TW200526266A - Non-tabletted, chewable, individually dosed administration forms - Google Patents
Non-tabletted, chewable, individually dosed administration forms Download PDFInfo
- Publication number
- TW200526266A TW200526266A TW093134361A TW93134361A TW200526266A TW 200526266 A TW200526266 A TW 200526266A TW 093134361 A TW093134361 A TW 093134361A TW 93134361 A TW93134361 A TW 93134361A TW 200526266 A TW200526266 A TW 200526266A
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- composition
- water
- weight
- dosage form
- stabilizer
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- UBQNRHZMVUUOMG-UHFFFAOYSA-N zonisamide Chemical compound C1=CC=C2C(CS(=O)(=O)N)=NOC2=C1 UBQNRHZMVUUOMG-UHFFFAOYSA-N 0.000 description 1
- 229960004496 zotepine Drugs 0.000 description 1
- HDOZVRUNCMBHFH-UHFFFAOYSA-N zotepine Chemical compound CN(C)CCOC1=CC2=CC=CC=C2SC2=CC=C(Cl)C=C12 HDOZVRUNCMBHFH-UHFFFAOYSA-N 0.000 description 1
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Description
200526266 九、發明說明: 【發明所屬之技術領域】 本發明係關於醫藥活性化合物之獨立給劑投藥劑型,其 係由封裝於泡穴或腔穴中的非旋劑、可咀嚼凝膠組合物組 成;係關於一種用於製造該等獨立給劑投藥劑型之方法; 係關於可由上述方法獲得的獨立給劑投藥劑型;且係關於 穩定劑在增強自該等泡穴或腔穴中移除該組合物之簡易性 上的用途。 【先前技術】 諸如口香糖之可咀嚼傳遞系統係用於經口施以醫藥活性 化合物之極理想構件。口香糖組合物之缺點在於其通常包 括水不溶性膠基,其殘留在口中且必須拋棄。此外,多種 活性化合物均可具有膠基親合性,因此使得精確給劑變得 困難。 英國專利申請案GB 2 009 597揭示可咀嚼及可吞咽、凝 膠化制酸劑組合物。該等組合物係藉由將制酸劑分散於溶 液中而獲得,該溶液包含水、碳水化合物或作為質感化劑 之多元醇以及膠凝劑,該膠凝劑之量足以使該液體分散液 在冷卻之後成為自行支撐之凝膠。在較佳具體實施例中, 可在該靜態液體分散液冷卻於經口單位劑量模具内之前對 其進行澆鑄且可讓其凝固。 δ亥方法不再需要固體投樂劑型之獨立成形及封裝。在封 裝操作中,將經軟化組合物單純應用至具有所要形狀之芙 材中,繼而凝固,藉此使該等劑型形成其特殊形狀。該2 97i98.doc 200526266 驟導致總體製造方法之成本效率改良。 國際專利申請案WO 87/00429描述不透明之明膠組合物 及其製造方法。該等組合物包含脂肪、脂肪油或脂肪衍生 物以改良用於對明膠組合物染色之染料的光穩定性。本說 明書規定所有合成或天然來源之脂肪、脂肪油或脂肪衍生 物以及部分氫化產物均可使用,其限制條件為其在生理上 安全。 吾人現已發現將明膠作為膠凝劑來製造如先前技術所述 之彼等非錠劑、可咀嚼組合物會生成在老化時常產生問題 之組合物,該問題在於其不能輕易地自封裝中移除,其已 在該封裝中成形而未留下殘餘物。對於包含大量鹼性成份 之組合物而言,在移除膠凍組合物時留在封裝中之殘餘物 的問題特別顯著,此係因為該等成份傾向於使明膠基質去 穩定。當該封裝之形狀顯示為具有小半徑曲率之邊緣或部 分時,該問題亦特別顯著。 【發明内容】 吾人已藉由加入包含混合物之基質材料而解決了該段 題’該混合物包含明膠、作為溶劑之至少一種水溶性醇及 /或水及至少-種選自由下列各物組成之群的穩定劑:^ 油及脂肪酸之醋;及由該等甘油及脂肪酸之酷與聚乙二藥 的醇解/酯化反應所產生的產物,該穩定劑具有介於Μ。。至 63°C範圍内之炼點。該步驟生成非錢劑、獨立給劑之㈣ 劑型,其包含溶解或分散在基質材料中之至少一種醫二 性物質的組合物,該組合物在高溫時為塑料。該等投藥南 97198.doc 200526266 型可自封裝中移除,而不留下殘餘物。在本發明之較佳具 體實施例中,僅將一種穩定劑加入基質材料中。 【實施方式】 所本發明組合物包含下列基本成份:至少一種醫藥活性物 質;以該組合物之至少0·2重量%之量存在的明膠;至少一 種如上所述之穩定劑;及作為溶劑之至少一種水溶性醇及 /或水,其中水係以不超過該組合物之46重量%的量存在。 其亦可包含將紋理及本體賦予最終凝膠之質感化劑及其它 可選組份,例如防腐劑、抗氧化劑、消泡劑、甜味劑、掩 未Μ、色素及芳香劑。本發明之較佳具體實施例僅使用一 種穩定劑。 、用於本I明之貝感化劑為糖,例如葡萄糖、蔗糖及果 糖、糖醇(例如山梨糖醇、甘露糖醇及麥芽糖醇)及多糖, ο 士澱粕、纖維素及官能化纖維素衍生物。 =了確保消費者可接受,本發明之賴劑、獨立給劑之 杈藥d型取好具有在低於3rc之溫度下不顯示塑料變形之 組合物。 ;系藉由自含有膠原蛋白之動物原材料(如皮膚及骨 二^丁萃取而獲得的蛋白,該等原材料已預先由酸性或 驗性處理進行調節。市t明膠—般含有84_92% 、 0-1-2%的鹽且剩餘為水。 处六;係根據已取得該等3韓之原材料及根據其成谬 邮旦Γ刀級’其成膠能力通常係、如布倫(Bl_)凝朦強度 97198.doc 200526266 雖然所有類型的明膠均可用於製造本發明之獨立給劑投 藥劑型,但吾人已發現具有介於14〇及27〇度布倫之間、較 佳介於180及250度布倫之間的布倫範圍之明膠會生成在可 口性上具有最佳消費者接受性之組合物。由驗性處理所獲 得的明膠通常比由酸性處理所獲得者受青睞。 本發明組合物最好包含超過該組合物的〇 2%重量、更佳 超過1重量%且亦更佳超過該組合物的5重量%之量的明 膠。 本發明之穩定劑係選自由下列各物組成之群··甘油及脂 肪酸之酯;及由該等甘油及脂肪酸之酯與聚乙二醇的醇解 /醋化反應所生成的產物,該穩定劑具有介於42它至63它範 圍内之熔點。 該等穩定劑之實例為甘油與脂肪酸之單、二及三酯及其 混合物,較佳為甘油與脂肪酸之二酯。較佳之脂肪酸為彼 等選自C10-C20、較佳C16_C18不飽和、飽和脂肪酸之物 質。該等脂肪酸之實例為月桂酸、油酸、亞麻油酸、亞麻 酸、棕櫚酸及硬脂酸。較佳之市售酯的實例為購自 Uniqema之Est〇P 3745 GDS T2。穩定劑之其它實例為甘油 及上述脂肪酸之酯的醇解/酯化反應產物。較佳之實例為 氫化栋摘仁油或氫化棕櫊油與PEG 1500(例如,購自
Gattefoss6 之 Gelucire® 44/14 及 Gelucire ⑧ 50/13)的醇解 / 酯 化反應產物。 在本發明之具體實施例中,穩定劑係以超過該調配物的 1重量%之量存在。 97198.doc 200526266 在本發明之具體實施例中,存在於該組合物中之溶劑或 多種溶劑的總用量為該組合物之至少10重量%,更佳超過 違組合物之2 5重量%,亦更佳超過該組合物之$ 〇重量%。 在本發明之較佳具體實施例中,該組合物包含超過該組 合物的46重量%之至少一種水溶性醇。 在本叙明之另一具體貫施例中,本發明組合物之水量不 超過該組合物之46重量%,較佳不超過該組合物之35重量 %,最佳不超過該組合物之25重量%,最佳不超過該組合 物之15重量%。 本毛月之組σ物包含至少一種分散或溶解於呈熔化狀態 的基質材料中之醫藥活性物質。該醫藥活性物質不需以任 何特定劑型使其成功加入該熔化基質材料中,尤其不需要 且亦不偏好提供以由閃流(flashfl〇w)方法所製得㈣^ 基質載劑之組份形式的醫藥活性物質。 在本發明之—具體實施例中,該等非錠劑、獨立給劑之 投藥劑型包含超過18重量%之醫藥活性物質。 本發明之獨立給劑投攀南丨刑π —人i λ ^ Η又条釗型可包含之適合醫藥活性物質 變化廣泛且通常代表任^ 籍$ '衣仕Π %疋樂物組合。說明性類別及特 定貫例包括·· a)制酸劑:
無機或有機I呂鹽 酸鋁、矽酸鋁、
無機或有機祕鹽’例如鋁酸鉍 次碳酸絲或擰檬酸站; ’例如尿囊酸鋁、胺基乙酸鋁、 葡糖庚酸鋁或聚半乳糖醛酸鋁; 磷 、碳酸絲、石夕酸叙、 97198.doc 200526266 iii) 無機或有機鈣鹽,例如磷酸鈣或胺基乙酸鈣; iv) 無機或有機鎂鹽,例如碳酸鎂、鹼式碳酸鎂、磷酸 鎂或矽酸鎂; v) 氧化物及氫氧化物,例如氧化铭、水合氫氧化ί呂 (algeldrate)(氫氧化紹)、氧化或氫氧化鎂/#5 ; vi) 如矽酸鹽之鋁及鈉混合鹽、如水滑石之鋁及鎂混合 鹽(驗式碳酸铭及鎮)、紹碳酸鎮(驗式碳酸铭及鎂) 或氫氧化鎂鋁(鹼式硫酸鋁及鎂)如矽酸鎂之鉍及鎂 混合鹽及如矽鎂鋁或鋁矽酸鎂之鋁矽酸鎂; vii) 如碳酸氫鈉或碳酸氫鉀之碳酸氫鹽; viii) 甘胺酸; ix) 海藻酸及其鹽; 及其混合物; b)用於消化性潰瘍及胃-食管逆流之藥物: 雷尼替丁(Ranitidine)*、尼紮替丁(Nizatidine)、法莫替 丁(Famotidine)、西 σ米替丁(Cimetidine)、羅沙替丁 (Roxatidine)、旅芳替丁(Pifatidine)、羅沙替丁(Roxatidine)、 舒福替丁(Sufotidine)、拉吱替丁(Lafutidine)、奥沙替丁 (Osutidine)、泮托拉唾(Pantoprazole)、奥美拉 口坐 (Omeprazole)、蘭索拉口坐(Lansoprazole)、埃索美拉口坐 (Esomeprazole)、雷貝拉嗤(Rabeprazole)、艾沙拉 °坐 (Esaprazole)、帕利拉嗤(Pariprazole)、阿立旅嗤 (Aripiprazole)、來明拉嗤(Leminoprazole)、安莫西林 (Amoxicillin)、丙大觀黴素(Trospectomycin)、開羅理黴 97198.doc -11 - 200526266 素(Clarithromycin)、醋胺己酸鋅(zinc Acexamate)、西
曲酸S旨、羅曲酸、多司馬醋(Dosmalfate)、氟拉法g旨 (Flavalfate)、硫糖鋁、如檸檬酸鉍或鹼式水揚酸鉍之鉍 鹽、曲來肽、迪可來古胺(Dicl〇guamine)、硫噁嗓 (Sulfoxazine)、利奥前列素、利替培南、曲莫前列素、 貝奈克Sa、派拉米派(Pramipide)、米索前列醇、阿萊肽 (Alaptide)、丙谷胺、阿足雷特(Azuletil)、特利派喃 (Trepenone)、多烯磷脂醯膽鹼、普勞諾托、曲昔匹特、 米多利胺(Midoriamine)、依卡倍特、喹托司特、硫糖 肽肖主尼特、誤夫拉坦(Revaprazan)及其混合物; c) 用於官能性胃腸病症之藥物;推進劑 甲氧氯普胺、西尼必利、氣波必利、西沙比得、紮考必 利莫"必利、伊托必利、普卡比利、多潘立_、依卡 派特、聚卡波非鈣、替加色羅及其混合物; d) 輕渴劑 番渴葉驗、番 3芋、比沙可ϋ定 合物; 瀉葉苷A + β、甘油、匹可硫酸、乳糖 乙 醇、乳S同糖、驗式碳酸鎮及盆混
#座守勿 奥利斯特、安 二乙胺苯 蜮毛膜性 甲求異丙 文非他_、安非他酮(bup: 丙酮、西布曲日日 — . 、虱西汀、間羥胺、 腺政素、芬特 胺、去甲麻黃驗、黃驗、苯雙 f)消化藥;酵素製劑3田司及其混合' 97198.doc -12- 200526266 澱粉酶、纖維素酶、乳糖酶、脂肪酶及其混合物; g) 維生素 維生素混合物、奥立多元素混合物及其混合物; h) 促進食慾藥 苯嗟σ定、隱海普它定(Cryptoheptadine)、肉毒驗、斯特 利胺(Stolimine)及其混合物; i) 抗血栓形成劑;血小板凝集抑制劑
地他唑、乙醯水揚酸、第斯格瑞、依前列醇、埃替非巴 肽、肝素、氯11比格雷(Clopidrogel)、雙喊σ定胺醇、阿昔 單抗、氯苄噻唑啶、達肝素、達那肝素、苄丙酮香豆 素、苯茚二酮、雙香豆素、依前列醇、依諾肝素、那屈 肝素、抗凝血酶III、吲哚布芬、帕肝素、亭紮肝素、皮 膚素、地西盧定、瑞肝素、托姆博姆都林 (Thombomoduline)、比伐盧定、阿地肝素、重組水虫至 素、替法可近、方得派靈(Fondaparine)、芬普若可孟 (Fenprocumone)、舍托肝素、貝米肝素、伊得羅派瑞 (Idraparinux)、醋石肖香豆素、加貝醋、舒洛地特、去纖 苷、伊波格雷、西洛他唾、西前列烯、阿秦司特、磺曲 苯、他前列烯、氣克羅孟、°比考他胺、前列地爾、苯績 。坐g同、貝前列素、達曲班、範利普若斯特(Variprost)、 沙特雷哲(Satrigel)、沙格雷酯、替羅非班、艾格雷普雷 斯特(Ecraprost)、拉米非班、來達非班、珍米洛非班、 多考斯諾(Polycosinol)、保克斯非班(Roxifiban)、洛非 班(Lotrafiban)、斯布若非班(Sibraflban)、艾尼多非波特 97198.doc -13- 200526266 (Almdofibatide)、奥波非班、阿加曲班、泰克勞麥羅 (Ticlomarol)及其混合物; j) 抗貧血製劑;三價鐵.製劑 鐵蛋白、鐵蛋白琥珀酸鹽、鐵葡聚糖及其混合物; k) 抗心律失常藥 奎尼丁、艾司洛爾、吡美諾、乙醯卡尼、吡西卡尼、瑞 卡南、盤替卡尼(pentlcainide)、氟卡胺、腺苷、利多卡 因、美托洛爾、普萘洛爾、鈉多洛爾、氧烯洛爾、苯妥 英、醋丁洛爾、索他洛爾、卡替洛爾、麥地高辛 (Medigoxine)、普魯卡因胺、溴苄乙銨、胺碘酮、丙吡 胺、美西律、莫雷西嗪、妥卡胺、普羅帕酮、巴蘆卡 尼、烯丙洛爾、奥騰折帕、維拉帕米、地丙苯酮、艾特 辛(Etacizin)、比地索胺、阿爾馬爾、西苯唑啉、替拉西 嗪、吲哚洛爾、地爾硫卓、阿替洛爾、多菲萊德、替地 沙米、司美利特、索他洛爾、阿莫蘭特、尼非卡蘭、伊 布利特、蘭地洛爾、決奈達隆、他林洛爾、他可得諾桑 (Tecadenoson)、地高辛、茚諾洛爾、普拉馬林、阿普林 定、丁萘醯胺、布托笨定、勞拉義明、勞卡尼及其:合 物; l) 心臟刺激劑、有機硝酸酯 單硝酸異山梨醇酯或二硝酸異山梨醇酯、硝酸甘油、硝 酸季戍四醇酯、嗎多明及其混合物; m) 抗高血歷藥;a(ALPHA)腎上腺素受體括抗劑 多沙対、烏拉地爾、尼普地洛、㈣拉明、略嗤嗓、 97l98.doc 200526266 拉貝洛爾、胺磺洛爾、特拉唑嗪、莫那匹爾及其混合 物; η)利尿劑 胺苯蝶啶、坎利酸酯、螺内酯、呋喃苯胺酸、托拉塞 米、西氯他寧、吡咯他尼、氣噻嗪、氯噻酮、氫氟噻 嗪、苄氟噻嗪、甲氣噻嗪、泊利噻嗪、氯帕胺、喹噻 酮、布美他尼、吲達帕胺、希帕按、環戊噻嗪、烯睾丙 内酯、多卡巴胺、氫氣噻嗪、美托拉宗、阿佐塞米、阿 那立肽、烏拉立肽、依卡曲爾、坎沙曲、阿米洛利、依 他尼酸、坎瓦坦(Conivaptan)、替米沙坦、美布噻嗪及 其混合物; 〇)末梢血管擴張劑 雙氫麥角灯、吼拉西坦、尼麥角林、長春布甯、卡屈 嗪、氟桂利嗪、甲麥角林、肼苯噠嗪、法舒地爾、尼可 地爾、林西多明、西地那非、桂利嗪、庚胺醇、阿米三 嗪、蘿巴新、己酮可可鹼、曲美他嗪、丁咯地爾、前列 地爾、溴長春胺、桂哌酯、地拉卓、利多氟嗪、嗎多 明、尼可地爾、硝苯啶、曲匹地爾、複方吲哚洛爾及其 混合物; P)血管保護藥 地奥司明、海得斯明(Hidroxmin)、橙皮苷、曲克蘆丁及 其混合物; q)抗尚血壓藥-選擇性^BETA)阻斷劑 阿替洛爾、艾司洛爾、卡替洛爾、美托洛爾、必索洛 97198.doc 200526266 爾、卡維地洛、奈必洛疆 、夂# Λ, 、曰奈洛爾、特他洛爾、倍他 洛爾、基他洛爾、尼# ^他 ……各、替利洛爾、甲侧、的 多洛爾、氧烯洛爾、醋 、、内 〜爾、索他洛爾、嗔$ 拉貝洛爾、喷布洛疆、〜 S馬洛爾、 _ 基利洛編、i:廿、々7T5 m、查柘次m 丄 竭月女石頁洛爾、烯丙洛 爾、氣拉/各爾、波α弓丨纟欠蔽 久W洛爾、索喹洛爾、 洛爾、他林洛爾、艾沙 # …、 吲°木 爾、苯呋洛爾、貝凡久礙 + ▲ ’印在洛 ° 布克莫羅(Bucomolome)、布 尼洛爾、丁非洛爾、卡 ^ 下祖洛爾、拉洛諾普諾 (Lervonoprolol)、硝苯洛 m 而西吴托、布那唑嗪、多 沙唑嗪、哌那节、< y 那地爾、哌法辛、哌那沙苄、吲哚 拉明、利美尼定、洛非而6 μ ,、 疋、奈派地爾、派唑嗪及其混 合物; r) 具有主要血管效應之選擇性每通道阻滞劑 胺氣地平、尼索地平、尼卡士 F _ , 尼卞地十、尼群地平、非洛地 平、阿尼帕米、°坐尼沙胺、貝尼地平、達羅地平、嗟帕 米、粉防已鹼、樂卡地平、加洛帕米、节普地爾、二兩 維林、依拉地平、范尼地平(Franidipine)、尼伐地平、 左乙拉西坦、尼莫地平、維拉帕米、阿雷地平、法舒地 爾、多他利嗪、拉西地平、洛美利嗪、西尼地平、硝苯 啶、地爾硫卓、帕洛地平、莫那匹爾、泛托法隆、司莫 地爾、艾非尼地平(Efenidipino)、美尼地平、巴尼地 平、依高地平、普拉地平、富羅地平(Furaldipine)、西 克蘭迪酷(Ciclandelate)及其混合物; s) 作用於腎素-jk管收縮素之試劑;ACE抑制劑 97198.doc -16 - 200526266 依那曰利、雷米普利、啥那普利、卡托普利、培哚普 利、祸辛晋利、群多普利、西拉普利、利生普利、螺普 利、莫昔普利、地拉普利、阿拉普利、依那普利拉、貝 那日’利分替阿普利(Fentiapril)、佐芬普利、福辛普利 拉烏身^利、替莫普利、賽若那普利(Ceranapril)、佐 芬普利拉、咪達普利及其混合物; t)血管收縮素π拮抗劑 i人地沙坦、洛沙坦、依普沙坦、依貝沙坦、纈沙坦、他 素沙坦、替米沙坦、奥美沙坦及其混合物; U)膽固醇及甘油三酯還原劑 阿伐他>丁、洛伐他汀、普伐他汀、斯伐他汀、氟伐他 /T 達伐他〉丁、伊伐他、;丁、羅素他ί丁、普伐他汀、普羅 布可、聚可沙諾(P〇lyC〇san〇l)、環丙貝特、非諾貝特、 笨紮貝特、氣貝特、菲利考(Filicol)、吉非羅齊、笨氟 雷司、考來烯胺、植物留醇、阿西莫司、比尼貝特、克 利貝特、考來替蘭、二乙胺基乙基葡聚糖、考來斯特 (Colestrol)、依塞羅酯、依託貝特、木古藥酉旨 (Gugulipid)、美格魯托、甲亞油醯胺、柊酸戊四醇g旨、 歐莫卡(Omacor)、吡貝特、山梨菸酯、舒洛地特、磺托 酸及其混合物; v) 雌激素;女性避孕藥 雖二醇、乙炔雌二醇、炔諾酮及其混合物; w) 用於良性前列腺肥大之藥物 刺李萃取物、阿呋唑嗪、度泰利特、非那斯特萊 97198.doc 200526266 (Finisteride)、奥生多龍、坦洛新及其混合物,· X)鈣離子平衡劑;抗副甲狀腺激素 降鈣素、依降鈣素及其混合物; y)抗腫瘤劑 阿米地辛(Ameticine)、阿莫司汀、地吖醌、嫘莫司汀、 美法侖、依莫、雌莫司、;τ、雷莫司、迪布洛莫司 汀(Dibromomulcito!)、牛磺莫司汀、替莫唑胺、卡鉑、 福莫司汀、艾若諾斯(Aranose)、培磷醯胺、依鉑、二甲 磺酸丁酯、泊非黴素、異環磷醯胺、克洛若布斯 (Clorambucil)、六甲蜜胺、順鉑、洛莫司汀、英丙舒 凡、二演甘露糖醇、二漠衛矛醇、奈達始、奥沙利銘、 潑尼莫司汀、替莫唾胺、特利舒凡(Tre()suflan)、曲鱗 胺、環磷醯胺、甲胺嗓吟、甘胺硫嗓吟、卡培他濱、卡 莫氟、克拉屈濱、阿糖胞普、去氧氟尿苷、依諾他濱、 氟達拉濱、吉西他濱、噴司他丁、雷替曲塞、替加氟、 依託治苦、吸柔比星、胺魯米特、阿納Μ、白卡羅他 邁、氯膦酸、環硫雄醇、依西美坦、法屈。垒、氣他米 特、福美司坦、敗維司群、來曲唑、美雄烷、尼魯米 特、他莫昔芬、托瑞米芬、曲洛司坦、雲芝素、香益多 糖、溶鏈菌製劑、丙考達唑、西咗喃、烏克瑞 (Ukrain)、維如利金、順式維甲酸、安丫啶、視:醛 歐洲紫杉醇、依立替康、米替福新、米托葱I:基胺 (Nltracrine)、波特佐米(B〇rtez〇mib)、紫杉醇、外吩 姆、雷佐生、索布佐生、替尼泊苷、括朴替康、長春地 97198.doc -18- 200526266 而負。夫替尼(Geftinib)、伊馬替尼、博來黴 素、f地孕酮、來諾拉提及其混合物; z)抗發炎及抗風濕產物 醋氯芬酸、二氯芬酸、酮咯酸、美洛昔康、萘普生、吡 鋼洛芬、阿西美辛、阿氯芬酸、胺芬酸、安啦昔康、阿 紮丙宗、丁笨羥酸、布替巴芬、卡洛芬、軟骨素、桂美 辛環氯啼敲、右酮洛芬、二苯啦嗪醯胺、屈噁昔康、 依莫法宗、苯乙胺茴酸、依匹唑、依特柳酯、芬布芬、 芬替酸、非普拉宗、氟諾洛芬、氟比洛芬、胍美柳、異 丁普生、吲哚美辛、酮洛芬、氯那唑酸、馬布洛芬、萘 丁美酮、尼美舒利、奥沙美辛、帕沙米特、哌立索唑、 ϋ比羅昔康、普拉洛芬、丙谷美辛、普羅喹宗、普洛迪西 尼酸(Proticinic acid)、舒林酸、他尼氟酯、托芬那酸、 托美汀、紮托布洛芬、苄達明、依託芬那酯、聯苯乙 酸、非普地醇、艾多克瑞胺(Idocrilamide)、氣替潑諾、 範西夫萊(Vessiflex)、格魯克鹽(Glucosaline)、塞内考 昔、透明質酸、曱氣滅酸鹽、派普洛克辛(Piproxen)、 替諾昔康、伐地考昔、依託考昔、羅非考昔及其混合 物; aa)二膦酸鹽 利塞膦酸鹽、替魯膦酸鹽、氣膦酸鹽、帕米膦酸鹽、 依替膦酸鹽、阿侖膦酸鹽、唑來瞵酸鹽、克萊莫膦酸 鹽(Cimadronate)、奈瑞膦酸鹽(Neridronate)、奥帕膦 酸鹽、米諾膦酸鹽(Minodronate)、伊班膦酸鹽及其浪 9719S.doc -19- 200526266 合物; bb)止痛藥 乙醯水楊酸、乙醯胺苯酚、可待因、二氫可待因、右 布洛芬、阿明洛芬、卡巴匹林酯、恩氟烷、二氟苯水 揚酸、安氟醚、依託咪酯、夫洛非甯、磷柳酯、異氟 烷、異尼辛、酮咯酸、氣諾昔康、克羅尼辛酯 (Clonixinate)、咪達唑侖、莫苯唑酸、萘普生、奈福 泮、普魯泊福、利馬唑、羅非考昔、羅哌卡因、七氟 醚、帕瑞考昔、丙帕他莫、紮托布洛芬、阿西美辛、 舒林酸、吲哚美辛、甲芬那酸、酮洛芬、二氣芬酸、 °比羅昔康、氟吼汀、莫笨唑酸、布洛芬、非諾洛芬、 氟比洛芬、艾莫托門汀(Amtolmentin)、非普地醇、塞 内考昔、伐地考昔、依託考昔、氟丙喹宗、奈福泮、 艾斯桑汀(Asthaxantin)及其混合物; cc)抗偏頭痛製劑 阿莫曲坦、普魯泊福、加巴噴丁、唑尼沙胺、利生普 利、丙戊酸鹽、吡洛芬、吲哚拉明、利多卡因、美托 洛爾、麥角胺、塞庚啶、普萘洛爾、苯噻啶、氟桂利 嗪、納多洛爾、甲麥角林、酮洛芬、美西麥角、布克 利嗅、σ塞嗎洛爾、替阿斯匹酮(TiaSpir〇ne)、乾。比妒、 生長抑素、乙拉西坦、桂利嗪、雙氫麥角胺、小白菊 (Feverfew)、屈大麻紛(Dronabinol)、多他利嗪、、各美 利嗪、布洛芬、舒馬曲坦、那拉曲坦、多奈呢齊、佐 米曲坦、萘普生、利紮曲坦、孟魯司特、氟伐曲坦、 97198.doc -20· 200526266 肉毒桿菌毒素、阿尼地坦、艾維替普坦(Avitriptan)、 依立曲坦、甲氧氯普胺(Metoclopramide)、他吉因 (Targinine)、胺茶驗、托滅酸、異美汀及其混合物; dd)抗癲癇藥 苯巴比妥、氯硝西泮、非爾胺酯、磷苯妥英 (Fosphentoin)、加巴喷丁、拉莫三嗓、左乙拉西坦、 奥卡西平、替加賓、托α比酷、丙戊酸鹽、赦癲易、嗤 尼沙胺、米拉醋胺、登齊醇、溴他西尼、依特比妥、 安定、氣甲噻唑、氯硝西泮、氣巴占、米夫巴比托 (Mefobarbital)、美芬妥英、撲米酮、乙醯唾胺、丙戊 醯胺、雷利托林、S分加賓、利卡波加賓 (Licarbazepine)、勞拉 西泮、抗癇靈 (Antiepilepsirine)、盧非醯胺、紮萊普隆、阿比卡麥 (Abecamil)、氣西加S同、塞福太、米得夫泰 (Midafotel)、立馬醋胺、卡馬西平、乙琥胺、麥蘇克 斯麥(Metsuximide)、瑞替各賓(Retigabine)、戊諾醯胺 及其混合物; ee)抗精神病藥 氟略σ定醇、舒必利、布洛喃塞利(Blonanserin)、螺環 旅σ定酮、林卡吐、異夫洛塞賓(Isofloxythepin)、瑞莫 必利、奈莫必利、溴他西尼、珠氣噻醇、維拉必利、 溴σ底利多、氟旅利多、三氟拉嗓、溴西泮、左美丙 嗪、三氟丙嗪、奮乃靜、甲硫達嗪、氣普噻噸、氟奮 乃靜、略氰噃、替沃°塞σ頓、氟旅嗟。頓、苯旅利多、氟 97198.doc -21 - 200526266 司必林、匹莫齊特、氯氮平、哌泊噻嗪、洛沙平、泰 必利、佐替平、舒托必利、碳酸链、阿森納平 (Asenapme)、替阿斯派酮(Tiaspir〇ne)、利坦色林、扭 度螺酮、安哌齊特、氯司帕明、納美芬、丙氣扳嗪、 月女石哭必利、末夫基普瑞(Levosuipriride)、利培_、丙 唤、派羅匹隆、阿立π辰唑、氯丙嗪、卡匹帕明、羅派 瑞東(lloperidone)、瑞莫必利、卡馬西平、奥氮平、 喹硫平、齊拉西_、丙戊酸鹽、阿紮哌隆、氰美馬 嗪、替米哌隆、比菲普洛諾(Bifepnm〇x)及其混合物; ff)抗焦慮藥 安定、氣氮卓、吡多醇、舒必利、勞拉西泮、苯巴比 妥、曱丙胺S曰、丁螺環酮、舒立克隆、西酜普蘭、溴 替唑侖、阿地唑侖、依替唑侖、溴他西尼、麥地卡 (Medicar)、恩西拉嗪、氣氟卓酯、普萘洛爾、氣氮 卓、羥嗪、二氟拉嗪、奥沙西泮、美達西泮、氣硝西 泮、氧烯洛爾、溴西泮' 氣巴占、去甲西泮、飢他嗤 侖、哈拉西泮、阿普唑侖、氟奮乃靜、氯丙咪嗪、文 拉法辛、利坦色林、伊莎匹隆、坦度螺酮、丁螺環 酮、帕秦克隆、氟辛克生、氟西汀、塞福太、紮托司 瓊、帕戈隆、卡匹帕明、撒尼派托(Sunepitr〇n)、舍曲 林、帕羅西汀、環苯紮林、氰美馬嗓、戊諾酿胺、氣 噻西泮及其混合物; gg)抗抑鬱藥 西Sil普鬧、文拉法辛、杯替Jr、 曰陳]人4在宁托莫西>丁、克勞普來酮 97198.doc -22- 200526266 (Clopradone)、苯萘達林、舍曲林、非莫西汀、經丙 替林、維喹啉、氯伏胺、米拉醋胺、溴法羅明、氰帕 明、嗎氯貝胺、米那普侖、阿地唑侖、奈法唑酮、阿 澤米安塞林(Azamianserin)、瑞波西汀、嗟萘普〉、丁、托 洛沙酮、氟伏沙明、阿米替林、丙咪嗪、三氟拉嗪、 苯乙肼、氟奮乃靜、氟娘噻噸、異卡波肼、笨環丙 胺、曲米帕明、地昔帕明、因息頓、去甲替林、普羅 替林、多慮平、碳酸鐘、氣丙咪嗪、度硫平、曲拉唾 酮、布替林、維洛沙嗪、馬普替林、阿莫沙平、洛非 帕明、丁胺苯丙酮、利坦色林、多康唾、帕羅西、汀、 伊莎匹隆、酚加賓、坦度螺酮、司普替林、安非他 酮、拉紮貝胺、氟辛克生、阿屈非尼、腺苷蛋胺酸、 莫達非尼、利托西汀、氟西汀、塞羅普利、利托西 >丁、貝洛塞平、撒尼派g同(Sunepitron)、阿戈美拉、;丁、 阿瑞吡坦、安咪奈丁、諾米芬辛、吡啶甲酸鉻及其混 合物; hh)酒精依賴之治療 阿坎酸酯、赦癲易、安定、戒酒硫、利坦色林、納曲 酉同、納美芬、卡馬西平、羥基丁酸鹽、硝法唑、美他 多辛及其混合物; ii)鼻減充血劑 偽麻黃鹼、氟替卡松、茚咪唑、硫吲唑啉、伊並托平 及其混合物; jj)用於哮喘/阻塞性氣道疾病的藥物 97198.doc -23 - 200526266 沙美特羅、非諾特羅、伊並托平、說替卡松、氯地米 松、氟托(FlUtropium)、他尼氟酯、特布他林、氧托 (〇Xltr〇PiUm)、咯利普蘭、塞曲司特、普侖司特、福 莫特羅、沙丁胺醇(Albuter〇1)、沙丁胺= ㈣bUtamol)、米地司坦、替奥托(Ti〇tr〇pi㈣)、斯本 阿代特(Sibenadet)、、羅就司特、胺茶驗、布德松、阿 米三噪、格隆演錢、班布特羅、馬布待羅、普魯卡他 魯、女洛特羅、利米特羅、瑞普特羅、吼布特羅、達 =班、雷馬曲班、托美司特、異丁司特、泊比司特、 魯司特、孟魯司特、甲潑尼龍、地塞米松、曲安西 龍、替潑尼旦、莫米松、氯替潑諾、氟尼縮松、氫化 可的松及其混合物; kk)接疫樂或止咳藥 羧甲司坦、西替沃酮、羥丙哌嗪、氣哌斯丁、奥紮格 雷、奈索司坦、左羥丙哌嗪、西替克新、右美沙芬、 胍杲柳、奈哌那隆、福多司坦、喹尼丁、氫可_、那 了丁 氣本σ比胺及其混合物; 11)用於全身性使用之抗組胺劑 特菲那定、依巴斯汀、右氣苯那敏、氮卓斯汀、阿伐 、斤/ 丁 依美斯〉丁、氯雷他定、旅香豆司特、笨海拉 月異丙嗓、芬克羅辛(Fenclozine)、左卡巴斯汀、氣 田他疋、新乃力近、司他斯汀、他戈利嗪、咪唑斯 /丁、西替利嗪、他齊茶鹼、依匹斯汀、奥洛他定、拜 曰特斯定(Bepotastine)、盧帕他定、諾拉咪嗤 97198.doc •24- 200526266 (Norastemizol)、曲普利啶、非索非那定、酮替酚、阿 糸他疋、氯馬斯丁、漠苯σ比胺及其混合物; mm) 口腔抗菌劑 沙威隆、氯胺-T、氯苄烷胺及其混合物; nn)其它藥物 新諾明(Sulfamethoxazole)、積雪草(Centella)、甲醯四 氫葉酸鈣、帕米多(palmidr〇1)、硫黏多糖酶、葡甘聚 糖白西尼多、細菌溶胞物、斯帕克(spagul)及其混 合物。 可存在於根據本發明之組合物中的活性物質最好係選 自由非親脂性活性物質組成之群。較佳之醫藥活性物 質為制酸化合物。用於本發明之較佳制酸劑通常為 妈、鎂、銘或鉍之碳酸鹽或羥基碳酸鹽及其組合,且 通常極難溶於水。本發明亦包括其它諸如碳酸氫鈉、 碳酸氫鈣及其它碳酸鹽、矽酸鹽及磷酸鹽之制酸劑。 較佳之制酸劑為諸如氫氧化鋁及氫氧化鎂之鋁及鎂制 酸劑且亦較佳之制酸劑為諸如水滑石、氫氧化鎂鋁及 紹碳酸鎮之結晶鋁鎂羥基碳酸鹽或硫酸鹽。鋁碳酸鎂 為特佳。必要時可使用制酸劑化合物之混合物。在將 制酸劑用作醫藥活性物質時,其係以介於該組合物之 5至50重量%、較佳介於該組合物之10至45重量%、更 佳介於該組合物之2〇至35重量%範圍内之量存在。 本發明組合物較佳包含水,更佳包含至少1 %重量之水 且不包含可食用膠狀物。 97i98.doc -25- 200526266 本發明亦係關於用於產生非錠劑、獨立給劑之投藥劑型 的方法,其包含下列步驟··(a)形成組合物,其包含分散或 溶解在基質材料中之至少一種醫藥活性物質,該基質材料 包含明膠、至少一種穩定劑及作為溶劑的至少一種水溶性 醇及/或水之混合物’其在南溫下為塑料,且於加熱槽内 使該組合物保持在37°C以上,(b)當該組合物為流體時,將 其轉移至加熱給劑裝置中,(c)經由受控機制將該組合物排 放至成形基材上,以便藉此將恆定量之流體調配物材料給 劑於該基材上,(d)冷卻該組合物,其中存在於該組合物中 之穩定劑或多種穩定劑係選自由甘油及脂肪酸之酯及由該 專酯與聚乙二醇的醇解/酯化反應所生成的產物組成之群 且具有介於42°C至631:範圍内之熔點;及(e)視情況密封含 有該組合物之基材。 本發明之可選性具體實施例為在上述方法的步驟之 前,將降低黏著力之分離劑置於腔穴或泡穴的内表面上。 該等降低黏著力之分離劑的實例為卵磷脂、滑石粉、殿 粉、凡士林及在25°C下為流體之脂肪。 本發明之較佳具體貫施例亦為獨立給劑投藥劑型之腔穴 或泡穴係由選自下列各物之材料製得:PvC(聚氯乙烯)、 PVDC(聚氯亞乙烯)、pp(聚丙烯)、Aciar或諸如〇PAn pvc(取向聚醯胺-鋁-聚氣乙烯)之層狀物。pvc為特別較 佳。(完全) 在歐洲專利申請案第〇 250 578號中描述及主張之製造方 法係藉由將穩定劑添加至待加工之組合物中來加以改良, 97198.doc -26- 200526266 且以该改良形式構成根據本發明之方法的特佳具體實施 例,泫申請案係以引用的方式明顯倂入本文中。 本务明之另一態樣係關於至少一種穩定劑之用途,該穩 疋劑係遥自由下列各物組成之群:⑴甘油及脂肪酸之酯; (11)由5亥等酯與聚乙二醇的醇解/酯化反應所生成的產物, 亚具有介於42 c至63°c範圍内之熔點以有助於自封裝組合 物之泡穴或腔穴中移除該等組合物,該等組合物包含分散 或浴解在基質材料中的醫藥活性物質,該基質材料包含明 膠及作為溶劑之至少一種水溶性醇及/或水之混合物,該 組合物在1¾温下為塑料。 如本文所用,術語”在高溫下為塑料,,意謂表示可於包含 在45 c及120 c之間的溫度下模製且在冷卻至2〇。〇以後保 持模製形態之組合物。 士本文所用,炫點’’意謂表示溫度,如歐洲藥典 (European Pharmac〇pea)2 2· 14所述之毛細管熔化物中所引 入的小物貝官柱在該溫度下存在絕對最後可見顆粒。適用 於汶測疋過程之裝置為購自Btichi Lab〇nechnik AG之熔點 裝置B-540 。 " 如本文所用,術語”非錠劑投藥劑型,,係用以意謂任何並 非藉由使用自知製錠方法(例如在偏心或旋轉壓縮機中對 粒狀或粉狀組合物進行製錠)而製得的劑型。 如本文所用,術語"可食用膠狀物”係用以意謂包含其它 亞拉伯膠、黃耆膠、瓊脂、黃原膠、藻酸鹽之多醣膠狀 物0 97198.doc -27- 200526266 如本文所用,術語"水溶性醇”意謂表示醫藥上可接受之 液體單羥基或多羥基醇,其可與水混合以形成每ι〇〇體積 水至少ίο體積醇之量的均勻溶液。該等醇之實例為乙醇、 正丙醇、I丙醇、甘油、丙二醇、π丁二醇及具有包含 在100與600道爾頓(Dalt〇n)之間的分子重量之聚乙二醇。 自泡穴進行移除測試 待測試之組合物係根據實例丨所述之方法而製得且給劑 於由PVC製造的泡穴封裝之具有25 mm直徑環狀截面的圓 柱狀腔穴中。該泡穴係以鋁箔來熱密封。 然後將该等泡穴在4(TC及75%相對濕度之氣候測試箱中 儲存10週。在該週期之後,將其於25它及6〇%相對濕度中 停留24小時。 對於每個待測試之產物而言,將每個調配物之5個樣品 給予由5個專業參與者組成之專門小組,且要求該等參與 者自封裝組合物之泡穴中藉由以拇指按壓該腔穴的塑料壁 直至該組合物經鋁箔自該腔穴:中排出而移除該組合物。在 已排出該組合物之後,移除剩餘鋁密封膜且在視覺上檢驗 塑料腔穴。若在空腔穴中可看見任何尺寸超過〇·5 mm之殘 餘物,則要求該等參與者將等級評定”失效”給予樣品。否 則,必須將等級評定指定為”通過’’。 實例 實例1 在ErwekaSG3W反應器中將甘油之85%水溶液(2060.8 g) 加熱至65-75°C。在約4分鐘期間緩慢且連續添加288 g之 97l98.doc -28- 200526266 240度布倫豬皮明膠,直至已發生完全溶解。將該混合物 攪拌額外10分鐘。加入48 g卵磷脂且將該混合物攪拌10分 鐘。然後在約15分鐘期間緩慢且連續添加800 g鋁碳酸鎂 且在75-80°C下將該混合物攪拌額外20分鐘。繼續加入3.2 gr芳香劑且將該溶液攪拌5分鐘。將4 g熔化組合物給劑於 由PVC製造的泡穴封裝之具有25 mm直徑環狀截面之圓柱 狀腔穴中。該泡穴係以鋁箔來熱密封。 各個別腔穴之組合物係如下所述。 成份 重量% 鋁碳酸鎂 25.00 明膠 9.00 甘油(100重量%) 54.74 水 9.66 印石粦脂 1.50 芳香劑 0.10 實例2至7 根據實例1所述之方法來製造組合物2至7,該方法係經 改良為其中使用1900.8 gr甘油溶液,且其中在已發生明膠 之完全溶解以後且在添加卵磷脂以前添加160 g穩定劑。 在明膠溶解以後,將該混合物攪拌20分鐘且將反應器之溫 度升至75-80°C,並在約5分鐘期間緩慢且連續添加160 g穩 定劑。 以下組合物均係根據該程序製得。 實例 穩定劑(商品名) 穩定劑(化學性質) 熔化範圍(°C) 2 Cutine HR 氫化蓖麻油 87-88 3 Compritol 888 ΑΤΟ 山俞酸甘油醋 71.4-72.2 4 Akofine NF 氫化棉子油 63.4-63.9 97198.doc -29- 200526266 5 Estol 3745 GDS T2 甘油二酯80 59.0-59.7 6 Gelucire 50/13 硬脂醯聚乙二醇-32甘油酯 50.3-51.0 7 Gelucire 44/14 月桂基酸聚乙二醇-32甘油酯 43.6-44.2 為了評估穩定劑之作用,對實例1至7之組合物進行上述 自泡穴進行移除測試”,其具有以下結果。 實例 自泡穴進行移除測試 1 失效 2 失效 3 失效 4 失效 5 通過 6 通過 7 通過 97198.doc 30-
Claims (1)
- 200526266 十、申請專利範圍: 1 · 一種非錠劑、獨立給劑之投藥劑型,其包含溶解或分散 在基質材料中之至少一種醫藥活性物質的組合物,該基 質材料包含至少〇·2重量%之明膠、至少一種穩定劑及作 為溶劑之至少一種水溶性醇及/或水的混合物,該組合物 在高溫下為塑料,其特徵在於: a·邊穩定劑係選自由下列各物組成之群··⑴甘油及脂 肪酸之醋;(ii)由該等甘油及脂肪酸之酯與聚乙二醇 的醇解/酯化反應所生成的產物;且 b. 在於該穩定劑具有介於42°C至63°C範圍内之熔點; c. 在於水係以不超過該組合物的46重量%之量存在。 2·如請求項1之非錠劑、獨立給劑之投藥劑型,其中該穩 定劑係以超過該調配物的1重量%之量存在。 3·如請求項1或2之非錠劑、獨立給劑之投藥劑型,其特徵 在於其係封裝於由膜成形之泡穴或腔穴中。 4·如凊求項1或2之非錠劑、獨立給劑之投藥劑型,其特徵 在於其包含超過18重量%之至少一種醫藥活性物質。 5·如請求項1或2之非錠劑、獨立給劑之投藥劑型,其特徵 在於其包含制酸劑。 6·如μ求項1或2之非錠劑、獨立給劑之投藥劑型,其特徵 在於其包含佔該組合物的至少1〇重量%之作為溶劑的至 少一種水溶性醇及/或水。 7·如請求項6之非錠齊彳、獨立給劑之投藥劑型,其特徵在 於其包含超過該組合物的46重量%之至少一種水溶性 97198.doc 200526266 醇。 8.如請求項1或2之非錠劑、獨立給劑之投藥劑型,其特徵 在於其包含水’其量較佳超過該總組合物之1重量%。 9·如請求項1或2之非錠劑、獨立給劑之投藥劑型,其特徵 在於該組合物不包含可食用膠狀物。 10· —種用於產生非錠劑、獨立給劑之投藥劑型的方法,其 包含下列步驟: 籲形成組合物,其包含分散或溶解在基質材料中之至少 一種醫藥活性物質,該基質材料包含至少〇·2重量% 之明膠、至少一種穩定劑及作為溶劑的至少一種水 溶性醇及/或水之混合物,其在高溫下為塑料且於加 熱槽内使該組合物保持37°C以上; 籲當該組合物為流體時,將其轉移至加熱給劑裝置中; 鲁經由受控機制將該組合物排放至成形基材上,以便藉 此將恒定篁之流體調配物材料給劑於該基材上; _冷卻該組合物; 籲視情況密封含有該組合物之基材, 其中水係以不超過該組合物的4 6重量%之量存在且該至 少一種穩定劑係選自由下列各物組成之群:〇)甘油及脂 肪酸之醋;(π)由該等醋與聚乙二醇的醇解/酯化反應所 生成的產物且具有介於42°C至63t範圍内之馆:點。 11.如請求項10之方法,其中該穩定劑係以超過該調配物的 1重量%之量存在。 12·如請求項10或11之方法,其特徵在於該組合物包含超過 97198.doc 200526266 18重量%之醫藥活性物質。 13.如請求項10或11之方法,其特徵在於該等醫藥活性物質 包含制酸劑。 j 14 ·如凊求項1 〇或11之方法’其特徵在於該組合物包含水, • 其量較佳超過該總組合物之1重量〇/〇。 15·如請求項10或1 1之方法,其特徵在於該組合物包含佔該 組合物的至少10重量%之作為溶劑的至少一種水溶性醇 及/或水。 16·如請求項10或11之方法,其特徵在於該組合物包含超過 該組合物的46重量%之至少一種水溶性醇。 17·如請求項1〇或11之方法,其特徵在於該組合物不包含可 食用膠狀物。 18·如請求項1〇或11之方法,其中該腔穴或泡穴包含選自由 PVC、PVDC、PP、Aclar或諸如opa-銘 -PVC之層狀物組 成之群的材料。 1 9· 一種由請求項1〇或丨丨之方法所獲得的非錠劑、獨立給劑 之投藥劑型。 20· —種至少一種穩定劑之用途,該穩定劑係選自由下列各 物組成之群:(i)甘油及脂肪酸之酯;(Η)由該等酯與聚乙 二醇的醇解/酯化反應所生成的產物,其具有介於42。〇至 63°C範圍内之熔點以有助於自封裝組合物之泡穴或腔穴 中移除該等組合物,該等組合物包含分散或溶解在基質 • 材料中的至少一種醫藥活性物質,該基質材料包含明膠 及作為溶劑之至少一種水溶性醇及/或水的混合物,該組 97198.doc 200526266 合物在高溫下為塑料。 2 1 ·如請求項20之用途,其中該等穩定劑之用量係超過該組 合物之1重量%。 97198.doc 200526266 七、 指定代表圖: (一) 本案指定代表圖為:(無) (二) 本代表圖之元件符號簡單說明: 八、 本案若有化學式時,請揭示最能顯示發明特徵的化學式: (無) 97198.doc
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AU2007288253B2 (en) | 2006-08-23 | 2013-05-02 | Xenon Pharmaceuticals Inc. | Derivatives of 4-(N-azacycloalkyl) anilides as potassium channel modulators |
US8993593B2 (en) | 2006-08-23 | 2015-03-31 | Valeant Pharmaceuticals International | N-(4-(6-fluoro-3,4-dihydroisoquinolin-2(1H)-yl)-2,6-dimethylphenyl)-3,3-dimethylbutanamide as potassium channel modulators |
KR20090083479A (ko) | 2006-11-28 | 2009-08-03 | 밸리언트 파마슈티컬즈 인터내셔널 | 칼륨 채널 조절제로서의 1,4 디아미노 이환 레티가빈 유사체 |
US8367684B2 (en) | 2007-06-13 | 2013-02-05 | Valeant Pharmaceuticals International | Derivatives of 4-(N-azacycloalkyl) anilides as potassium channel modulators |
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US7786146B2 (en) | 2007-08-13 | 2010-08-31 | Valeant Pharmaceuticals International | Derivatives of 5-amino-4,6-disubstituted indole and 5-amino-4,6-disubstituted indoline as potassium channel modulators |
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BRPI0416215A (pt) | 2006-12-26 |
JP2007510690A (ja) | 2007-04-26 |
ATE492270T1 (de) | 2011-01-15 |
EP1682097B1 (en) | 2010-12-22 |
NO20062723L (no) | 2006-06-12 |
EP1682097A2 (en) | 2006-07-26 |
NZ546375A (en) | 2009-11-27 |
ES2358332T3 (es) | 2011-05-09 |
MY143793A (en) | 2011-07-15 |
WO2005048974A2 (en) | 2005-06-02 |
US20070134318A1 (en) | 2007-06-14 |
WO2005048975A1 (en) | 2005-06-02 |
ECSP066553A (es) | 2006-12-20 |
CN1878542A (zh) | 2006-12-13 |
CA2548615A1 (en) | 2005-06-02 |
AR048050A1 (es) | 2006-03-29 |
UA90253C2 (ru) | 2010-04-26 |
ES2235626A1 (es) | 2005-07-01 |
CO5690531A2 (es) | 2006-10-31 |
UY28586A1 (es) | 2005-05-31 |
IL175285A (en) | 2011-04-28 |
ES2235626B1 (es) | 2006-11-01 |
KR20060116821A (ko) | 2006-11-15 |
PE20050488A1 (es) | 2005-08-24 |
RU2006120087A (ru) | 2007-12-27 |
AU2004290517A1 (en) | 2005-06-02 |
JP4879021B2 (ja) | 2012-02-15 |
RU2369379C2 (ru) | 2009-10-10 |
IL175285A0 (en) | 2006-09-05 |
ZA200602416B (en) | 2009-06-24 |
WO2005048974A3 (en) | 2006-02-23 |
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