JP2016503767A - 改良された許容性および良好な保存安定性を有する錠剤 - Google Patents
改良された許容性および良好な保存安定性を有する錠剤 Download PDFInfo
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- JP2016503767A JP2016503767A JP2015548443A JP2015548443A JP2016503767A JP 2016503767 A JP2016503767 A JP 2016503767A JP 2015548443 A JP2015548443 A JP 2015548443A JP 2015548443 A JP2015548443 A JP 2015548443A JP 2016503767 A JP2016503767 A JP 2016503767A
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- UURAUHCOJAIIRQ-QGLSALSOSA-N tiamulin Chemical compound CCN(CC)CCSCC(=O)O[C@@H]1C[C@@](C)(C=C)[C@@H](O)[C@H](C)[C@@]23CC[C@@H](C)[C@]1(C)[C@@H]2C(=O)CC3 UURAUHCOJAIIRQ-QGLSALSOSA-N 0.000 description 1
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Abstract
Description
‐少なくとも一つの医薬成分、
‐少なくとも28重量%の肉の香味料および
‐少なくとも2重量%の安定剤、
を含む錠剤を提供する。
‐少なくとも一つの医薬成分、
‐少なくとも30重量%の肉の香味料、
‐3から8重量%の安定剤、
を含む錠剤を提供する。
好ましくは本発明の錠剤は、充填剤としてデンプンまたはデンプン誘導体を含み、それらはある程度崩壊剤としても作用する。デンプンは、例えば、小麦、米、コーン、タピオカ、ライ麦、燕麦またはジャガイモ由来であり得る。加工デンプンは、物理的に前処理されたデンプン(例えば、アルファー化デンプン等)、または化学的に改変されたデンプン(例えば、ヒドロキシエチルデンプン、ヒドロキシプロピルデンプン、メチル化デンプン、カルボキシメチル化デンプン、酢酸デンプン、ヒドロキシプロピル酢酸デンプン、ヒドロキシエチル酢酸デンプン、リン酸デンプン、硫酸デンプン等)、または化学的にまたはイオン的に架橋されたデンプン(ジスターチホスフェート、硫酸ヒドロキシプロピルデンプン、カルボン酸ジエステル化デンプン)またはアニオンデンプン誘導体の塩、等であり得る。好ましくは、デンプン、例えばコーンスターチ等は、充填剤として、錠剤全体の重量に基づいて、特に典型的に5から30重量%、好ましくは8から20重量%、特に好ましくは10から15重量%の具体的な量で存在する。
(a)活性成分および任意のさらなる賦形剤を混合、顆粒化し、ならびに必要ならば顆粒を粉砕し、
(b)肉の香味料および任意のさらなる賦形剤を、(a)由来の混合物に添加しさらにすべてを均一で圧縮可能な混合物を形成するように処理し、ならびに
(c)混合物を、その後錠剤を形成するために処理する、
方法によって調製され得る。
(a)活性成分および任意のさらなる賦形剤を混合、顆粒化し、必要ならば顆粒を篩分けし、
(b)肉の香味料を、さらなる賦形剤と共に均一に混合し、場合により乾式で顆粒化し、
(c)任意のさらなる賦形剤を、(a)および(b)由来の混合物に添加し、さらにすべてを均一で圧縮可能な混合物を形成するように処理し、ならびに
(d)混合物を、その後錠剤を形成するために処理する、
方法によって調製され得る。
調整方法
第一調製段階(「前混合」)
プラジカンテル、フェバンテルおよびパモ酸ピランテルおよび同様にコーンスターチおおびラクトース一水和物のいくらかを、ミキサー造粒機において混合する。該混合物をポビドンおよびラウリル硫酸ナトリウムの水溶液により顆粒化し、その後乾燥し、注意深く篩分けする。
肉の香味料、残りのコーンスターチ、および微結晶セルロースを乾燥混合し、圧縮しそして篩分けする。
必要とされる量の前混合物および後混合物を、クロスカルメロースナトリウム、ステアリン酸マグネシウムおおび無水二酸化ケイ素と混合する。最終混合物を次に錠剤を形成するために処理する。
Claims (13)
- ‐少なくとも一の活性医薬成分、
‐少なくとも28重量%の肉の香味料および
‐少なくとも2重量%の安定剤、
を含む錠剤。 - 少なくとも30重量%の肉の香味料を含む、請求項1の錠剤。
- 3から8重量%の安定剤を含む、請求項1または2の錠剤。
- デンプンまたはデンプン誘導体を含む、先行する請求項のいずれかの錠剤。
- ラクトースを含む、先行する請求項のいずれかの錠剤。
- フェバンテル、プラジカンテルおよびピランテルを含む群から選択される少なくとも一の活性成分を含む、先行する請求項のいずれかの錠剤。
- フェバンテル、プラジカンテルおよびピランテルを含む、請求項6の錠剤。
- ピランテルがパモ酸ピランテルの形態である、請求項6または7の錠剤。
- 動物における疾病を制御する際の使用のための、請求項1の錠剤。
- 動物における蠕虫を制御する際の使用のための、請求項6の錠剤。
- 動物における疾病を制御するための薬剤を調製のための、請求項1の錠剤の使用。
- 動物における蠕虫を制御するための薬剤を調製するための、請求項6の錠剤の使用。
- (a)活性成分、および任意のさらなる賦形剤が混合、顆粒化され、および必要ならば顆粒が篩分けされ、
(b)肉の香味料がさらなる賦形剤と均一に混合されおよび可能ならば乾式造粒され、
(c)任意のさらなる賦形剤が(a)および(b)からの混合物に添加され、すべてが均一で圧縮可能な混合物を形成するように処理され、および
(d)混合物が引き続き錠剤を形成するために処理される、
請求項1の錠剤を調製するための方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP12198101 | 2012-12-19 | ||
EP12198101.3 | 2012-12-19 | ||
PCT/EP2013/076878 WO2014095845A1 (de) | 2012-12-19 | 2013-12-17 | Tabletten mit verbesserter akzeptanz und guter lagerstabilität |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2016503767A true JP2016503767A (ja) | 2016-02-08 |
JP2016503767A5 JP2016503767A5 (ja) | 2018-01-11 |
JP6393274B2 JP6393274B2 (ja) | 2018-09-19 |
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JP2020500898A (ja) * | 2016-12-09 | 2020-01-16 | バイエル・アニマル・ヘルス・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツングBayer Animal Health Gmbh | 医薬製剤およびその製造方法 |
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KR102253847B1 (ko) * | 2012-12-19 | 2021-05-21 | 바이엘 애니멀 헬스 게엠베하 | 향상된 수용성 및 우수한 저장 안정성을 가지는 정제 |
CN106580896A (zh) * | 2016-12-07 | 2017-04-26 | 成都乾坤动物药业股份有限公司 | 一种非班太尔分散片及其制备方法 |
CN113038937A (zh) * | 2018-09-05 | 2021-06-25 | 硕腾服务有限责任公司 | 可口的抗寄生虫制剂 |
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