JP2016138106A - 薬物送達のための咀嚼可能な剤形の製造方法およびその製品 - Google Patents
薬物送達のための咀嚼可能な剤形の製造方法およびその製品 Download PDFInfo
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Abstract
【解決手段】(a)活性成分及び乾燥した非活性成分を混合機の混合室に提供する工程で、室は略水平に配置され混合される材料を受けるための壁により画定された空間を有し回転可能な混合シャフトが室の空間を通って縦方向に伸び、シャフトを回転させるために駆動装置が混合シャフトに動作可能に結合される工程と(b)乾燥した混合物が形成されるまで回転させる混合シャフトに混合室の空間の壁から離れたその間の場所に該成分を投入することにより乾燥した活性成分及び非活性成分を混合室内でブレンドする工程と(c)柔らかい咀嚼可能な混合物を形成するために乾燥した混合物に軟化剤を添加しブレンドする工程と(d)柔らかい咀嚼可能な混合物を均一な重量の塊に形成する工程とを含み、さらに前記咀嚼可能な混合物はいずれ工程の間でも加熱されない方法。
【選択図】なし
Description
本発明は、経口投与可能な薬学的用量単位、特に、チャンク(chunk)等の食用塊の形態での単位に関する。
薬物を、咀嚼可能な錠剤または糖剤などの食用薬剤として製剤することにより、患者、特に硬い錠剤またはカプセルを飲み込むことに抵抗することが多い動物による薬剤の受け入れを増加させることができる。残念ながら、多くの薬物および他の活性成分(集合的に「活性物」と総称する)は、極めて苦いかあるいは受け入れ難い味であり、咀嚼するには不快である。
本発明は、独特のソフトチューの薬剤と、その製造のための方法を提供する。本発明のソフトチューは、特にペット動物の口に合うものである。それらは、少なくとも食品グレード品質の非活性成分を含み、最も好ましくは、動物由来の非活性成分を含まない。したがって、当該ソフトチューは、感染因子または汚染物質の伝染の心配なく、また、同じ製造施設内で生産された他の製品に対する二次汚染のリスクもなく、製造することができる。
A.本発明のソフトチューに使用する材料
一般に、柔らかい咀嚼可能な薬剤およびおやつには、製造性、食感、および製品の外観を向上させるために、結合剤、ビタミン、および色素等の非活性成分物質が含まれている。当業者はそのような非活性成分に精通しており、本発明における使用には水を含む必要はない。
本発明のソフトチューの活性および非活性成分は、材料をブレンドし、それを混合容器の側面に沿って投入することができる、水平混合機の混合容器に添加される。この動作により、加熱することなく、または混合物へ医薬品グレードの水を添加する必要なく、成分を十分かつ均一にブレンドすることができる。
犬糸状虫の治療のためのイベルメクチンのソフトチュー
活性物の送達に適したソフトチューの例を、以下の製法1に記載する。
本発明のソフトチューの活性成分をコーティングする方法
活性物(イベルメクチン)を粉砕し、20メッシュの篩で篩い分けを行った。100グラムのイベルメクチンと900グラムのStarch 1500を3分から5分間、乾式混合することにより、10%の倍散を作成した。得られた倍散を流動層カラム中で流動化し、トップの噴霧流動コーターであるWursterコーターや他の適したデバイスを使用して食品グレードのコーティング(OPADRY(商標))を施した。
本発明のソフトチューの例示的な製造方法
オートブランを除く実施例1および2に列挙したすべての乾燥成分を、20メッシュの篩を通して篩い分けし、ブランとともに水平混合ブレンダの混合容器に入れ、5分間混合した。グリセリンを徐々に添加し、次に植物油と、油に添加されているTenox 4とを徐々に添加した。生成物を3分間混合した。PEG 8000を溶融した後チュー混合物に比較的速やかに添加し、次にそれをさらに1分間混合した。混合物は、「クッキー生地状」の外観を呈した。
Claims (23)
- 薬学的活性成分の送達のための、柔らかい咀嚼可能な薬剤ビヒクルを製造する方法であって、
(a)前記薬剤ビヒクルの前記活性成分および乾燥した非活性成分を、混合機の混合室に提供する工程であって、
(i)前記室は略水平に配置され、混合される材料を受けるための、壁により画定された空間を有し、
(ii)回転可能な混合シャフトが前記室の空間を通って縦方向に伸び、
(iii)前記シャフトを回転させるために、駆動装置が前記混合シャフトに動作可能に結合される、工程と、
(b)乾燥した混合物が形成されるまで、回転させる前記混合シャフトに、前記混合室の空間の壁から離れたその間の場所に該成分を投入させることにより、乾燥した前記活性成分および非活性成分を前記混合室内でブレンドする工程と、
(c)柔らかい咀嚼可能な混合物を形成するために、前記乾燥した混合物に軟化剤を添加し、それをブレンドする工程と、
(d)柔らかい咀嚼可能な混合物を、均一な重量の個々の塊に形成する工程とを含み、
さらに、前記乾燥した、またはブレンドされた咀嚼可能な混合物は、いずれの混合または形成工程の間でも加熱されない、方法。 - 工程(a)において、前記活性成分が混合容器に添加される前に、賦形剤による前記活性成分の倍散を調製する工程をさらに含む、請求項1記載の方法。
- 前記柔らかい咀嚼可能な混合物に、融解したパラフィンワックスを添加しブレンドする工程(c)'をさらに含む、請求項1記載の方法。
- 工程(a)において、前記活性成分が混合容器に添加される前に、前記活性成分を食品グレードコーティングでコーティングする工程(d)'をさらに含む、請求項1または2記載の方法。
- 薬学的に許容される容器に前記個々の塊が置かれる工程(e)をさらに含む、請求項1記載の方法。
- 柔らかい咀嚼可能な塊として薬学的に許容される活性成分を含む薬剤ビヒクルであって、前記薬剤は請求項1記載の方法に従い生産される、薬剤ビヒクル。
- 非活性成分をさらに含み、前記非活性成分のすべては食品グレード品質である、請求項6記載の薬剤ビヒクル。
- 前記非活性成分が、放射線処理されている、または殺菌されている、請求項7記載の薬剤ビヒクル。
- 非活性成分をさらに含み、前記非活性成分はいずれも動物由来ではない、請求項6記載の薬剤ビヒクル。
- 前記非活性成分は、食品グレード品質の香料を含む、請求項7記載の薬剤ビヒクル。
- 前記非活性成分は、非動物由来の香料を含む、請求項9記載の薬剤ビヒクル。
- 前記香料は、大豆タンパク製品である、請求項11記載の薬剤ビヒクル。
- 前記香料は、人工ベーコン風味大豆タンパク製品である、請求項12記載の薬剤ビヒクル。
- 潤滑剤、保湿剤、および充填剤をさらに含む、請求項6記載の薬剤ビヒクル。
- 前記薬学的活性成分は、賦形剤による倍散として調製される、請求項6記載の薬剤ビヒクル。
- 前記軟化剤は油を含む、請求項14記載の薬剤ビヒクル。
- 前記軟化剤はワックスを含む、請求項14記載の薬剤ビヒクル。
- 前記薬学的活性物質はコーティングされている、請求項6記載の薬剤ビヒクル。
- 保存料をさらに含む、請求項6記載の薬剤ビヒクル。
- 前記軟化剤は油およびワックスを含み、前記保湿剤はグリセリンを含み、前記潤滑剤はステアリン酸塩を含む、請求項14記載の薬剤ビヒクル。
- 前記薬学的活性成分は、駆虫薬、鎮痛薬、抗生物質、抗ウイルス薬、抗炎症薬、内部寄生虫駆除薬、外部寄生虫駆除薬、および抗真菌薬より成る成分の群から選択される、請求項20記載の薬剤。
- 前記薬学的活性成分は駆虫薬である、請求項21記載の薬剤。
- 式1の成分と活性成分とを有する、請求項22記載の薬剤。
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US11/296,181 US20070128251A1 (en) | 2005-12-07 | 2005-12-07 | Process for manufacturing chewable dosage forms for drug delivery and products thereof |
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JP2014164910A Pending JP2015013868A (ja) | 2005-12-07 | 2014-08-13 | 薬物送達のための咀嚼可能な剤形の製造方法およびその製品 |
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JP2018017327A Pending JP2018109009A (ja) | 2005-12-07 | 2018-02-02 | 薬物送達のための咀嚼可能な剤形の製造方法およびその製品 |
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JP2014164910A Pending JP2015013868A (ja) | 2005-12-07 | 2014-08-13 | 薬物送達のための咀嚼可能な剤形の製造方法およびその製品 |
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US (2) | US20070128251A1 (ja) |
EP (1) | EP1957110B8 (ja) |
JP (4) | JP2009518417A (ja) |
AU (1) | AU2006321955A1 (ja) |
BR (1) | BRPI0619504A2 (ja) |
CA (1) | CA2632855C (ja) |
DK (1) | DK1957110T3 (ja) |
ES (1) | ES2834394T3 (ja) |
NZ (1) | NZ568394A (ja) |
PL (1) | PL1957110T3 (ja) |
PT (1) | PT1957110T (ja) |
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Also Published As
Publication number | Publication date |
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CA2632855C (en) | 2015-10-27 |
DK1957110T3 (da) | 2020-12-21 |
US8293265B2 (en) | 2012-10-23 |
EP1957110B8 (en) | 2020-12-23 |
EP1957110B1 (en) | 2020-09-23 |
US20070128251A1 (en) | 2007-06-07 |
EP1957110A4 (en) | 2011-08-03 |
JP2009518417A (ja) | 2009-05-07 |
AU2006321955A1 (en) | 2007-06-14 |
BRPI0619504A2 (pt) | 2011-10-04 |
CA2632855A1 (en) | 2007-06-14 |
WO2007067582A3 (en) | 2007-08-02 |
PT1957110T (pt) | 2020-12-04 |
WO2007067582A2 (en) | 2007-06-14 |
PL1957110T3 (pl) | 2021-03-22 |
US20090280159A1 (en) | 2009-11-12 |
JP2015013868A (ja) | 2015-01-22 |
ES2834394T3 (es) | 2021-06-17 |
NZ568394A (en) | 2010-06-25 |
JP2018109009A (ja) | 2018-07-12 |
EP1957110A2 (en) | 2008-08-20 |
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