JP5674667B2 - 崩壊性粒子組成物及び口腔内速崩壊錠 - Google Patents
崩壊性粒子組成物及び口腔内速崩壊錠 Download PDFInfo
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- JP5674667B2 JP5674667B2 JP2011526775A JP2011526775A JP5674667B2 JP 5674667 B2 JP5674667 B2 JP 5674667B2 JP 2011526775 A JP2011526775 A JP 2011526775A JP 2011526775 A JP2011526775 A JP 2011526775A JP 5674667 B2 JP5674667 B2 JP 5674667B2
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- hydrochloride
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- starch
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- mannitol
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- JCQBWMAWTUBARI-UHFFFAOYSA-N tert-butyl 3-ethenylpiperidine-1-carboxylate Chemical compound CC(C)(C)OC(=O)N1CCCC(C=C)C1 JCQBWMAWTUBARI-UHFFFAOYSA-N 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
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- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- 235000013337 tricalcium citrate Nutrition 0.000 description 1
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- LMJSLTNSBFUCMU-UHFFFAOYSA-N trichlormethiazide Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC2=C1NC(C(Cl)Cl)NS2(=O)=O LMJSLTNSBFUCMU-UHFFFAOYSA-N 0.000 description 1
- 229960002741 triclofos sodium Drugs 0.000 description 1
- ITMCEJHCFYSIIV-UHFFFAOYSA-M triflate Chemical compound [O-]S(=O)(=O)C(F)(F)F ITMCEJHCFYSIIV-UHFFFAOYSA-M 0.000 description 1
- QDWJJTJNXAKQKD-UHFFFAOYSA-N trihexyphenidyl hydrochloride Chemical compound Cl.C1CCCCC1C(C=1C=CC=CC=1)(O)CCN1CCCCC1 QDWJJTJNXAKQKD-UHFFFAOYSA-N 0.000 description 1
- 229960004479 trihexyphenidyl hydrochloride Drugs 0.000 description 1
- KVJXBPDAXMEYOA-CXANFOAXSA-N trilostane Chemical compound OC1=C(C#N)C[C@]2(C)[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CC[C@@]32O[C@@H]31 KVJXBPDAXMEYOA-CXANFOAXSA-N 0.000 description 1
- 229960001670 trilostane Drugs 0.000 description 1
- 229960005345 trimebutine Drugs 0.000 description 1
- 229960001177 trimetazidine Drugs 0.000 description 1
- 229960004453 trimethadione Drugs 0.000 description 1
- IRYJRGCIQBGHIV-UHFFFAOYSA-N trimethadione Chemical compound CN1C(=O)OC(C)(C)C1=O IRYJRGCIQBGHIV-UHFFFAOYSA-N 0.000 description 1
- YDGHCKHAXOUQOS-BTJKTKAUSA-N trimipramine maleate Chemical compound [O-]C(=O)\C=C/C([O-])=O.C1CC2=CC=CC=C2[NH+](CC(C[NH+](C)C)C)C2=CC=CC=C21 YDGHCKHAXOUQOS-BTJKTKAUSA-N 0.000 description 1
- 229960002835 trimipramine maleate Drugs 0.000 description 1
- 229950004678 tripamide Drugs 0.000 description 1
- UHLOVGKIEARANS-QZHINBJYSA-N tripamide Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC(C(=O)NN2C[C@@H]3[C@H]4CC[C@H](C4)[C@@H]3C2)=C1 UHLOVGKIEARANS-QZHINBJYSA-N 0.000 description 1
- 229960001593 triprolidine hydrochloride Drugs 0.000 description 1
- 229960003674 tropisetron hydrochloride Drugs 0.000 description 1
- XIEGSJAEZIGKSA-LUNMCBQDSA-N tropisetron hydrochloride Chemical compound Cl.C1=CC=C2C(C(=O)O[C@H]3C[C@H]4CC[C@@H](C3)N4C)=CNC2=C1 XIEGSJAEZIGKSA-LUNMCBQDSA-N 0.000 description 1
- 229960001341 troxipide Drugs 0.000 description 1
- RUDATBOHQWOJDD-UZVSRGJWSA-N ursodeoxycholic acid Chemical compound C([C@H]1C[C@@H]2O)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC(O)=O)C)[C@@]2(C)CC1 RUDATBOHQWOJDD-UZVSRGJWSA-N 0.000 description 1
- 229960001661 ursodiol Drugs 0.000 description 1
- 229940064636 valacyclovir hydrochloride Drugs 0.000 description 1
- 229960004699 valsartan Drugs 0.000 description 1
- 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
- 229960001572 vancomycin hydrochloride Drugs 0.000 description 1
- LCTORFDMHNKUSG-XTTLPDOESA-N vancomycin monohydrochloride Chemical compound Cl.O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC1=C2C=C3C=C1OC1=CC=C(C=C1Cl)[C@@H](O)[C@H](C(N[C@@H](CC(N)=O)C(=O)N[C@H]3C(=O)N[C@H]1C(=O)N[C@H](C(N[C@@H](C3=CC(O)=CC(O)=C3C=3C(O)=CC=C1C=3)C(O)=O)=O)[C@H](O)C1=CC=C(C(=C1)Cl)O2)=O)NC(=O)[C@@H](CC(C)C)NC)[C@H]1C[C@](C)(N)[C@H](O)[C@H](C)O1 LCTORFDMHNKUSG-XTTLPDOESA-N 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- 239000005526 vasoconstrictor agent Substances 0.000 description 1
- 229940124549 vasodilator Drugs 0.000 description 1
- 239000003071 vasodilator agent Substances 0.000 description 1
- 229950005577 vesnarinone Drugs 0.000 description 1
- 229920002554 vinyl polymer Polymers 0.000 description 1
- 235000019156 vitamin B Nutrition 0.000 description 1
- 239000011720 vitamin B Substances 0.000 description 1
- 235000010374 vitamin B1 Nutrition 0.000 description 1
- 239000011691 vitamin B1 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
- 150000003710 vitamin D derivatives Chemical class 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- 235000019168 vitamin K Nutrition 0.000 description 1
- 239000011712 vitamin K Substances 0.000 description 1
- 150000003721 vitamin K derivatives Chemical class 0.000 description 1
- 229940046008 vitamin d Drugs 0.000 description 1
- 229940046010 vitamin k Drugs 0.000 description 1
- 229960001729 voglibose Drugs 0.000 description 1
- 229960000883 warfarin potassium Drugs 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
- 229940075420 xanthine Drugs 0.000 description 1
- FJHBOVDFOQMZRV-XQIHNALSSA-N xanthophyll Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/C1=C(C)CC(O)CC1(C)C)C=CC=C(/C)C=CC2C=C(C)C(O)CC2(C)C FJHBOVDFOQMZRV-XQIHNALSSA-N 0.000 description 1
- 239000012138 yeast extract Substances 0.000 description 1
- 235000013618 yogurt Nutrition 0.000 description 1
- 239000009538 yokuinin Substances 0.000 description 1
- 229960004764 zafirlukast Drugs 0.000 description 1
- 229960001028 zanamivir Drugs 0.000 description 1
- ARAIBEBZBOPLMB-UFGQHTETSA-N zanamivir Chemical compound CC(=O)N[C@@H]1[C@@H](N=C(N)N)C=C(C(O)=O)O[C@H]1[C@H](O)[C@H](O)CO ARAIBEBZBOPLMB-UFGQHTETSA-N 0.000 description 1
- 229960002555 zidovudine Drugs 0.000 description 1
- HBOMLICNUCNMMY-XLPZGREQSA-N zidovudine Chemical compound O=C1NC(=O)C(C)=CN1[C@@H]1O[C@H](CO)[C@@H](N=[N+]=[N-])C1 HBOMLICNUCNMMY-XLPZGREQSA-N 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
- 235000016804 zinc Nutrition 0.000 description 1
- IUWLTSZHVYHOHY-FJXQXJEOSA-L zinc;(2s)-2-(3-azanidylpropanoylazanidyl)-3-(1h-imidazol-5-yl)propanoate Chemical compound [Zn+2].[NH-]CCC(=O)[N-][C@H](C([O-])=O)CC1=CN=CN1 IUWLTSZHVYHOHY-FJXQXJEOSA-L 0.000 description 1
- 229960001360 zolmitriptan Drugs 0.000 description 1
- UTAZCRNOSWWEFR-ZDUSSCGKSA-N zolmitriptan Chemical compound C=1[C]2C(CCN(C)C)=CN=C2C=CC=1C[C@H]1COC(=O)N1 UTAZCRNOSWWEFR-ZDUSSCGKSA-N 0.000 description 1
- 229960005111 zolpidem tartrate Drugs 0.000 description 1
- 229960002911 zonisamide Drugs 0.000 description 1
- UBQNRHZMVUUOMG-UHFFFAOYSA-N zonisamide Chemical compound C1=CC=C2C(CS(=O)(=O)N)=NOC2=C1 UBQNRHZMVUUOMG-UHFFFAOYSA-N 0.000 description 1
- 229960000820 zopiclone Drugs 0.000 description 1
- HDOZVRUNCMBHFH-UHFFFAOYSA-N zotepine Chemical compound CN(C)CCOC1=CC2=CC=CC=C2SC2=CC=C(Cl)C=C12 HDOZVRUNCMBHFH-UHFFFAOYSA-N 0.000 description 1
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- 229930007845 β-thujaplicin Natural products 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
Description
(1) マンニトール及びキシリトールから形成される複合粒子中に無機賦形剤及びスターチ類が分散してなり、
(a)マンニトールとキシリトールとの合計が70〜90重量部;
(b)無機賦形剤が2〜15重量部;
(c)スターチ類が5〜25重量部であって、
かつ成分(a)、(b)及び(c)の総量が100重量部となることを特徴とする、崩壊性粒子組成物であり、
(2) マンニトール及びキシリトールから形成される複合粒子中に無機賦形剤及びスターチ類が均質に分散してなり、
(a)マンニトールとキシリトールとの合計が70〜90重量部;
(b)無機賦形剤が2〜15重量部;
(c)スターチ類が5〜25重量部であって、
かつ成分(a)、(b)及び(c)の総量が100重量部となることを特徴とする、崩壊性粒子組成物であり、
(3) (a)マンニトールとキシリトールとの合計が75〜85重量部;
(b)無機賦形剤が3〜9重量部;
(c)スターチ類が10〜15重量部である、(2)に記載の組成物であり、
(4) マンニトールとキシリトールとの重量比が99:1〜90:10である、(3)に記載の組成物であり、
(5) マンニトールとキシリトールとの重量比が99:1〜95:5である、(3)に記載の組成物であり、
(6) 無機賦形剤が、メタケイ酸アルミン酸マグネシウム、ケイ酸アルミン酸マグネシウム、無水ケイ酸、ケイ酸カルシウム、リン酸水素カルシウム、炭酸カルシウム又はタルクから選択される少なくとも1種以上である、(1)〜(5)のいずれかに記載の組成物であり、
(7) スターチ類が、バレイショデンプン、コムギコデンプン、モチコメデンプン、サツマイモデンプン、タピオカデンプン、ライススターチ、コーンスターチ、ワキシーコーンスターチ又はヒドロキシプロピルスターチから選択される少なくとも1種以上である、(1)〜(5)のいずれかに記載の組成物であり、
(8) 成分(a)〜(c)を含む分散液を噴霧乾燥する工程を含む、(1)〜(7)のいずれかに記載の組成物の製造方法であり、
(9) (1)〜(7)のいずれかに記載の組成物100重量部に対して、活性物質を0.1〜200重量部及び崩壊剤を10〜100重量部以下を配合してなる口腔内速崩壊錠であり、
(10) 崩壊剤が、バレイショデンプン、コムギコデンプン、モチコメデンプン、サツマイモデンプン、タピオカデンプン、ライススターチ、コーンスターチ、ワキシーコーンスターチ、ヒドロキシプロピルスターチ又はクロスポビドンである、(9)に記載の口腔内速崩壊錠であり、
(11) さらに滑沢剤を含む(9)〜(10)のいずれかに記載の口腔内速崩壊錠であって、滑沢剤の添加が外部添加である、口腔内速崩壊錠である。
解熱鎮痛消炎剤として、アクタリット、アスピリン、アセトアミノフェン、アンピロキシカム、イブプロフェン、インドメタシン、インドメタシンファルネシル、エテンザミド、エトドラク、エピリゾール、エモルファゾン、塩酸トラマドール、塩酸ブプレノルフィン、オキサプロジン、ケトプロフェン、サリチル酸ナトリウム、ザルトプロフェン、ジクロフェナクナトリウム、スリンダク、スルピリン水和物、セレコキシブ、チアプロフェン酸、チアラミド塩酸塩、テノキシカム、ナプロキセン、ブコローム、ペンタゾシン、メフェナム酸、メロキシカム、モフェゾラク、ロキソプロフェンナトリウム水和物などが挙げられる。
その他の中枢神経系用薬として、塩酸チアプリド、塩酸ドネペジル、タルチレリン水和物、テルグリド、マジンドール、リルゾールなどが挙げられる。
自律神経剤としては、アンベノニウム塩化物、オキサピウムヨウ化物、ジスチグミン臭化物、プロパンテリン臭化物、メペンゾラート臭化物などが挙げられる。
鎮けい剤としては、アフロクアロン、エペリゾン塩酸塩、塩酸ピペリドレート、チザニジン塩酸塩、チメピジウム臭化物水和物、トルペリゾン塩酸塩、バクロフェン、パパベリン塩酸塩、ブチルスコポラミン臭化物、ブトロピウム臭化物、フロプロピオン、メチル硫酸N−メチルスコポラミンなどが挙げられる。
不整脈用剤としては、アジマリン、アセブトロール塩酸塩、アテノロール、アルプレノロール塩酸塩、アロチノロール塩酸塩、塩酸アプリンジン、塩酸アミオダロン、塩酸ソタロール、塩酸ピルジカイニド、塩酸プロパフェノン、塩酸ベプリジル、オクスプレノロール塩酸塩、カルテオロール塩酸塩、キニジン硫酸塩水和物、コハク酸シベンゾリン、酢酸フレカイニド、ジソピラミド、ナドロール、ピンドロール、ブフェトロール塩酸塩、フマル酸ビソプロロール、プロカインアミド塩酸塩、プロプラノロール塩酸塩、ベラパミル塩酸塩、メキシレチン塩酸塩などが挙げられる。
血管収縮剤としては、安息香酸リザトリプタン、塩酸ミドドリン、ジヒドロエルゴタミンメシル酸塩、臭化水素酸エレトリプタン、スマトリプタン、ゾルミトリプタンなどが挙げられる。
高脂血症用剤としては、アトルバスタチンカルシウム水和物、エゼミチブ、エラスターゼES、クリノフィブラート、クロフィブラート、コレスチミド、シンバスタチン、ソイステロール、デキストラン硫酸ナトリウム、ニコモール、ニセリトロール、ピタバスタチンカルシウム、フェノフィブラート、プラバスタチンナトリウム、フルバスタチンナトリウム、プロブコール、ベザフィブラート、ポリエンホスファチジルコリン、ロスバスタチンカルシウムなどが挙げられる。
去たん剤としては、L−エチルシステイン塩酸塩、L−塩酸メチルシステイン、L−カルボシステイン、塩酸アンブロキソール、フドステイン、ブロムヘキシン塩酸塩などが挙げられる。
鎮咳去たん剤としては、塩酸エプラジノン、グアイフェネシン、コデインリン酸塩水和物、チペピジンヒベンズ酸塩などが挙げられる。
含嗽剤としては、アズレンスルホン酸ナトリウムなどが挙げられる。
制酸剤としては、酸化マグネシウム、水酸化マグネシウム、炭酸水素ナトリウム、沈降炭酸カルシウム、メタケイ酸アルミン酸マグネシウムなどが挙げられる。
利胆剤としては、アネトールトリチオン、ウルソデオキシコール酸、トレピブトン、ニコチン酸、ナフチル酢酸などが挙げられる。
その他の消化器官用薬としては、アカメガシワエキス、アズレンスルホン酸ナトリウム、塩化セチルピリジニウム、塩化デカリニウム、塩酸アザセトロン、塩酸イトプリド、塩酸インジセトロン、塩酸グラニセトロン、塩酸セビメリン水和物、塩酸トロピセトロン、塩酸ラモセトロン、オンダンセトロン、キタサマイシン酢酸エステル、クエン酸モサプリド、臭化ドミフェン、デキサメタゾン、トリメブチンマレイン酸塩、ドンペリドン、ピロカルピン塩酸塩、ポリカルボフィルカルシウム、メサラジン、メトクロプラミドなどが挙げられる。
たん白同化ステロイド剤としては、メスタノロン、メテノロンなどが挙げられる。
男性ホルモン剤としては、メチルテストステロンなどが挙げられる。
卵胞ホルモン及び黄色ホルモン剤としては、アリルエストレノール、エストリオール、エチニルエストラジオール、クロルマジノン酢酸エステル、結合型エストロゲン、酢酸メドロキシプロゲステロン、ジドロゲステロン、ノルエチステロン、プレグナンジオール、ホスフェストロールなどが挙げられる。
その他のホルモン剤としては、カリジノゲナーゼ、クロミフェンクエン酸塩、シクロフェニル、ダナゾール、トリロスタン、フィナステリドなどが挙げられる。
子宮収縮剤としては、メチルエルゴメトリマレイン酸塩などが挙げられる。
避妊薬としては、エチニルエストラジオール・ノルエチステロン、エチニルエストラジオール・レボノルゲストレイル、デソゲストレル・エチニルエストラジオールなどが挙げられる。
その他の泌尿生殖器官用薬としては、イミダフェナシン、ウラジロガシエキス、塩酸オキシブチニン、塩酸バルデナフィル水和物、塩酸プロピベリン、クエン酸シルデナフィル、コハク酸ソリフェナシン、酒石酸トルテロジン、シロドシン、セルニチンポーレンエキス、タムスロシン塩酸塩、ナフトピジル、フラボキサート塩酸塩、リトドリン塩酸塩などが挙げられる。
ビタミンB1剤としては、塩酸ジセアミン、オクトチアミン、チアミンジスルフィド、ビスベンチアミン、フルスルチアミン、ベンフォチアミンなどが挙げられる。
ビタミンC剤としては、アスコルビン酸などが挙げられ、ビタミンE剤としては、トコフェロールコハク酸エステルカルシウム、トコフェロール酢酸エステルなどが挙げられる。
ビタミンK剤としては、フィトナジオン、メナテトレノンなどが挙げられる。
その他のビタミン剤としては、アスタキサンチン、フコキサンチン、ルテインなどが挙げられる。
無機質製剤としては、L−アスパラギン酸カリウム、塩化カリウム、クエン酸第一鉄ナトリウム、グルコン酸カリウム、ヨウ素レシチン、硫酸鉄水和物などが挙げられる。
血液凝固阻止剤としては、ワルファリンカリウムなどが挙げられる。
その他の血液・体液用薬としては、アスピリン、イコサペント酸エチル、塩酸サルポグレラート、シロスタゾール、チクロピジン塩酸塩、ベラプロストナトリウム、リマプロスト アルファデクス、硫酸クロピドグレルなどが挙げられる。
解毒剤としては、エデト酸カルシウム二ナトリウム、グルタチオン、炭酸水素ナトリウム、ホリナートカルシウムなどが挙げられる。
酵素製剤としては、セミアルカリプロティナーゼ、セラペプターゼ、プロナーゼ、ブロメライン、リゾチーム塩酸塩などが挙げられる。
その他の代謝性医薬品としては、アザチオプリン、アデノシン三リン酸二ナトリウム、アレンドロン酸ナトリウム水和物、イノシンプラノベクス、イプリフラボン、エチドロン酸二ナトリウム、エパルレスタット、エベロリムス、L−システイン、塩化レボカルニチン、塩酸ラロキシフェン、カモスタットメシル酸塩、シクロスポリン、タクロリムス、ミゾリビン、メトトレキサート、リセドロン酸ナトリウム水和物、レフルノミドなどが挙げられる。
その他の化学療法剤としては、イトラコナゾール、塩酸テルビナフィン、フルコナゾールなどが挙げられる。
実施例で得られた各錠剤についての評価は、次の方法により行った。
[口腔内崩壊時間]
錠剤(1錠ずつ n=6)を、3〜8人の被験者の口腔内の舌上に乗せて完全に崩壊するまでの時間を測定し、その平均値を口腔内崩壊時間とした。
[官能試験]
錠剤を、5人の被験者の口腔内の舌上に乗せ、自然に崩壊させた。その後、食感・味覚についてアンケートをとった。
[錠剤の硬度]
ロードセル式錠剤硬度計〔PC−30、岡田精工(株)製〕を用いて測定した。
[打錠障害]
打錠機の臼杵及び打錠後の錠剤を観察し、スティッキング及びキャッピング、ハリツキ及び重量バラツキを評価した。
国際公開WO2005/55989号パンフレットに記載の方法で、苦味活性物質としてクエン酸モサプリドのマスキング粒子を作成した。撹拌造粒機を用い、クエン酸モサプリド・2水和物21重量部、メチルセルロース20重量部及びD−マンニトール59重量部に水10重量部を噴霧して造粒した後、80℃で1晩乾燥させ、32meshの篩で篩過し、マスキング粒子を作成した。
クエン酸モサプリドは大日本住友製薬(株)製を、メチルセルロースは信越化学工業のメトローズSM−25(粘度2.53mm2/S(20℃における2%水溶性粘度(日本薬局方)))を、マンニトールは三菱フードテック(株)製マンニットPを用いた。
表1の処方成分が分散液全体100重量部に対して35重量部になるように水を均質に分散させたのち、噴霧乾燥機(L−8型、大川原化工機社製)を用いて、出口温度80℃で噴霧乾燥し、流動性の良い白色の球状の造粒粒子を得た。
L−HPCは低置換度ヒドロキシプロピルセルロースを示す。
キシリトールは三菱フードテック(株)製キシリットXCを、ケイ酸カルシウムはエーザイフードケミカルのフローライトREを、メタケイ酸アルミン酸マグネシウムは富士化学工業(株)製(ノイシリンUFL2(登録商標))を用いた。コーンスターチは日本コーンスターチ(株)製コーンスターチWを、ライススターチは島田化学工業(株)製ミクロパールを、HPS(ヒドロキシプロピルスターチ)はフロイント産業製HPS101を、L−HPCは低置換度ヒドロキシプロピルセルロース(信越化学工業(株)製LH−21)を用いた。
実施例1又は2で製造した崩壊性粒子組成物に、表2の成分とステアリン酸マグネシウム0.4重量部、アスパルテーム0.2重量部及びメントール0.2重量部とを添加・混合したのち、ロータリー打錠機により設定硬度50Nとして打錠し、重量240mg、直径8mm、9Rの錠剤を得た(実施例4−9及び11−12)。
実施例3で製造した崩壊性粒子組成物に、表2の成分とステアリン酸マグネシウム0.4重量部を添加・混合したのち、ロータリー打錠機により設定硬度50Nとして打錠し、重量240mg、直径8mm、9Rの錠剤を得た(実施例10)。
アセトアミノフェンは不二化学薬品(株)製アセトアミノフェン微粉を、CMCは五徳薬品(株)のカルボキシメチルセルロースNS−300を、クロスポビドンはBASFジャパン(株)のコリドンCLを、結晶セルロースKG−802は旭化成ケミカルズ(株)のセオラスKG−802を用いた。
マンニトール78重量部、キシリトール2重量部、ケイ酸カルシウム6重量部及びコーンスターチ14重量部を混合した。その混合物67.6重量部、参考例1で製造したマスキング粒子25重量部、ヒドロキシプロピルスターチ7重量部及びステアリン酸マグネシウム0.4重量部を混合した。得られた打錠用粉末をロータリー打錠機により設定硬度50Nとして打錠しようとしたが、低密度で流動性の悪いものであったため、臼への充填がスムーズではなく実施例同様の設定錠剤を得ることができなかった。
マンニトール78重量部、キシリトール2重量部、ケイ酸カルシウム6重量部及びコーンスターチ14重量部を乳鉢に入れ適量の水を加えて混練したのち、32meshの篩で篩過して造粒し、80℃で1晩乾燥させた。その混合物67.6重量部、参考例1で製造したマスキング粒子25重量部、ヒドロキシプロピルスターチ7重量部及びステアリン酸マグネシウム0.4重量部を混合した。得られた打錠用粉末をロータリー打錠機により設定硬度50Nとして打錠しようとしたが、ハリツキを生じ、また錠剤の重量バラツキが大きく、実施例同様の設定錠剤を得ることができなかった。
Claims (8)
- マンニトール及びキシリトールから形成される複合粒子中に無機賦形剤及びスターチ類が分散してなり、
(a)マンニトールとキシリトールとの合計が70〜90重量部;
(b)無機賦形剤が2〜15重量部;
(c)スターチ類が5〜25重量部であって、
かつ成分(a)、(b)及び(c)の総量が100重量部となることを特徴とする、崩壊性粒子組成物。 - マンニトール及びキシリトールから形成される複合粒子中に無機賦形剤及びスターチ類が均質に分散してなり、
(a)マンニトールとキシリトールとの合計が70〜90重量部;
(b)無機賦形剤が2〜15重量部;
(c)スターチ類が5〜25重量部であって、
かつ成分(a)、(b)及び(c)の総量が100重量部となることを特徴とする、崩壊性粒子組成物。 - (a)マンニトールとキシリトールとの合計が75〜85重量部;
(b)無機賦形剤が3〜9重量部;
(c)スターチ類が10〜15重量部である、請求項2に記載の組成物。 - マンニトールとキシリトールとの重量比が99:1〜90:10である、請求項3に記載の組成物。
- マンニトールとキシリトールとの重量比が99:1〜95:5である、請求項3に記載の組成物。
- 無機賦形剤が、メタケイ酸アルミン酸マグネシウム、ケイ酸アルミン酸マグネシウム、無水ケイ酸、ケイ酸カルシウム、リン酸水素カルシウム、炭酸カルシウム又はタルクから選択される少なくとも1種以上である、請求項1〜5のいずれか1項に記載の組成物。
- スターチ類が、バレイショデンプン、コムギコデンプン、モチコメデンプン、サツマイモデンプン、タピオカデンプン、ライススターチ、コーンスターチ、ワキシーコーンスターチ又はヒドロキシプロピルスターチから選択される少なくとも1種以上である、請求項1〜5のいずれか1項に記載の組成物。
- 成分(a)〜(c)を含む分散液を噴霧乾燥する工程を含む、請求項1〜7のいずれか1項に記載の組成物の製造方法。
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JP7545204B2 (ja) * | 2019-12-06 | 2024-09-04 | 小林製薬株式会社 | 錠剤 |
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WO2011019046A1 (ja) | 2011-02-17 |
US8900602B2 (en) | 2014-12-02 |
EP2465540A1 (en) | 2012-06-20 |
US20120165413A1 (en) | 2012-06-28 |
EP2465540B1 (en) | 2016-10-05 |
EP2465540A4 (en) | 2013-01-09 |
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