TW537903B - New stable pharmaceutical preparation for producing propellant gas-free aerosols - Google Patents
New stable pharmaceutical preparation for producing propellant gas-free aerosols Download PDFInfo
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Description
537903 A7 經濟部中央標準局員工消費合作社印製 五、發明説明(1 ) — 一一^一~ 本發明係有關用以製備無推進氣體的霧劑,呈安定含乙 醇的活性物質溶液形式之醫藥製劑。 於過去2 0年内,計量霧劑的使用已成爲確定的治療阻礙 性肺疾病,特別是氣喘之成份。通常係使用氟氯碳化合物 作爲推進氣體。自從這類推進氣體的臭氧破壞潛能被公認 <後’有越來越多的努力投入替代物之開發。其中一種替 代物爲噴霧器的開發,其中係在高壓下噴出藥物學活性物 質之水溶液而產生可吸入粒子霧。這種噴霧器的優點爲不 需要任何種推進氣體。 有些噴霧器載於例如PCT專利申請案W091/14468之中, 其内容要在下文作爲參考。於其中所載噴霧器之中,係使 用咼壓將含有活性物質的確定體積溶液透過小噴口噴出而 產生可吸入的氣霧劑,其較佳粒度爲1至10,較佳者2至5微 米。 在此之前,都假設使用含推進氣體的傳統計量氣霧劑即 可在氣霧中得到最佳的肺結合粒子水平。如今令人訏異地 發現,經由使用含乙醇的活性物質溶液配合,例如,上述 噴霧器,即可產生比通常用含推進氣體的計量氣霧劑之情 況明顯較爲佳的可吸入粒子譜。 上所述,於一部份中,本發明提出一種用以製備無推 進氣體的霧劑之醫藥製劑,其包含具有至少7〇%(w…乙 的藥物學活性物質之溶液。 適合於供本發明範圍内的醫藥製劑所用之溶劑爲含有至 少7〇〇/〇(V/V)乙醇的溶液;較佳者爲含有至少85%(v/v)乙醇的 ___ _4_ 本紙張尺度適用中國國家標格(210x^^y (請先閱讀背面之注意事項再填寫本頁) 裝- 訂 >0^^ - - _ m -= r i—ϋ —'1 —-ϋΒ— S 面ma cm HI 1ϋ- ΒβΒϋ m —fin —m 537903 A7 B7 經濟部中央標準局員工消費合作社印製 五、發明説明(2 ) 4液’而特別較佳者爲具有高於95%(v/v)乙醇含量的溶液 。其濃度係表成體積百分比(v/v),其餘部份的水。最特別 較佳者爲已含有少量水’例如%%,的乙醇,如此其不再 具有吸濕性及共沸地揮發掉。 除了水之外,該溶劑可包含其他的共溶劑且該醫藥製劑 也可含調味料和其他藥用賦形劑。共溶劑的例子爲含有羥 基或其他極性基者,例如醇,特別是異丙醇,二醇,特別 者丙二醇,聚乙二醇,聚丙二醇,二醇醚,甘油,聚氧化 乙#醇和聚氧乙烯脂肪酸酯。共溶劑適合用來增加賦形劑 和可能的活性物質之溶解性。 經溶解的醫藥物質在成品醫藥製劑中的比例爲〇〇〇1至5% ’較佳者0.〇5至3%,最佳者〇〇1至2%之間,所有百分比都 是以重量計者。醫藥物質的最大濃度決定於其在溶劑中的 溶解度及達到所欲治療效果所需的劑量。 有關▲新痛製劑中的醫藥活性劑可以使用適合於經由吸 入給藥且可溶於所指定溶劑中的任何物質。這些物質可包 括’特別者’ >9 模擬劑(betamimetics),抗膽驗能藥,抗過 敏藥,P AF -拮抗劑和特別的,類固醇及彼等活性物質的組 合0 下面爲特別提出作爲例子者: Tiotropium bromide,3·[(羥基二·2-嘧吩基乙醯基)氧基]_ 8,8_二甲基偶氮雜雙環[m]辛·6_烯-溴化物 作爲/?-模擬劑者: Bambuterol Bitolterol Carbuterol Formoterol -5- 本紙張尺度適用中國國家標準(CNS ) A4規格(210X 297公釐) (請先閲讀背面之注意事項再填寫本頁) 裝· 訂 ·線 537903 A7 B7 五、發明説明(3 )
Clenbuterol Fenoterol Hexoprenaline Procaterol
Ibuterol Pirbuterol Salmeterol Tulobuterol
Reproterol Salbutamol Sulfonterol Terbutaline l-(2·氣-4-¾基苯基)-2-[4-(l·苯幷味嗤基)-2 -甲基-2 -丁胺基] 乙醇, 丁四醇-5’-羥基-8’-(1 •羥基-2-異丙胺基丁基)-2Η-1,4-苯幷嘮 畊·3-(4Η)-酮, 1-(4 -胺基-3·氯-5-二鼠甲基苯基)-2-第二丁胺基)乙醉’ 1-(4 -乙氧談胺基-3-氣基-5·氣苯基)-2·(第三丁胺基)乙醇。 有關抗膽鹼能劑:
Ipratropium bromide Oxitropium bromide Trospium chloride 二苯基乙醇酸-Ν-Θ-氟乙基降莨菪醇酯 methobromide 有關類固醇: 布德松(Budesonide) 氯地米松(Beclomethasone)(或其17,21·二丙酸酯) 經濟部中央標準局員工消費合作社印製 (請先閱讀背面之注意事項再填寫本頁) 地塞米松-21 •異菸撿酸酯 氟尼縮松(Flunisolide) 有關抗過敏藥: 色甘酸二鋼 Nedocromil Epinastin -6- 本紙張尺度適用中國國家標準(CNS ) A4規格(210X 297公釐) 經濟部中央標準局員工消費合作社印製 537903 A7 _β7 五、發明説明(4 ) 有關PAF-拮抗劑: WEB 2〇86(4-(2_氯苯基)_9·甲基_2_[3_(4_嗎啉基)_3_丙醯」_ 基]-611-嘍吩幷-[3,2_幻[1,2,4]-三唑弁[4,34][1,4]二氮雜萆) web 2170 (6·(2_氯苯基)-8,9-二氫-1·甲基-8-[(4-嗎啉基)羰基]-4H,7H-環戊[4,5]邊吩幷[3,2_幻[1,2,4]三唑弁[43&][1,4]二氮雜萆) 本發明醫藥製劑可含有其他賦形劑例如大豆卵磷脂或界 面活性物質。 此外也令人訏異地發現有機或無機酸的添加,較佳地配 合錯合物形成劑,可導致含類固醇製劑的安定性(存放期) 之改良。此點經發現對於含有以氟尼縮松(Flunis〇lide)或其 水合物或半水合物或Budenoside作爲活性物質且其含有乙 醇爲其溶劑之醫藥製劑特別有用。 典機的例子包括鹽酸,硫酸或蹲酸,·有機酸的例子包 括抗壞血酸,檸檬酸,蘋果酸,酒石酸,順丁烯二酸,丁 二酸,反丁晞二酸,乙酸,甲酸,丙酸等。 酸在成品醫藥製劑中的含量於每一情況中都經選擇以使 液的pH値介於2.0至7.0,更特別是3.〇至4.0之間。 於一較佳實施例中,本發明醫藥製劑也含有一錯合物形 成劑。錯合物形成劑的例子包括EDTA,檸檬酸,氮基三乙 酸及彼等的鹽。錯合物形成劑的含量以成品醫藥製劑爲基 礎計算時爲介於0.1至3毫克/100毫升,較佳者〇 2至2毫克 /1〇〇笔升’特別者介於〇·9至1.1毫克/1〇〇毫升之間。 較佳的錯合物形成劑爲£1)1^(乙二胺四乙酸或其鹽,例 本紙張尺度適用中國國 (請先閲讀背面之注意事項再填寫本頁) -裝_
1T 經濟部中央標準局員工消費合作社印製 537903 A7 B7 五、發明説明(5 ) 如二鈉鹽)。本發明較佳醫藥製劑於作爲溶劑的乙醇(96% v/v)中,含有1.667%氟尼縮松(Flunisolide),且另含0.01% (v/v) EDTA作爲錯合物形成劑並經由添加酸將其pH値調整 至pH 3.0至4.0之間。 可在本發明醫藥製劑中用爲活性成份的類固醇之例子有
Seratrodast Mycophenolate mofetil Pranlukast Zileuton Butixocort 布德松(Budesonide) Deflazacort Fluticasone Promedrol Mometasone furoate Tipredane 氯地美松 Icomethasone enbutate Ciclometasone Cloprednol 氟考丁酯 Halometasone Deflazacort Alclometasone Ciclometasone Alisactide Prednicarbate 可酸氫化可的松 Tixocortol pivalate Alclometasone dipropinonate Lotrisone Canesten-HC Deprodone Fluticasone propionate 6-甲氧化潑尼松 Halopredone acetate 氫化可的松 Mometasone furoate Hydrocortisone aceponate Mometasone -8- 本紙張尺度適用中國國家標準(CNS ) A4規格(210X 297公釐) -mB 111 _ πϋϋ· (請先閲讀背面之注意事項再填寫本頁) 、1Τ 線 537903 A7 B7 五、發明説明(6 經濟部中央標準局員工消費合作社印製
Ulobetasol propionate 氟經脱皮甾醇 Meprednisone 地塞米松 Medrysone 丙_化膚氫松 Deprodone Propionate Fluocinonide Difluprednate 黑菸蝓酸地塞米松 氟考龍 氟烴氫化潑泥松 Formebolone Endrisone 氣氟松 氯氟美松 Diflorasone Amcinonide Cortivazol Fluodexan 布德松(Budesonide) Demetex 9α -氯·6α _ii/j,17乙 二烯-17々-羧酸甲酯_ 氨基導眠能 氫化可的松 Fluorometholone 倍他米松 Fluclorolone acetonide 乙酸對氟米松 Aristocort diacetate Mazipredone 戊酸倍他米松 二丙酸氯地米松 Formocortal Cloprednol 氣氬美松酮 氟尼縮松(Flunisolide) 氟α惡米松 氫化可的松_17· 丁酸酯 Flucortin 二丙酸倍他米松 金剛虎酸倍他米松 Triiostane 氣氟美松酮 Trimacinolon Benetonid r -二羥基-16 α -甲基-3-氧基-1,4-雄留 17-丙酸酯。 -9 本紙張尺度適用中國國家檩準(CNS ) A4規格(210X 297公釐) (請先閲讀背面之注意事項再填寫本頁) 言 經濟部中央標準局員工消費合作社印製 537903 A7 —~~—~— B7 五、發明説明(7 ) —一—一—_ 於另一邵份中,本發明提出在含有至少70體積%乙醇的 ,谷液中含醫藥活性物質所構成的醫藥製劑對於製備供吸入 給藥用的無推進氣體組合物之用途。 於又另一部份中,本發明提出一種製備本發明製劑的方 法,其包括將藥學活性物質和至少7〇% v/v的乙醇製成混合 物v 亥活〖生物*和乙醇兩者都必須爲給患者經由吸入給藥 可接受的純度品級。 表I所不爲一種沈積研究結果,其於一方是用標準市售計 量霧劑Inhacort®(氟尼縮松(Flunis〇Hde),二氣甲烷,三氟_ 氟甲fe,cryofluoran,山梨糖醇三油酸酯)二MD][具另一方 疋用含有氟尼縮松(Flunisolide)/96%(v/v)乙醇的本發明醫藥 製劑進行的,其係用如上述PCT申請案WO 91/14468中的噴 務器進行的(BINEB® ;技術數據:藥物製劑給用體積丨5微升 ’壓力約3 00巴’從兩個大小爲5 X 8微米的噴口擠嘴2次)。 表1 :沈積研究 肺(%) ΒΙΝΕΒ® 39.7(9.9) MDI 15.3(5.1) α(%) 39.9(9.4) 66.9(7.1) 呼出部份(%) 10.4(4.9) 1.4(1.3) 中心肺區(%) 10.7(2.5) 4.5(1.8) 中肺區(%) 14.9(3.6) 5.4(1.9) 周圍胺區(%) 14.1(4.3) 5.4(1.4) 周圍區/中央區比例 1.3(0.2) 1.3(0.2) 此表清楚地顯示出本發明醫藥製劑用所述喷霧器給藥時 -10 - 本紙張尺度適用中國國家標準(CNS ) A4規格(210X297公釐) (請先閱讀背面之注意事項再填寫本頁}
537903 A7 B7 五、發明説明(8 ) 之優點。 實施例: 氟尼縮松(卩1111^〇11(16)半水合物-6“-氟_11々,16從,17“,21· 四氟孕甾-1,4-二烯-3,20-16丙酮化物半水合物,具有442.5 I分子量。在BINEB中使用時,每劑量爲將250微克的氟尼 縮松(Flunisolide)溶解在is微升溶液中成爲i 667%(克/100 毫升)之濃度。 使用96%乙醇作爲溶劑。此外,成品醫藥製劑中含有1毫 克/100毫升的EDTA-二鈉。該醫藥製劑的pH値係用0.1N HC1 調到 pH 4。 以類似上述實驗的方式,製備含有布德松(Budesonide)作 爲活性物質之方劑。 (請先閱讀背面之注意事項再填寫本頁) -裝· 訂 經濟部中央標準局員工消費合作社印製 製成下列醫藥製劑混合物,其中含有氟尼縮松 (Flunisolide)-半水合物作爲活性物質。 表II 實驗編號 組合 乙醇含量。/〇 (v/v) pH EDTA二鋼含量 ,毫克/100毫升 1 1 85 3.6 0 2 A 96 3.6 0 3 B 85 7.0 0 4 AB 96 7.0 0 5 C 85 3.6 1 6 AC 96 3.6 1 7 BC 85 7.0 1 8 ABC 96 7.0 1 ·線 -11 - 本紙張尺度適用中國國家標隼(CNS ) A4規格(210X297公釐) 537903 A7 B7 五、發明説明(9 氟尼縮松(Flunisolide)-半水合物的含量為1 666 7亳克八⑻ 亳升。溶液的pH値係用iN Hc_整並用 ,二=00 Rad10meter Copenhagen測定的。樣品係轉移到5亳升 中並儲存在8GX:避光之下。組合Ac在3{)天儲存後顯示出最 低的分解產物量。 表III列出另含EDTA:納作爲錯合物形成劑的其他方劑例 子。 表III 成份 I 量,毫克/ 100毫升 II 量,毫克/ 100毫升 III 量,毫克/ 100毫升 IV 量,毫克/ 1 〇〇毫升 氟尼縮松 半水合物 1667 1667 1667 1667 二鈉 EDTA 1 1 1 1 0.1N HC1 至pH 3.6 至pH 3.2 至pH 4.0 至pH 3.6 薄荷醇 - - - 两 乙醇96% 至100毫升 至100¾升 至100毫升 至100毫升 (請先閱讀背面之注意事項再填寫本頁) •裝· T m _ 、-口
¾I 經濟部中央標準局員工消費合作社印製 將上述諸方劑包裝在5毫升玻璃針藥瓶内並儲存在8(rc 下。基於其小量的分解產物來看,較佳的製劑的製劑ΠΙ。 表IV列出布德松(Budesonide)的一些方劑例子。 12-
本紙張尺度適用中國國家榡準(CNS ) μ規格(210X 297公U 537903 A7 B7 五、
發明説明(10
表IV 成份 I II III 量,毫克 量,毫克 量,毫克 /100毫升 /100毫升 /100毫升 布德松 1333 1333 1333 二鋼 EDTA 〇·1Ν HC1 至pH 3.2 3.2 3.6 乙醇96% 100 100 於密封的玻璃針藥瓶中在80°c下儲存3個月後了^ 測定分解產物的量。其中方劑IV和V顯示出最小的分解產 物量。 «^1裝丨 (請先閱'^11背面之注意事項再填寫本頁〕 訂 經濟部中央標準局員工消費合作社印製 -13- 本紙張尺度適用中國國家標準(CNS ) A4規格(210X 297公釐)
Claims (1)
- 537903 第0851〇7489號專利申請案 中文申請專利範圍替換本(92年2 8 8 8 A Β c D Λ- χ· 六、申請專利範圍 — 1 . 一種用以製備無推進氣體之可吸入式霧劑之醫藥製 劑’ Μ可吸入式霧劑係用於將呈溶液形式之活性物質 投遞至肺部’該醫藥製劑之特徵在於活性物質係選自 /5 -模擬劑、抗膽鹼能劑、抗過敏劑、pAF_拮抗劑、類 固醇及該等活性物質之組合,其含量為0.001至5重量 百分比’其一併與視須要之調味劑及/或醫藥上可接受 之賦形劑溶解於無推進氣體之溶劑,其係由7〇至 96% (體積比)之乙醇所組成,其餘則為水及視須要之助 溶劑。 2 ·根據申請專利範圍第1項之醫藥製劑,其特徵係在於該 溶劑含有85至96% (體積比)之乙醇。 3 ·根據申請專利範圍第1項之醫藥製劑,其特徵係在於該 溶劑含有95至96% (體積比)之乙醇。 4 ·根據申請專利範圍第丨項之醫藥製劑,其特徵係在於該 溶劑含有96% (體積比)之乙醇。 5 ·根據申請專利範圍第1項之醫藥製劑,其特徵係在於該 活性物質係選自沒-模擬劑、抗膽鹼能劑及/或抗過敏 劑。 6 ·根據申請專利範圍第1至3項中任一項之醫藥製劑,其 特徵係在於該溶劑中除活性物質外,具有一或多種醫 藥上可接受之賦形劑或調味劑。 7 .根據申請專利範圍第2或3項之醫藥製劑,其特徵係在 於該醫藥製劑含有錯合劑。 8 ·根據申請專利範圍第4項之醫藥製劑,其特徵係在於該 本紙張尺度適用中國國家標準(CNS) A4規格(210 X 297公釐) 537903 A8 B8 _ C8 -------- D8 六、申請專利範圍 — ---- 醫藥製劑含有作為錯合劑之EDTA或其鹽。 9 .根據申凊專利範圍第i至4項中任一項之醫藥製劑,特 徵係在於該活性物質為帝歐托皮恩(Ti〇tr〇pium)或其酸加 成鹽。 10·根據申請專利範圍第丨至4項中任一項之醫藥製劑,其 特徵係在於該活性物質為3_[(羥基二_2_者吩基乙醯基) 氧基]-8,8 -二曱基-8 -偶氮雜雙環[3,2,1]辛-6-烯或其 酸加成鹽。 11 ·根據申請專利範圍第1至4項中任一項之醫藥製劑,其 特徵係在於該活性物質為引普拖平溴化物(ipratropium broimde)、澳賽拖平溴化物(〇xitr〇pium br〇mide)或拖斯平氯 化物(trospium chloride)。 12·根據申請專利範圍第1至*項中任一項之醫藥製劑,其 特徵係在於該活性物質為帝歐托皮恩(Ti〇tr〇pium)或其酸 加成鹽。 13·根據申請專利範圍第4項之醫藥製劑,其特徵係在於該 活性物質為類固醇,且該醫藥製劑含有有機或無機 酸。 14·根據申請專利範圍第1或4項之醫藥製劑,其特徵係在 於該活性物質為類固醇,且該醫藥製劑含有有機或無 機’以及錯合劑。 15·根據申請專利範圍第1或4項之醫藥製劑,其特徵係在 於該活性物質為類固醇,且該醫藥製劑含有有機或無 機酸,以及作為錯合劑之EDTA或其鹽。 -2 - 本紙張尺度適用中國國家標準(CNS) A4規格(210 X 297公釐) 537903 AB c D 六、申請專利範圍 16. 根據申請專利範圍第1或*項之醫藥製劑,其特徵係在 於該活性物質為類固醇,且該醫藥製劑含有有機或無 機酸,以及錯合劑,其含量為界於〇 · 1及5毫克/ 100毫 升溶液。 17. 根據申請專利範圍第1或4項中任一項之醫藥製劑,其 特徵係在於該活性物質為類固醇,且該醫藥製劑含有 有機或無機酸,及該溶液的pH值係經調整至界於3 · 2及 4」° 18. 根據申請專利範圍第1或4項中任一項之醫藥製劑,其 特徵係在於該活性物質為氟尼縮松(flunisoli⑽或布德松 (budesonide),且該醫藥製劑含有有機或無機酸。 19· 一種用以製備無推進氣體之可吸入式霧劑之醫藥製 劑’活性物質係呈溶液形式,其包含96% (體積)之乙醇 及4 % (體積)之水作為溶劑,且其中每1〇〇毫升溶劑中包 含1 · 667克的氟尼縮松半水合物和1毫克的EDTA二鈉, 且其pH值係調整至4.0。 20. —種用以製備供推進氣體之可吸入式霧劑之醫藥製 劑,活性物質係呈溶液形式,其包含9〇% (體積)之乙醇 及10%(體積)之水作為溶劑,且其中每1〇〇毫升溶劑 中包含1 · 6 67克的氟尼縮松半水合物和i毫克的EDTA二 鈉,且其pH值係調整至4 . 〇。 21. —種用以製備無推進氣體之可吸入式霧劑之醫藥製 劑’活性物質係呈溶液形式,其包含%%(體積)之乙醇 及4%(體積)之水作為溶劑’且其中每1〇〇毫升溶劑中包 -3 - 本紙張尺度適用中國國家標準(CNS) A4規格(210 X 297公 537903含1 . 333克的布德松和1毫克的EDTA二鈉,且其pH值係 _整至4.0。 22· —種用以製備無推進氣體之可吸入式霧劑之醫藥製 劑,活性物質係呈溶液形式,其包含9〇% (體積)之乙醇 及10% (體積)之水作為溶劑,且其中每1〇〇毫升溶劑中包 含1 · 333克的布德松和!毫克的EDTA二鈉,且其值係 調整至4.0。 23·根據申請專利範圍第i至4項中任一項之醫藥製劑,其 特徵係在於該醫藥製劑係用於吸入器,其係以兩個喷 射器於高壓下噴霧溶液,經由兩個小噴嘴開口喷出, 藉此產生可吸入式無推進氣體之霧劑,其粒子大小為i 至10微米。 24. —種霧劑,其係由大小為i至1〇微米之可吸入式粒子所 組成,其係將根據申請專利範圍第丨至4項中任一項之 活性物質係呈溶液形式之醫藥製劑藉由吸入器噴霧$ 得,該吸入器係以兩個喷射器於高壓下噴霧溶液,經 由兩個小噴嘴開口噴出。 -4- 本紙張尺度適用中國@家標準(CNS) A4規格(21Qχ 297公董)- ' ___
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DE19653969A1 (de) * | 1996-12-20 | 1998-06-25 | Boehringer Ingelheim Kg | Neue wässrige Arzneimittelzubereitung zur Erzeugung treibgasfreier Aerosole |
US20030215396A1 (en) | 1999-09-15 | 2003-11-20 | Boehringer Ingelheim Pharma Kg | Method for the production of propellant gas-free aerosols from aqueous medicament preparations |
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