、分散劑、消泡劑(defoamer)、賦形劑(excipients)、稀釋液、黏結劑、釋放速率修飾劑、滑動劑和潤滑劑、及其組合等。於此可使用任何藥學上可接受或藥效上可接受之界面活性劑、乳化劑、分散媒介(dispersing agent)、分散劑(dispersants)及消泡劑。例如,可使用吐溫-80(tween-80)(從Fisher Scientific International公司購得)、吐溫-20(tween-20)、吐溫-100(tween-100)、烷基硫酸鹽以及其它等,且最後的濃度不超過50%,例如從約0.1%至約10%。於一濕潤劑之例示中,其為界面活性劑,例如十二烷基硫酸鈉(sodium lauryl sulfate,SLS)。舉例而言,約為0.3%或約為0.5%的SLS可用於藥物配方。
此外,藥物配方可包含潤滑劑、黏結劑、掺合劑(blender)、抗黏劑、滑動劑、溼潤劑、染料、色素、不黏劑(nonstick agents)、分散劑、覆層材料及其混合,以與藥物混合物之核心結合。潤滑劑之例示可包含硬脂酸(stearic Acid)、單硬脂酸甘油酯(glycerol monostearate)、滑石粉(talc)、硬脂酸鈣(calcium stearate)、硬脂酸鎂(magnesium stearate)、固體聚乙二醇(solid polyethylene glycols)、十二烷基硫酸鈉(sodium lauryl sulfate)、惰性矽玻璃材(inert silicon glass materials)、膠狀二氧化矽(colloidal silicon dioxide)、以及高級脂肪酸(higher fatty acids)及其鹼金族金屬與鹼土族金屬鹽類其中之一,但不限於此。潤滑劑之例示包含硬脂酸,但不限於此。此外,1995年版之書籍Remington's Pharmaceutical Sciences於所揭示的各式賦形劑例如稀釋劑、潤滑劑、染料等,可用於最佳化藥學組合物。潤滑劑與抗黏劑的重量大致在藥學組合物重量約0.5%至約20%間變化,例如從約2.5%至約10%。此述能與藥學組合物核心混合之例示包含硬脂酸鎂、二氧化矽與滑石粉,其最後濃度為藥物成份重量之1%至約7%。稀釋劑之例示為乳糖。
於下述例子係用以在不限制本發明範圍下,闡明本發明。合適的水凝膠包含羥丙基甲基纖維素(hydroxypropylmethyl cellulose)與其類似者。此外,可包含一無毒的、藥學上可接受、有效量的能離子化之化合物,該化合物能夠修飾藥物從水凝膠的釋放速率。所使用的水凝膠的量可經由製備一系列以不同量之水凝膠與疏水性藥物(例如西洛他唑)結合的藥錠來決定。釋放特性可分別於各種的測試條件下來決定,例如水/0.3%十二烷基硫酸鈉、水/0.5%十二烷基硫酸鈉、模擬胃液(SGF,pH值為1.2-無酵素)、模擬腸液(SIF,pH值為7.5-無酵素)、pH值6.8的緩衝環境等。
於此併入參考之由美國藥典第二十二版規格(united States Pharmacopeia(USP)XXII standards)所定之槳法(paddle method),可用於決定一特定藥物配方的釋放特性,特定藥物的釋放曲線可修飾至零級釋放速率。亦可使用USP其他規格的方法。藥學組合物可包含約1%至約80%的疏水性藥物療效量,以及約4%至約80%水膨脹水凝膠聚合物。藥學組合物中的疏水性藥物可包含西洛他唑或其藥學上等效鹽類。水膨脹水凝膠聚合物之一例示為羥丙甲基纖維素。
依據本發明之一實施例,提供了一經控制釋放之藥學組合物,其包含約1%至約80%的西洛他唑療效量,以及約
4%至約80%的水膨脹水凝膠聚合物。經控制之釋放藥學組合物係經配製,以獲得一恆定釋放速率。例如,可獲得含有零級釋放速率的西洛他唑與水膨脹水凝膠聚合物材料之經控制釋放藥學組合物。水膨脹水凝膠聚合物材料之一例示為羥丙甲基纖維素。
依據本發明之一實施例,則提供了一種施用含有西洛他唑之藥學組合物的方法。該方法包含對哺乳類動物施用一有效量的藥學組合物,該藥學組合物含有約1%至約80%的西洛他唑療效量,以及約4%至約80%水膨脹水凝膠聚合物。水膨脹水凝膠聚合物材料之一例示為羥丙甲基纖維素。
依據本發明之一實施例,藥學組合物亦可包含界面活性劑,例如親水性界面活性劑或疏水性界面活性劑。界面活性劑之一例示為約0.01%至約5%的十二烷基硫酸鈉。除了水凝膠與有效藥學組合物外,藥學組合物亦可包含惰性固體稀釋劑,例如乳糖、葡萄糖、麥芽糖、果糖、玉米澱粉、米澱粉或其類似者。
其他添加劑例如黏合劑例如聚乙烯吡咯烷酮(polyvinylpyrrolidone)、澱粉、明膠、微晶纖維素(microcrystalline cellulose)和類似者可加入藥錠配方。此外,可考慮將著色劑、穩定劑、潤滑劑(例如硬脂酸、棕櫚酸(palmitic acid)、硬脂酸鎂和其類似者)加入藥錠的成分中,加入量則以能產生體內與體外所需之藥物釋放表現的量而決定。可使用傳統製程製造口服劑型(例如藥錠與膠體)所合適的尺寸。
例示一製備150 mg的西洛他唑延長釋放藥錠。每一藥錠包含約150mg的西洛他唑,重量百分率為11.7%的羥丙甲基纖維素,重量百分率為1.7%的十二烷基硫酸鈉,重量百分率為33%的乳糖以及重量百分率約3.3%的單硬脂酸甘油酯。藥錠則利用旋壓機直接壓合製備。
例示二製備含有約150mg西洛他唑,重量百分率為18.3%的羥丙甲基纖維素,重量百分率為1.7%的十二烷基硫酸鈉,重量百分率為26.7%的乳糖以及重量百分率為約3.3%的單硬脂酸甘油酯之西洛他唑延長釋放藥錠。
例示三製備含有約150mg西洛他唑,重量百分率為10%的羥丙甲基纖維素,重量百分率為36.7%的乳糖以及重量百分率為約3.3%的單硬脂酸甘油酯之西洛他唑延長釋放藥錠。
例示四製備含有約150mg西洛他唑,重量百分率為16.7%的羥丙甲基纖維素,重量百分率為30%的乳糖以及重量百分率為約3.3%硬脂酸的西洛他唑延長釋放藥錠。
第1圖繪示了依據本發明一或多個實施例,如例示一至四所述而製備的代表性西洛他唑口服劑型的體外溶離曲線。所有例示皆呈現恆定的釋放速率。依據例示一至四所製備的所有藥錠,其體外溶離曲線係呈現零級釋放速率,適用作為西洛他唑之經控制釋放或延長釋放的口服劑型。
例示五製備具有約150mg的西洛他唑、羥丙甲基纖維素、非凝膠不可溶聚合物、稀釋劑以及潤滑劑的西洛他唑經控制釋放藥錠(每一藥錠總重為300mg)。
第2圖則繪示依例示五所述而製備的代表性西洛他唑口服劑型在SIF與SGF條件下,進行測試的體外溶離曲線(分別如線202與204所示),其中依據美國藥典(USP)所述之步驟,裝置2之槳速約為50rpm,並具有約0.5%的十二烷基硫酸鈉。
在SIF與SGF條件下,依據例示5所製備所有藥錠的體外溶離曲線皆呈現零級釋放速率,適用作為西洛他唑之經控制釋放或延長釋放的口服劑型。
例示六製備具有約300mg的西洛他唑、羥丙甲基纖維素、疏水性聚合物、稀釋劑以及潤滑劑的西洛他唑經控制釋放藥錠(每一藥錠總重為600mg)。
第3圖則繪示如例示六所述而製備的代表性西洛他唑口服劑型的體外溶離曲線,其係依據美國藥典(USP)所述之步驟,在槳速約為50rpm,且具有約0.3%的十二烷基硫酸鈉的條件下進行測試。依據例示六所製備的所有藥錠的體外溶離曲線皆呈現零級釋放速率,適用作為西洛他唑之經控制釋放或延長釋放的口服劑型。
例示七製備具有約100mg的西洛他唑、羥丙甲基纖維素、疏水性聚合物、稀釋劑以及潤滑劑的西洛他唑經控制釋放藥錠。
第4圖則繪示如例示七所述而製備的代表性西洛他唑口服劑型的體外溶離曲線,其依據美國藥典(USP)所述之步驟,在槳速約為50rpm,且具有約0.3%的十二烷基硫酸鈉的條件下進行測試。依據例示七所製備的所有藥錠的體外溶離曲線係呈現西洛他唑的經控制釋放。
例示八製備具有約150mg的西洛他唑、藻酸鈉、疏水性聚合物、稀釋劑以及潤滑劑的西洛他唑經控制釋放藥錠(每一藥錠總重為300mg)。
第5圖則繪示如例示八所述而製備的代表性西洛他唑口服劑型的體外溶離曲線,其依據美國藥典(USP)所述之步驟,在槳速約為50rpm,且具有約0.3%的十二烷基硫酸鈉的條件下進行測試。依據例示八所製備的所有藥錠的體外溶離曲線係呈現西洛他唑的經控制釋放。
例示九製備具有約150mg的西洛他唑、EUDRAGITNE、稀釋劑以及潤滑劑的西洛他唑經控制釋放藥錠(每一藥錠總重為300mg)。
第6圖則繪示如例示九所述而製備的代表性西洛他唑口服劑型的體外溶離曲線,其依據美國藥典(USP)所述之步驟,在槳速約為50rpm,且具有約0.3%的十二烷基硫酸鈉的條件下進行測試。依據例示九所製備的所有藥錠的體外溶離曲線係呈現西洛他唑的持續釋放。
例示十製備具有約100mg的西洛他唑、水膨脹水凝膠單聚物、非凝膠不可溶聚合物、稀釋劑以及潤滑劑的西洛他唑經控制釋放藥錠(每一藥錠總重為200mg)。
第七圖則繪示如例示十所述而製備的代表性西洛他唑口服劑型的體外溶離曲線,其依據美國藥典(USP)所述之步驟,在槳速約為50rpm,且具有約0.3%的十二烷基硫酸鈉的條件下進行測試。
如第七圖所示,依據例示十所製備的所有藥錠的體外溶離曲線係呈現西洛他唑的經控制釋放。線702與線704呈現出水凝膠單聚物與非凝膠不可溶聚合物具有不同重量比(分別為約4:1與1:4)之藥錠的溶離曲線。線702與線706則呈現出使用相同的水膨脹水凝膠單聚物,以相同的約4:1的比例與不同非凝膠不可溶聚合物結合的藥錠之溶離曲線。
雖然本發明已以實施例揭露如上,然其並非用以限定本發明,任何熟習此技藝者,在不脫離本發明之精神和範圍內,當可作各種之更動與潤飾,因此本發明之保護範圍當視後附之申請專利範圍所界定者為準。
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上述總結之發明內容可參照繪示於附圖中之實施例,以獲致本發明之特徵、優點與目的,且更作更詳盡的了解。然而,當注意的是,所附圖示僅作為例示之用,不當限制本發明之範圍,本發明可具有其他均等有效之實施例。
第1圖係繪示依照本發明一實施例,代表性藥物配方之例示釋放速率曲線圖。
第2圖係繪示依照本發明一實施例,代表性疏水性藥物藥錠在不同pH值下之例示釋放速率曲線圖。
第3圖係繪示依照本發明一實施例,與第1圖之例示相較,以不同劑量強度與不同濕潤劑濃度所製備的代表性疏水性藥物之藥錠其釋放速率曲線圖。
第4圖係繪示依照本發明一實施例,與第3圖之例示相較,以不同劑量強度所製備的代表性疏水性藥物之藥錠其釋放速率曲線圖。
第5圖係繪示依照本發明一實施例,與第2圖之例示相較,以不同聚合物所製備的代表性疏水性藥物之藥錠其釋放速率曲線圖。
第6圖係繪示依照本發明一實施例,與第5圖之例示相較,以不同聚合物所製備的代表性疏水性藥物之藥錠其釋放速率曲線圖。
第7圖係繪示依照本發明一實施例,西洛他唑(cilostazol)之代表性藥錠其例示釋放速率曲線圖。
Claims (21)
- 一種藥學組合物,包含:一粉末狀之非交聯水膨脹單聚物;以及一粉末狀之非凝膠不可溶聚合物,其中該非交聯水膨脹單聚物與該非凝膠不可溶聚合物以約1:10至10:1的重量比結合,且與一療效有效量之粉末狀的西洛他唑(cilostazol)疏水性藥物直接壓合。
- 如申請專利範圍第1項所述之藥學組合物,更包含一溼潤劑。
- 如申請專利範圍第2項所述之藥學組合物,其中該濕潤劑為一界面活性劑。
- 如申請專利範圍第1項所述之藥學組合物,其中該疏水性藥物重量為該藥學組合物重量的約1%至95%。
- 如申請專利範圍第1項所述之藥學組合物,其中該非交聯水膨脹單聚物重量為該藥學組合物重量的約4%至80%。
- 如申請專利範圍第1項所述之藥學組合物,其中該非交聯水膨脹單聚物為一非離子性聚合物。
- 如申請專利範圍第1項所述之藥學組合物,其中該非交 聯水膨脹單聚物為一離子性聚合物。
- 如申請專利範圍第1項所述之藥學組合物,其中該非凝膠不可溶聚合物重量為該藥學組合物重量的約4%至80%。
- 如申請專利範圍第1項所述之藥學組合物,其中該非交聯水膨脹單聚物係選自由所下列所組成之群組:羥丙基甲基纖維素(hydroxypropyl methylcellulose)、藻酸鹽(alginate)、藻酸鈉(sodium alginate)、羥丙基纖維素(hydroxypropyl cellulose)、纖維素水凝膠(cellulose hydrogel)及其組合。
- 如申請專利範圍第1項所述之藥學組合物,其中該非凝膠不可溶聚合物為一疏水性聚合物。
- 如申請專利範圍第1項所述之藥學組合物,其中該非凝膠不可溶聚合物為一陰離子聚合物。
- 如申請專利範圍第1項所述之藥學組合物,其中該非凝膠不可溶聚合物係選自由所下列所組成之群組:乙基纖維素(ethyl cellulose)、聚甲基丙烯酸聚合物(polymethyl acrylate polymer)、疏水性不溶水之聚合物(hydrophobic water-insoluble polymer)、陰離子不溶水聚合物(anionic water-insoluble polymer)、腸溶性不溶水聚合物(enteric water-insoluble polymer)、pH依賴型之不溶水聚合物(pH-dependent water-insoluble polymer)、醋酸纖維素(cellulose acetate)、聚醋酸乙烯酯(polyvinyl acetate)及其組合。
- 一種經控制釋放之藥學組合物,包含:一粉末狀非交聯水膨脹單聚物;以及一粉末狀非凝膠不可溶聚合物,其中該非交聯水膨脹單聚物與該非凝膠不可溶聚合物以約1:10至10:1的重量比結合,且與一療效有效量之粉末狀的西洛他唑(cilostazol)直接壓合,該療效有效量為該藥學組合物重量的約1%至95%。
- 如申請專利範圍第13項所述之經控制釋放的藥學組合物,其中該西洛他唑(cilostazol)之溶離為一零級釋放速率。
- 如申請專利範圍第13項所述之經控制釋放的藥學組合物,其中該非交聯水膨脹單聚物係選自由所下列所組成之群組:羥丙基甲基纖維素(hydroxypropyl methylcellulose)、藻酸鹽(alginate)、藻酸鈉(sodium alginate)、羥丙基纖維素(hydroxypropyl cellulose)、纖維素水凝膠(cellulose hydrogel)及其組合。
- 如申請專利範圍第13項所述之經控制釋放的藥學組合 物,其中該非交聯水膨脹單聚物為羥丙基甲基纖維素(hydroxypropyl methylcellulose)。
- 如申請專利範圍第13項所述之經控制釋放的藥學組合物,其中該非交聯水膨脹單聚物為一非離子性聚合物。
- 如申請專利範圍第13項所述之經控制釋放的藥學組合物,其中該非交聯水膨脹單聚物為一離子性聚合物。
- 如申請專利範圍第13項所述之經控制釋放的藥學組合物,其中該非凝膠不可溶聚合物係選自由所下列所組成之群組:乙基纖維素(ethyl cellulose)、聚甲基丙烯酸聚合物(polymethyl acrylate polymer)、疏水性不溶水之聚合物(hydrophobic water-insoluble polymer)、陰離子不溶水聚合物(anionic water-insoluble polymer)、腸溶性不溶水聚合物(enteric water-insoluble polymer)、pH依賴型之不溶水聚合物(pH-dependent water-insoluble polymer)、醋酸纖維素(cellulose acetate)、聚醋酸乙烯酯(polyvinyl acetate)及其組合。
- 如申請專利範圍第13項所述之經控制釋放的藥學組合物,更包含一濕潤劑。
- 一種如申請專利範圍第1項所述之藥學組合物之用 途,其係用於製備抑制血小板聚集之藥物。
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US11/772,017 US20080075785A1 (en) | 2006-09-22 | 2007-06-29 | Controlled release hydrogel formulation |
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