JP2012512159A - アスコルビン酸リン酸塩の持続放出系 - Google Patents
アスコルビン酸リン酸塩の持続放出系 Download PDFInfo
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/04—Drugs for skeletal disorders for non-specific disorders of the connective tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Abstract
Description
2−ホスファ−L−アスコルビン酸三ナトリウム塩(AZP)、(>98%(HPLC),Fluka,ロット番号:1322473 52607420)について以下の乾燥条件を試験した:90℃/24時間真空下、160℃/30分間乾燥窒素ブランケット下、及び200℃/30分間乾燥窒素ブランケット下。試験した時間は、評価時間、配合時間、並びにサンプル回収及び冷却時間を含む。
乾燥窒素ブランケット下のグローブボックス内で、実施例1に記載のように160℃/30分間で予め乾燥させたAZP32ミリグラムの量を20mLの瓶に計量した。シリンジを用いて9.0mLのCH2Cl2を直ちに瓶に添加し、瓶に蓋をした。グローブボックスからAZP溶液を取り出し、10分間超音波処理した。この溶液をグローブボックスに戻し、次いで0.6グラムの40/60 PCL/PLAポリマー(ロット番号D99069,Birmingham Polymer,Inc.)をAZP溶液に添加し、再度蓋をした。混合物をグローブボックスから取り出し、ポリマーが完全に溶解するまで室温で振盪させた。VirTic凍結乾燥機(モデル:AdVantage,MFR:VirTic)の棚を6℃に予冷することにより、溶媒流延フィルムを調製した。AZP/ポリマー溶液を5cm×5cmのテフロンコーティングされた金属型に注ぎ、次いで直ちに予冷した棚に移した。窒素ブランケットを用いて蒸発を緩徐に進行させて、水の凝結を防いだ。溶媒を除去した後、約150マイクロメートル〜200マイクロメートルの厚さを有するフィルムを回収し、次のプロセス又は/及び特性評価のために真空下で保存した。
AZP/ポリマー組成物を以下のように調製した:乾燥窒素でパージされたグローブボックス内にて、30.4グラムの25/75PCL/PGAポリマー(ロット番号UAZC020,Ethicon)及び0.63グラムの実施例1に記載のように160℃/30分間予め乾燥させたAZPを容器に計量し、一緒に乾燥混合することにより2重量%のAZP/ポリマー組成物を調製した。一方、30mLのBrabenderミキサ(モデル:R.E.E.6/2,C.W.Brabender Instruments,Hackensack,NJ)を200℃に予熱した。乾燥窒素ブランケットを維持した。ミキサを30rpmの速度に設定した。AZP/ポリマー混合物を速やかにグローブボックスからミキサに移し、閉めた。物質を約10分間混合させた。混合を停止し、AZPポリマー組成物を回収した。制御放出組成物への更なる加工の準備が整うまで、真空下で組成物を保存した。
AZP/ポリマー組成物を以下のように調製した:乾燥窒素でパージされたグローブボックス内にて、30.4グラムの40/60PCL/PLAポリマー(ロット番号UAZC020,Ethicon,Inc,Somerville,NJ)及び0.63グラムの実施例1に記載のように160℃/30分間予め乾燥させたAZPを容器に計量し、一緒に乾燥混合することにより2重量%のAZP/ポリマー組成物を調製した。AZP/ポリマーを乾燥窒素ブランケット下で混合した。30mLのBrabenderミキサ(モデル:R.E.E.6/2,C.W.Brabender Instruments Hackensack,NJ)を160℃に予熱した。乾燥窒素ブランケットを維持した。ミキサを30rpmの速度に設定した。AZP/ポリマー混合物をミキサに速やかに添加し、閉じた。物質を約10分間混合させた。混合を停止し、AZPポリマー組成物を回収した。望ましい制御放出組成物への更なる加工の準備が整うまで、真空下で組成物を保存した。このプロセスを繰り返して、5wt%及び10wt%のAZP/ポリマー組成物を調製した。
AZP/ポリマー組成物を以下のように調製した:乾燥窒素でパージされたグローブボックス内にて、30.4グラムの35/65PCL/PGAポリマー(ロット番号UAZC020,Ethicon)及び0.63グラムの実施例1に記載のように160℃/30分間予め乾燥させたAZPを容器に計量し、一緒に乾燥混合することにより2重量%のAZP/ポリマー組成物を調製した。一方、30mLのBrabenderミキサ(モデル:R.E.E.6/2,C.W.Brabender Instruments)を130℃に予熱した。乾燥窒素ブランケットを維持した。ミキサを30rpmの速度に設定した。AZP/ポリマー混合物を速やかにグローブボックスからミキサに移し、閉めた。物質を約10分間混合させた。混合を停止し、AZPポリマー組成物を回収した。制御放出組成物への更なる加工の準備が整うまで、真空下で組成物を保存した。このプロセスを繰り返して、5wt%及び10wt%のAZP/ポリマー組成物を調製した。
(1) アスコルビン酸リン酸塩の制御放出組成物を作製する方法であって、
約160℃以下の温度で約30分間アスコルビン酸リン酸塩を乾燥させる工程と、
約160℃以下の温度で、前記乾燥させたアスコルビン酸リン酸塩を吸収性脂肪族ポリエステルポリマーと溶融ブレンドして、アスコルビン酸リン酸塩及びポリマー組成物を形成する工程と、を含む、方法。
(2) 約160℃以下の温度で、前記アスコルビン酸及びポリマー組成物を所望の形態に加工する更なる工程を含む、実施態様1に記載の方法。
(3) 前記組成物が、前記組成物の約0.5重量%〜約20重量%の量のアスコルビン酸を含む、実施態様1に記載の方法。
(4) 前記組成物が、前記組成物の約2重量%〜約10重量%の量のアスコルビン酸を含む、実施態様1に記載の方法。
(5) 前記吸収性脂肪族ポリエステルポリマーが、ラクチド、グリコリド、イプシロン−カプロラクトン、ジオキサノン、及びトリメチレンカーボネートからなる群から選択されるモノマーから調製されるホモポリマー又はコポリマーである、実施態様1に記載の方法。
(6) 前記吸収性脂肪族ポリエステルポリマーが、イプシロン−カプロラクトン及びグリコリドから調製されるコポリマーである、実施態様1に記載の方法。
(7) 前記組成物が、繊維、ロッド、ねじ、止め金、縫合糸アンカー、フィルム、及びこれらの組み合わせからなる群から選択される医療機器に形成される、実施態様2に記載の方法。
(8) 前記吸収性ポリマー及び前記アスコルビン酸リン酸塩が、約5分間〜約30分間溶融ブレンドされる、実施態様1に記載のプロセス。
(9) 前記組成物と、少なくとも1つの生物活性剤とを組み合わせる工程を更に含む、実施態様1に記載のプロセス。
(10) 前記組成物を生存組織と組み合わせる工程を更に含む、実施態様1に記載のプロセス。
(12) 制御放出組成物であって、
160℃以下の温度で約30分間アスコルビン酸リン酸塩を乾燥させる工程と、
約160℃以下の温度で、前記乾燥させたアスコルビン酸リン酸塩と吸収性脂肪族ポリエステルポリマーとを溶融ブレンドして、アスコルビン酸リン酸塩及びポリマー組成物を形成する工程と、を含む、方法により製造されるアスコルビン酸リン酸塩の制御放出組成物を含む、制御放出組成物。
(13) 前記プロセスが、約160℃以下の温度で前記アスコルビン酸及びポリマー組成物を所望の形態に加工する更なる工程を含む、実施態様12に記載の組成物。
(14) 前記組成物が、約0.5重量%〜約20重量%の量のアスコルビン酸リン酸塩を含む、実施態様12に記載の組成物。
(15) 前記組成物が、約2重量%〜約10重量%の量のアスコルビン酸リン酸塩を含む、実施態様12に記載の組成物。
(16) 前記吸収性脂肪族ポリエステルポリマーが、ラクチド、グリコリド、イプシロン−カプロラクトン、ジオキサノン、及びトリメチレンカーボネートからなる群より選択されるモノマーから調製されるホモポリマー又はコポリマーである、実施態様12に記載の組成物。
(17) 前記吸収性脂肪族ポリエステルポリマーが、イプシロン−カプロラクトン及びグリコリドから調製されるコポリマーである、実施態様12に記載の組成物。
(18) 前記組成物が、繊維、ロッド、ねじ、止め金、縫合糸アンカー、フィルム、及びこれらの組み合わせからなる群から選択される医療機器に形成される、実施態様13に記載の組成物。
(19) 前記吸収性ポリマー及び前記アスコルビン酸リン酸塩が、約5分間〜約30分間溶融ブレンドされる、実施態様12に記載の組成物。
(20) 前記組成物が少なくとも1つの生物活性剤を更に含む、実施態様12に記載の組成物。
(22) 前記組成物が細胞を更に含む、実施態様12に記載の組成物。
(23) 20重量%以下のバースト放出後、制御放出されるアスコルビン酸リン酸塩及び吸収性脂肪族ポリエステルポリマーを含む制御放出組成物。
(24) 医療機器であって、
160℃以下の温度で約30分間アスコルビン酸リン酸塩を乾燥させる工程と、
約160℃以下の温度で、前記乾燥させたアスコルビン酸リン酸塩を吸収性脂肪族ポリエステルポリマーと溶融ブレンドして、アスコルビン酸リン酸塩及びポリマー組成物を形成する工程と、を含む、方法により製造されるアスコルビン酸リン酸塩の制御放出組成物、を含む、医療機器。
Claims (24)
- アスコルビン酸リン酸塩の制御放出組成物を作製する方法であって、
約160℃以下の温度で約30分間アスコルビン酸リン酸塩を乾燥させる工程と、
約160℃以下の温度で、前記乾燥させたアスコルビン酸リン酸塩を吸収性脂肪族ポリエステルポリマーと溶融ブレンドして、アスコルビン酸リン酸塩及びポリマー組成物を形成する工程と、を含む、方法。 - 約160℃以下の温度で、前記アスコルビン酸及びポリマー組成物を所望の形態に加工する更なる工程を含む、請求項1に記載の方法。
- 前記組成物が、前記組成物の約0.5重量%〜約20重量%の量のアスコルビン酸を含む、請求項1に記載の方法。
- 前記組成物が、前記組成物の約2重量%〜約10重量%の量のアスコルビン酸を含む、請求項1に記載の方法。
- 前記吸収性脂肪族ポリエステルポリマーが、ラクチド、グリコリド、イプシロン−カプロラクトン、ジオキサノン、及びトリメチレンカーボネートからなる群から選択されるモノマーから調製されるホモポリマー又はコポリマーである、請求項1に記載の方法。
- 前記吸収性脂肪族ポリエステルポリマーが、イプシロン−カプロラクトン及びグリコリドから調製されるコポリマーである、請求項1に記載の方法。
- 前記組成物が、繊維、ロッド、ねじ、止め金、縫合糸アンカー、フィルム、及びこれらの組み合わせからなる群から選択される医療機器に形成される、請求項2に記載の方法。
- 前記吸収性ポリマー及び前記アスコルビン酸リン酸塩が、約5分間〜約30分間溶融ブレンドされる、請求項1に記載のプロセス。
- 前記組成物と、少なくとも1つの生物活性剤とを組み合わせる工程を更に含む、請求項1に記載のプロセス。
- 前記組成物を生存組織と組み合わせる工程を更に含む、請求項1に記載のプロセス。
- 前記組成物を細胞と組み合わせる工程を更に含む、請求項1に記載のプロセス。
- 制御放出組成物であって、
160℃以下の温度で約30分間アスコルビン酸リン酸塩を乾燥させる工程と、
約160℃以下の温度で、前記乾燥させたアスコルビン酸リン酸塩と吸収性脂肪族ポリエステルポリマーとを溶融ブレンドして、アスコルビン酸リン酸塩及びポリマー組成物を形成する工程と、を含む、方法により製造されるアスコルビン酸リン酸塩の制御放出組成物を含む、制御放出組成物。 - 前記プロセスが、約160℃以下の温度で前記アスコルビン酸及びポリマー組成物を所望の形態に加工する更なる工程を含む、請求項12に記載の組成物。
- 前記組成物が、約0.5重量%〜約20重量%の量のアスコルビン酸リン酸塩を含む、請求項12に記載の組成物。
- 前記組成物が、約2重量%〜約10重量%の量のアスコルビン酸リン酸塩を含む、請求項12に記載の組成物。
- 前記吸収性脂肪族ポリエステルポリマーが、ラクチド、グリコリド、イプシロン−カプロラクトン、ジオキサノン、及びトリメチレンカーボネートからなる群より選択されるモノマーから調製されるホモポリマー又はコポリマーである、請求項12に記載の組成物。
- 前記吸収性脂肪族ポリエステルポリマーが、イプシロン−カプロラクトン及びグリコリドから調製されるコポリマーである、請求項12に記載の組成物。
- 前記組成物が、繊維、ロッド、ねじ、止め金、縫合糸アンカー、フィルム、及びこれらの組み合わせからなる群から選択される医療機器に形成される、請求項13に記載の組成物。
- 前記吸収性ポリマー及び前記アスコルビン酸リン酸塩が、約5分間〜約30分間溶融ブレンドされる、請求項12に記載の組成物。
- 前記組成物が少なくとも1つの生物活性剤を更に含む、請求項12に記載の組成物。
- 前記組成物が生存組織を更に含む、請求項12に記載の組成物。
- 前記組成物が細胞を更に含む、請求項12に記載の組成物。
- 20重量%以下のバースト放出後、制御放出されるアスコルビン酸リン酸塩及び吸収性脂肪族ポリエステルポリマーを含む制御放出組成物。
- 医療機器であって、
160℃以下の温度で約30分間アスコルビン酸リン酸塩を乾燥させる工程と、
約160℃以下の温度で、前記乾燥させたアスコルビン酸リン酸塩を吸収性脂肪族ポリエステルポリマーと溶融ブレンドして、アスコルビン酸リン酸塩及びポリマー組成物を形成する工程と、を含む、方法により製造されるアスコルビン酸リン酸塩の制御放出組成物、を含む、医療機器。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/332,414 | 2008-12-11 | ||
US12/332,414 US8034363B2 (en) | 2008-12-11 | 2008-12-11 | Sustained release systems of ascorbic acid phosphate |
PCT/US2009/067289 WO2010068654A1 (en) | 2008-12-11 | 2009-12-09 | Sustained release systems of ascorbic acid phosphate |
Publications (2)
Publication Number | Publication Date |
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JP2012512159A true JP2012512159A (ja) | 2012-05-31 |
JP5684140B2 JP5684140B2 (ja) | 2015-03-11 |
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EP (1) | EP2358356B1 (ja) |
JP (1) | JP5684140B2 (ja) |
CN (1) | CN102368999B (ja) |
BR (1) | BRPI0923362B8 (ja) |
CA (1) | CA2745934C (ja) |
WO (1) | WO2010068654A1 (ja) |
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EP2358356B1 (en) | 2012-09-19 |
BRPI0923362B8 (pt) | 2021-07-27 |
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CA2745934C (en) | 2018-01-02 |
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US8034363B2 (en) | 2011-10-11 |
US20110104232A1 (en) | 2011-05-05 |
BRPI0923362B1 (pt) | 2020-10-13 |
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