JP5538905B2 - ポリマーを主成分とするフィルムおよびこれから製造した薬物放出系 - Google Patents
ポリマーを主成分とするフィルムおよびこれから製造した薬物放出系 Download PDFInfo
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- JP5538905B2 JP5538905B2 JP2009549585A JP2009549585A JP5538905B2 JP 5538905 B2 JP5538905 B2 JP 5538905B2 JP 2009549585 A JP2009549585 A JP 2009549585A JP 2009549585 A JP2009549585 A JP 2009549585A JP 5538905 B2 JP5538905 B2 JP 5538905B2
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- HELHAJAZNSDZJO-OLXYHTOASA-L sodium L-tartrate Chemical compound [Na+].[Na+].[O-]C(=O)[C@H](O)[C@@H](O)C([O-])=O HELHAJAZNSDZJO-OLXYHTOASA-L 0.000 description 1
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- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 description 1
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- ILJSQTXMGCGYMG-UHFFFAOYSA-N triacetic acid Chemical compound CC(=O)CC(=O)CC(O)=O ILJSQTXMGCGYMG-UHFFFAOYSA-N 0.000 description 1
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- 150000003626 triacylglycerols Chemical class 0.000 description 1
- 239000001069 triethyl citrate Substances 0.000 description 1
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 description 1
- 235000013769 triethyl citrate Nutrition 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
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- MWOOGOJBHIARFG-UHFFFAOYSA-N vanillin Chemical compound COC1=CC(C=O)=CC=C1O MWOOGOJBHIARFG-UHFFFAOYSA-N 0.000 description 1
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Images
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C39/00—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
- B29C39/003—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor characterised by the choice of material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C39/00—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
- B29C39/14—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of indefinite length
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C71/00—After-treatment of articles without altering their shape; Apparatus therefor
- B29C71/02—Thermal after-treatment
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B13/00—Machines and apparatus for drying fabrics, fibres, yarns, or other materials in long lengths, with progressive movement
- F26B13/10—Arrangements for feeding, heating or supporting materials; Controlling movement, tension or position of materials
- F26B13/101—Supporting materials without tension, e.g. on or between foraminous belts
- F26B13/104—Supporting materials without tension, e.g. on or between foraminous belts supported by fluid jets only; Fluid blowing arrangements for flotation dryers, e.g. coanda nozzles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J2200/00—General characteristics or adaptations
- A61J2200/20—Extrusion means, e.g. for producing pharmaceutical forms
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- General Engineering & Computer Science (AREA)
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- Compositions Of Macromolecular Compounds (AREA)
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Description
Vo = (2grr)(ρp - ρl)/9μ
v/Vo = 1/(1 + κΦ)
ここで、κは定数であり、またΦは該分散相の体積分率である。該液相におけるより多量の懸濁粒子は、低い粘度をもたらす。粒子の幾何形状も、重要なファクタである。というのは、該粒子の寸法は、粒子-粒子流動相互作用に影響を与えるからである。
μ/μo = 1 + 2.5φ
ここで、μoは、連続相の粘度であり、またφは、該固体の体積分率である。より高い体積分率においては、該分散体の粘度は、以下の式で表すことができる:
μ/μo = 1 + 2.5Φ+ C1Φ2 + C2Φ3 + ・・・・・
ここでCは定数である。
τmax = 3Vμ/2r
α (n-1/n) = αo (n-1/n) - ((n-1)/(2n-1))(τ/K)1/n (2π/λ)(3+n)/nh(2n+1)/nt
ここで、αは、表面波の振幅であり、αoは初期振幅であり、λは表面粗さの波長であり、および「n」および「K」両者は、粘度ベキ乗則指数である。本例において、平坦化の挙動は、粘度と関連付けられ、nの減少に伴って増大し、かつKの増大に伴って減少する。
楕円形状の粒子または楕円体は、球形粒子と比較して、低度に沈降する傾向を持つことから、これらが、該フィルム形成マトリックス中で均一性を維持する高い能力を持つために、これら楕円形状の粒子または楕円体が、望ましいものである。
該ポリマーは、水溶性、水膨潤性、水-不溶性、または1またはそれ以上の水溶性、水膨潤性、水-不溶性ポリマーの組合せであり得る。該ポリマーは、セルロースまたはセルロース誘導体を含むことができる。有用な水溶性ポリマーの具体的な例は、ポリエチレンオキサイド(PEO)、プルラン、ヒドロキシプロピルメチルセルロース(HPMC)、ヒドロキシエチルセルロース(HPC)、ヒドロキシプロピルセルロース、ポリデキストロース、ポリビニルピロリドン、カルボキシメチルセルロース、ポリビニルアルコール。アルギン酸ナトリウム、プロピレングリコールアルギネート、カラギーナン、ポリエチレングリコール、キサンタンガム、トラガカンスゴム、グアーガム、アカシアガム、アラビアゴム、ポリアクリル酸、メチルメタクリレートコポリマー、ポロキサマー(poloxamers)ポリマー、アクリル酸とアルキルアクリレートとのコポリマー(ペムレン(PemulenTM)ポリマーとして入手できる)、カルボキシビニルコポリマー、デンプン、ゼラチン、ペクチン、およびこれらの組合せを含むが、これらに限定されない。
該用語「制御放出(性)」とは、予め選択されたまたは所望の速度での、活性成分の放出を意味するものとする。この速度は、用途に応じて変えることができる。望ましい速度は、迅速または即座の放出プロフィール並びに遅延、持続または周期的放出を含む。本発明では、放出パターンの組合せ、例えば活性成分の初期の急激に増大する放出、これに伴うその低レベルでの持続的な放出をも意図している。パルス化された薬物放出も、本発明において意図されている。
一態様において、該風味-隠蔽剤は、粒状の生物学的作用(bioeffecting)剤上の薄膜被覆である。この態様において有用な風味-隠蔽剤は、ポリマーおよび非-ポリマー材料を含む。ポリマーの非-限定的な例は、アクリル系ポリマー、セルロース系ポリマーまたはビニルポリマーを含む。非-ポリマー材料の非-限定的な例は、クラウンエーテル、完全水添オイルおよびワックスを含む。更に、該風味-隠蔽剤は、水溶性、水-不溶性または部分的に水溶性のものであり得る。
活性成分を該フィルムに導入する場合、単位面積当たりの該活性成分の量は、該フィルムの均一分布性によって決定される。例えば、該フィルムが個々の投与剤形に裁断される場合、該投与剤形における該活性成分の量は、高い精度で知ることができる。これは、所定の面積内の該活性成分の量が、該フィルムの他の部分における、同一の寸法の面積内の該活性成分の量と、実質的に同一であることから達成される。用量における精度は、該活性成分が医薬、即ち薬物である場合に、特に有利である。
本発明の該フィルム製品は、該活性成分の広範囲に及ぶ量を収容することができる。該フィルムは、要求される用量が高いか、または極端に低いかとは無関係に、正確な用量(フィルムのサイズ、および元のポリマー/水の組合せにおける該活性成分の濃度により決定される)を与えることができる。従って、該フィルムに配合された活性成分または薬理組成物の型に依存して、該活性成分の量は、約300mg程度、望ましくは約150mgまで、またはマイクログラム程度、またはこれらの間の任意の量であり得る。
消泡および/または脱泡成分も、また本発明のフィルムと共に使用できる。これらの成分は、該フィルム-形成組成物からの、取込み空気等の空気の除去において役立つ。上記の如く、このような取込み空気は、不均一なフィルムの生成をもたらす恐れがある。シメチコンは、特に有用な消泡および/または脱泡剤の一つである。しかし、本発明は、これらに限定されず、他の消泡および/または脱泡剤を適宜使用することができる。
また、様々な他の成分およびフィラーを、本発明のフィルムに添加することができる。これらは、以下に列挙するものを含むが、これらに限定されない:界面活性剤;該混合物内の各成分を相溶化するのに役立つ可塑剤;ポリアルコール;該フィルムから酸素を放出させることにより、より滑らかなフィルム表面の形成を助ける、シリコーン-含有化合物等の消泡剤;および該成分の分散状態を維持するのに役立つ、熱硬化性ゲル、例えばペクチン、カラギーナン、およびゼラチン;および幾つかの活性成分の溶解度および/または安定性を改善する、シクロデキストリンおよび篭を形成する分子等の包接化合物。
本発明のフィルムは、乾燥する前に、シートに成形する必要がある。所定の成分を併合して、上記ポリマー、水、および活性成分または他の所望の成分を含有する、多成分マトリックスを製造した後、この組合せを、当分野において公知の任意の方法で、例えば該多成分マトリックスを押出、塗布、展開、注型、または圧伸成形することにより、シートまたはフィルムに成形する。多層フィルムが望ましい場合、その製造は、同一のまたは異なる組成を持つことができる、成分の2以上の組合せを同時-押出することによって達成できる。また、多層フィルムの製造は、既に形成されたフィルム上に、該組合せを塗布、展開、または注型することにより達成し得る。
該乾燥工程も、該フィルム組成物の均一性の維持に関する、寄与因子である。粘度増加組成物または、例えば上記ポリマーの選択によって粘度が制御されている組成物の存在しない条件下で、該フィルム内の成分が高い凝集または凝塊形成傾向を示す可能性がある場合には、制御乾燥工程は特に重要である。制御された乾燥工程を必要としない、正確な用量のフィルムを製造するもう一つの方法は、所定のウエル上で該フィルムを注型することである。この方法によれば、該成分は凝集する恐れがあるが、各ウエルが該投薬単位自体を画成するので、隣接投与剤形に対する該活性成分の移動を引起さない。
本発明のフィルムを、該フィルム製造工程中に、その化学的および物理的な均一性について検査することが望ましいであろう。特に、該フィルムのサンプルを取出し、様々なサンプル間で、フィルム成分における均一性につきテストすることができる。フィルムの厚みおよび全体としての外観も、均一性のためにチェックすることができる。均一なフィルムが、特に安全性および効力の観点から、製薬的に活性な成分については、望ましい。
本発明の薄いフィルムは、多くの用途に対して十分に適したものである。該フィルム成分の高度の均一性は、該フィルムを、医薬の配合に対して特に適したものとする。更に、該フィルムの構築において使用される該ポリマーは、該フィルムに対して、ある範囲内の崩壊時間を可能とするように選択することができる。フィルムが崩壊する時間の変更または延長は、該活性成分が放出される速度の調節により達成でき、これは、徐放型の放出系を得ることを可能とする。更に、該フィルムは、幾つかの身体表面、特に口腔、肛門、膣、目等の粘膜を含む表面、皮膚表面または身体内の創傷のある表面、例えば外科手術中の表面、および同様な表面の何れかに、活性成分を投与するために使用することができる。
実施例A-I:
本発明の水溶性の薄いフィルムを、以下の表1に示す成分および量を使用して、製造した。
2: OSIから入手できる。
3: ファイザー社(Pfizer, Inc.)から入手でき、チモール(0.064%)、ユーカリプトール(0.092%)、メチルサリチレート(0.060%)、メントール(0.042%)、水(72.8%まで)、アルコール(26.9%)、安息香酸、ポロキサマー407、安息香酸ナトリウム、およびカラメルカラーを含む。
4: ピュアコート(Pure Cote) B792として、グレインプロセッシング社(Grain Processing Corporation)から入手できる。
5: クラリチン(Claritin)としてシェリング社(Schering Corporation)から入手できる。
6: 日本国の林原生化学研究所(Hayashibara Biochemical Laboratories, Inc.)から入手できる。
制御された分解時間を持ち、また水溶性および水-不溶性ポリマーの組合せを含む薄いフィルムおよび活性成分の制御された放出を可能とする水溶性フィルムを、以下の表3に記載する成分を、ほぼ表3に記載された量で使用して製造する。
正確な用量を与える、フィルムを製造するもう一つの方法は、本発明の組成物A-Iの何れに対しても使用できる。この方法は、先ず混合により各成分を併合することから始める。次いで、この成分の組合せを、個々のウエルまたは金型に分割する。このような方法において、乾燥中の該成分の凝集は、個々のウエルによって防止される。
2: ICIアメリカ社から入手できる。
3: ピュアコート(Pure Cote) B792として、グレインプロセッシング社(Grain Processing Corporation)から入手できる。
4: マコーミック(McCormick)社から入手できる。
5: カロシロップ(Karo Syrup)なる名称で、ベストフーズ社(Bestfoods, Inc.)から入手できる。
これら吸収値を、以下の表5に示す。
実施例P-W:
本発明に関連している、フィルム製造における様々な条件間の相互作用を明らかにするために、組成物P-Wを製造した。以下の表6に示す成分を併合し、以下の表7に掲載するプロセスパラメータを使用して、フィルムに成形し、その調製は、該フィルムの底部からの乾燥を具体化するように設計された、6mのトンネル乾燥畿内で行った。これら実施例各々は、異なる成分を含む処方物および処理技術の、生成するフィルム製品に及ぼす効果を示す。
固形分の量の増大は、得られるフィルムの重量を改善するが、長い乾燥時間が必要となった。これは、水の容易な除去を妨害する、フィルム表面の封止によるものであった。従って、組成物W1-W3については、乾燥機の第一の3mの区画における温度を下げた。これにより、該フィルムの上部表面の、上記の如き早期の乾燥が防止された。より大きなフィルム厚においてさえ、該フィルムは、より高い塗布機線速度においても、含水率5%まで乾燥された。
実施例X-AA:
これらの製品は甘く、如何なる感知可能な薬物の後味をも呈さなかった。
消泡/脱泡剤(即ち、シメチコン)の配合は、該フィルム製品中の気泡が実質的に減じられまたは排除された均一なフィルムを与えるのみならず、他の利点をも与えた。これらフィルムは、より望ましい器官感覚受容特性を示した。これらフィルムは、消費者に、より良好な口当たりを与える、低い「紙-様の」、改善された構造を有していた。
表9における組成物を製造し(本発明の組成物BA-BGにおいて、シメチコンの添加を含む)、真空条件下で混合して、気泡を除去した。
対照的に、比較例BH-BIは、より粗い表面を有し、得られたフィルム内に気泡の存在を示し、該フィルムは、均一性の低い構造および均一性の低い該成分の分布をもたらすことが観測された。
2: OSIから入手できる。
3: ファイザー社(Pfizer, Inc.)から入手でき、チモール(0.064%)、ユーカリプトール(0.092%)、メチルサリチレート(0.060%)、メントール(0.042%)、水(72.8%まで)、アルコール(26.9%)、安息香酸、ポロキサマー407、安息香酸ナトリウム、およびカラメルカラーを含む。
4: ピュアコート(Pure Cote) B792として、グレインプロセッシング社(Grain Processing Corporation)から入手できる。
5: クラリチン(Claritin)としてシェリング社(Schering Corporation)から入手できる。
6: 日本国の林原生化学研究所(Hayashibara Biochemical Laboratories, Inc.)から入手できる。
本発明の以下の実施例は、界面活性剤としてエトキシル化ヒマシ油を使用する、あるいはまた界面活性剤、可塑剤および/またはポリアルコールを含まない、フィルムおよびフィルム形成組成物を説明する。望ましくは、本発明のフィルムおよびフィルム形成組成物は、本質的に界面活性剤を含まないものである。更に、本発明のフィルムおよびフィルム形成組成物は、望ましくは本質的に界面活性剤を含まないように処方される。更に、本発明のフィルムおよびフィルム形成組成物は、望ましくは本質的に可塑剤を含まないように処方される。その上、本発明のフィルムおよびフィルム形成組成物は、望ましくは本質的にポリアルコールを含まないように処方される。更に、本発明のフィルムおよびフィルム形成組成物は、望ましくは本質的に界面活性剤および可塑剤を含まないように、処方される。その上、本発明のフィルムおよびフィルム形成組成物は、望ましくは本質的に界面活性剤、可塑剤およびポリアルコールを含まないように処方される。
2: バスフ(BASF)社から入手できる、エトキシル化ヒマシ油、クレモフォア(CremophorTM) EL。
3: プロピレングリコール
4: シリコーンエマルション
この真空の解除後、該液体6gを、200μmのラセンを巻付けたロッド及びKコントロールコーターモデル(Control Coater Model) 101[RKプリントコートインダストリー社(RK Print Coat Inst. Ltd.)]を用いて、塗布紙に付加した。該塗膜を付加した、この紙製の基板は、シリコーン塗布紙であった。次いで、この塗布された紙を、含水率が約5%となるまで、90℃にて乾燥した。該処方物を塗布し、次いで約60μmなる厚みとなるまで乾燥したが、これは口腔内で迅速に溶解した。
2: プロピレングリコール。
3: ポリジメチルシロキサンエマルション
4: 薬物配合状態を模倣するように機能付けされている。
2: バージニアデア(Virginia Dare)社から入手できる、プロスイート(Prosweet)。
3: 薬物配合状態を模倣するように機能付けされている。
この真空の解除後、該液体を、350μmの平滑なバーおよびKコントロールコーターモデル(Control Coater Model) 101[RKプリントコートインダストリー社(RK Print Coat Inst. Ltd.)]を用いて、塗布紙に付加した。該塗膜を付加した、この紙製の基板は、シリコーン塗布紙であった。次いで、この塗布された紙を、含水率が約4%となるまで、90℃にて乾燥した。該処方物を塗布し、乾燥してフィルムとした。このフィルムは、許容できる風味を持ち、口腔内で迅速に溶解した。該風味-隠蔽性香料は、味覚受容体に影響して、該受容体を、様々な典型的に望ましくない風味を知覚しないように隠蔽する成分である。このフィルムは、破壊されることなしに、180度曲げテストに合格し、口腔内で溶解した。
実施例CD:
本発明の以下の実施例は、香料および風味-隠蔽助剤をも含有する、風味-隠蔽処理された製薬的に活性な薬剤を使用する、フィルムおよびフィルム-形成組成物について説明する。風味-隠蔽性香料は、味覚受容体に作用して、該受容体を、様々な典型的に望ましくない風味を知覚しないように隠蔽する、成分である。
2: マフコワールドワイド社(Mafco Worldwide Corp.)から入手できる、マグナスイート(Magna Sweet)。
3: ガット(Gatte), LLC社から入手できる、被覆されたアセタミノフェンである、ガットエンテリック(Gutte Enteric)である。
該真空の解除後、該液状溶液を、350μmの平滑なバーを用いて、塗布紙に付加した。該塗膜を付加した、該紙製の基板は、シリコーン被覆紙であった。次いで、この塗布された紙を、約11分間に渡り、約3%の水分が残されるまで、90℃にて乾燥した。
該処方物を塗布し、乾燥して、フィルムを得た。このフィルムは、許容できる風味を持ち、口腔内で中程度に迅速に溶解した。このフィルムは、立てておいた際にカールを生じなかった。このフィルムは、破壊されることなしに、180度曲げテストに合格し、口腔内で溶解した。
実施例CE-CF:
本発明の薄いフィルム組成物は、以下の表14に記載の成分を、そこに記載した量で使用して製造した。
2: セントリー(Sentry)社から入手できる。
3: アマリロバイオサイエンス社(Amarillo Biosciences Inc.)社から入手できる。
実施例CEにおいて、該フィルムは、引続き、約80℃にて、約6分間、オーブン内で乾燥された。これらフィルムは、含水率約4.3%まで乾燥された。実施例CFでは、該フィルムを約60℃にて、約10分間、オーブン内で乾燥した。これらフィルムは、含水率約5.06%まで乾燥された。乾燥後、該フィルム内に含まれる、ウシ抽出物由来のタンパク質をテストして、これが実質的に活性を維持しているか否かを決定した。該活性をテストするため、本例のフィルム状の投与単位を、ヒトに投与した。該用量を摂取した後、該ヒトの血液につき、マイクロアレイ(microarray)を行った。アペンディックスA(これを参考としてここに組入れる)に掲載したこれら結果、および図32にグラフとして示した結果は、該タンパク質が、実施例CEおよびCF両者の、最終的な乾燥フィルム製品において、その活性をほぼ100%維持していることを立証している。従って、該熱感受性の活性成分は、該乾燥工程中に、実質上分解もしくは変性されることはなかった。
実施例CG:
本発明の薄いフィルム組成物を、以下の表15に記載する成分を、該表に指定した量で使用して、製造した。
2: マフコワールドワイド社(Mafco Worldwide Corp.)から入手できる、風味-隠蔽香料。
3: バージニアデア(Virginia Dare)社から入手できる、風味-隠蔽香料。
4: セントリー(Sentry)社から入手できる。
この得られた乾燥フィルムは、乾燥後に、該ワイヤラックおよびスクリーンの圧痕を示した。これらの形状は、該乾燥工程において典型的に使用されるワイヤ支持体の圧痕を含む。均一な熱の拡散がないと、該ワイヤ支持体は、該基板と接触している点においてより強力に熱を伝導し、これら点において高い蒸発率に導いた。これはより一層激しい混合を引起し、結果としてより多くの粒子を該接触点に引付けた。この結果は、該接触点における凝集物として見られる、高い粒子密度の存在を示す。
上記表15における成分を、CHに関して掲載した量にて、混合することにより併合し、次いで350μmの平滑なバーにより、K-コントロールコーターを使用して、剥離紙上で3枚のフィルムに注型した。均一に熱を分布させる、炉用フィルタでライニングしたトレーの上で、これらフィルムを、80℃のエアーオーブン内で、9分間乾燥させた。これらフィルムを、含水率が約2.20%となるまで乾燥させた。図17に示したように、該乾燥されたフィルム200は、縞模様を全く示さず、また均質であり、即ち粒子の凝集体は全く発現されなかった。該活性粒子は、該乾燥フィルム内で完全な状態にあるものと考えられた。これらフィルムは、十分な強度を呈し、破壊されることなしに、180度曲げテストに合格した。該テストにおいて、該フィルムは、加圧により半分に折りまげられる。
実施例CI:
以下の表16に記載の成分を、該表に指定された量にて使用して、本発明の薄いフィルム組成物を製造した。
2: マフコワールドワイド社(Mafco Worldwide Corp.)から入手できる、風味-隠蔽香料。
3: FMCバイオポリマー社から入手できる、アビセル(Avicel) CL-611。
4: ファイザー社からバイアグラ(ViagraTM)として入手できる。
5: バージニアデア(Virginia Dare)社から入手できる、風味-隠蔽香料。
6: アンジェラー(Ungerer)&Co.社から入手できる。
7: 冷却剤。
8: セントリー(Sentry)社から入手できる。
該第一フィルムに対する該熱電対により得た結果を、以下の表17に掲載し、また図33にグラフで表した。該第二のフィルムに関する結果を、以下の表18に掲載し、また図34にグラフで表した。これらの結果は、10分間の乾燥後においてさえ、該フィルムの温度は、実質的に該オーブン環境の温度よりも低い(少なくとも約5℃)ことを示している。乾燥時間が10分未満のフィルムは、かなり大きな温度差を経験する可能性がある。例えば、本発明の多くのフィルムに対して特に望ましい時間枠である、4〜6分間の乾燥は、約25℃〜約30℃なる範囲の温度差を生じる。従って、フィルムは、その内部に含まれる熱感受性活性成分を害することなく、高い、恐らく有害な温度にて乾燥することができる。
以下の実施例は、ポリエチレンオキサイド(PEO)単独またはこれとヒドロキシプロピルセルロース(HPC)またはヒドロキシプロピルメチルセルロース(HPMC)との組合せを含む、水溶性ポリマーを含有する、本発明のフィルム組成物を説明する。以下の表19に掲載した成分を、同表に指定した量で使用して、薄いフィルム組成物を製造した。
該180度曲げテストに関連して、該乾燥フィルムを、湿度分析器(メトラートレド(Mettler Toledo)社からのHR73モイスチャーアナライザ(Moisture Analyzer))内に配置し、湿度(%)を得、また本発明に従って80℃にて乾燥した後、該フィルム内に残留するあらゆる溶媒(例えば、水)を除去した。次に、これらのフィルムを、約180度折り曲げて、破損の有無を観測した。折り曲げ中に破損したフィルムは、不合格とした。折り曲げ中に、フィルムが破損しなかった場合、200gの重りを、約8.5mmなる高さから、該折り曲げたフィルム上に落下させた。この際に破損したフィルムは、不合格であると判断し、また破損しなかったフィルムは、合格とした。しかし、この可撓性テストは、極端なテストであることに注意すべきである。このテストにおいて不合格であったフィルムは、本発明の範囲内において依然として使用可能であると考えられる。より具体的には、このように極端に高い可撓性を必要としない幾つかの用途が、存在し得る。
また、これらのフィルムを、溶解速度についてテストした。重さ2.85gの重りを取付けた、約20mm×100mmなるサイズのフィルム片を、32.5℃の水浴中に、深さ約50mmまで沈めた。該フィルムが溶解し、2つの小片に分離するに要する時間を、(秒単位で)測定した。
本発明の以下の実施例では、PEOまたはPEO-ポリマーブレンドおよび活性成分を含む、フィルムを説明する。これらの成分を含む薄いフィルム組成物は、これら成分を、以下の表21に記載の量にて使用して製造した。
2: セントリー社から入手できる。
3: シェリング社からクラリチン(Claritin)として入手できる。
乾燥後、これらフィルムを、180度曲げテスト、溶解テスト、およびカールテストを含む様々な特性に関するテストを、実施例CJ-DBにおいて記載したようにして実施した。該フィルムは、また引裂抵抗についてもテストした。引裂抵抗は、パネルテストにより測定した。該テストにおいて、パネル構成員は、該フィルムの対向する端部を引っ張ることにより、該フィルムの引裂を試みた。きれいに引き裂かれたフィルムを、低グレードのものとし、僅かに伸張され、また破壊され始めたフィルムを、中程度のグレードのものとし、また伸張され、かつ引裂困難であったフィルムを、高グレードのものとした。
実施例DH-DZ:
本発明の以下の実施例は、PEOまたはPEO-HPCポリマーブレンドを含有するフィルムを説明するものである。これらフィルム組成物は、変動する分子量を持つPEOを含む。これらの成分を含む薄いフィルム組成物は、これら成分を、以下の表22に記載する量(該ポリマー成分の質量%単位で掲載されている)にて使用して製造した。
上に示したように、該ポリマー成分におけるPEOの濃度および分子量を変化させて、様々なフィルム特性を得た。一般に、該ポリマー成分におけるPEOの濃度が高いほど、該フィルムによって示される接着性および引裂抵抗はより高い。約50%またはそれ以上のPEOを含むフィルム組成物は、50%未満のPEOを含むものよりも、より高いランクの引裂抵抗を達成した。しかし、より低濃度のPEOを含むものの引裂抵抗は、少量のより高分子量のPEOと、より低分子量のPEOとを組み合わせることによって(例えば、組成物DTおよびDU),改善されることが示された。
実施例EA:
以下の本発明の実施例では、PEOおよびポリビニルピロリドン(PVP)ポリマーブレンドを含むフィルムについて説明する。これら成分を含む薄いフィルム組成物は、これら成分を、以下の表24に記載した量で使用して製造した。特に、該フィルムのポリマー成分は、約80%のPEOおよび20%のPVP、または4:1なる比で、PEOおよびPVPを含んでいた。
2: フィッシャー(Fisher)から入手できる。
3: セントリー(Sentry)社から入手できる。
実施例EB-ED:
本発明の以下の実施例は、PEOを主成分とするポリマー成分を含む、押出フィルムを説明するものである。フィルム組成物は、実施例ECについては表25に、また実施例EDについては表26に記載した量を用いて製造した。
実施例ECについては、上記表25に掲載した成分のブレンドを製造した。該HPC、PEO、スクラロース、および沈降炭酸カルシウムを、大きな電気ブレンダーに入れ、混合した。オレンジ濃縮香料およびツイーン80を含む溶液を、混合しつつ該ブレンダーに添加し、その後シメチコンおよび該食用着色料の溶液を、混合しつつ該ブレンダーに添加した。この混合された組成物を、上記表27の仕様に従って押出した。
実施例EDについては、上記表26に掲載した成分のブレンドを調製した。該PEO、スクラロース、および沈降炭酸カルシウムを、大きな電気ブレンダーに入れ、混合した。オレンジ濃縮香料およびツイーン80を含む溶液を、混合しつつ該ブレンダーに添加し、その後シメチコンおよび該食用着色料の溶液を、混合しつつ該ブレンダーに添加した。この混合された組成物を、上記表27の仕様に従って押出した。
実施例EE-EH:
本発明の以下の実施例は、緻密化剤を含むフィルムを説明するものである。PEO-ポリマーブレンドおよび緻密化剤(シメチコン)を含む、薄いフィルム組成物を、以下の表28に記載の量で、これら成分を使用して製造した。
本発明の以下の実施例は、PEOまたはPEO-ポリマーブレンドを含むフィルムを説明するものである。特に、PEOを、ポリビニルピロリドン(PVP)、デンプン(アルファ化変性コーンスターチ)、ナトリウムカルボキシメチルセルロース(CMC)、ヒドロキシプロピルセルロース(HPC)、ヒドロキシプロピルメチルセルロース(HPMC)またはポリビニルアルコール(PVA)と組合せて、該フィルムの該ポリマー成分を生成した。これら成分を含む薄いフィルム組成物は、図38に記載した量を使用して、本発明の方法に従って製造した。
図38に掲載された該ポリマー成分に加えて、これらフィルム組成物各々は、約4%のスクラロース、約38.85%の炭酸カルシウム、約6%のオレンジ香料、約0.15%のツイーン80、約1%のシメチコン、および食用着色料を含んでいた。これら実施例の該ポリマー成分中に含まれている該PEOは、約200,000なる分子量を有していた。
実施例EX-FK:
本発明の以下の実施例は、PEOまたはPEO-ポリマーブレンド(HPCとのブレンド)および様々な活性成分を含むフィルムを説明するものである。これら成分を含む薄いフィルム用組成物は、本発明の方法に従って、以下の表30および31に記載した量を用いて製造した。
2: シアリス(CialisTM)として、リリー(Lilly) ICOS, LLCから入手できる。
3: ファイザー社からバイアグラ(登録商標)として入手できる。
4: イモジウム(Imodium)として入手できる。
5: N-2,3-トリメチル-2-イソプロピルブタンアミド。
6: N-エチル-p-メンタン-3-カルボキシアミド。
2: モビック(MobicTM)として入手できる。
3: リスパーダル(RisperdalTM)として入手できる。
4: ファイザー社から入手できる。
5: アレルギー治療薬。
6: 抗生物質。
7: ニクロゾールテクノロジーズ(Nicrosol Technologies)から入手できる、メガバック(MegaBacTM)。
8: アレルギー治療薬。
9: N-エチル-p-メンタン-3-カルボキシアミド。
実施例GA-GR:
以下の本発明の実施例は、PEOまたはPEO/ポリマーブレンドを含むが、可塑剤を含まないフィルムを説明するものである。可塑剤が存在しないことは、追加の成分、例えばより多くの香料成分の添加を可能とする。可塑剤が存在しないことは、またより小さなフィルムの製造を可能とする。
実施例GA〜GRにおけるフィルムの成分を以下(表32Aおよび32B)に示す。全てのフィルムは、該成分を併合し、デグッサデンタルマルチバックコンパクト(Degussa Dental Multivac Compact)を用いて、減圧下で攪拌することにより製造した。混合後、該組成物を、250μmの平滑なバーで、K-コントロールコーターを用いて、剥離紙上に複数のフィルムとして注型した。
PVA: ポリビニルアルコール(スペクトラム);
HPMC: ヒドロキシプロピルメチルセルロース;
Pec: ペクチン(ジーヌシトラスタイプ-ケルコ(Genu Citrus Type-Kelco);
Polydex: ポリデキストロース(スタライト(Sta-Lite) III-テートライル(Tate Lyle));
HPC: ヒドロキシプロピルセルロース(クルセルハーキュルス(Klucel Hercules));
SA: ナトリウムアルギネート(マニュセオール(Manuceol) LD);
Pul: プルラン(P120、林原(Hayashibara));
Car: カラギーナン(タイプ(Type) GP-911NF-FMC);
PVP: ポリビニルピロリドン(プラスドン(Plasdone) K-ISPテクノロジーズ(Technologies));
デンプン:ピュアコート(Pure Cote) B793(グレインプロセッシング(Grain Processing));
Cデンプン:コーンスターチ(ピュアデント(Pure Dent) B810、グレインプロセッシング);
PGA:プロピレングリコールアルギネート(スペクトラム);
Polox:ポロキサマー188(バスフ(BASF));
Pem:ペムレン(Pemulen)(Tri-NF-ノベオン(Noveon));
Xan:キサンタン(ケルトロール(Keltrol) 630、ケルコ(Kelco));
Suc:スクラロース(マックネイルヌートリーショナル(Mcneil Nutritional));
MAG:モノ-アンモニウムグリチルリチネート(マグナスイート100、マフコワールドワイド社(Mafco Worldwide Corp.));
Sim:シメチジン(セントリーシメチコンエマルション);
Dex:デキストロメトルファン-Dx(60%(w/w))(コーティングプレース(Coating Place));
Men:メントール結晶、USP「ダブルクリスタライズド(Double Crystallized)」(カメロン&スチュアート(Cameron & Stuart));
チェリー:チェリー香料(FJ7561、アンジェラー(Ungerer));
ミント:ミント香料(AN144185、ノルビル(Norville));
苦味:苦味-隠蔽香料(FN8642、アンジェラー(Ungerer));
ジューシー:ジューシーフルーツ香料(AN143563、ノルビル(Norville));
BHT:ブチレート化ヒドロキシトルエン(スペクトラム);
クール:クールキー(Cool Key)香料(AN144429、ノルビル(Norville));
赤色:FD&C レッド(Red)#40;
TD:二酸化チタン(USP BC3328、ウイッタカー(Whittaker));
黄色:FD&C イエロー(Yellow);
ツイーン:ツイーン80(フィッシャー(Fisher));
PCC:沈降炭酸カルシウム(A-1-330-13、バイカリティーヘビー(Vicality Heavy) PCC);
オレンジ:オレンジ濃縮香料:「100%活性」(FJ 7916、アンジェラー&カンパニー(Ungerer & Company));
Gly:グリセロールモノオレエート(アルド(Aldo) MO KFG、ロンザ社(Lonza Inc.));
Cyclo:シクロヘキサンカルボキシアミド(WS-3、ミレニウムケミカル(Millenium Chemical))
SB:重炭酸ナトリウム;
MS:ステアリン酸マグネシウム(マリンクロットベイカー(Mallinckrodt Baker));
Lop:ロペラミドHCl(プレシロール(Precirol) AT05、ガットファッセ(Gattefasse));
SC:クエン酸ナトリウム(スペクトラム);
マスク:隠蔽性香料(AN 140825、ノルビル(Norville));
青:FD&Cブルー(Blue) #1;
柑橘類:シトラスタンゴ(Citrus Tango)香料(AN 146924、ノルビル(Norville));
Van:バニラ香料(FK 3685、アンジェラー(Ungerer));
CoQ10: ヒドロQソルブ(Hydro Qsorb) CoQ10粉末、20%CoQ10、(ティッセン社(Tischen Corp.));
メントール:メントール香料(FK 5364、アンジェラー(Ungerer));
CDC:セチリジン二塩酸塩;
グレープ:グレープ香料(FJ 7914、アンジェラー(Ungerer));
Rasp:キイチゴ香料(188a10、アベレイ社(Abelei Inc.));
CA:クエン酸(スペクトラム);
Span:スパン(Span) 80、(スペクトラム);
PSP:プレドニサロン(Prednisalone)リン酸ナトリウム(スペクトラム);
DW:蒸留水。
PVA: ポリビニルアルコール(スペクトラム);
HPMC: ヒドロキシプロピルメチルセルロース;
Pec: ペクチン(ジーヌシトラスタイプ-ケルコ(Genu Citrus Type-Kelco);
Polydex: ポリデキストロース(スタライト(Sta-Lite) III-テートライル(Tate Lyle));
HPC: ヒドロキシプロピルセルロース(クルセルハーキュルス(Klucel Hercules));
SA: ナトリウムアルギネート(マニュコール(Manucol) LD);
Pul: プルラン(P120、林原(Hayashibara));
Car: カラギーナン(タイプ(Type) GP911NF-FMC);
PVP: ポリビニルピロリドン(プラスドン(Plasdone) K-ISPテクノロジーズ(Technologies));
デンプン:ピュアコート(Pure Cote) B793(グレインプロセッシング(Grain Processing));
Cデンプン:コーンスターチ(ピュアデント(Pure Dent) B810、グレインプロセッシング);
PGA:プロピレングリコールアルギネート(スペクトラム);
Polx:ポロキサマー188(バスフ(BASF));
Pem:ペムレン(Pemulen)(Tri-NF-ノベオン(Noveon));
Xan:キサンタン(ケルトロール(Keltrol) 630、ケルコ(Kelco));
実施例HA-HR:
本発明の以下の実施例は、ポリビニルアルコール(PVA)ポリマーブレンドを含むフィルムを説明するものである。特に、PVAを、他のポリマー、例えばポリエチレンオキサイド(PEO)、コーンスターチおよびポリデキストロースと併合した。以下の表35Aおよび35Bに示されたように、該フィルムに対する質量%の関数としての、種々の成分の量を用いて、前に記載した如く、これらの成分を含む、薄いフィルム組成物を製造した。
Claims (27)
- 溶解性フィルム製品であって、
ポリエチレンオキサイド単独またはこれと少なくとも1種の追加のポリマー成分との組合せを含むポリマーを含有し、
前記ポリエチレンオキサイドが、約100,000〜約4,000,000なる範囲内の分子量を持ち、 該フィルム製品が、添加された可塑剤を含まない、
ことを特徴とする、前記溶解性フィルム製品。 - 前記ポリエチレンオキサイドが、前記ポリマーの少なくとも約20質量%なる量で存在する、請求項1記載のフィルム製品。
- 前記ポリエチレンオキサイドが、前記ポリマーの約100質量%までの量で存在する、請求項1記載のフィルム製品。
- 前記少なくとも1種の追加のポリマー成分が、前記ポリマーの約80質量%までの量で存在する、請求項1記載のフィルム製品。
- 前記少なくとも1種の追加のポリマー成分が、ポリビニルアルコール、ヒドロキシプロピルメチルセルロース、ペクチン、ポリデキストロース、ヒドロキシプロピルセルロース、アルギン酸ナトリウム、プルラン、カラギーナン、ポリビニルピロリドン、デンプン、プロピレングリコールアルギネート、ポロキサマー、アクリル酸およびアルキルアクリレートのコポリマー、キサンタン、またはこれらの組合せからなる群から選択される、請求項1記載のフィルム製品。
- 前記少なくとも1種の追加のポリマー成分が、ポリビニルアルコールである、請求項1記載のフィルム製品。
- 前記ポリエチレンオキサイドが、約100,000〜約900,000なる範囲内の分子量を持つ、請求項1記載のフィルム製品。
- 前記ポリエチレンオキサイドが、約100,000〜約300,000なる範囲の分子量を持ち、約600,000〜約900,000なる範囲の分子量を持つポリエチレンオキサイドと組合されている、請求項1記載のフィルム製品。
- 更に、化粧剤、薬剤、生物活性剤、およびこれらの組合せからなる群から選択される活性成分をも含む、請求項1記載のフィルム製品。
- 前記生物活性剤が、酵素、抗原およびアレルゲンからなる群から選択される、請求項9記載のフィルム製品。
- 前記活性成分が、ACE-阻害剤、抗-狭心症薬、抗-不整脈薬、抗-喘息薬、抗-コレステロール血症薬、鎮痛薬、麻酔薬、抗-痙攣薬、抗-鬱薬、抗-糖尿病薬、下痢止製剤、解毒薬、抗-ヒスタミン薬、抗-高血圧症薬、抗-炎症薬、抗-高脂血症薬、抗-躁病薬、制嘔吐薬、抗-卒中薬、抗-甲状腺製剤、抗-腫瘍薬、抗-ウイルス剤、アクネ治療薬、アルカロイド、アミノ酸製剤、鎮咳薬、抗-尿酸血症薬、抗-ウイルス薬、同化促進製剤、全身性または非-全身性抗-感染薬、抗-新生物薬、抗-パーキンソン症候群薬、抗-リウマチ薬、食欲増進剤、生物学的応答改善剤、血液改善剤、骨代謝調節剤、心臓血管作用薬、中枢神経系刺激薬、コリンエステラーゼ阻害剤、避妊薬、鬱血除去薬、ダイエタリーサプリメント、ドーパミン受容体アゴニスト、子宮内膜症治療薬、酵素、勃起不全治療薬、排卵誘発薬、胃腸薬、ホメオパシー治療薬、ホルモン、高カルシウム血症および低カルシウム血症治療薬、免疫調節薬、免疫抑制剤、片頭痛製剤、動揺病治療薬、筋弛緩薬、肥満治療薬、骨粗鬆症製剤、分娩促進薬、副交感神経遮断薬、副交感神経興奮薬、プロスタグランジン、精神療法薬、呼吸器疾患治療薬、鎮静剤、禁煙補助薬、交感神経遮断薬、振戦治療製剤、尿路疾患治療薬、血管拡張薬、緩下薬、制酸剤、イオン交換樹脂、解熱薬、食欲抑制剤、去痰薬、抗-不安薬、抗-潰瘍剤、抗-炎症性物質、冠状動脈拡張剤、大脳血管拡張薬、末梢血管拡張薬、向精神剤、刺激薬、抗-高血圧症薬、血管収縮薬、片頭痛治療薬、抗生物質、トランキライザー、抗-精神病薬、抗-腫瘍薬、抗-凝血剤、抗-血栓薬、催眠薬、鎮吐薬、制吐薬、抗痙攣剤、神経筋作用薬、高血糖および低血糖症治療薬、甲状腺および抗-甲状腺製剤、利尿薬、鎮痙薬、子宮弛緩薬、抗-肥満薬、造血剤、抗-喘息薬、咳止め剤、粘液溶解薬、DNAおよび遺伝子改質剤、およびこれらの組合せからなる群から選択される、請求項9記載のフィルム製品。
- 更に、緻密化剤をも含む、請求項1記載のフィルム製品。
- 前記緻密化剤が、シメチコンである、請求項12記載のフィルム製品。
- 更に、溶解度増強剤をも含む、請求項1記載のフィルム製品。
- 前記フィルムが、可撓性である、請求項1記載のフィルム製品。
- 前記ポリマーが、粘膜組織に対する接着を助長するのに十分な量で、ポリエチレンオキサイドを含む、請求項1記載のフィルム製品。
- 水溶性フィルム製品であって、
約20〜約100質量%なる範囲のポリエチレンオキサイド、約0〜約80質量%なる範囲の少なくとも1種の追加のポリマー成分を含むポリマー;
活性成分;
スクラロース;
沈降炭酸カルシウム;
少なくとも1種の香味料;
シメチコン;
水;および
少なくとも1種の着色剤
を含み、前記ポリエチレンオキサイドが、約100,000〜約4,000,000なる範囲内の分子量を持ち、該フィルム製品が、添加された可塑剤を含まないことを特徴とする、前記水溶性フィルム製品。 - 前記少なくとも1種の追加のポリマー成分が、ポリビニルアルコール、ヒドロキシプロピルメチルセルロース、ペクチン、ポリデキストロース、ヒドロキシプロピルセルロース、アルギン酸ナトリウム、プルラン、カラギーナン、ポリビニルピロリドン、デンプン、プロピレングリコールアルギネート、ポロキサマー、アクリル酸およびアルキルアクリレートのコポリマー、キサンタン、またはこれらの組合せからなる群から選択される、請求項17記載のフィルム製品。
- フィルム組成物形状にある、喫食可能な水溶性放出系であって、
ポリエチレンオキサイド単独またはこれと少なくとも1種の追加のポリマー成分との組合せを含むポリマーを含有し、
前記ポリエチレンオキサイドが、約100,000〜約4,000,000なる範囲内の分子量を持ち、 該フィルム製品が、添加された可塑剤を含まない、
ことを特徴とする、前記喫食可能な水溶性放出系。 - 前記少なくとも1種の追加のポリマー成分が、ポリビニルアルコール、ヒドロキシプロピルメチルセルロース、ペクチン、ポリデキストロース、ヒドロキシプロピルセルロース、アルギン酸ナトリウム、プルラン、カラギーナン、ポリビニルピロリドン、デンプン、プロピレングリコールアルギネート、ポロキサマー、アクリル酸およびアルキルアクリレートのコポリマー、キサンタン、またはこれらの組合せからなる群から選択される、請求項19記載の喫食可能な水溶性放出系。
- 更に、化粧剤、薬剤、生物活性剤、およびこれらの組合せからなる群から選択される、活性成分をも含む、請求項19記載の喫食可能な水溶性放出系。
- 成分の実質的に均一な分布を有する、フィルムの製造方法であって、以下の諸工程:
(a) ポリエチレンオキサイド単独またはこれと少なくとも1種の追加のポリマー成分との組合せを含む少なくとも1種の水溶性ポリマー、溶媒、および活性成分を併合して、該成分の均一な分布を有するマトリックスを製造する工程;
(b) 該マトリックスからフィルムを製造する工程;および
(c) 該フィルムを乾燥する工程、
を含み、
前記ポリエチレンオキサイドが、約100,000〜約4,000,000なる範囲内の分子量を持ち、該フィルムが、添加された可塑剤を含まないことを特徴とする、前記フィルムの製造方法。 - 前記マトリックスからフィルムを製造する前記工程が、更に上部面および下部面を持つ表面上で、該マトリックスを流込み成形する工程をも含む、請求項22記載の方法。
- 前記フィルムの乾燥工程が、更に前記表面の前記下部面に熱を適用する工程を含む、請求項22記載の方法。
- 実質的に均一な成分の分布を有する、フィルムの製造方法であって、以下の諸工程:
(a) ポリエチレンオキサイド単独またはこれと少なくとも1種の追加のポリマー成分との組合せを含む少なくとも1種の水溶性ポリマー、および活性成分を併合して、該成分の均一な分布を有するマトリックスを製造する工程;および
(b) 該マトリックスを押出して、フィルムを製造する工程;
を含み、前記ポリエチレンオキサイドが、約100,000〜約4,000,000なる範囲内の分子量を持ち、該フィルムが、添加された可塑剤を含まないことを特徴とする、前記フィルムの製造方法。 - 更に、前記押出されたフィルムを冷却する工程をも含む、請求項25記載の方法。
- 以下の諸工程:
(a) ポリエチレンオキサイド単独またはこれと少なくとも1種の追加のポリマー成分との組合せを含む少なくとも1種の水溶性ポリマー、溶媒、および活性成分を併合して、該成分の均一な分布を有するマトリックスを製造する工程;
(b) 該マトリックスを押出して、フィルムを製造する工程;および
(c) 該フィルムを乾燥する工程、
によって製造され、前記ポリエチレンオキサイドが、約100,000〜約4,000,000なる範囲内の分子量を持ち、該フィルムが、添加された可塑剤を含まないことを特徴とする、喫食性で可撓性のフィルム製品。
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US11/674,223 | 2007-02-13 | ||
US11/674,223 US20070281003A1 (en) | 2001-10-12 | 2007-02-13 | Polymer-Based Films and Drug Delivery Systems Made Therefrom |
PCT/US2008/000973 WO2008100375A2 (en) | 2007-02-13 | 2008-01-25 | Polymer-based films and drug delivery systems made therefrom |
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-
2007
- 2007-02-13 US US11/674,223 patent/US20070281003A1/en not_active Abandoned
-
2008
- 2008-01-25 JP JP2009549585A patent/JP5538905B2/ja active Active
- 2008-01-25 CN CN200880011498A patent/CN101668519A/zh active Pending
- 2008-01-25 AU AU2008216887A patent/AU2008216887A1/en not_active Abandoned
- 2008-01-25 WO PCT/US2008/000973 patent/WO2008100375A2/en active Application Filing
- 2008-01-25 CA CA002678066A patent/CA2678066A1/en not_active Abandoned
- 2008-01-25 EP EP08724791.2A patent/EP2120897A4/en not_active Withdrawn
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EP2120897A2 (en) | 2009-11-25 |
US20070281003A1 (en) | 2007-12-06 |
AU2008216887A1 (en) | 2008-08-21 |
CA2678066A1 (en) | 2008-08-21 |
WO2008100375A3 (en) | 2008-11-06 |
JP2010518241A (ja) | 2010-05-27 |
EP2120897A4 (en) | 2013-07-31 |
WO2008100375A2 (en) | 2008-08-21 |
US9108340B2 (en) | 2015-08-18 |
US20140008832A1 (en) | 2014-01-09 |
CN101668519A (zh) | 2010-03-10 |
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