JP6081436B2 - ヒドロキシアルキルセルロース微粒子 - Google Patents
ヒドロキシアルキルセルロース微粒子 Download PDFInfo
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- JP6081436B2 JP6081436B2 JP2014243228A JP2014243228A JP6081436B2 JP 6081436 B2 JP6081436 B2 JP 6081436B2 JP 2014243228 A JP2014243228 A JP 2014243228A JP 2014243228 A JP2014243228 A JP 2014243228A JP 6081436 B2 JP6081436 B2 JP 6081436B2
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- fine particles
- hydroxyalkyl cellulose
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Description
本願は、2009年11月24日に日本に出願された特願2009−266821号及び2010年6月14日に日本に出願された特願2010−135622号に基づき優先権を主張し、その内容をここに援用する。
ヒドロキシアルキルセルロースは、通常、粒子状にして供給される。ヒドロキシプロピルセルロース粒子の調製法としてスプレードライ法が報告されている。スプレードライ法を用いた場合、目的の粒子を得るためには希薄溶液からの粒子調製が必要であり、生産性の点で問題を有していた。また、特許文献1には、貼付剤の粘着層に用いるための、粒子径が1〜150μmであるヒドロキシプロピルセルロース粒子が開示されている。また、特許文献2や特許文献3には、固形製剤に用いるための、乾式レーザー回折法により測定される体積平均粒子径が25μm以下の低置換度ヒドロキシプロピルセルロース粒子が開示されている。これらのヒドロキシプロピルセルロース粒子は、振動ミルなどによって得られた粉末を流動層造粒して調製されている。
このような従来のヒドロキシアルキルセルロース粒子は、直接打錠法による錠剤製造における圧縮特性が十分でなく、得られる錠剤の引張強度や崩壊性が必ずしも満足できるものでなかった。
そこで、本発明の一態様は、引張強度や崩壊性に優れた固形製剤を得るのに適したヒドロキシアルキルセルロース微粒子を提供することを課題とする。
〈1〉 体積平均粒子径(D50)が0.1μm以上15μm未満であり、ヒドロキシアルキル基の含有量が40〜80重量%の範囲にあり、2%水溶液の20℃における粘度が2.0〜5.9mPa・sの範囲にある、ヒドロキシアルキルセルロース微粒子。
〈2〉 前記体積平均粒子径(D50)が0.1μm以上10μm未満である、前記〈1〉に記載のヒドロキシアルキルセルロース微粒子。
〈4〉 ヒドロキシアルキルセルロースがヒドロキシプロピルセルロースである、前記〈1〉〜〈3〉のいずれか1項に記載のヒドロキシアルキルセルロース微粒子。
〈5〉 固形製剤に用いられる前記〈1〉〜〈4〉のいずれか1項に記載のヒドロキシアルキルセルロース微粒子。
〈6〉 前記〈1〉〜〈5〉のいずれか1項に記載のヒドロキシアルキルセルロース微粒子を含有して成る固形製剤。
また、本発明のヒドロキシアルキルセルロース微粒子は、直接打錠法等による錠剤などの固形製剤の製造に好適に用いられる。本発明のヒドロキシアルキルセルロース微粒子を用いて直接打錠法等によって錠剤などの固形製剤を製造すると、固形製剤の引張強度が高くなり、また圧縮圧力のバラツキによる崩壊性のバラツキが非常に小さくなる。また、本発明のヒドロキシアルキルセルロース微粒子を用いると、結合力が高まり固形製剤の崩壊時間を長くすることができるので、製剤に徐放性を付与しやすい。
さらに水溶液として供給されるヒドロキシアルキルセルロースは、2%水溶液の20℃における粘度が、2.0〜20.0mPa・sの範囲にあることが好ましく、2.0〜10.0mPa・sの範囲にあることがより好ましい。
パルス衝撃波の発生領域に供給されるヒドロキシアルキルセルロース水溶液は、その濃度が、1〜30重量%であることが好ましく、1〜20重量%であることがより好ましく、1〜10重量%であることがさらに好ましく、1〜5重量%であることが殊更に好ましい。
イルス剤、サルファ剤、抗炎症剤、精神神経用剤、眼圧降下剤、制吐剤、止瀉薬、痛風治療剤、不整脈治療剤、血管収縮剤、消化剤、睡眠又は催眠導入(誘導)剤、交感神経遮断剤、貧血治療剤、抗てんかん剤、抗めまい剤、平行傷害治療剤、結核治療剤、ビタミン欠乏症治療剤、痴呆治療剤、尿失禁治療剤、鎮うん剤、口内殺菌剤、寄生虫駆除剤、ビタミン剤、アミノ酸類、ミネラル類などが挙げられる。医薬成分のうち、一般に生薬成分は、打錠成形性が悪いものが多いため、本発明の固形製剤を適用するのが好ましい。
農薬としては、例えば、抗菌剤、抗ウイルス剤、殺菌剤、殺ダニ剤、殺虫剤、殺線虫剤、殺鼠剤、除草剤、植物生長調節剤、肥料、薬害軽減剤などが挙げられる。
健康食品用成分としては、健康増強を目的のために配合する成分であれば限定されないが、例えば、青汁粉末、アグリコン、アガリクス、アシュワガンダ、アスタキサンチン、アセロラ、アミノ酸(バリン、ロイシン、イソロイシン、リジン、メチオニン、フェニルアラニン、トレオニン、トリプトファン、ヒスチジン、シスチン、チロシン、アルギニン、アラニン、アスパラギン酸、海藻粉末、グルタミン、グルタミン酸、グリシン、プロリン、セリン等)、アルギン酸、いちょう葉エキス、イワシペプチド、ウコン、ウロン酸、エキナセア、エゾウコギ、オリゴ糖、オレイン酸、核タンパク、カツオブシペプチド、カテキン、カリウム、カルシウム、カロチノイド、ガルシニア、L一カルニチン、キトサン、共役リノール酸、キダチアロエ、ギムネマシルベスタエキス、クエン酸、クミスクチン、グリセリド、グリセノール、グルカゴン、グルタミン、グルコサミン、L一グルタミン、クロレラ、クランベリーエキス、キャッツクロー、ゲルマニウム、酵素、高麗人参エキス、コエンザイムQIO、コラーゲン、コラーゲンペプチド、コリウスフォルスコリン、コンドロイチン、サイリウムハスク末、サンザシエキス、サポニン、脂質、L一シスチン、シソエキス、シトリマックス、脂肪酸、植物ステロール、種子エキス、スピルリナ、スクワレン、セイヨウシロヤナギ、セラミド、セレン、セントジョーンズワートエキス、大豆インフラボン、大豆サポニン、大豆ペプチド、大豆レシチン、単糖、タンパク質、チェ
ストツリーエキス、鉄、銅、ドコサヘキサエン酸、トコトリエノール、納豆キナーゼ、納豆菌培養エキス、ナイアシンナトリウム、ニコチン酸、二糖、乳酸菌、ニンニク、ノコギリヤシ、発芽米、ハトムギエキス、ハーブエキス、バレリヤンエキス、パントテン酸、ヒアルロン酸、ビオチン、ピコリン酸クロム、ビタミンA、A2ビタミンB1、B2、B6、ビタミンB12、ビタミンC、ビタミンD、ビタミンE、ビタミンK、ヒドロキシチロソール、ビフィズス菌、ビール酵母、フラクトオリゴ糖、フラボノイド、ブッチャーズブルームエキス、ブラックコホシュ、ブルーベリー、プルーンエキス、プロアントシアニジン、プロテイン、プロポリス、ブロメライン、プロバイオティクス、ホスファチジルコリン、ホスファチジルセリン、β一カロチン、ペプチド、ベニバナエキス、マイタケエキス、マカエキス、マグネシウム、マリアアザミ、マンガン、ミトコンドリア、ミネラル、ムコ多糖、メラトニン、メシマコブ、メリロートエキス末、モリブデン、野菜粉末、葉酸、ラクトース、リコピン、リノール酸、リポ酸、燐(リン)、ルテイン、レシチン、ロズマリン酸、ローヤルゼリー、DHA、EPA等が挙げられる。
糖衣基剤としては、白糖が用いられ、さらに、タルク、沈降炭酸カルシウム、リン酸カルシウム、硫酸カルシウム、ゼラチン、アラビアゴム、ポリビニルピロリドン、プルラン等があげられる。
水溶性フィルムコーティング基剤としては、例えば、ポリビニルアルコール、ポリビニルアルコール−ポリエチレングリコールグラフトコポリマー、ポリビニルアルコール−アクリル酸−メタクリル酸メチルコポリマー、ポリビニルアセタールジエチルアミノアセテート、アミノアルキルメタクリレートコポリマー、ポリビニルピロリドン、マクロゴールなどの合成高分子;プルランなどの多糖類等が挙げられる。
腸溶性フィルムコーティング基剤としては、例えば、メタアクリル酸コポリマーL、メタアクリル酸コポリマーLD、メタアクリル酸コポリマーSなどのアクリル酸誘導体;セラックなどの天然物等が挙げられる。
徐放性フィルムコーティング基剤としては、例えば、アミノアルキルメタクリレートコポリマーRS、アクリル酸エチル・メタクリル酸メチル・共重合体乳濁液などのアクリル酸誘導体等が挙げられる。
ヒドロキシプロピルセルロース微粒子または原末10重量%、シリカ(富士シリシア化学社製「サイリシア350」)0.5重量%、ステアリン酸マグネシウム1重量%、およびエリスリトール88.5重量%を十分に混合して合剤Aを得た。
EE/CE(%)=〔(Expansion Energy)/(Cycle Energy)〕×100
図9に示すBの領域がEEに相当し、AとBとを合わせた領域がCEに相当する。
ln(1/(1−D)) = K×P + A
Dは、見かけの相対密度; Pは、圧縮圧力(MPa); Kは、x軸を圧縮圧P、y軸をln(1/(1−D))として、データをプロットしたときに描かれる直線部の傾き;およびAは、前記直線部を外挿したときの圧縮圧力P=0MPaにおける値(すなわち、外挿線のy軸切片)である。降伏圧は1/Kで算出される。
TS=2P/(πDT)
TSは錠剤の引張強度(MPa)、Pは錠剤の硬度(N)、πは円周率、Dは錠剤の直径(mm)、およびTは錠剤の厚さ(mm)である。
日本薬局方に適合するヒドロキシプロピルセルロース原末(2%水溶液の20℃における粘度6.0〜10.0mPa・s;日本曹達社製「HPC L」)を水に溶かして、1%、2%、5%、および10%水溶液をそれぞれ得た。なお、ヒドロキシプロピルセルロースHPC Lの原末は体積平均粒子径103.6μmで不定形状をしていた(図12を参照)。
パルス燃焼器を有する粉砕乾燥装置(大川原化工機社製「ハイパルコン」)に前記ヒドロキシプロピルセルロース水溶液を供給し、当該水溶液にパルスジェットを与えて粉砕乾燥を行った。前記水溶液が供給される領域における排気ガス温度は80℃に設定した。
この粉砕乾燥によって、ヒドロキシプロピルセルロース微粒子が得られた。これらの微粒子はいずれも若干扁平した球形であった(図13を参照)。微粒子の粒子径D16、D50、およびD84は、表1に示すとおりであった。得られたヒドロキシプロピルセルロース微粒子の2%水溶液の20℃における粘度は、いずれも原末と同じであったことから、乾燥過程においてヒドロキシプロピルセルロース自身の熱劣化が無かったことがわかる。
実施例1におけるヒドロキシプロピルセルロース2%水溶液をヒドロキシプロピルセルロース(2%水溶液の20℃における粘度3.0〜5.9mPa・s;日本曹達社製「HPC SL」)の2%水溶液に替えた以外は実施例1と同じ手法にてヒドロキシプロピルセルロース微粒子を得た。当該微粒子の粒子径D16、D50、およびD84は、表2に示すとおりであった。この微粒子は若干扁平した球形であった。微粒子の2%水溶液の20℃における粘度は原末と同じであった。なお、ヒドロキシプロピルセルロースHPC SLの原末は体積平均粒子径83.3μmで角張った異形状をしていた。
ヒドロキシプロピルセルロース(2%水溶液の20℃における粘度6.0〜10.0mPa・s;日本曹達社製「HPC L」)の10%および20%水溶液を用いた以外は実施例1と同じ手法にてヒドロキシプロピルセルロース微粒子を得た。当該微粒子の粒子径D16、D50、およびD84は、表2に示すとおりであった。これらの微粒子は若干扁平した球形であった(図14および図15を参照)。微粒子の2%水溶液の20℃における粘度は原末と同じであった。
実施例3におけるヒドロキシプロピルセルロース20%水溶液をヒドロキシプロピルセルロース(2%水溶液の20℃における粘度2.0〜2.9mPa・s;日本曹達社製「HPC SSL」)の20%水溶液に替えた以外は実施例3と同じ手法にてヒドロキシプロピルセルロース微粒子を得た。当該微粒子の粒子径D16、D50、およびD84は、表3に示すとおりであった。この微粒子は若干扁平した球形であった(図16を参照)。微粒子の2%水溶液の20℃における粘度は原末と同じであった。なお、ヒドロキシプロピルセルロースHPC SSLの原末は角張った異形状をしていた。
ヒドロキシプロピルセルロース(2%水溶液の20℃における粘度6.0〜10.0mPa・s;日本曹達社製「HPC L」)の1%水溶液を、スプレードライ法によって150℃で乾燥させた。この乾燥によって、ヒドロキシプロピルセルロースSD1が得られた。このSD1の形状は図17に示すようなものであった。SD1の粒子径D16、D50、およびD84は、表3に示すとおりであった。
水溶液濃度を2%に変え且つスプレードライ法における乾燥温度を180℃に変えた以外は、比較例1と同じ手法でヒドロキシプロピルセルロースSD2を得た。このSD2の形状は図18に示すようなものであった。SD2の粒子径は、D16、D50、およびD84は、表3に示すとおりであった。
また、図3および図4から、本発明のヒドロキシプロピルセルロース微粒子(LMまたはSLM)を用いた錠剤は、引張強度が高く、崩壊時間が長くなることがわかる。特に2%水溶液の20℃における粘度が3.0〜5.9mPa・sであるヒドロキシプロピルセルロースを用いた、SLとSLMとの対比では、崩壊時間に顕著な差が現れた。
さらに、図7に示すように、従来の一般的乾燥法であるスプレードライ法で得たヒドロキシプロピルセルロース(SD2)を用いた錠剤は、原末をそのまま用いた錠剤に比べて引張強度が高くなっているものの、本発明のヒドロキシプロピルセルロース微粒子(LM)を用いた錠剤に比べると引張強度がかなり低いことがわかる。
図8および図9に示すように、2%水溶液の20℃における粘度や、粉砕乾燥に供給する水溶液の濃度によって、錠剤の強度や崩壊時間を調整できることがわかる。
ヒドロキシプロピルセルロース微粒子(LM)3重量%、シリカ(富士シリシア化学社製「サイリシア350」)0.5重量%、ステアリン酸マグネシウム1重量%、クロスポビドン(崩壊剤)10重量%、15重量%および20重量%、ならびにエリスリトール85.5重量%、80.5重量%および75.5重量%を十分に混合して合剤B−1、B−2およびB−3をそれぞれ得た。
前記合剤B−1、B−2およびB−3を用いた以外は錠剤Aの製造方法と同じ手法にて錠剤B−1、B−2およびB−3をそれぞれ得た。当該錠剤について、上記と同じ手法にて錠剤の引張強度を求めた。その結果を図10に示す。崩壊剤の添加によって、引張強度がさらに高くなることがわかる。また、前記合剤B−1、B−2およびB−3は、いずれも上記崩壊試験による崩壊時間が30秒以内であった。
ヒドロキシプロピルセルロース10重量%、乳糖(フロイント産業社製「ダイラクトースS」)63重量%、コーンスターチ(日本食品化工社製「コーンスターチW」)27重量%、及びステアリン酸マグネシウム0.5重量%(外割り)を十分に混合して合剤Cを得た。合剤Cを用いた以外は錠剤Aの製造方法と同じ手法にて錠剤Cを得た。当該錠剤Cについて、上記と同じ手法にて錠剤の硬度および崩壊時間を求めた。それらの結果を図19に示す。
なお、ヒドロキシプロピルセルロースとしては、実施例3と同じ手法で得られた体積平均粒子径12μmのヒドロキシプロピルセルロース微粒子L2、実施例4と同じ手法で得られた体積平均粒子径12μmのヒドロキシプロピルセルロース微粒子SSL2、およびヒドロキシプロピルセルロース原末HPC Lの100メッシュ通過品(体積平均粒子径44μm;以下、「LB」と表記する。)をそれぞれ用いた。ヒドロキシプロピルセルロース微粒子SSL2の粒径分布を図20に示す。
ヒドロキシプロピルセルロース2.5重量%、乳糖(フロイント産業社製「ダイラクトースS」)73.1重量%、コーンスターチ(日本食品化工社製「コーンスターチW」)24.4重量%、及びステアリン酸マグネシウム0.5重量%(外割り)を十分に混合して合剤Dを得た。合剤Dを用いた以外は錠剤Aの製造方法と同じ手法にて錠剤Dを得た。当該錠剤Dについて、上記と同じ手法にて錠剤の硬度および崩壊時間を求めた。それらの結果を図19に示す。
なお、ヒドロキシプロピルセルロースとしては、実施例4と同じ手法で得られた体積平均粒子径12μmのヒドロキシプロピルセルロース微粒子SSL2を用いた。ヒドロキシプロピルセルロース微粒子SSL2を少量添加することによって、高い硬度で且つ短い崩壊時間の錠剤が得られることがわかる。
ヒドロキシプロピルセルロース5重量%、アセトアミノフェン(山本化学社製 微粉)50重量%、乳糖(フロイント産業社製「ダイラクトースS」)31.5重量%、コーンスターチ(日本食品化工社製「コーンスターチW」)13.5重量%、及びステアリン酸
マグネシウム0.5重量%(外割り)を十分に混合して合剤Eを得た。合剤Eを用いた以外は錠剤Aの製造方法と同じ手法にて錠剤Eを得た。当該錠剤Eについて、上記と同じ手法にて錠剤の硬度および崩壊時間を求めた。それらの結果を図21に示す。
なお、ヒドロキシプロピルセルロースとしては、実施例2と同じ手法で得られた体積平均粒子径13μmのヒドロキシプロピルセルロース微粒子SL2、およびヒドロキシプロピルセルロース原末HPC SLの100メッシュ通過品(体積平均粒子径40μm;以下、「SLB」と表記する。)をそれぞれ用いた。
アセトアミノフェン(山本化学社製、微粉)50重量%、乳糖(フロイント産業社製「ダイラクトースS」)35重量%、コーンスターチ(日本食品化工社製「コーンスターチW」)15重量%、及びステアリン酸マグネシウム0.5重量%(外割り)を十分に混合して合剤Fを得た。合剤Fを用いた以外は錠剤Aの製造方法と同じ手法にて錠剤Eを得た。当該錠剤Fについて、上記と同じ手法にて錠剤の硬度および崩壊時間を求めた。結合剤無しの結果を図21に示す。
ヒドロキシプロピルセルロース10重量%、グルコサミン(プロテインケミカル社製「グルコサミンGM」)86重量部、シュガーエステル(三菱化学フーズ社製「S−370F」)4重量部を十分に混合して合剤Gを得た。合剤Gを用いた以外は錠剤Aの製法と同じ手法にて錠剤Gを得た。当該錠剤Gについて、上記と同じ手法にて錠剤の硬度および崩壊時間を求めた。それらの結果を図22に示す。
なお、ヒドロキシプロピルセルロースとしては、ヒドロキシプロピルセルロース原末HPC Lの100メッシュ通過品(LB)、および、実施例4と同じ手法で得られた体積平均粒子径12μmのヒドロキシプロピルセルロース微粒子SSL2をそれぞれ用いた。
実施例4と同じ手法で得られた体積平均粒子径12μmのヒドロキシプロピルセルロース微粒子SSL2を3重量部、ステアリン酸マグネシウム(滑沢剤)を1重量部、クロスポビドン(崩壊剤)1重量部、エリスリトール95重量部を圧縮圧力200MPaで打錠して錠剤Hを得た。SSL2を3重量部、ショ糖脂肪酸エステル(三菱化学フーズ社製「SE,S−170」)(滑沢剤)3重量部、クロスポビドン(崩壊剤)1重量部、エリス
リトール93重量部を圧縮圧力200MPaで打錠して錠剤Iを得た。SSL2を2重量部、ショ糖脂肪酸エステル(三菱化学フーズ社製「SE,S−170」)(滑沢剤)3重量部、クロスポビドン(崩壊剤)1重量部、エリスリトール94重量部を圧縮圧力200MPaで打錠して錠剤Jを得た。SSL2を1.5重量部、ショ糖脂肪酸エステル(三菱化学フーズ社製「SE,S−170」)(滑沢剤)3重量部、クロスポビドン(崩壊剤)1重量部、エリスリトール94.5重量部を圧縮圧力200MPaで打錠して錠剤Kを得た。
錠剤H〜Kの引張強度、崩壊時間、口腔内での崩壊時間は表4に示すとおりであった。
「口腔内での崩壊時間」とは、成人男女6名が、口腔内を蒸留水ですすいだ後、錠剤を一
つ口腔内へふくみ、かまずに完全に崩壊するまでの時間を測定した平均値である。
ヒドロキシプロピルセルロース微粒子含量が減少するにつれて引張強度は減少したが、
含量が1.5重両部の処方(錠剤K)においても1MPaの引張強度を示した。崩壊時間
はいずれの処方でもほぼ同程度の値を示した。また、錠剤Kの口腔内での崩壊時間は20
秒程度であった。以上より、ヒドロキシプロピルセルロース微粒子を用いて口腔内崩壊性
にすぐれた錠剤を調製可能であることが判った。
Claims (3)
- 体積平均粒子径(SD50)が0.1μm以上15μm未満であり、ヒドロキシプロピル基の含有量が53〜78重量%の範囲にあり、2%水溶液の20℃における粘度が2.0〜2.9mPa・sの範囲にある、ヒドロキシプロピルセルロース微粒子を、含有して成る固形製剤。
- 前記ヒドロキシプロピルセルロース微粒子の体積平均粒子径(SD50)が0.1μm以上10μm未満である、請求項1に記載の固形製剤。
- 前記ヒドロキシプロピルセルロース微粒子の形状が球状である、請求項1または2に記載の固形製剤。
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