JP2013535222A - 生体物質用の乾燥貯蔵安定化組成物 - Google Patents
生体物質用の乾燥貯蔵安定化組成物 Download PDFInfo
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Abstract
【選択図】図1
Description
本出願は、2010年8月13日に米国特許商標庁に出願された米国仮特許出願第61/373,711号の利益を主張する。その全内容は参考として本明細書に組み込まれているものとする。
本明細書において用いられる用語は、特定の実施態様のみを示す目的のために使用され、限定することを意図していないと理解すべきである。本明細書及び特許請求の範囲で使用するように、単数「a」、「an」及び「the」は、その内容が別に明示されない限り、複数対象を含む。従って、例えば「タンパク質」とは、単数タンパク質又は2以上のタンパク質の組み合わせを含むことを意味し;「酵素」、「細菌」などは、単数又はいくつかの種類の混合物などを含むことを意味する。
本発明による生体物質の安定な凍結又は乾燥粉末の調製のための組成物は、炭水化物混合物及びガラス増強剤を含む。そのような物質は、好ましい生体物質と混合した場合、液体窒素中でビーズ、糸状のもの、又は液滴を形成し、及び本発明の方法により効率良くアモルファスガラス状構造に乾燥させ、前記生物活性物質の貯蔵及び投与のための大量の安定な乾燥組成物を提供することができる(乾燥後の異なる製剤の物理的観測及び水分活性(Aw)に関して図1を参照)。炭水化物混合物は、製剤に構造的安定性を提供し、及び/又は生物活性物質に物理的及び化学的保護効果を提供し、並びに再構築又は再水和の際の悪影響を予防し又は低減する。
さまざまな乾燥技術が、組成物を乾燥するために効果的に使用することができる。これらの方法は、凍結乾燥又は真空乾燥よりも複雑でなく及び高価でない一方で、一般的に生体物質に対してより有害である。多くの生体物質は、凍結乾燥又は冷気乾燥(chill drying)を使用した場合よりも周囲又はより高い温度で行う方法を使用して保存した場合のほうが、著しい立体構造変化及び望まない反応をより生じやすい。結果として、現在知られている保護剤を使用した場合でも、多くの再水和された生体物質の活性は、それ自体で十分ではなく、そして仮に低温乾燥により貯蔵した場合よりも著しく低い。
乾燥及び安定組成物の調製
基本的な炭水化物混合物
約70gのトレハロース(Cargill Minneapolis, MN)、約5gのインスタント(instant)イヌリン(Cargill Minneapolis, MN)、及び約3gのアルギン酸ナトリウム(ISP Corp., Wayne, NJ)を、乾燥形態で均質に混合した。
約17gのカゼイン加水分解物(限外濾過された加水分解物、Marcor, Carlstadt, NJ)、及び5gのクエン酸ナトリウム又はアスコルビン酸ナトリウム(Sigma, St. Louis, MO)を、乾燥形態で均質に混合した。
生の濃縮ラクトバチルス・ラムノサス(Lactobacillus rhamnosus)(10%固形分で100ml、発酵回収物から直接)をブレンダーに添加し、そして35℃で保持した。約78gの基本炭水化物混合物、及び約22gの基本ガラス増強剤混合物をプロバイオティクス細菌培養物にゆっくりと添加し、そして35℃で10分間、混合を行った。次に、粘性のあるスラリーを、穿孔底部を有する容器に移し、そして液体窒素を含むバス内に滴下した。その後、ビーズを液体窒素から除去し、そして早急に乾燥に移した。
凍結ビーズを、200g/sq ftの充填能力でトレー上に広げ、そして早急に凍結乾燥機(Model 25 SRC, Virtis, Gardiner, NY)中の棚に設置した。次に、真空を2000〜2700mトールの間に調節し、そして棚の温度を+30℃上げた。これらの温度及び真空圧力設定を、5時間維持した。任意により、凍結ビーズの温度を、約1000mトールで真空圧力を適用し、及び10分間パージすることを固形凍結ビーズに行うことにより、第一液体乾燥を開始する前に、約−20℃に順化した。次に、第一乾燥ステップを、2000〜2700mトールに真空圧力を調節し、そして棚温度を+30℃上げて行った。これらの温度及び真空圧力設定を5時間維持した。その後、第二乾燥ステップを、完全真空(150〜200mトール)で、棚温度を30℃〜50℃の間に維持して、さらに3時間行った。製剤を完全に乾燥し、そしてその水分活性を、Aw=0.23でHygropalm Aw1機器(Rotonic Instrument Corp., Huntington, NY)により測定した。
乾燥プロバイオティクス細菌の貯蔵安定性
図1は、実施例1由来の乾燥安定プロバイオティクス細菌及び市販の乾燥プロバイオティクス細菌(Culturelle, Amerifit, Inc., Cromwell, CT)の40℃、33%RH及び30℃、43%RHの2つの異なる加速貯蔵条件下での貯蔵安定性を示す。市販のプロバイオティクス細菌は、加速貯蔵条件下、最初の数週間以内でその生存能力を失ったが、一方で本発明のプロバイオティクス細菌の乾燥組成物は、60日後、30℃、43%RHで1.18 logのみを失い、40℃、33%RHで1.09 logのみを失った。
プロバイオティクス細菌(ラクトバチルス・ラムノサス(Lactobacillus rhamnosus)を含む安定な乾燥組成物のスケールアップ製造
ラクトバチルス・ラムノサス(Lactobacillus rhamnosus)(商業的供給源由来の400gの凍結濃縮物)を、37℃で、ジャケット付き二重遊星型ミキサー(jacketed dual planetary mixer)(DPM, 1qt, Ross Engineering Inc. Savannah, GA)中で解凍し、そして固形分含量を、蒸留水で10重量%に調節した。約212gのトレハロース(Cargill Minneapolis, MN)、約20gのインスタントイヌリン(Cargill Minneapolis, MN)、約12gのアルギン酸ナトリウム(ISP Corp., Wayne, NJ)、約136gのカゼイン加水分解物(限外濾過加水分解物、Marcor, Carlstadt, NJ)、及び20gのアスコルビン酸ナトリウム(Sigma, St. Louis, MO)を、乾燥形態で均質に混合した。粉末混合物を、プロバイオティクス培養物にゆっくりと添加し、そして40RPM、37℃で、10分間撹拌を行った。次にスラリーを、穿孔底部を有する容器に移し、そして液体窒素を含むバス内に滴下した。その後、ビーズを液体窒素から除去し、密封されたアルミホイルバッグに移し、そして数週間の間、ディープフリーザー中で、−80℃で貯蔵した。
プロバイオティクス細菌(ビフィドバクテリウム・ラクティス(Bifidobacterium lactis))を含む安定な乾燥組成物のスケールアップ製造
ビフィドバクテリウム・ラクティス(Bifidobacterium lactis)(商業的供給源由来の400gの凍結濃縮物)を、37℃で、ジャケット付き二重遊星型ミキサー(DPM, 1qt, Ross Engineering Inc. Savannah, GA)中で解凍した。約212gのトレハロース(Cargill Minneapolis, MN)、約20gのインスタントイヌリン(Cargill Minneapolis, MN)、約12gのアルギン酸ナトリウム(ISP Corp., Wayne, NJ)、及び20gのアスコルビン酸ナトリウム(Sigma, St. Louis, MO)を、乾燥形態で均質に混合した。粉末混合物を、プロバイオティクス培養物にゆっくりと添加した。約136gのエンドウ豆タンパク質加水分解物(限外濾過加水分解物、Marcor, Carlstadt, NJ)を、80gの蒸留水に溶解し、そして混合物を、完全に溶解するまで手短にレンジ加熱するか、又はウォーターバス中で60℃に加温し、そしてその後、約35℃まで冷却した。乾燥混合粉末及びエンドウ豆タンパク質加水分解物を含む溶液を、プロバイオティクス細菌濃縮物に添加し、40RPM、37℃で20分間、混合を行った。次にスラリーを、穿孔底部を有する容器に移し、そして液体窒素を含むバス内に滴下した。その後、ビーズを液体窒素から除去し、密封されたアルミホイルバッグに移し、そして数週間の間、ディープフリーザー中で、−80℃で貯蔵した。
プロバイオティクス細菌(ビフィドバクテリウム・ラクティス(Bifidobacterium lactis))を含むヒドロゲル製剤の調製
ビフィドバクテリウム・ラクティス(Bifidobacterium lactis)の濃縮されたプロバイオティクススラリーを、実施例1に従って調製する。基本製剤に、0.5gのリン酸水素カルシウムを添加し、続いて0.5gのグルコノラクトンを添加する。スラリーを、次の2時間の間室温で硬化させ、固形ヒドロゲルを形成させる。フィルムゲルを、市販のスライサー/シュレッダーを使用して、薄くて長い糸状のものにスライスする。薄い糸状のものを、湿潤状態でトレー上に直接充填するか、又は液体窒素中で瞬間凍結し、500g/sq ftの充填能力でトレー上に充填し、そして実施例3で記載したように、乾燥のために凍結乾燥機中に設置する。製剤の水分活性(Aw)は、0.05(HygroPalm Aw1, Rotonic Huntington, NYで測定)である。乾燥製剤は、標準ハンマー製粉装置を使用して、微粉にさらに粉砕し、50〜250ミクロンスクリーンを通して篩過する。
ガラス増強剤及び炭水化物混合物の間のモル比の最適化
ガラス増強剤及び炭水化物混合物のさまざまなモル割合を含むいくつかの組成物を、実施例1に従って調製した。プロバイオティクス細菌(ラクトバチルス・パラカゼイ(L. paracasei))の濃縮された培養物を、商業的供給源から取得し、そしてスラリーを、瞬間凍結及びパージステップなしで、湿潤形態でトレー上に早急に充填した以外は実施例1に記載したように乾燥組成物を調製した。スラリーを、第一及び第二乾燥段階の間に、棚の温度を40℃まで上げたことを以外は、実施例1及び3に記載したように第一及び第二段階で乾燥した。安定な粉末を、37℃、33%RHで84日間、加速貯蔵条件に供した。図2は、乾燥細菌の安定性に関するさまざまなモル比の影響を示す。結果は、最適なガラス増強剤と炭水化物混合物の間のモル比が、約0.12〜0.15であることを示唆した。
プロバイオティクス細菌(ラクトバチルス・アシドフィラス(L. acidophilus))の貯蔵安定性に関する本発明の組成物の効果
実施例1に記載したように、炭水化物混合物及びガラス増強剤混合物を含む組成物を調製した。プロバイオティクス細菌(ラクトバチルス・アシドフィラス(L. acidophilus))の濃縮された培養物を、商業的供給源から取得し、実施例1及び3に記載したように乾燥組成物で調製し、適切な粉末を、24℃、33%RHで537日間、加速貯蔵条件に供した。図3は、本発明の組成物で処方されたプロバイオティクス細菌の優れた安定性を示す。結果は、プロバイオティクス細菌の生存能力が、特定の条件下で537日の貯蔵を過ぎて、0.18 logのみ低下したことを示す。
プロバイオティクス細菌(ラクトバチルス・アシドフィラス(L. acidophilus))の貯蔵安定性に関するさまざまなガラス増強剤化合物の効果
実施例1で記載したような炭水化物混合物と、カゼイン加水分解物及びクエン酸ナトリウム若しくはアスコルビン酸ナトリウム又は両方の組み合わせを含むガラス増強剤とを含むいくつかの組成物を調製した。プロバイオティクス細菌(ラクトバチルス・アシドフィラス(L. acidophilus))の濃縮された培養物を、商業的供給源から取得し、そしてスラリーを、瞬間凍結及びパージステップなしで、湿潤形態でトレー上に早急に充填した以外は実施例1に記載したように乾燥組成物を調製した。スラリーを、実施例1及び3に記載したように第一及び第二段階で乾燥し、そして安定な粉末を、24℃、43%RHで180日間、加速貯蔵条件に供した。図4は、乾燥細菌の安定性に関するさまざまなガラス増強化合物の影響を示す。結果は、顕著なより良い安定性が、タンパク質加水分解物に加えてさらにガラス増強剤の包含により得られることを示唆した。特に、酢酸ナトリウム及びアスコルビン酸ナトリウムの等量の包含が、最も安定な組成物を提供した。実施例5及び6の両方の結果は、さまざまなガラス増強剤が、菌株に依拠して、より効果的になるかもしれないし、さらに不安定化するように働くかもしれないことを示唆した。
プロバイオティクス細菌(ビフィドバクテリウム・ラクティス(Bifidobacterium lactis))の貯蔵安定性に関するさまざまなタンパク質加水分解物/糖比の効果
実施例1で記載したような炭水化物組成物及びガラス増強剤を含むいくつかの組成物、並びに同じ量であるがさまざまな比のエンドウ豆タンパク質加水分解物/トレハロース及びアスコルビン酸ナトリウムを含む又は含まない組成物を調製した。プロバイオティクス細菌(ビフィドバクテリウム・ラクティス(Bifidobacterium lactis))の濃縮された培養物を商業的供給源から取得し、実施例1及び3に記載されたように乾燥組成物で調製し、そして安定な粉末を35℃、43%RHで7週間、加速貯蔵条件に供した。図5は、乾燥細菌の安定性に関するアスコルビン酸ナトリウムを含む又は含まない、1:4、1:2.5、及び1:1.5の比のエンドウ豆タンパク質加水分解物/トレハロースの効果を示す。結果は、顕著により良い安定性が、エンドウ豆タンパク質加水分解物/トレハロースの比率を増加することで得られることを示唆した。特に、エンドウ豆タンパク質加水分解物/トレハロースの1:1.5の比が、より安定な組成物を提供した。より高いエンドウ豆タンパク質加水分解物/トレハロース比でのアスコルビン酸ナトリウムの包含が、アスコルビン酸ナトリウムを除いた製剤と比較してより優れた安定性を生じる。
プロバイオティクス細菌(ラクトバチルス・ラムノサス(L. rhamnosus))の最大安定性に関するpHの最適化
実施例1で記載したような炭水化物混合物及びガラス増強剤を含むいくつかの組成物を、異なるpHで調製した。プロバイオティクス細菌(ラクトバチルス・ラムノサス(L. rhamnosus))の濃縮された培養物を、商業的供給源から取得し、そして実施例1及び3に記載されたような乾燥組成物で調製した。安定な粉末を、40℃、33%RHで8週間、加速貯蔵条件に供した。図6は、乾燥細菌の安定性に関するスラリーのpHの影響を示す。結果は、最適な安定性が中性pH(約7)で達成したことを示唆した。
酵素を含む安定な乾燥粉末
40重量%のフィターゼ(BASF, GmBH)を含むヒドロゲル製剤を、実施例1及び4に記載したような400gの炭水化物混合物と、200gのガラス増強剤混合物と、400gのフィターゼとを水1000mlで混合することにより調製した。細かく刻んだヒドロゲル製剤を、液体窒素中で瞬間凍結し、そして50℃の第一及び第二乾燥温度で、真空オーブン中で乾燥した。乾燥製剤の充填及び貯蔵安定性の決定のために、乾燥サンプルを微量遠心チューブ中で正確に重量測定する(<100mg)。200μlのジメチルスルホキシド(DMSO)を添加する。製剤をボルテックスによってDMSO緩衝液中に溶解する。このサンプルに、0.05NのNaOH、0.5%のSDS、及び0.075Mのクエン酸(三ナトリウム塩)を含む0.8mlの溶液を添加する。チューブを、45℃で10分間、超音波破砕し、続いて5000rpmで10分間、手短に遠心分離する。透明なDMSO/NaOH/SDS/クエン酸塩の溶液のアリコートを、マイクロプレートのウェルに入れ、ブラッドフォード(Bradford)アッセイ方法を使用してタンパク質含量を分析する。95℃に20分間の暴露の後の安定な酵素乾燥組成物の安定性は、本発明の組成物を含まない乾燥酵素よりも顕著に高い。
伝染性サケ貧血(ISAV)を含む安定な乾燥粉末
ISAVワクチン(Novozyme, Denmark)の濃縮スラリーを、ISAVワクチン濃縮物、炭水化物混合物、及びガラス増強剤を含むスラリーに、0.5%酢酸を含む20mlの4%キトサン溶液を添加したこと以外は実施例4に従って調製する。0.5gのリン酸水素カルシウムを添加し、続いて0.5gのグルコノラクトンを添加する。スラリーを、次の2時間の間室温で硬化させ、固形ヒドロゲルを形成させる。フィルムゲルを、市販のスライサー/シュレッダーを使用して、薄くて長い糸状のものにスライスする。薄い糸状のものを、湿潤状態でトレー上に直接充填するか、又は液体窒素中で瞬間凍結し、1500g/sq ftの充填能力でトレー上に充填し、そして実施例3で記載したように、乾燥のために凍結乾燥機中に設置する。製剤の水分活性(Aw)は、0.25である。乾燥製剤は、標準ハンマー製粉装置を使用して、微粉にさらに粉砕し、50〜150ミクロンスクリーンを通して篩過する。安定な乾燥ISAV組成物を、乾燥組成物で流通飼料を上塗りし、そして大西洋サケに与えることにより、経口ワクチン接種のために使用する。
外来種の餌の調製
本発明に従った具体的に標的とした外来種のためのペレット餌を、農薬を含んで調製する。実施例9に記載したように200gの製剤を調製し、そして200gの水を添加する。この溶液に90gのロテノン及び0.5gのリン酸水素カルシウムを添加し、続いて0.5gのグルコノラクトンを添加する。スラリーを、標準工業用噴霧乾燥機で早急に噴霧乾燥し、そして乾燥製剤を、環境又はすぐ近くの生態系に毒の有害な影響を及ぼすことなく標的とする具体的な外来種のために使用する。
保護された植物プロバイオティクス細菌製剤の調製
リゾバクテリア(Rhizobacteria)などの生物学的な制御剤を、実施例4に従って乾燥組成物で調製する。乾燥リゾバクテリア(Rhizobacteria)組成物の有効性を、ノトバイオート条件下、レタスの生育について評価する。植物あたりのリゾバクテリア(Rhizobacteria)乾燥組成物の100mg投与量を、砂を有するジャー内に植菌し、そして催芽(24時間)したレタス芽生えを植えた。滅菌したホーグランド(Hoagland)溶液の5ml栄養素投与量を、ジャー中の植物に与えた。ジャーを、28℃、12時間日長で維持された生育室において無作為に設置する。植菌後、7日間隔毎で、植物及び付着した砂を、ジャーから注意深く除いた。根を滅菌リン酸緩衝液(pH7.0)中で洗浄し、そして根長測定を記録する。
本明細書で引用する参照文献の内容は、すべての目的のために参照により援用する。
Claims (35)
- 組成物の全重量基準で、約0.5%〜90%の間を含む炭水化物成分;及び約0.5%〜40%の間の加水分解された動物タンパク質又は植物タンパク質を含むタンパク質成分を含む生体物質のための乾燥安定化組成物。
- 前記炭水化物成分が、オリゴ糖、多糖、及び二糖からなる群から選択される少なくとも1つの糖であり、ここで前記炭水化物成分の全重量基準で、前記オリゴ糖が、約5%〜10%の間、二糖が40%〜80%の間、多糖が5%〜10%の間である、請求項1に記載の乾燥安定化組成物。
- 前記生体物質が、生細胞、死細胞、又は弱毒化細胞、微生物、ウィルス、細菌、プロバイオティクス細菌、植物及び土壌細菌、又は酵母、細胞培養物、タンパク質、組み換えタンパク質、酵素、ペプチド、ホルモン、ワクチン、抗生物質、薬物、及びそれらの混合物を含む、請求項1に記載の乾燥安定化組成物。
- 前記加水分解されたタンパク質成分が、加水分解カゼイン、加水分解ホエイタンパク質、加水分解エンドウ豆タンパク質、加水分解大豆タンパク質、及びそれらの混合物を含む、請求項1に記載の乾燥安定化組成物。
- 前記炭水化物成分が、多糖、オリゴ糖、二糖、及びそれらの混合物を含む、請求項1に記載の乾燥安定化組成物。
- 前記多糖成分が、セルロースアセテートフタレート(CAP)、カルボキシ‐メチル‐セルロース、ペクチン、アルギン酸ナトリウム、アルギン酸の塩、ヒドロキシルプロピルメチルセルロース(HPMC)、メチルセルロース、カラギナン、ゲランガム、グアガム、アラビアガム、キサンタンガム、ローカストビーンガム、キトサン及びキトサン誘導体、コラーゲン、ポリグリコール酸、デンプン及び加工デンプン、並びにそれらの混合物を含む、請求項2に記載の乾燥安定化組成物。
- 前記オリゴ糖成分が、シクロデキストリン、イヌリン、マルトデキストリン、デキストラン、フルクト‐オリゴ糖(FOS)、ガラクト‐オリゴ糖(GOS)、マンナン‐オリゴ糖(MOS)、及びそれらの混合物である、請求項2に記載の乾燥安定化組成物。
- 前記二糖成分が、トレハロース、スクロース、ラクトース、及びそれらの混合物である、請求項5に記載の乾燥安定化組成物。
- 組成物の全重量基準で、約0.5%〜90%の間を含む炭水化物成分;約0.5%〜40%の間の加水分解された動物タンパク質又は植物タンパク質を含むタンパク質成分、及び約0.5%〜20%の間のカルボン酸を含むカルボン酸成分を含む、生体物質のための乾燥安定化組成物。
- 前記カルボン酸成分が、乳酸、アスコルビン酸、マレイン酸、シュウ酸、マロン酸、リンゴ酸、コハク酸、クエン酸、グルコン酸、グルタミン酸、及びそれらの塩、又はそれらの混合物を含む、請求項9に記載の乾燥安定化組成物。
- 前記炭水化物成分が、約5%〜10%の間を含むオリゴ糖、40%〜80%の間を含む二糖、及び5%〜10%の間を含む多糖を含む、請求項9に記載の乾燥安定化組成物。
- 前記生体物質が、生細胞、死細胞、又は弱毒化細胞、微生物、ウィルス、細菌、プロバイオティクス細菌、植物及び土壌細菌、又は酵母、細胞培養物、タンパク質、組み換えタンパク質、酵素、ペプチド、ホルモン、ワクチン、抗生物質、薬物、及びそれらの混合物を含む、請求項9に記載の乾燥安定化組成物。
- 前記加水分解されたタンパク質成分が、加水分解カゼイン、加水分解ホエイタンパク質、加水分解エンドウ豆タンパク質、加水分解大豆タンパク質、及びそれらの混合物を含む、請求項9に記載の乾燥安定化組成物。
- 前記炭水化物成分が、多糖、オリゴ糖、二糖、及びそれらの混合物を含む、請求項9に記載の乾燥安定化組成物。
- 前記多糖成分が、セルロースアセテートフタレート(CAP)、カルボキシ‐メチル‐セルロース、ペクチン、アルギン酸ナトリウム、アルギン酸の塩、ヒドロキシルプロピルメチルセルロース(HPMC)、メチルセルロース、カラギナン、ゲランガム、グアガム、アラビアガム、キサンタンガム、ローカストビーンガム、キトサン及びキトサン誘導体、コラーゲン、ポリグリコール酸、デンプン及び加工デンプン、並びにそれらの混合物を含む、請求項11に記載の乾燥安定化組成物。
- 前記オリゴ糖成分が、シクロデキストリン、イヌリン、マルトデキストリン、デキストラン、フルクト‐オリゴ糖(FOS)、ガラクト‐オリゴ糖(GOS)、マンナン‐オリゴ糖(MOS)、及びそれらの混合物である、請求項11に記載の乾燥安定化組成物。
- 前記二糖成分が、トレハロース、スクロース、ラクトース、又はそれらの混合物である、請求項14に記載の乾燥安定化組成物。
- 前記組成物がアモルファスガラス状の状態で乾燥される、請求項1又は9に記載の生体物質のための乾燥安定化組成物。
- 二糖/オリゴ糖/多糖の重量比が、約10:0.2:0.1〜約10:2:1である、請求項2又は11に記載の乾燥安定化組成物。
- 前記乾燥が、凍結乾燥、空気乾燥、真空乾燥、流動床乾燥(fluid bed drying)、及び噴霧乾燥からなる群から選択される1以上のプロセスである、乾燥方法。
- 生体物質のための乾燥安定化組成物の調製方法であって、以下:
(a)水性溶媒中で生体物質と、請求項1又は9に記載の組成物の混合物とを混合して、粘性のあるスラリーを形成し;
(b)液体窒素中で前記スラリーを瞬間凍結して、固形凍結粒子、ビーズ、液滴、又は糸状のもの(string)を形成し;
(c)真空下、製剤温度をその凍結温度超で、蒸発によって前記製剤の第一液体乾燥ステップを行い;
(d)最大真空及び20℃以上の温度で、前記製剤の水分活性を減少させるために十分な時間、前記製剤の第二乾燥を行うこと
を含む、方法。 - 前記第一乾燥ステップを開始する前に、前記固形凍結粒子の順化ステップをさらに含む、請求項21に記載の調製方法。
- 前記乾燥安定化組成物がアモルファスガラス状の状態で乾燥される、請求項21に記載の調製方法。
- 前記スラリーが、瞬間凍結の前に、pH若しくは温度変化により、又はポリマー鎖の架橋によりフイルムヒドロゲルに固められる、請求項21に記載の調製方法。
- 前記スラリーが所望の形状に形成される、請求項24に記載の調製方法。
- 前記順化ステップが、真空下及び前記製剤凝固点未満の温度で行われる、請求項22に記載の調製方法。
- 前記順化ステップが0〜60分の間で行われる、請求項22に記載の調製方法。
- 前記第一液体乾燥ステップが2000mトール超の真空圧力下で行われる、請求項21に記載の調製方法。
- 前記乾燥安定化組成物が、自由流動性粉末(free flowing powder)に切断され、破砕され、製粉され、又はそれぞれ微粉末化(pulverize)される、請求項21に記載の調製方法。
- 前記粉末が約1000μm未満の粒子サイズを有する、請求項29に記載の調製方法。
- 前記乾燥安定化組成物の水分活性(Aw)が0.3未満のAwである、請求項21に記載の調製方法。
- 前記製剤が、再構成液体(reconstituted liquid)、微粉末(ground powder)、錠剤、ペレット、カプセル、食品又は飼料の形態である、請求項1又は9に記載の乾燥安定化組成物を含む経口送達製剤。
- 前記生体物質が、製剤の保存可能期間の間、安定である、請求項1又は9に記載の組成物を含む経口送達製剤。
- 前記製剤が食品、動物飼料、栄養補助食品、医薬品、又はワクチン製品として消費される、請求項1又は9に記載の乾燥安定化組成物を含む経口送達製剤。
- 前記組成物が、バー、液体栄養剤(liquid formula)、コロイド状懸濁液、粉末、錠剤、カプセルの形態で、食品、食品添加物、動物飼料、動物飼料添加物、栄養補助食品、医薬品、又はワクチン製品として消費される、請求項1又は9に記載の生体物質のための乾燥安定化組成物。
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