JPWO2010023874A1 - ロペラミド塩酸塩含有フィルム製剤 - Google Patents
ロペラミド塩酸塩含有フィルム製剤 Download PDFInfo
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- JPWO2010023874A1 JPWO2010023874A1 JP2010526532A JP2010526532A JPWO2010023874A1 JP WO2010023874 A1 JPWO2010023874 A1 JP WO2010023874A1 JP 2010526532 A JP2010526532 A JP 2010526532A JP 2010526532 A JP2010526532 A JP 2010526532A JP WO2010023874 A1 JPWO2010023874 A1 JP WO2010023874A1
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- Prior art keywords
- film
- loperamide hydrochloride
- drug
- terpenes
- coating layer
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Abstract
Description
ロペラミド塩酸塩、テルペン類及びフィルム形成剤を含有する薬物含有中間層の両面に、フィルム形成剤及び可塑剤を含有するコーティング層(但し、テルペン類は含有しない)を積層させることを特徴とする、方法を提供するものである。
ロペラミド塩酸塩、テルペン類及びフィルム形成剤を含有する薬物含有中間層の両面に、フィルム形成剤及び可塑剤を含有するコーティング層(但し、テルペン類は含有しない)を積層させることを特徴とする、製造方法を提供するものである。
本発明のフィルム製剤におけるロペラミド塩酸塩の投与量は適宜設定することが可能であるが、例えば、成人に対して1回当たりの服用量が0.5〜2mgであり、かつ1日当たりの服用量が1〜4mgであることが好ましく、1回当たりの服用量が0.5〜1mgであり、かつ1日当たりの服用量が1〜2mgであることがより好ましい。このように、成人に対して1日当たり1回〜数回に分けて口腔内に投与することが可能であり、また年齢、体重、病状により投与量を適宜増減することもできる。
本発明のフィルム製剤におけるロペラミド塩酸塩の含有量は、フィルム製剤全体に対して0.1〜15質量%が好ましく、0.5〜10質量%が更に好ましく、1〜5質量%が特に好ましい。特に好ましい態様として、ロペラミド塩酸塩は、薬物含有中間層中に1〜5質量%、特に2〜4質量%含有させることが好ましい。
本発明においては、テルペン類として、メントール及びハッカ油が好ましい。
可塑剤の含有量は、フィルム製剤全体に対して1〜20質量%が好ましく、3〜15質量%が更に好ましく、5〜10質量%が特に好ましい。特に好ましい態様として、可塑剤は、コーティング層及び薬物含有中間層中に、5〜10質量%、特に7〜10質量%それぞれ含有させることが好ましい。
ロペラミド塩酸塩以外の止瀉剤としては、例えば、アクリノール、塩化ベルベリン、グアヤコール、クレオソート、サリチル酸フェニル、炭酸グアヤコール、タンニン酸ベルベリン、次サリチル酸ビスマス、次硝酸ビスマス、次炭酸ビスマス、次没食子酸ビスマス、タンニン酸、タンニン酸アルブミン、メチレンチモールタンニン、カオリン、天然ケイ酸アルミニウム、ヒドロキシナフトエ酸アルミニウム、ペクチン、薬用炭、沈降炭酸カルシウム、乳酸カルシウム、リン酸水素カルシウム、アセンヤク、ウバイ、オウバク、オウレン、クジン、ゲンノショウコ、五倍子、サンザシ、センブリ、ヨウバイヒ等が挙げられる。
他の生薬としては、例えば、ニンジン、ヨクイニン、カミツレ、ケイヒ、葛根湯、マオウ、ナンテンジツ、オウヒ、オンジ、カンゾウ、キョウニン、シャゼンジ、シャゼンソウ、セキサン、セネガ、トコン、バイモ、アセンヤク、ウイキョウ、オウゴン、カロニン、ケイヒ、ゴオウ、ゴミン、サイシン、シオン、ジャコウ、シャジン、ショウキョウ、ソウハクヒ、ソヨウ、チクセツニンジン、チンピ、ニンジン、バクモンドウ、ハンゲ、アカメガシワ等が挙げられる。
着色剤としては、例えば、黄色三二酸化鉄、褐色酸化鉄、カラメル、黒酸化鉄、酸化チタン、三二酸化鉄、タール色素、アルミニウムレーキ色素、銅クロロフィリンナトリウム等が挙げられる。
着香剤としては、例えば、オレンジフレーバー、グレープフルーツフレーバー、ストロベリーフレーバー、レモンフレーバー等が挙げられる。
矯味剤としては、例えば、アスコルビン酸、酒石酸、クエン酸、リンゴ酸及びこれらの塩等の酸味剤や、アスパルテーム、ステビア、スクラロース、グリチルリチン酸、ソーマチン、アセスルファムカリウム、サッカリン、サッカリンナトリウム等の甘味剤等が挙げられる。
賦形剤は、フィルム製剤全体に対して15〜60質量%、特に15〜30質量%添加することが好ましい。特に好ましい態様としては、賦形剤をコーティング層中に5〜20質量%、特に7〜15質量%添加し、薬物含有中間層中に10〜40質量%、特に25〜35質量%添加することである。
難水溶性高分子物質は、フィルム製剤全体に対して好ましくは1〜10質量%の範囲で添加することができる。着色剤は、フィルム製剤全体に対して好ましくは0.05〜10質量%の範囲で添加することができる。抗酸化剤は、フィルム製剤全体に対して好ましくは0.1〜5質量%の範囲で添加することができる。矯味剤は、フィルム製剤全体に対して好ましくは1〜10質量%の範囲で添加することができる。着香剤は、フィルム製剤全体に対して好ましくは0.01〜0.1質量%の範囲で添加することができる。
水500gに粉末還元麦芽糖水アメ50g及びマクロゴール400 40gを溶解した。次いで、この液に、無水エタノール750gに酸化チタン50gを分散した液を加えた。そして、得られた液にヒプロメロース360gを加えてコーティング層調製液を得た。
水810g及び無水エタノール810gの混液にロペラミド塩酸塩27g、マクロゴール400 64.8g、粉末還元麦芽糖水アメ256.5g、サッカリンナトリウム54g及びl−メントール27gを溶解した。この液にヒドロキシプロピルセルロース380.7g及び着香剤1.35gを加えて薬物含有中間層調製液を得た。
PETフィルム上にコーティング層調製液を均一に塗布した後、温風にて乾燥し面積2.72cm2当たりの質量が5mgのコーティング層を形成した。コーティング層の上方に薬物含有中間層調製液を均一に塗布した後、温風にて乾燥し面積2.72cm2当たりの質量が7.5125mgの薬物含有中間層を形成し、中間製品1を得た。
中間製品1を2式作製し、薬物含有中間層同士が対向するように張り合わせ圧着し、2つのPETフィルム間に、コーティング層、薬物含有中間層、コーティング層が順次積層された中間製品2を得た。
中間製品2の一方のPETフィルムを剥離し、面積2.72cm2に裁断し、他方のPETフィルムを剥離して、本発明にかかるフィルム製剤を得た。
水500gに粉末還元麦芽糖水アメ50g及びマクロゴール400 40gを溶解した。次いで、この液に、無水エタノール250gにl−メントール25gを溶解した液及び無水エタノール500gに酸化チタン50gを分散した液を加えた。そして、得られた液にヒプロメロース335gを加えてコーティング層調製液を得た。
水810g及び無水エタノール810gの混液にロペラミド塩酸塩27g、マクロゴール400 64.8g、粉末還元麦芽糖水アメ256.5g及びサッカリンナトリウム54gを溶解した。この液にヒドロキシプロピルセルロース407.7g及び着香剤1.35gを加えて薬物含有中間層調製液を得た。
PETフィルム上にコーティング層調製液を均一に塗布した後、温風にて乾燥し面積2.72cm2当たりの質量が5mgのコーティング層を形成した。コーティング層の上方に薬物含有中間層調製液を均一に塗布した後、温風にて乾燥し面積2.72cm2当たりの質量が7.5125mgの薬物含有中間層を形成し、中間製品aを得た。
中間製品aを2式作製し、薬物含有中間層同士が対向するように張り合わせ圧着し、2つのPETフィルム間に、コーティング層、薬物含有中間層、コーティング層が順次積層された中間製品bを得た。
中間製品bの一方のPETフィルムを剥離し、面積2.72cm2に裁断し、他方のPETフィルムを剥離して、フィルム製剤を得た。
水500gに粉末還元麦芽糖水アメ50g及びマクロゴール400 40gを溶解した。次いで、この液に、無水エタノール250gにl−メントール25gを溶解した液及び無水エタノール500gに酸化チタン50gを分散した液を加えた。そして、得られた液にヒプロメロース335gを加えてコーティング層調製液を得た。
水810g及び無水エタノール810gの混液にロペラミド塩酸塩27g、マクロゴール400 64.8g、粉末還元麦芽糖水アメ256.5g、サッカリンナトリウム54g及びl−メントール27gを溶解した。この液にヒドロキシプロピルセルロース380.7g及び着香剤1.35gを加えて薬物含有中間層調製液を得た。
PETフィルム上にコーティング層調製液を均一に塗布した後、温風にて乾燥し面積2.72cm2当たりの質量が5mgのコーティング層を形成した。コーティング層の上方に薬物含有中間層調製液を均一に塗布した後、温風にて乾燥し面積2.72cm2当たりの質量が7.5125mgの薬物含有中間層を形成し、中間製品cを得た。
中間製品cを2式作製し、薬物含有中間層同士が対向するように張り合わせ圧着し、2つのPETフィルム間に、コーティング層、薬物含有中間層、コーティング層が順次積層された中間製品dを得た。
中間製品dの一方のPETフィルムを剥離し、面積2.72cm2に裁断し、他方のPETフィルムを剥離して、フィルム製剤を得た。
実施例1、比較例1及び比較例2で得られたフィルム製剤の服用感を評価した。フィルム製剤の評価は6名のパネラーにより服用感(苦味)について官能試験を実施した。評価基準は、「苦味がほとんど気にならない」を2点とし、「苦味がやや気になる」を1点とし、「苦味が気になり、不味である」を0点とした。したがって、合計点数の値が大きいほど、苦味がマスキングされていることを意味する。その合計点数を、各フィルム製剤の組成とともに表1に示した。
一方、ロペラミド塩酸塩を含み、かつメントールを含まない薬物含有中間層を、メントールを含有するコーティング層で挟み込んだ比較例1のフィルム製剤は、ロペラミド塩酸塩の不快な味をマスキングすることができなかった。また、ロペラミド塩酸塩とメントールを含有する薬物含有中間層を、メントールを含有するコーティング層で挟み込んだ比較例2のフィルム製剤も、ロペラミド塩酸塩の不快な味をマスキングすることができなかった。
したがって、ロペラミド塩酸塩の不快な味のマスキングは、単にメントールを配合することだけでは達成することができず、メントールを薬物含有中間層のみに配合することにより、不快な味のマスキングが達成されることが判明した。
また、本発明のフィルム製剤(実施例1)を水なしで服用させたところ、30秒以内に口腔内で溶解したことから、即効性が期待されることが確認された。
Claims (7)
- ロペラミド塩酸塩、テルペン類及びフィルム形成剤を含有する薬物含有中間層の両面に、フィルム形成剤及び可塑剤を含有するコーティング層(但し、テルペン類は含有しない)が積層されていることを特徴とするフィルム製剤。
- テルペン類がメントールである、請求項1に記載のフィルム製剤。
- フィルム形成剤がヒドロキシプロピルセルロース及び/又はヒプロメロースである、請求項1又は2に記載のフィルム製剤。
- 口腔内溶解型である、請求項1〜3いずれか1項に記載のフィルム製剤。
- ロペラミド塩酸塩由来の苦味をマスキングしたものである、請求項1〜4いずれか1項に記載のフィルム製剤。
- ロペラミド塩酸塩を含有するフィルム製剤の苦味のマスキング方法であって、
ロペラミド塩酸塩、テルペン類及びフィルム形成剤を含有する薬物含有中間層の両面に、フィルム形成剤及び可塑剤を含有するコーティング層(但し、テルペン類は含有しない)を積層させることを特徴とする、方法。 - ロペラミド塩酸塩由来の苦味をマスキングしたロペラミド塩酸塩を含有するフィルム製剤の製造方法であって、
ロペラミド塩酸塩、テルペン類及びフィルム形成剤を含有する薬物含有中間層の両面に、フィルム形成剤及び可塑剤を含有するコーティング層(但し、テルペン類は含有しない)を積層させることを特徴とする、製造方法。
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PCT/JP2009/004087 WO2010023874A1 (ja) | 2008-08-25 | 2009-08-25 | ロペラミド塩酸塩含有フィルム製剤 |
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JP5101191B2 (ja) * | 2007-06-29 | 2012-12-19 | リンテック株式会社 | フィルム状製剤およびその製造方法 |
EP2543366B1 (en) * | 2010-03-03 | 2018-10-24 | Kyukyu Pharmaceutical Co., Ltd. | Film preparation containing medicament with unpleasant taste |
BR112012025943A2 (pt) * | 2010-04-15 | 2017-07-25 | Chromocell Corp | compostos, composições e métodos para reduzir ou eliminar o sabor amargo. |
SI2647648T1 (sl) * | 2010-12-03 | 2017-10-30 | Nippon Soda Co., Ltd. | Trdna farmacevtska oblika, ki vsebuje hidroksialkilcelulozo z nizko viskoznostjo |
KR101318059B1 (ko) * | 2011-07-01 | 2013-10-15 | 광동제약 주식회사 | 로페라마이드와 베타-시클로덱스트린 포접물을 함유하는 가식성 필름제제 |
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JPH05117149A (ja) | 1991-06-12 | 1993-05-14 | Ota Seiyaku Kk | 医薬製剤 |
JPH0930969A (ja) | 1995-05-18 | 1997-02-04 | Taisho Pharmaceut Co Ltd | 経口用組成物 |
JPH09323931A (ja) | 1996-06-04 | 1997-12-16 | Taisho Pharmaceut Co Ltd | 塩酸ロペラミド配合液剤組成物 |
JPH10101582A (ja) | 1996-09-30 | 1998-04-21 | Taisho Pharmaceut Co Ltd | 口腔内溶解型固形剤 |
FR2766089B1 (fr) * | 1997-07-21 | 2000-06-02 | Prographarm Lab | Comprime multiparticulaire perfectionne a delitement rapide |
JP2000095707A (ja) | 1998-09-22 | 2000-04-04 | Rohto Pharmaceut Co Ltd | 苦味を有する薬物を含有する口中溶解型又は咀嚼型固形内服医薬組成物 |
US6596298B2 (en) * | 1998-09-25 | 2003-07-22 | Warner-Lambert Company | Fast dissolving orally comsumable films |
US7067116B1 (en) * | 2000-03-23 | 2006-06-27 | Warner-Lambert Company Llc | Fast dissolving orally consumable solid film containing a taste masking agent and pharmaceutically active agent at weight ratio of 1:3 to 3:1 |
US20080050422A1 (en) * | 2001-10-12 | 2008-02-28 | Monosolrx, Llc. | Method of administering a film product containing a drug |
ES2735512T3 (es) * | 2001-10-12 | 2019-12-19 | Aquestive Therapeutics Inc | Película delgada con heterogeneidad uniforme no autoagregable, proceso para su producción y sistemas de administración de fármacos hechos a partir de la misma |
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KR20050000424A (ko) * | 2002-05-16 | 2005-01-03 | 규큐 야쿠힝 고교 가부시키가이샤 | 속용성 필름형상 제제 |
JP2005232072A (ja) * | 2004-02-19 | 2005-09-02 | Sato Pharmaceutical Co Ltd | 高湿度及び低湿度下で安定なフィルム製剤及びフィルム食品 |
JP4413665B2 (ja) * | 2004-03-19 | 2010-02-10 | 救急薬品工業株式会社 | 口腔内粘膜フィルム剤 |
JP2005289867A (ja) * | 2004-03-31 | 2005-10-20 | Lintec Corp | 経口投与剤 |
PE20060935A1 (es) * | 2004-10-21 | 2006-10-26 | Novartis Ag | Composicion farmaceutica que comprende diclofenaco |
US20070166336A1 (en) * | 2005-12-13 | 2007-07-19 | David Delmarre | Stable and palatable oral liquid sumatriptan compositions |
JP4953673B2 (ja) * | 2006-03-22 | 2012-06-13 | リンテック株式会社 | 経口投与剤 |
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Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |