JP7497346B2 - チュアブル錠およびその調製方法 - Google Patents
チュアブル錠およびその調製方法 Download PDFInfo
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- JP7497346B2 JP7497346B2 JP2021520605A JP2021520605A JP7497346B2 JP 7497346 B2 JP7497346 B2 JP 7497346B2 JP 2021520605 A JP2021520605 A JP 2021520605A JP 2021520605 A JP2021520605 A JP 2021520605A JP 7497346 B2 JP7497346 B2 JP 7497346B2
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- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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Description
-国際特許出願公開第WO09080020号(US8,722,022に対応)
-国際特許出願公開第WO09080022号(US8,603,440に対応)
-国際特許出願公開第WO10008879号(US2011/0104239に対応)
-国際特許出願公開第WO13091631号(US2017/224671に対応)
-米国特許第6,551,634号
-国際特許出願公開第WO10003425号(US2011/117173に対応)
-日本特許第5836037号
-国際特許出願公開第WO17105564号.....
-米国特許出願公開第2016/296474号
-米国特許出願公開第2006/039872号
-米国特許出願公開第2001/053397号
-国際特許出願公開第WO9320708号
本開示は、その第1の態様に従って、(i)生物活性分子を含む圧縮コアと、(ii)前記圧縮コア上の保護層と、(iii)ガムベース粉末を含む保護層上の1つ以上のソフトコーティング層とを含むチュアブル錠を提供し、前記保護層は、水不溶性セルロース系ポリマーを含む。
(a)生物活性分子を含む圧縮錠剤の上に、水不溶性セルロース系ポリマーを含む保護材料を適用して、前記圧縮錠剤上に保護コーティングを形成することと、
(b)前記保護コーティングの上に1つ以上のソフトコーティング層を適用し、前記ソフトコーティング層は、ガムベース粉末を含むこととを含む。
-生物活性分子を含む圧縮錠剤の上に、水不溶性ポリマーを含む保護材料を適用して、前記圧縮錠剤上に保護コーティングを形成するステップ。
-前記保護コーティングの上に1つ以上のソフトコーティング層を適用するステップであって、前記ソフトコーティング層は、少なくともガムベース粉末、好ましくはガムベース粉末とソフトコーティング結合剤との組み合わせを含むステップ。
材料
錠剤:各錠剤の重量は800mgで、水溶性担体/充填剤としてソルビトール、滑沢剤としてステアリン酸マグネシウム、およびビタミン、ミネラル、植物由来成分(plant derived parts)、香味料のうちの1つ以上を含み、すべて以下の表1に示す。
(a)錠剤の作成:
各錠剤の成分をふるいにかけ、担体であるソルビトールと混合して、微細な混合物を形成し、そこへ滑沢剤であるステアリン酸マグネシウムを加え、均一な混合物が得られるまでさらに混合した。次に、混合物を打錠および除塵にかけた(従来の技術による)。
保護コーティングのために、エチルセルロース(AQUALON(商標)EC-N10)の99%エタノール溶液を、72μlに8mgのECを溶解することによって調製し、得られた溶液を、錠剤がドラム内で回転しているときに錠剤に噴霧した。エタノールを蒸発させて、乾燥したECコーティング錠剤(「EC錠剤」)を得た。理論に拘束されるものではないが、このEC層は、各錠剤を液体の浸透、したがって崩壊から防止および保護する(以下に説明するそれぞれの図を参照)。
表2に、ガム(ソフト)コーティングの組成を示す。
まず、イソマルトが完全に溶解するまで(透明な溶液が形成されるまで)沸騰した精製水にイソマルトを加えることにより、クラスティング溶液を調製した。次に、透明溶液を冷却した。
まず、イソマルトが完全に溶解するまで(透明な溶液が形成されるまで)沸騰した精製水にイソマルト(270mg)を加えることにより、着色料を調製した。次に、透明溶液を冷却した。
-ショウガ含有錠剤-ベニバナ抽出物
-マルチビタミン含有錠剤-黒ニンジン抽出物
-ハーブ含有錠剤-黒ニンジン抽出物
着色した錠剤の艶出しのために、艶出し剤として使用される微結晶蝋およびカルナウバ蝋とともに金属バッフルをドラムに配置した。次に、ドラムを高速(25~35RPM)で約20分間回転させた。
コーティング層は同一である(ただし、中間体の有無にかかわらず、保護コーティング)が、錠剤コアが異なる、様々なタイプの錠剤が形成された。
図2は、25℃で貯蔵してから12ヵ月後に撮影されたショウガ含有錠剤の写真画像である。
図4Aは、ハーブ含有コア錠剤(表1の錠剤3)およびEC保護コーティングを使用して製造された錠剤の製造から1年後に撮影された写真画像である。比較すると、図4Bは、同じ方法で製造された錠剤の写真画像であるが、保護(EC)噴霧層を有しない。
図5は、EC保護層を含まないマルチビタミン含有錠剤(表1のコア錠剤#2)の写真画像である。画像は製造から1年後に撮影されたものである。
エチルセルロース系保護コーティングの非自明な選択をさらに強調するために、ビタミン含有コア錠剤(表1のコア錠剤2として)を上記のように調製し、Ethocelについて上記したのと同じ方法でヒドロキシプロピルメチルセルロースで、または蜜蝋(最初に60℃で液化)もしくはカルナウバ蝋(粉末として適用)でコーティングした。これらの保護層のいずれも、一度水中に置かれたコーティングされた錠剤の崩壊を首尾よく防止せず、これは、Ethocelコーティングについて図4A~4Bに示された結果と完全に矛盾している。
Claims (24)
- (i)生物活性分子を含む圧縮コアと、(ii)前記圧縮コア上の保護層であって、セルロース系ポリマーを含む保護層と、(iii)前記保護層上の1つ以上のソフトコーティング層であって、各ソフトコーティング層が、ガムベース粉末を含むソフトコーティング層とを含み、前記セルロース系ポリマーが、エチルセルロースポリマーを含む、チュアブル錠。
- 前記セルロース系ポリマーが、エチルセルロースポリマーであり、前記保護層が、任意選択で残留有機溶媒を含む、請求項1に記載のチュアブル錠。
- 前記圧縮コアが、9~12キロポンドの硬度を有する圧縮錠剤である、請求項1または2に記載のチュアブル錠。
- 前記保護層の上に、前記ガムベース粉末の2つ以上の層を含む、請求項1~3のいずれか一項に記載のチュアブル錠。
- 前記ガムベース粉末の10~25の層を含む、請求項1~4のいずれか一項に記載のチュアブル錠。
- 前記ソフトコーティング層のそれぞれが、前記ガムベース粉末を前記保護層または前のソフトコーティング層に結合するためのソフトコーティング結合剤を含む、請求項1~5のいずれか一項に記載のチュアブル錠。
- 前記ソフトコーティング結合剤が、糖系材料およびアラビアガムを含む、請求項6に記載のチュアブル錠。
- 前記ソフトコーティング層が油性剤を含む、請求項1~7のいずれか一項に記載のチュアブル錠。
- 前記油性剤が油性香味料を含む、請求項8に記載のチュアブル錠。
- 前記油性剤が2つ以上のソフトコーティング層の間に存在する、請求項8または9に記載のチュアブル錠。
- 前記ソフトコーティング層が、ハードコーティング結合剤を含むハードコーティングでコーティングされている、請求項1~10のいずれか一項に記載のチュアブル錠。
- 前記ハードコーティング結合剤が、糖系材料およびアラビアガムを含む、請求項11に記載のチュアブル錠。
- 室温で少なくとも1年間貯蔵した後、その外層に目に見える亀裂がないことによって決定されるように、貯蔵安定性である、請求項1~12のいずれか一項に記載のチュアブル錠。
- チュアブル錠の調製方法であって、
(a)生物活性分子を含む圧縮錠剤の上に保護層を形成するために保護材料を適用することであって、前記保護材料が、セルロース系ポリマーおよび有機溶媒を含み、前記セルロース系ポリマーが、エチルセルロースポリマーを含む、保護材料を適用することと、
(b)前記保護層の上に1つ以上のソフトコーティング層を適用することであって、前記ソフトコーティング層が、ガムベース粉末を含む、ソフトコーティング層を適用することと、を含む、方法。 - 前記適用することが、前記セルロース系ポリマーが前記有機溶媒に溶解しているときに、前記セルロース系ポリマーを前記圧縮錠剤上に噴霧することを含む、請求項14に記載の方法。
- 前記セルロース系ポリマーがエチルセルロースである、請求項14または15に記載の方法。
- 前記有機溶媒がエタノール、または99%エタノールである、請求項16に記載の方法。
- 前記1つ以上のソフトコーティング層を適用する前に、前記有機溶媒を蒸発させることを含む、請求項14~17のいずれか一項に記載の方法。
- 前記1つ以上のソフトコーティング層を適用することが、保護された錠剤をソフトコーティング結合剤溶液で湿潤させ、前記湿潤した錠剤上にガムベース粉末を展延することを含む、請求項14~18のいずれか一項に記載の方法。
- 前記ソフトコーティング結合剤溶液が、水に溶解された糖系材料およびアラビアガムを含む、請求項19に記載の方法。
- 前記1つ以上のソフトコーティング層を適用することが、湿潤した錠剤をドラム内で混合しながらガムベース粉末を前記ドラムに導入し、それによって前記錠剤上に前記ガムベース粉末の層を形成することを含む、請求項14~20のいずれか一項に記載の方法。
- 追加のソフトコーティング層を適用する前に、前記ガムベース粉末の層を乾燥させることを含む、請求項21に記載の方法。
- 前記錠剤をドラム内で混合しながらガムベース粉末を前記ドラムに前記導入することを10~25回繰り返して、前記ガムベース粉末の10~25の層を含むソフトコーティングを得る、請求項22に記載の方法。
- 前記ソフトコーティング層上にハードコーティングを適用することを含む、請求項14~23のいずれか一項に記載の方法。
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IL262768A IL262768B (en) | 2018-11-04 | 2018-11-04 | Chewable tablet and method for its preparation |
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PCT/IL2019/051205 WO2020089921A1 (en) | 2018-11-04 | 2019-11-04 | A chewable tablet and method of preparing the same |
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DK2229156T3 (en) | 2007-12-20 | 2017-02-06 | Fertin Pharma As | CHEW GUM TABLE AND PROCEDURE FOR DOSING PHARMACEUTICAL ACTIVE INGREDIENTS IN SUCH CHEW GUM TABLE |
DK2229158T3 (en) | 2007-12-20 | 2016-12-12 | Fertin Pharma As | Compressed chewing gum tablet |
CA2729072A1 (en) | 2008-06-24 | 2010-01-21 | Wm. Wrigley Jr. Company | Probiotic chewing gum method of manufacture |
US20140328973A1 (en) | 2011-12-22 | 2014-11-06 | Bruno Provstgaard Nielsen | Method of releasing nicotine from chewing gum |
CN103340835B (zh) * | 2013-07-11 | 2014-09-17 | 河南中帅医药科技股份有限公司 | 一种适用于婴幼儿及儿童的口腔崩解片及其制备方法 |
US10441535B2 (en) | 2014-12-29 | 2019-10-15 | NeuroGum, LLC | Nutraceutical confectionary composition containing caffeine and L-theanine |
CA2981759C (en) | 2015-04-07 | 2021-10-12 | Church & Dwight Co., Inc. | Multicomponent gummy compositions with soft core |
-
2018
- 2018-11-04 IL IL262768A patent/IL262768B/en active IP Right Grant
-
2019
- 2019-11-04 WO PCT/IL2019/051205 patent/WO2020089921A1/en active Application Filing
- 2019-11-04 AU AU2019372816A patent/AU2019372816B2/en active Active
- 2019-11-04 PL PL19805764.8T patent/PL3873438T3/pl unknown
- 2019-11-04 CA CA3114290A patent/CA3114290A1/en active Pending
- 2019-11-04 ES ES19805764T patent/ES2932535T3/es active Active
- 2019-11-04 JP JP2021520605A patent/JP7497346B2/ja active Active
- 2019-11-04 PT PT198057648T patent/PT3873438T/pt unknown
- 2019-11-04 US US17/284,984 patent/US20210346286A1/en active Pending
- 2019-11-04 CN CN201980063531.6A patent/CN112770733A/zh active Pending
- 2019-11-04 EP EP19805764.8A patent/EP3873438B1/en active Active
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20110070287A1 (en) | 2008-05-26 | 2011-03-24 | Bruno Provstgaard Nielsen | Film-Coated Compressed Chewing Gum |
JP2011527184A (ja) | 2008-07-08 | 2011-10-27 | アルシアノ・ア/エス | 粉末状チューイングガム組成物、これらの使用およびこうした組成物の調製方法 |
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PT3873438T (pt) | 2023-01-05 |
AU2019372816A1 (en) | 2021-04-22 |
JP2022505029A (ja) | 2022-01-14 |
US20210346286A1 (en) | 2021-11-11 |
PL3873438T3 (pl) | 2023-01-23 |
EP3873438B1 (en) | 2022-09-28 |
ES2932535T3 (es) | 2023-01-20 |
WO2020089921A1 (en) | 2020-05-07 |
IL262768B (en) | 2020-08-31 |
EP3873438A1 (en) | 2021-09-08 |
CN112770733A (zh) | 2021-05-07 |
AU2019372816B2 (en) | 2024-07-04 |
IL262768A (en) | 2020-05-31 |
CA3114290A1 (en) | 2020-05-07 |
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