JP5824524B2 - ヒドロキシアルキルセルロース微粒子を含有する口腔内崩壊錠 - Google Patents
ヒドロキシアルキルセルロース微粒子を含有する口腔内崩壊錠 Download PDFInfo
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- JP5824524B2 JP5824524B2 JP2013536221A JP2013536221A JP5824524B2 JP 5824524 B2 JP5824524 B2 JP 5824524B2 JP 2013536221 A JP2013536221 A JP 2013536221A JP 2013536221 A JP2013536221 A JP 2013536221A JP 5824524 B2 JP5824524 B2 JP 5824524B2
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- 235000019187 sodium-L-ascorbate Nutrition 0.000 description 1
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- FDDDEECHVMSUSB-UHFFFAOYSA-N sulfanilamide Chemical compound NC1=CC=C(S(N)(=O)=O)C=C1 FDDDEECHVMSUSB-UHFFFAOYSA-N 0.000 description 1
- 229940124530 sulfonamide Drugs 0.000 description 1
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- IWVCMVBTMGNXQD-UHFFFAOYSA-N terramycin dehydrate Natural products C1=CC=C2C(O)(C)C3C(O)C4C(N(C)C)C(O)=C(C(N)=O)C(=O)C4(O)C(O)=C3C(=O)C2=C1O IWVCMVBTMGNXQD-UHFFFAOYSA-N 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- TUNFSRHWOTWDNC-HKGQFRNVSA-N tetradecanoic acid Chemical compound CCCCCCCCCCCCC[14C](O)=O TUNFSRHWOTWDNC-HKGQFRNVSA-N 0.000 description 1
- UEUXEKPTXMALOB-UHFFFAOYSA-J tetrasodium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O UEUXEKPTXMALOB-UHFFFAOYSA-J 0.000 description 1
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- KVEZIRCKNOTGKY-UHFFFAOYSA-N thiazosulfone Chemical compound S1C(N)=NC=C1S(=O)(=O)C1=CC=C(N)C=C1 KVEZIRCKNOTGKY-UHFFFAOYSA-N 0.000 description 1
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- YEZNLOUZAIOMLT-UHFFFAOYSA-N tolfenamic acid Chemical compound CC1=C(Cl)C=CC=C1NC1=CC=CC=C1C(O)=O YEZNLOUZAIOMLT-UHFFFAOYSA-N 0.000 description 1
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- 229960004974 trepibutone Drugs 0.000 description 1
- 229960002117 triamcinolone acetonide Drugs 0.000 description 1
- YNDXUCZADRHECN-JNQJZLCISA-N triamcinolone acetonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O YNDXUCZADRHECN-JNQJZLCISA-N 0.000 description 1
- FAPSXSAPXXJTOU-UHFFFAOYSA-L trimethyl-[6-(trimethylazaniumyl)hexyl]azanium;dibromide Chemical compound [Br-].[Br-].C[N+](C)(C)CCCCCC[N+](C)(C)C FAPSXSAPXXJTOU-UHFFFAOYSA-L 0.000 description 1
- UJMBCXLDXJUMFB-UHFFFAOYSA-K trisodium;5-oxo-1-(4-sulfonatophenyl)-4-[(4-sulfonatophenyl)diazenyl]-4h-pyrazole-3-carboxylate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)C1=NN(C=2C=CC(=CC=2)S([O-])(=O)=O)C(=O)C1N=NC1=CC=C(S([O-])(=O)=O)C=C1 UJMBCXLDXJUMFB-UHFFFAOYSA-K 0.000 description 1
- GXPHKUHSUJUWKP-UHFFFAOYSA-N troglitazone Chemical compound C1CC=2C(C)=C(O)C(C)=C(C)C=2OC1(C)COC(C=C1)=CC=C1CC1SC(=O)NC1=O GXPHKUHSUJUWKP-UHFFFAOYSA-N 0.000 description 1
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- GXPHKUHSUJUWKP-NTKDMRAZSA-N troglitazone Natural products C([C@@]1(OC=2C(C)=C(C(=C(C)C=2CC1)O)C)C)OC(C=C1)=CC=C1C[C@H]1SC(=O)NC1=O GXPHKUHSUJUWKP-NTKDMRAZSA-N 0.000 description 1
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- SJSNUMAYCRRIOM-QFIPXVFZSA-N valsartan Chemical compound C1=CC(CN(C(=O)CCCC)[C@@H](C(C)C)C(O)=O)=CC=C1C1=CC=CC=C1C1=NN=N[N]1 SJSNUMAYCRRIOM-QFIPXVFZSA-N 0.000 description 1
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- 229930003231 vitamin Natural products 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 235000019155 vitamin A Nutrition 0.000 description 1
- 239000011719 vitamin A Substances 0.000 description 1
- 235000010374 vitamin B1 Nutrition 0.000 description 1
- 239000011691 vitamin B1 Substances 0.000 description 1
- 235000019163 vitamin B12 Nutrition 0.000 description 1
- 239000011715 vitamin B12 Substances 0.000 description 1
- 235000019164 vitamin B2 Nutrition 0.000 description 1
- 239000011716 vitamin B2 Substances 0.000 description 1
- 235000019158 vitamin B6 Nutrition 0.000 description 1
- 239000011726 vitamin B6 Substances 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
- 235000019166 vitamin D Nutrition 0.000 description 1
- 239000011710 vitamin D Substances 0.000 description 1
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- 235000019165 vitamin E Nutrition 0.000 description 1
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- 238000005550 wet granulation Methods 0.000 description 1
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- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
Classifications
-
- 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
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
- Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
Description
本願は、2011年9月26日に日本に出願された特願2011−209968号および2012年1月30日に日本に出願された特願2012−017180号に基づき優先権を主張し、その内容をここに援用する。
〈1〉累積粒度分布における50%粒子径が15μm以上40μm未満で、ヒドロキシアルキル基の含有量が40〜80質量%の範囲にあり、且つ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アルキルセルロース微粒子を含有する口腔内崩壊錠。
〈2〉前記ヒドロキシアルキルセルロース微粒子は、累積粒度分布における50%粒子径が15μm以上25μm未満である、〈1〉に記載の口腔内崩壊錠。
〈3〉前記ヒドロキシアルキルセルロース微粒子は、累積粒度分布における10%粒子径が10μm以下で且つ累積粒度分布における90%粒子径が30〜60μmである、〈1〉または〈2〉に記載の口腔内崩壊錠。
〈5〉乾式製剤手法により得られたものである〈1〉〜〈4〉のいずれかひとつに記載の口腔内崩壊錠。
該ヒドロキシアルキルセルロース微粒子は、累積粒度分布における50%粒子径(D50)が、15μm以上40μm未満、好ましくは15μm以上25μm未満、より好ましくは15μm以上20μm未満である。
また、本発明に用いられるヒドロキシアルキルセルロース微粒子は、累積粒度分布における10%粒子径(D10)が、好ましくは10μm以下、より好ましくは2〜10μm、さらに好ましくは3〜9μmである。また累積粒度分布における90%粒子径(D90)が、好ましくは30〜60μm、より好ましくは30〜50μm、さらに好ましくは30〜40μmである。さらに(D90−D10)/D50の比は、好ましくは0.1〜7、より好ましくは0.5〜5、さらに好ましくは1〜3である。
ヒドロキシアルキルセルロース微粒子の粒度分布は、例えば、分級や粉砕、噴霧乾燥などにより調整することができる。好ましくは、超音波篩による分級、ジェットミルによる粉砕により、上記の累積粒度分布を有するヒドロキシアルキルセルロース微粒子を得ることができる。
医薬成分としては、滋養強壮保健薬、解熱鎮痛消炎薬、向精神病薬、抗不安薬、抗うつ薬、催眠鎮静薬、鎮痙薬、中枢神経作用薬、脳代謝改善剤、抗てんかん剤、交感神経興奮剤、胃腸薬、制酸剤、抗潰瘍剤、鎮咳去痰剤、鎮吐剤、呼吸促進剤、気管支拡張剤、抗アレルギー薬、歯科口腔用薬、抗ヒスタミン剤、強心剤、抗不整脈薬、利尿薬、血圧降下剤、血管収縮薬、冠血管拡張薬、末梢血管拡張薬、抗高脂血症剤、利胆剤、抗生物質、化学療法剤、抗糖尿病剤、骨粗しょう症用剤、骨格筋弛緩薬、鎮うん剤、ホルモン剤、アルカロイド系麻薬、サルファ剤、痛風治療薬、血液凝固阻止剤、抗悪性腫瘍剤、アルツハイマー病治療薬などが挙げられる。これらは1種単独で又は2種以上を組み合わせて用いることができる。
解熱鎮痛消炎薬としては、例えば、アスピリン、アセトアミノフェン、エテンザミド、イブプロフェン、塩酸ジフェンヒドラミン、dl−マレイン酸クロルフェニラミン、リン酸ジヒドロコデイン、ノスカピン、塩酸メチルエフェドリン、塩酸フェニルプロパノールアミン、カフェイン、無水カフェイン、セラペプターゼ、塩化リゾチーム、トルフェナム酸、メフェナム酸、ジクロフェナクナトリウム、フルフェナム酸、サリチルアミド、アミノピリン、ケトプロフェン、インドメタシン、ブコローム、ペンタゾシンなどが挙げられる。
pH調整剤としては、製剤技術の分野で通常使用されるものであれば使用でき、例えば、塩酸、硫酸、臭化水素酸、リン酸などの無機酸、酢酸、コハク酸、フマル酸、リンゴ酸、シュウ酸、乳酸、グルタル酸、サリチル酸、酒石酸などの有機酸、またはこれらの塩などが挙げられる。
pH緩衝剤としては、アミン系緩衝剤および炭酸塩系緩衝剤などが挙げられる。
界面活性剤としては、ラウリル硫酸ナトリウム、ポリソルベート80、硬化油、ポリオキシエチレン(160)ポリオキシポロピレン(30)グリコールなどが挙げられる。
酸味料としては、例えばクエン酸、酒石酸、リンゴ酸、アスコルビン酸などが挙げられる。
香料としては、ストロベリーを含む種々の果実香料並びにヨーグルト香料、レモン油、オレンジ油、メントールなどが挙げられる。
流動化剤としては、例えば、軽質無水ケイ酸、含水二酸化ケイ素、タルクなどが挙げられる。
清涼化剤としては、メントール、カンフルおよびボルネオールなどのテルペン系化合物(モノテルペンアルコールなど)などが挙げられる。
旨み成分としては、グルタミン酸、イノシン酸又はその塩などが挙げられる。
甘味増強剤としては、塩化ナトリウム、塩化カリウム、有機酸塩およびリン酸塩などが挙げられる。
ヒドロキシプロピルセルロース微粒子(10%粒子径6.5μm、50%粒子径17μm、90%粒子径35μm、2%水溶液の20℃における粘度2.6mPa・s、ヒドロキシアルキル基の含有量63質量%)3質量部、ステアリン酸マグネシウム(滑沢剤)0.5質量部、クロスポビドン(崩壊剤)2質量部、シリカ(流動化剤)0.5質量部、結晶セルロース(AvicelTM PH−102)(賦形剤)34.5質量部、およびアセトアミノフェン(原薬)60質量部の混合物を、小型回転式錠剤機(VELA5 0312SS2MZ、菊水製作所)を用いて、打錠圧10kNで打錠して錠剤A(錠剤質量200mg)を得た。製造直後の錠剤Aの硬度(kgf)、摩損度(%)および崩壊時間(min)を表1に示す。
硬度(kgf)は、ERWEKA硬度計(TBH28、ERWEKA社製)を用いて、錠剤10錠について測定し、その測定値を算術平均したものである。
摩損度(%)は、錠剤30錠を摩損度試験機(径27cm、TFT-1200、富山産業(株)社製)に入れ、100回転させた後に測定したものである。
崩壊時間(min)は、第十五改正日本薬局方崩壊試験法に準じて37℃の精製水中で錠剤が完全に崩壊するまでの時間を、錠剤6錠についてそれぞれ測定し、その測定値を算術平均したものである。
ヒドロキシプロピルセルロース微粒子(10%粒子径6.5μm、50%粒子径17μm、90%粒子径35μm、2%水溶液の20℃における粘度2.6mPa・s、ヒドロキシアルキル基の含有量63質量%)3質量部、ステアリン酸マグネシウム(滑沢剤)0.5質量部、クロスポビドン(崩壊剤)2質量部、シリカ(流動化剤)0.5質量部、乳糖/コーンスターチ(質量比7/3)(賦形剤)34.5質量部、およびアセトアミノフェン(原薬)60質量部の混合物を、実施例1と同じ装置を用いて、打錠圧10kNで打錠して錠剤B(錠剤質量200mg)を得た。製造直後の錠剤Bの硬度(kgf)、摩損度(%)、および崩壊時間(min)を表1に示す。
ここで、前記ヒドロキシプロピルセルロース微粒子は、ジェットミル粉砕により粒度分布が調整された。
ステアリン酸マグネシウム(滑沢剤)0.5質量部、クロスポビドン(崩壊剤)2質量部、シリカ(流動化剤)0.5質量部、結晶セルロース(AvicelTM PH−102)(賦形剤)37.5質量部、およびアセトアミノフェン(原薬)60質量部の混合物を、実施例1と同じ装置を用いて、打錠圧10kNで打錠して錠剤C(錠剤質量200mg)を得た。製造直後の錠剤Cの硬度(kgf)、摩損度(%)および崩壊時間(min)を表1に示す。
実施例1で得られた錠剤Aおよび比較例1で得られた錠剤Cを、25℃、湿度75%の条件下において保存し、1週間経過後および2週間経過後のそれぞれについて、摩損度(%)および硬度(kgf)を測定した。結果を図1および図2に示す。
実施例1で得られた錠剤Aおよび比較例1で得られた錠剤Cを、40℃、湿度75%の条件下において保存し、1週間経過後および2週間経過後のそれぞれについて、摩損度(%)を測定した。結果を図3に示す。
コーンスターチ(コーンスターチW 日本食品化工(株)製)1%水分散液(懸濁)を加熱処理することによってコーンスターチを一部α化デンプンへ変性して可溶化させてコーンスターチ溶液を得た。
転動流動層造粒機(SPIR−A−FLOW;フロイント産業(株)製)に、D−マンニトール(マンニットP 三菱商事フードテック(株)製)を入れ、D−マンニトールと同じ質量(固形分)の前記コーンスターチ溶液を間欠スプレー(スプレー圧力:1kg/cm2、スプレー時のスプレー量:17〜20ml/分、温度が34℃〜35℃になったときにスプレーを開始し、温度が28℃〜29℃になったときにスプレーを停止する。)しながら、造粒を行って、マンニトール顆粒を得た。
ヒドロキシプロピルセルロース微粒子(10%粒子径7.3μm、50%粒子径25μm、90%粒子径57μm、2%水溶液の20℃における粘度2.4mPa・s、ヒドロキシアルキル基の含有量64質量%、SSL−SFPという)2質量部、ステアリン酸マグネシウム(滑沢剤)1質量部、クロスポビドン(崩壊剤)3質量部、結晶セルロース(AvicelTM PH−102)(賦形剤)14質量部、および上記で調製したマンニトール顆粒80質量部の混合物を、小型回転式錠剤機(VELA5 0312SS2MZ、菊水製作所社製 杵臼径:8mmφ レンズ型)を用いて、打錠圧7kNで打錠して錠剤D1(錠剤質量約200mg)を得た。製造直後の錠剤D1の硬度(kgf)、摩損度(%)および崩壊時間(min)を表2に示す。
前記ヒドロキシプロピルセルロース微粒子は、ジェットミル粉砕により粒度分布が調整された。
表2に示す処方に変更した以外は実施例3と同じ方法で錠剤D2を得た。製造直後の錠剤D2の硬度(kgf)、摩損度(%)および崩壊時間(min)を表2に示す。
表2に示す処方に変更した以外は実施例3と同じ方法で錠剤E1〜E3を得た。なお、表中のSL微粉は、ヒドロキシプロピルセルロース微粒子(10%粒子径35μm、50%粒子径84μm、90%粒子径167μm、2%水溶液の20℃における粘度5.2mPa・s、ヒドロキシアルキル基の含有量64質量%)である。
製造直後の錠剤E1〜E3の硬度(kgf)、摩損度(%)および崩壊時間(min)を表2に示す。
錠剤D1、D2およびE1〜E3を、40℃、湿度75%の条件下において保存し、1週間経過後および2週間経過後のそれぞれについて、摩損度(%)、硬度(kgf)および崩壊時間(min)を測定した。その結果を図4〜6に示す。
図4〜6に示すとおり、本発明に係るヒドロキシプロピルセルロース微粒子を含有する錠剤(実施例3および4)は、ヒドロキシプロピルセルロース微粒子を含有していない錠剤(比較例2)または他の性状のヒドロキシプロピルセルロース微粒子を用いた錠剤(比較例3および4)に比して、高温高湿環境下における、硬度、摩損度および崩壊時間の変化が小さく、保存安定性に優れていることがわかる。
Claims (4)
- 累積粒度分布における50%粒子径が15μm以上40μm未満で、ヒドロキシアルキル基の含有量が40〜80質量%の範囲にあり、2%水溶液の20℃における粘度が2.0〜2.9mPa・sの範囲にあり、累積粒度分布における10%粒子径が10μm以下で且つ累積粒度分布における90%粒子径が30μm〜60μmであるヒドロキシアルキルセルロース微粒子を含有する口腔内崩壊錠。
- 前記ヒドロキシアルキルセルロース微粒子は、累積粒度分布における50%粒子径が15μm以上25μm未満である、請求項1に記載の口腔内崩壊錠。
- 前記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、請求項1または2に記載の口腔内崩壊錠。
- 乾式製剤手法により得られたものである、請求項1〜3のいずれかひとつに記載の口腔内崩壊錠。
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