TW202037361A - 用於藥物或營養物質給藥的無菌或經滅菌之包裝 - Google Patents

用於藥物或營養物質給藥的無菌或經滅菌之包裝 Download PDF

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TW202037361A
TW202037361A TW109105836A TW109105836A TW202037361A TW 202037361 A TW202037361 A TW 202037361A TW 109105836 A TW109105836 A TW 109105836A TW 109105836 A TW109105836 A TW 109105836A TW 202037361 A TW202037361 A TW 202037361A
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保羅朱塞普 戈比弗拉帝尼
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瑞士商艾迪安納製藥及生物科技股份有限公司
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Abstract

一種用於流質藥物或營養物質給藥之包裝，其特徵在於一外袋(1)，其具有一無菌或經滅菌之內腔(2)且將藥物或營養物質(6)之一瓶(5)收容在該腔(2)內部，處於一翻轉位置，該瓶(5)具有一頸部(7)及一可刺穿蓋(8)，及一裝置(9)，其位於該瓶之該蓋下方且可勾住該瓶(5)之該頸部(7)，用於取出及/或添補該藥物或營養物質(6)。該裝置包括一穿孔針(13)，其經構造成可相對於該瓶(5)軸向移動，及一外流管(15)，其延伸超出該袋(1)且配備有一可開啟之密封體(17)。在該蓋(8)穿孔且該密封體(17)開啟後，連接該瓶(5)內部至該外流管(15)之一第一通道(18)縱向穿過該穿孔針(13)，及一第二通道(19)，其具有一側開口(20)且配備有一疏水性過濾器(21)，其經構造成在該蓋(8)穿孔後僅允許空氣或其他氣態流體自該瓶(5)內部流進該袋(1)之該內腔(2)，或自該袋(1)之該內腔(2)流進該瓶(5)內部。

Description

用於藥物或營養物質給藥的無菌或經滅菌之包裝
本發明係關於一種無菌或經滅菌之包裝(亦即自始無菌或在後續階段滅菌)用於遞送藥物或營養物質。
已知適於藥物或營養物質給藥的無菌或經滅菌之包裝。該等包裝之實例揭示於EP 2962676 B1、EP 3158987 B1、EP 3545935 A1，及義大利新型專利號2020160000582078。
在該等包裝中，具有一無菌或經滅菌內腔之一外撓性袋收容一瓶藥物或營養物質，該瓶具有在一翻轉位置的一可刺穿蓋及置於其下方之一引入與取出裝置，配備有用於耦合該瓶之該蓋及該蓋之穿孔之工具，且配備有具有自該袋向外延伸之可開啟之密封體之一管。
該管可直接插入至其下方之填充有待與自該瓶取出之物質混合之液態物質之一撓性袋(EP 2962676 B1及EP 3158987 B1)，或止於一(公或母)連接器，其可繼而與其下方之填充有待與自該瓶取出之物質混合之液態物質之一撓性袋之一互補性(分別為母或公)連接器，或用於取出及/或添補該瓶中所容納之該藥物或營養物質之一注射器或雙向龍頭耦合，該雙向龍頭視其調整而連接上方袋之連接器至位於該袋之一側上之一注射器，或連接該注射器至位於其下方之一袋之連接器，以允許瓶與下方袋中物質按劑量混合(義大利新型專利號202016000058207及EP 3545935 A1)。
前述使用均具相同問題，亦即維持瓶內所含液體位準上方與具有連接器開啟時自管流出之間的壓力差，諸如利於物質流出管外，即便不以人工於容納瓶之袋外施加壓力亦然。
本發明之目的在於以簡單且安全方式解決前述問題，適用於封閉系統且在無菌狀態下，其無需訴求需另使用儀器裝置之措施。
為達此目的，本發明係關於一種用於流質藥物或營養物質給藥之包裝，其包括一外袋，其具有一無菌或經滅菌之內腔且將藥物或營養物質之一瓶收容在該腔內部，處於一翻轉位置，該瓶具有一可刺穿蓋，及一裝置，其位於該瓶之該蓋下方且可勾住該瓶之該頸部，用於取出及/或添補該藥物或營養物質，該裝置包括用於將瓶蓋穿孔之一針，其可相對於該瓶軸向移動，及一外流管，其延伸超出該袋且配備有一可開啟之密封體元件，該包裝之特徵在於在該蓋穿孔且該密封體元件開啟後，連接該瓶內部至該外流管之一第一通道縱向穿過該穿孔針，及一第二通道，其具有一側開口且配備有一疏水性過濾器，其經構造成在該蓋穿孔後僅允許空氣或其他氣態流體自該瓶內部流進該袋之該內腔，或自該袋之該內腔流進該瓶內部。
當針穿透瓶蓋且外流管之密封體元件設置為開啟時，由上方結構產生之壓力差促使瓶中藥物或營養物質經管外流，且接著至已與管連接之袋或注射器。在此階段，具有配備有疏水性過濾器側開口之通道確保瓶內氣壓妥適。
圖1所示包裝特徵在於一外部無菌或經滅菌撓性袋1，其中一內腔2係例如藉由經由配備有連接器4之管3遞送之臭氧或其他滅菌氣體與氧氣之混合物滅菌(例如EP 2667839 B1中所述之具氣密開/閉蓋之類型)，該內腔2容納且顯示藥物或營養物質6之經翻轉瓶5，其具有頸部7及處於耦合位置之密封(可開啟且可自動再氣密密封)蓋8，及取用及/或添補裝置9，其勾住瓶5之頸部7且可自外側袋1操作將瓶5之蓋8穿孔。虛線L指示瓶5內物質6的位準。
圖2提供由上主體10與下主體12及底柄部34組成且終止於易碎密封體元件17之裝置9之放大圖，上主體10配備有可勾住瓶5之頸部7之翻蓋11，耦合至上主體10之下主體12呈軸向滑動模式且包括穿孔針13，其具有向上突出之穿刺尖端14，其被密封容納於止於氣密可開啟且可自動釋放端連接器16(例如EP 2667839 B1中所述具氣密開/閉蓋之類型)之一撓性外流管15內。
穿孔針13藉由彼此沿縱向伴行之兩通道18與19穿透，前者頂端開放且下端由易碎元件17封閉，且後者頂端開放且透過配備有疏水性過濾器21之側開口20與袋1之內腔2永久通連，允許空氣或其他氣態流體通過，但防止任何液體通過。
在圖1所述初始狀態中，裝置9之下主體12設置自該裝置9之上主體10向下，袋1之內腔2內所含空氣或其他無菌混合物留在瓶5外，該瓶5繼而容納在密閉環境中之藥物或營養物質6。
自袋1外向下朝裝置9之下主體12推瓶5，針13之尖端14穿過瓶5之蓋8，藉此使得通道18與19與瓶5之內部通連，如圖3所示。
此允許空氣或另一無菌混合物穿過疏水性過濾器21、側開口20及上通道19直到瓶5內，一旦易碎密封體17斷裂，則因壓力差迫使藥物或營養物質6流出瓶5外，經由通道18向下至外流管15直到連接器16，且自該處至外部使用者裝置(用於取出及/或添補之注射器、另一收集袋或其他)。過濾器21防止物質6自側開口20流出。
如圖4所述，使用者裝置可含於用於注射或抽取之注射器22中，該注射器22具有用於開啟連接器16之接口23，或用於注射或抽取之類似注射器24中，該注射器24具有接口25及鎖緊接口裝置26，亦或簡單輸入或收集袋27，其所具連接器28經塑形與連接器16相配(或連接至袋1之外流管15)，及置於連接器16與下方袋之互補連接器30之間之雙向轉流龍頭29，其可耦合至用於取出與添補之注射器。
後者應用詳如圖5至9，其中對應於圖1至4之品項以相同代號顯示。
如圖5所示，雙向龍頭29置於兩袋1與31之間，前者容納藥物或營養物質6且後者填充有適當的液態物質35(或其他可與藥物或營養物質6混合之液態物質)且配備有具連接器53之進口管51及具有可開啟蓋54之出口管52，該雙向龍頭29包括3個噴嘴，其等各具連接器(36、38、32)，第一個可耦合至袋1之連接器16，第二個至袋31之連接器30，而第三個正常密封但可以注射器40開啟與穿孔，該注射器40具有滑動柱塞41與端部接口42。龍頭21可藉由操作轉動組件39而調整成兩個位置。龍頭29與袋1及31之間之連接可係永久性而非透過連接器16、36及30、38。
在此情況下，在使用前調整龍頭29以禁止與下方袋31之任何通連，同時以密封體17封閉管15，如圖5所示。
為了混合一劑量之藥物或營養物質6與液態物質35，以栓塞41推進注射器40，如圖5所示，藉由將接口41插入連接器32內而連接至龍頭29，接著微調龍頭29之轉動組件39至定位以禁止與管15通連且開啟對袋31之內腔的連接；接著回拉注射器之栓塞41直到自袋31取出一劑量的液態物質35(圖6)。
接著調整龍頭29以停止與袋31之內腔的通連，易碎密封體17斷裂以開啟針13之內通道18與管15之間之連接，且將瓶5向下推，藉此迫使針13的尖端進入瓶5之蓋8(圖7)。接著推動注射器40之栓塞41以遞送自袋31取出之定量液態物質至瓶5內，接著在其中形成藥物或營養物質6與液態物質35之混合物50(圖7)。在此階段，瓶5內空氣被迫流出瓶5外經由通道19及側開口20進入袋1之內腔2。疏水性過濾器21允許空氣通過但防止物質6或混合物50通過。
由於龍頭29仍設置於上述位置，故接著藉由將栓塞41後拉而自注射器40取出一劑量之混合物50，如圖8所示。先前被迫進入袋1之內腔2之空氣可經由具疏水性過濾器21之開口20及針13之通道18回流至瓶5中。
接著將龍頭29設置回到使管15密閉且開啟與袋31之內腔通連之位置，且推進栓塞41以遞送先前自瓶5取出之劑量之混合物50至袋31中(圖9)。接著袋31即備妥可用。
1:袋 2:內腔 3:管 4:連接器 5:瓶 6:藥品或營養物質 7:頸部 8:蓋 9:裝置 10:上主體 11:翻蓋 12:下主體 13:穿孔針 14:穿刺尖端 15:外流管 16:連接器 17:易碎密封體元件 18:通道 19:通道 20:側開口 21:疏水性過濾器 22:注射器 23:接口 24:注射器 25:接口 26:鎖緊接口裝置 27:袋 28:連接器 29:龍頭 30:連接器 31:袋 32:連接器 34:底柄部 35:液態物質 36:連接器 38:連接器 39:轉動組件 40:注射器 41:滑動柱塞 42:接口 50:混合物 51:進口管 52:出口管 53:連接器 54:蓋
將藉由隨附圖式中之非限制性實例顯示及描述可行之實施例及其應用可行性，其中： 圖1闡釋依本發明之呈初始密封狀態之包裝； 圖2顯示圖1之包裝中使用之取用及/或添補裝置，用於在設置於翻轉位置時，耦合及穿孔撓性袋內之藥物或營養物質之瓶蓋； 圖3顯示在藥物或營養物質給藥期間之圖1之包裝； 圖4闡釋不同於諸如圖1所示包裝之利用選項； 圖5至9顯示藉由雙向龍頭及注射器混合瓶內含物質與下方袋所含物質之處理序列細節。
1:袋
2:內腔
3:管
4:連接器
5:瓶
6:藥品或營養物質
7:頸部
8:蓋
9:裝置
10:上主體
11:翻蓋
12:下主體
13:穿孔針
14:穿刺尖端
15:外流管
16:連接器
17:易碎密封體元件
18:通道
19:通道
20:側開口
21:疏水性過濾器
34:底柄部

Claims (10)

  1. 一種用於藥物或營養物質給藥之包裝，其包括一外袋(1)，其具有一無菌或經滅菌之內腔(2)及在該腔(2)內之藥物或營養物質(6)之一瓶(5)，其具有設置於一翻轉位置的一頸部(7)及一可刺穿蓋(8)，及一裝置(9)，其可勾住該瓶之該頸部，用於取出及/或添補該瓶(5)中所容納之該物質(6)，及包括一針(13)，用於將該瓶之該蓋穿孔，該針(13)可相對於該瓶(5)軸向移動，及一外流管(15)，其延伸超出該袋(1)且配備有一可開啟之密封體元件(17)，其特徵在於在該蓋(8)穿孔且該密封體元件(17)開啟後，連接該瓶(5)內部至該外流管(15)之一第一通道(18)縱向穿透該穿孔針(13)，及一第二通道(19)，其具有一側開口(20)且配備有一疏水性過濾器(21)，其經構造成在該蓋(8)穿孔後僅允許空氣或其他氣態流體自該瓶(5)內部流進該袋(1)之該內腔(2)，或自該袋(1)之該內腔(2)流進該瓶(5)內部。
  2. 如請求項1之包裝，其中，該取出及/或添補裝置(9)係由一上主體(10)與一下主體(12)組成，該上主體(10)配備有可勾住該瓶(5)之該頸部(7)之摺緣；及該下主體(12)可軸向滑動耦合至該上主體(10)且包括該穿孔針(13)及一底柄部(34)，該穿孔針(13)之該第一通道(18)沿縱向穿透該底柄部(34)直到該可開啟之密封體(17)且被密封地收容在該外流管(15)內。
  3. 如請求項1或2之包裝，其中，該外流管(15)止於一端部開/閉連接器(16)。
  4. 如請求項3之包裝，其中，該端部連接器(16)可耦合至一開啟之注射器(22、24)。
  5. 如請求項1至4中任一項之包裝，其中，該袋(1)係由撓性材料製成。
  6. 如請求項1至5中任一項之包裝，其中，該袋(1)包括一管(3)，其具有一氣密開/閉連接器(4)，用於將臭氧或任何其他滅菌氣體之混合物導入該袋(1)之該內腔(2)中。
  7. 如請求項1至6中任一項之包裝，其包含一另一袋(31)，其位於該外袋(1)下方且經設計為容納待與該藥物或營養物質(6)混合之一液態物質(35)，及一雙向龍頭(29)，其位於該等袋(1與31)之間且配備有一側開/閉連接器(32)，具一滑動柱塞(41)之一開啟之注射器(40)可與該側開/閉連接器(32)耦合，該龍頭(29)可在一第一位置與一第二位置間調整，該第一位置禁止該側連接器(32)與該另一袋(31)之間的通連，及該第二位置禁止該側連接器(32)與該外袋(1)之該外流管(15)之間的通連。
  8. 如請求項7之包裝，其中，該龍頭(29)經由該龍頭(29)之連接器(36、38)耦合至該等袋(1、31)之對應連接器(16、30)而固定至該等袋(1、31)。
  9. 如請求項7之包裝，其中，該龍頭(29)藉由永久連接固定至該袋(1、31)。
  10. 如請求項1至3及5至6中任一項之包裝，其中，包括一收集袋(27)，其位於該外袋(1)下方且與該外袋(1)通連。
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IT201800004116A1 (it) 2018-03-30 2019-09-30 Adienne Pharma & Biotech Sa Confezione flessibile sterilizzata con compensatore di pressione per la ricostituzione dosata di sostanze fluide farmaceutiche o nutrizionali somministrabili a un paziente per infusione o iniezione.

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