JP2017526581A - カプセル投薬用コンテナー - Google Patents
カプセル投薬用コンテナー Download PDFInfo
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- JP2017526581A JP2017526581A JP2016565049A JP2016565049A JP2017526581A JP 2017526581 A JP2017526581 A JP 2017526581A JP 2016565049 A JP2016565049 A JP 2016565049A JP 2016565049 A JP2016565049 A JP 2016565049A JP 2017526581 A JP2017526581 A JP 2017526581A
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- Prior art keywords
- package
- capsule
- soft gel
- shell
- reduced thickness
- Prior art date
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Abstract
Description
タンパク質ベースのゲル化剤は、コラーゲン、卵白、ゼラチン、またはミルクベースのタンパク質から選択されても良い。「コラーゲン」は動物の結合組織のタンパク質を意味する。「ゼラチン」は部分加水分解によるコラーゲン由来の、半透明で、無色で、無臭の、脆くて、ほとんど味がない固体タンパク質物質を意味する。一般的にゼラチンはアルカリ性のゼラチン、酸性のゼラチン、または酵素のゼラチンに分類される。アルカリ性のゼラチンは、コラーゲンと水酸化カルシウムのようなベースとの処理から得られる。酸性のゼラチンは、コラーゲンと塩酸のような酸との処理から得られる。酵素のゼラチンは加水分解酵素を用いたコラーゲンの処理から生成される。ゼラチンは一般的に食物、薬剤、写真撮影、および化粧品製造においてゲル化剤として使用される。本発明の文脈において、「ゼラチン」はまた自然のゼラチンの合成類似体のような実施的に同等な物質を含む。
本発明のゲル化剤はまた、多糖ベースであっても良い。多糖ベースのゲル化剤は一般的に、デンプンやセルロースなどの植物源に由来する。多糖ベースのゲル化剤は微結晶性セルロース、カルボキシメチルセルロースナトリウム、メチルセルローズ、エチルセルロース、ヒドロキシエチルセルロース、ヒドロキシプロピルセルロース、およびヒドロキシプロピルメチルセルロースのようなセルロース誘導体、デンプン、およびデンプン誘導体、ペクチン、ガム、デキストリン、アルギン酸塩およびカラギナンから選択されても良い。典型的なデンプンは、アラカチャデンプン、クズウコンデンプン、バナナデンプン、大麦デンプン、パンノキデンプン、蕎麦デンプン、リードデンプン、キャッサバデンプン、里芋属デンプン、コーンデンプン、片栗デンプン、葛デンプン、マランガデンプン、キビデンプン、エン麦デンプン、オカデンプン、エンドウデンプン、ポリネシアン葛デンプン、ポテトデンプン、米デンプン、ライ麦デンプン、サゴデンプン、モロコシデンプン、スウィートポテトデンプン、タロデンプン、ヒシデンプン、小麦デンプン、山芋デンプン、およびその組み合わせを含む。
本発明の多糖ベースのゲル化剤はまたガムであっても良い。典型的なガムはアカシアガム、寒天、カラギナン、カシアガム、セルロースガム、ファーセレラン、ジェランガム、グアーガム、ガティガム、カラヤガム、カラマツガム、イナゴマメガム、ペクチン、シセゼンソウ、タラガム、トラガカント、キサンタンガム、またはその組み合わせを含む。
本発明の多糖ベースのゲル化剤はペクチンである。「ペクチン」は第一次細胞壁に存在し、特に陸生植物の非木質部分に特に豊富である複合的な多糖を意味する。ペクチンの構造の特徴はペクチンバックボーン、ホモガラクツロナンを形成するα−(1−4)−に結合したD−ガラクルトン酸の線状鎖である。このバックボーン中にガラクツロン酸が(1−2)−結合したL−ラムノースによって置換される領域がある。ラムノース残基から様々な中性糖分岐の側鎖を取る。
多糖ベースのゲル化剤はデキストリンである。「デキストリン」はデンプンまたはグリコーゲンの加水分解によって生成された低原子量の炭水化物のグループである。デキストリンはα−(1→4)またはα−(1→6)グリコシド結合によって結合されたD−グルコースのポリマーの混合である。
本発明の多糖ベースのゲル化剤はアルギン酸塩であっても良い。「アルギン酸塩」は茶色の藻類が水と結合することによって粘性ガムを形成する場所である細胞壁に広く配分されるアニオン性の多糖を意味する。アルギン酸塩は(1−4)−結合したβ−D−マンヌロン(M)およびC−5エピマーα−L−グルロネート(G)残基のホモポリマーブロックと、夫々異なった配列またはブロックで共有結合する線状コポリマーである。その色は白から黄色系の茶色の範囲である。それは繊維状、粒状、またはパウダー状で販売される。
本発明の多糖ベースのゲル化剤はカラギナンであっても良い。いくつかの実施形態では、カラギナンは特別な利点を提供し得る。「カラギナン」は赤い海藻から抽出された多糖ガムの一種を意味する。それらはガラクトスユニットおよび3、6アンヒドロガラクトース(3、6−AG)、硫酸化と非硫酸化の両方を繰り返すことから作られる線状硫酸化高原子量多糖から成る。そのユニットはアルファ1−3およびベータ1−4グリコシド結合によって加えられる。
Claims (23)
- 単回投与の製品を届けるためのソフトゲルカプセルパッケージ(100)であって、
タンパク質および多糖から選択される少なくとも1つのゲル化剤から作られるソフトゲルカプセルシェル(5)を有し、
前記ソフトゲルカプセルシェル(5)は、第1のシェルの厚さを有する少なくとも1つの領域と、当該ソフトゲルカプセルシェル(5)上の圧縮力の行使によって優先的に破裂するように形成された、シェルの厚さが減少した1またはそれ以上の領域(3)であって、前記カプセルシェル(5)中の開口を提供し、そこを介してパッケージ(100)に含まれる充填物が投薬され得る、前記シェルの厚さが減少した1またはそれ以上の領域(3)とを含む、ソフトゲルカプセルパッケージ(100)。 - 請求項1記載のパッケージ(100)において、前記ソフトゲルカプセルシェル(5)は前記パッケージ(100)に含まれる充填材料に不浸透性である、パッケージ(100)。
- 請求項1記載のパッケージ(100)において、前記ソフトゲルカプセルシェル(5)は、約0.05〜約5ml、または約0.1〜約3ml、または約0.2〜約2ml、または約0.25〜約1mlの内部容積を有する、パッケージ(100)。
- 請求項1記載のパッケージ(100)において、前記ソフトゲルカプセルシェル(5)は、球形、長方形、管状、円筒形、正方形、矩形、円盤状、猫耳形、または楕円形から選択される形状を有する、パッケージ(100)。
- 請求項1記載のパッケージ(100)において、前記厚さが減少した1またはそれ以上の領域(3)は円形状または線状である、パッケージ(100)。
- 請求項1記載のパッケージ(100)において、前記ソフトゲルカプセルシェル(5)は本体(1)および少なくとも1つの突起(2)を特徴づけるものである、パッケージ(100)。
- 請求項6記載のパッケージ(100)において、前記厚さが減少した1またはそれ以上の領域(3)は突起(2)上に位置される、パッケージ(100)。
- 請求項6記載のパッケージ(100)であって、2つの突起(2)を有し、前記厚さが減少した1またはそれ以上の領域(3)は前記2つの突起(2)の間のへこんだ領域部分に位置される、パッケージ(100)。
- 請求項7記載のパッケージ(100)において、前記突起(2)は、本体(1)から約0.5mm未満、または約0.4mm未満、または約0.3mm未満、または約0.2mm未満延びるものである、パッケージ(100)。
- 請求項1記載のパッケージ(100)において、前記ソフトゲルカプセルシェル(5)の表面は、さらに、質感領域を有する、パッケージ(100)。
- 請求項10記載のパッケージ(100)において、前記質感領域は、畝、縞、棒、帯、筋、片、斑点、線紋、リブ、およびそれらの組み合わせから選択される1またはそれ以上の構造によって作られる、パッケージ(100)。
- 請求項1記載のパッケージ(100)において、前記少なくとも1つのゲル化剤はタンパク質ベースのゲル化剤である、パッケージ(100)。
- 請求項12記載のパッケージ(100)において、前記タンパク質ベースのゲル化剤は、コラーゲン、ゼラチン、卵白、またはミルクベースのタンパク質からなる群から選択されるものである、パッケージ(100)。
- 請求項1記載のパッケージ(100)において、前記少なくとも1つのゲル化剤は多糖ベースのゲル化剤である、パッケージ(100)。
- 請求項14記載のパッケージ(100)において、前記多糖ベースのゲル化剤は、セルロースベースの材料、デンプン、加工デンプン、ペクチン、ガム、デキストリン、アルギン酸塩、カラギナン、およびそれらの混合物からなる群から選択されるものである、パッケージ(100)。
- 請求項1記載のパッケージ(100)において、前記ソフトゲルカプセル(5)は少なくとも2つのゲル化剤から作られるものである、パッケージ(100)。
- 請求項16記載のパッケージ(100)において、前記ゲル化剤は加工デンプンおよびイオタカラギナンを有するものである、パッケージ(100)。
- 請求項1記載のパッケージ(100)において、少なくとも1つのゲル化剤はゼラチンである、パッケージ(100)。
- 請求項18記載のパッケージ(100)において、前記ゼラチンは前記ソフトゲルカプセルシェル(5)の約25〜約45重量%の量を有するものである、パッケージ(100)。
- 請求項1記載のパッケージ(100)において、前記カプセル(5)は、さらに、可塑剤、防腐剤、香味剤、不透明化剤、緩衝剤、脆化防止剤、染料、崩壊剤、香水、香料、シェル質感化成分、真珠光沢顔料、光輝性顔料、および水からなる群から選択される1またはそれ以上の成分を有するものである、パッケージ(100)。
- 請求項17記載のパッケージ(100)において、前記カプセル(5)は、さらに、可塑剤、防腐剤、香味剤、不透明化剤、緩衝剤、脆化防止剤、染料、崩壊剤、香水、香料、シェル質感化成分、真珠光沢顔料、光輝性顔料、および水からなる群から選択される成分を有するものである、パッケージ(100)。
- 請求項1記載のパッケージ(100)において、前記カプセル(5)は、約0.024cm〜約0.1778cmの第1の厚さと、前記第1の厚さより約30%〜約70%、または約40%〜約50%薄い、厚さが減少した領域(3)における第2の厚さとを有するものである、パッケージ(100)。
- 請求項1記載のパッケージ(100)を製造する方法であって、
ソフトゲル材料の2つの部分の間で充填組成物を提供する工程と、
前記充填組成物をカプセル化するソフトゲルカプセルを作るために前記ソフトゲル材料の2つの部分を融合する工程と、
前記融合する工程の前または間に、前記ソフトゲルカプセルのカプセルシェル(5)上に、厚さが減少した少なくとも1つの領域(3)を作り出す工程と、
を有する、方法。
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US201462000615P | 2014-05-20 | 2014-05-20 | |
US62/000,615 | 2014-05-20 | ||
PCT/US2015/030126 WO2015179159A1 (en) | 2014-05-20 | 2015-05-11 | Capsule dispensing container |
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PT3145836T (pt) | 2019-05-30 |
TWI667045B (zh) | 2019-08-01 |
WO2015179159A1 (en) | 2015-11-26 |
US20150335586A1 (en) | 2015-11-26 |
US10898438B2 (en) | 2021-01-26 |
ES2725706T3 (es) | 2019-09-26 |
EP3145836A4 (en) | 2017-12-20 |
JP6573423B2 (ja) | 2019-09-11 |
KR20170012227A (ko) | 2017-02-02 |
SI3145836T1 (sl) | 2019-06-28 |
US20170239186A1 (en) | 2017-08-24 |
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AU2015264543A1 (en) | 2016-11-17 |
CN106458426A (zh) | 2017-02-22 |
BR112016027031B1 (pt) | 2022-02-08 |
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DK3145836T3 (da) | 2019-05-06 |
AR100519A1 (es) | 2016-10-12 |
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