JP6133270B2 - 薬剤カートリッジのためのブリスター包装 - Google Patents
薬剤カートリッジのためのブリスター包装 Download PDFInfo
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- JP6133270B2 JP6133270B2 JP2014502878A JP2014502878A JP6133270B2 JP 6133270 B2 JP6133270 B2 JP 6133270B2 JP 2014502878 A JP2014502878 A JP 2014502878A JP 2014502878 A JP2014502878 A JP 2014502878A JP 6133270 B2 JP6133270 B2 JP 6133270B2
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- blister
- blister packaging
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D83/00—Containers or packages with special means for dispensing contents
- B65D83/04—Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills
- B65D83/0445—Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills all the articles being stored in individual compartments
- B65D83/0463—Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills all the articles being stored in individual compartments formed in a band or a blisterweb, inserted in a dispensing device or container
Description
ブリスター包装アセンブリの製造
基部マテリアル又はシートのロールと、蓋フィルムと、を、市販の熱成形機(Pharmworks TF−2X)に接続して提供する。基部マテリアルは、米国のKlockner Pentaplastにより製造された2層のポリ塩化ビニル層の間のフルオロポリマー層からなる。基部マテリアルを、約12−25サイクル/分(cpm)からの速度で形成工程に入れ、図面において規定されたブリスターを作るのに要する寸法で特にデザインされた熱、空気圧及び機械的プラグの組み合わせを用いて成形した。本実施例において、ブリスターウェルを形成するプラスチックを軟化するための温度は、約130℃から約150℃の範囲であり得る。医薬製剤を含むカートリッジは、ブリスターの空洞に自動的に入れられ、その後、柔軟性強化アルミニウムホイル(Alcan)からなる蓋ストックをこのアセンブリにかぶせる。成形され満たされた基部マテリアルと蓋とをともに、約150℃から約170℃の範囲の温度に熱せられた道具と圧力とが蓋におけるシーラント層の活性化をもたらすシーリング工程送られてシールされたブリスターを作る。シーリング工程の後、成形され満たされたブリスターのウェブ(web)は、ミシン目を入れる工程に送られ、その後、最終的に、最終のブリスター包装を作るダイカット工程に送られる。
ブリスター包装の水蒸気透過率
実施例1で製造されたブリスター包装の水蒸気透過率を検証した。ポリ塩化ビニルの外層及び内層並びにACLARの中間層ならなる三層の積層体のブリスター基部シートと柔軟性強化ホイルの蓋とを備えるシールされたブリスター包装は、三層の積層体のブリスター基部シートのブリスター基部シートとゲージ厚において同様なPETの単一層からなり、柔軟性強化ホイルの蓋を有するブリスター基部シートから作られたブリスター包装と比較した。各々のブリスター包装は、ブリスター包装の基部を通して、29ゲージ(0.33mm×13mm)の針を備えるシリンジを用いて3mL(3つのブリスターの各々において1mL)の水を注入した。水を注入した後、基部マテリアルの穴を、迅速に硬化するエポキシ粘着剤を用いてふさいだ。包装を通過する水蒸気を、シールされたガラス容器中の該包装上にクリーンな乾燥窒素ガスの流れを通し、窒素ガスによりピックアップされた水分の量を計測することにより、一定期間分析した。包装を透過してシールされたジャー(jar)に放出された水蒸気の測定を、Mocon Permatran装置において、実験開始時と一定期間後に行い、分析した。
ブリスター基部シートの空洞の均一性
これらの実験において、3つの異なるブリスター基部シート積層体を、ブリスター基部シートを作るための120℃から125℃の範囲に設定された温度、1分あたり12−25サイクルで155℃と165℃との間で設定するシーリング温度、及び約6barの空気圧を用いて、実施例1で記載されるのと同様に製造した。ブリスター基部シートにおける空洞の厚さを、図13で示されるような種々の位置で測定して、ブリスター又は空洞の完全性及び均一性を評価した。
水蒸気の浸透
ホイルでオーバーラップ包装したブリスター基部シートを、水蒸気の浸透特性及び適切にタイトな包装を形成する能力のために選択した。
本出願は、米国仮特許出願61/470,982(出願日2011年4月1日)に基づ
く優先権主張の利益を有する。この出願は、本明細書に参照により取り込まれる。
(付記)
(付記1)
ブリスター包装であって、
医薬製剤を収容するカートリッジを保持するように構成された、空間と、ドーム構造と、シェルフと、を有する1又は2以上の空洞を備えるブリスター基部シートと、
前記ブリスター包装に接着された蓋と、
を備え、
前記1又は2以上の空洞は、外面及び内面を有する、
ことを特徴とするブリスター包装。
(付記2)
前記シェルフは、前記空洞の前記内面においてカートリッジ上部保持機構を形成する、 ことを特徴とする付記1に記載のブリスター包装。
(付記3)
前記シェルフは、前記ドーム構造から伸長し、前記1又は2以上の空洞の実質的に平坦な端部を形成し、前記1又は2以上の空洞の前記内面においてカートリッジ保持機構を形成する刻み目又は凹部を有する、
ことを特徴とする付記1又は2に記載のブリスター包装。
(付記4)
前記空間の領域は、容器と、前記容器を覆う蓋又は上部と、を有する医薬製剤カートリッジを収容するように構成される、
ことを特徴とする付記1乃至3のいずれか1つに記載のブリスター包装。
(付記5)
活性成分を含む医薬製剤を含むカートリッジをさらに備える、付記1乃至4のいずれか1つに記載のブリスター包装。
(付記6)
前記医薬製剤は、ジケトピペラジンを含む、
ことを特徴とする付記5に記載のブリスター包装。
(付記7)
ジケトピペラジンは、ビス−3,6−(N−フマリル−4−アミノブチル)−2,5−ジケト−ジケトピペラジンである、
ことを特徴とする付記5に記載のブリスター包装。
(付記8)
前記活性成分は、ペプチド、タンパク質、低分子又は核酸である、
ことを特徴とする付記1乃至7のいずれか1つに記載のブリスター包装。
(付記9)
前記活性成分は、インスリン、グルカゴン様ペプチド1、グルカゴン、オキシトシン、オキシントモジュリン、ペプチドYY、スマトリプタン、ペプチジルペプチダーゼIV阻害薬、副甲状腺ホルモン、デオキシリボヌクレアーゼI、及びこれらの活性フラグメント又はこれらのアナログからなる群より選択される、
ことを特徴とする付記1乃至7のいずれか1つに記載のブリスター包装。
(付記10)
前記ブリスター基部シートは、ポリ塩化ビニル及びACLARより選択される少なくとも3層を備える、
ことを特徴とする付記1乃至9のいずれか1つに記載のブリスター包装。
(付記11)
前記ACLARの層は、約230μmから約720μmの厚さを有する前記ブリスター基部シートの中間層を形成する、
ことを特徴とする付記10に記載のブリスター包装。
(付記12)
前記蓋は、アルミニウム、プラスチックポリマー又はコポリマーから選択される1又は2以上の層を備えるホイルを備える、
ことを特徴とする付記1乃至11のいずれか1つに記載のブリスター包装。
(付記13)
前記蓋は、約10μmから75μmの厚さを有する、
ことを特徴とする付記1乃至12のいずれか1つに記載のブリスター包装。
(付記14)
前記ブリスター基部シートは、100μmよりも厚い厚さを有する、
ことを特徴とする付記1乃至13のいずれか1つに記載のブリスター包装。
(付記15)
医薬製剤を収容するカートリッジのためのブリスター包装を製造する方法であって、
フィルムをブリスター基部シートに接着することを含み、
空洞は、ポリ塩化ビニル及びACLARより選択される少なくとも3層を備えるブリスター基部シートで成形され、
容器及び上部を備えるカートリッジは、前記フィルムが前記ブリスター基部シートに接着されるときに前記空洞の中にあり、
前記ブリスター基部シートは、前記空洞を互いに分けるように任意にミシン目が入れられる、
ことを特徴とする方法。
(付記16)
前記カートリッジは、活性成分を含む医薬製剤を備える、
ことを特徴とする付記15に記載の方法。
(付記17)
前記医薬製剤は、ジケトピペラジンを含む、
ことを特徴とする付記16に記載の方法。
(付記18)
ジケトピペラジンは、ビス−3,6−(N−フマリル−4−アミノブチル)−2,5−ジケト−ジケトピペラジンである、
ことを特徴とする付記17に記載の方法。
(付記19)
前記活性成分は、ペプチド、タンパク質、低分子又は核酸である、
ことを特徴とする付記16乃至18のいずれか1つに記載の方法。
(付記20)
前記活性成分は、インスリン、グルカゴン様ペプチド1、グルカゴン、オキシトシン、オキシントモジュリン、ペプチドYY、スマトリプタン、ペプチジルペプチダーゼIV阻害薬、副甲状腺ホルモン、デオキシリボヌクレアーゼI、及びこれらの活性フラグメント又はこれらのアナログからなる群より選択される、
ことを特徴とする付記16乃至18のいずれか1つに記載の方法。
Claims (16)
- ブリスター基部シートを備えるブリスター包装であって、
ジケトピペラジン及び活性成分を含む医薬製剤を収容する薬剤カートリッジを収容するように構成され、投薬前配置及び投与配置を有するように構成され、容器を収容するように構成されたドーム構造及びカートリッジの蓋又は上部を収容するように構成されたシェルフを備える空間と、内面と、外面と、を有する1又は2以上の空洞と、
前記ブリスター包装に接着された蓋と、
を備え、
前記シェルフは、前記投薬前配置において前記カートリッジを保持するように、及び前記カートリッジが前記投与配置に到達しないように前記ドーム構造で構成された外面において刻み目を備える、
ことを特徴とするブリスター包装。 - 前記シェルフは、前記空洞の前記内面においてカートリッジ上部保持機構を形成する、
ことを特徴とする請求項1に記載のブリスター包装。 - 前記シェルフは、前記ドーム構造から伸長し、前記1又は2以上の空洞の実質的に平坦な端部を形成し、前記1又は2以上の空洞の前記内面においてカートリッジ保持機構を形成する刻み目又は凹部を有する、
ことを特徴とする請求項1又は2に記載のブリスター包装。 - 蓋又は上部は、前記容器を覆う、
ことを特徴とする請求項1乃至3のいずれか1項に記載のブリスター包装。 - 前記活性成分は、ペプチド、タンパク質、低分子又は核酸である、
ことを特徴とする請求項1乃至5のいずれか1項に記載のブリスター包装。 - 前記活性成分は、インスリン、グルカゴン様ペプチド1、グルカゴン、オキシトシン、オキシントモジュリン、ペプチドYY、スマトリプタン、神経伝達物質アゴニスト、神経伝達物質アンタゴニスト分子、ペプチジルペプチダーゼIV阻害薬、副甲状腺ホルモン、デオキシリボヌクレアーゼI、及びこれらの活性フラグメント又はこれらのアナログからなる群より選択される、
ことを特徴とする請求項1乃至6のいずれか1項に記載のブリスター包装。 - 前記ブリスター基部シートは、ポリ塩化ビニル及びACLARより選択される少なくとも3層を備える、
ことを特徴とする請求項1乃至7のいずれか1項に記載のブリスター包装。 - 前記ACLARの層は、約230μmから約720μmの厚さを有する前記ブリスター基部シートの中間層を形成する、
ことを特徴とする請求項8に記載のブリスター包装。 - 前記蓋は、アルミニウム、プラスチックポリマー又はコポリマーから選択される1又は2以上の層を備えるホイルを備える、
ことを特徴とする請求項1乃至9のいずれか1項に記載のブリスター包装。 - 前記蓋は、約10μmから75μmの厚さを有する、
ことを特徴とする請求項1乃至10のいずれか1項に記載のブリスター包装。 - 前記ブリスター基部シートは、約100μmよりも厚い厚さを有する、
ことを特徴とする請求項1乃至11のいずれか1項に記載のブリスター包装。 - 医薬製剤を収容する1又は2以上のカートリッジを収納するよう構成されたブリスター包装を製造する方法であって、
フィルムを、ジケトピペラジン及び活性成分を含む医薬製剤を収容する薬剤カートリッジを収容するように構成され、投薬前配置及び投与配置を有するように構成され、容器を収容するように構成されたドーム構造並びにカートリッジの蓋又は上部を収容するように構成され、前記投薬前配置において前記カートリッジを保持するように、及び前記カートリッジが前記投与配置に到達しないように前記ドーム構造で構成された外面において刻み目を備えるシェルフを備える空間と、内面と、外面と、を有する1又は2以上の空洞を備えるブリスター基部シートに接着することを含む、
ことを特徴とする方法。 - 前記活性成分は、ペプチド、タンパク質、低分子又は核酸である、
ことを特徴とする請求項13又は14に記載の方法。 - 前記活性成分は、インスリン、グルカゴン様ペプチド1、グルカゴン、オキシトシン、オキシントモジュリン、ペプチドYY、スマトリプタン、神経伝達物質アゴニスト、神経伝達物質アンタゴニスト分子、ペプチジルペプチダーゼIV阻害薬、副甲状腺ホルモン、デオキシリボヌクレアーゼI、及びこれらの活性フラグメント又はこれらのアナログから選択される、
ことを特徴とする請求項13乃至15のいずれか1項に記載の方法。
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