JPWO2020071395A1 - 強度が改善された硬質カプセル、及びその製造方法 - Google Patents
強度が改善された硬質カプセル、及びその製造方法 Download PDFInfo
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- JPWO2020071395A1 JPWO2020071395A1 JP2020550474A JP2020550474A JPWO2020071395A1 JP WO2020071395 A1 JPWO2020071395 A1 JP WO2020071395A1 JP 2020550474 A JP2020550474 A JP 2020550474A JP 2020550474 A JP2020550474 A JP 2020550474A JP WO2020071395 A1 JPWO2020071395 A1 JP WO2020071395A1
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- hard capsule
- capsule
- film
- mass
- polyvinyl alcohol
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
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- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/485—Inorganic compounds
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- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4891—Coated capsules; Multilayered drug free capsule shells
Abstract
ポリビニルアルコール及びポリビニルアルコール共重合体からなる群から選ばれる少なくとも一種の基剤に、平均粒子径が0.01μm以上10μm以下のシリカ粒子を添加することにより硬質カプセルのカプセル皮膜の強度を改善する。
Description
項1.ポリビニルアルコール及びポリビニルアルコール共重合体からなる群から選ばれる少なくとも一種の基剤と、平均粒子径が0.01μm以上10μm以下のシリカ粒子とを含有する皮膜からなる硬質カプセル。
項2.前記シリカ粒子の平均粒径が0.02μm以上1μm以下である、項1に記載の硬質カプセル。
項3.水分を除く前記硬質カプセルの皮膜成分合計を100質量%とした場合に、該皮膜成分に含まれる前記シリカ粒子の含有量が、1質量%以上45質量%以下である、項1又は2に記載の硬質カプセル。
項4.さらに、層状粘土鉱物を含む皮膜からなる、項1〜3のいずれか一項に記載の硬質カプセル。
項5.前記層状粘土鉱物が、フィロケイ酸塩である、項4に記載の硬質カプセル。
項6.前記フィロケイ酸塩が、ベントナイトである、項5に記載の硬質カプセル。
項7.前記ポリビニルアルコールが、けん化度78%〜95%の範囲を有する部分けん化ポリビニルアルコールであり、及び前記ポリビニルアルコール共重合体が、けん化度78%〜95%の範囲を有する部分けん化ポリビニルアルコール共重合体である、項1〜6のいずれか一項に記載の硬質カプセル。
項8.ポリビニルアルコール及びポリビニルアルコール共重合体からなる群から選ばれる少なくとも一種の基剤と、平均粒子径が0.01μm以上10μm以下のシリカ粒子及び溶媒とを含有する硬質カプセル調製液。
項9.前記シリカ粒子の平均粒径が0.02μm以上1μm以下である、項8に記載の硬質カプセル調製液。
項10.前記硬質カプセル調製液の前記溶媒を除く固形分合計を100質量%とした場合に、前記シリカ粒子の含有量が、1質量%以上45質量%以下である、項8又は9に記載の硬質カプセル調製液。
項11.さらに、層状粘土鉱物を含む、項8〜10のいずれか一項に記載の硬質カプセル調製液。
項12.前記層状粘土鉱物が、フィロケイ酸塩である、項11に記載の硬質カプセル調製液。
項13.前記フィロケイ酸塩が、ベントナイトである、項12に記載の硬質カプセル調製液。
項14.前記ポリビニルアルコールが、けん化度78%〜95%の範囲を有する部分けん化ポリビニルアルコールであり、及び前記ポリビニルアルコール共重合体が、けん化度78%〜95%の範囲を有する部分けん化ポリビニルアルコール共重合体である、項8〜13のいずれか一項に記載の硬質カプセル調製液。
項15.下記工程を含む硬質カプセルの調製方法:
前記項8〜14のいずれか一項に記載の硬質カプセル調製液を使用して、硬質カプセルを調製する工程。
項16.前記硬質カプセルの調製方法が、硬質カプセルの硬度を改善するためのものである、項15に記載の硬質カプセルの調製方法。
(1)硬質カプセル材料
はじめに、本明細書、及び特許請求の範囲等で使用される用語について説明する。本発明で使用される用語は、特に記載がない限り、本項の説明にしたがう。
残留飽和水分量は乾燥減量での含水率で表すことができ、その測定は、以下のようにして行うことができる。
デシケータに、炭酸カリウム飽和水溶液を入れて恒湿状態とした雰囲気中に試料(硬質カプセル、又はフィルム)を入れ密閉し、25℃で1週間調湿する。なお、炭酸カリウム飽和水溶液の存在下では、相対湿度約43%の雰囲気を作成することができる。調湿後の試料の質量(湿質量)を測定した後、次いで当該試料を105℃で2時間加熱乾燥し、再度試料の質量(乾燥質量)を測定する。乾燥前の質量(湿質量)と乾燥後の質量(乾燥質量)の差から、下式に従って、105℃で2時間加熱乾燥することによって減少する水分量の割合(含水率)を算出する。
本態様の硬質カプセルの皮膜は、基剤と、強度改善剤とを含む皮膜からなる。基剤の含有量は、水分を除く硬質カプセルの皮膜成分合計を100質量%とした場合に、100質量%から基剤以外のカプセル皮膜含有成分の含有量の合計質量%を減じた量である。
本態様の硬質カプセルを調製するためのカプセル調製液は、溶媒と上記2.で述べた成分を含む。溶媒は、水性溶媒である限り特に制限されない。溶媒として好ましくは水、エタノール、及びこれらの混合物、より好ましくは水である。
強度改善剤を2種、又は3種を組み合わせて使用する場合、硬質カプセルに含有される強度改善剤の含有量の合計量の下限値は、上記いずれかの強度改善剤の含有量の下限値を最下限値とすることができる。また、硬質カプセルに含有される強度改善剤の含有量の合計量上限値は、上記いずれかの強度改善剤の含有量の上限値を最上限値とすることができる。
カプセル調製液(浸漬液)の調製方法は、特に制限されない。例えば約70〜100℃程度に加熱した精製水に、必要に応じてゲル化剤やゲル化補助剤を溶解した後、ポリビニルアルコール及び/又はポリビニルアルコール共重合体を溶解させて、均一なカプセル調製液(浸漬液)を調製する方法がある。
カプセル調製液に含まれる各成分の濃度は、後述する。
(1)ポリビニルアルコール及び/又はポリビニルアルコール共重合体(また必要に応じてゲル化剤やゲル化補助剤)を含有するカプセル調製液(浸漬液)に、カプセル成型用ピンを浸漬する工程(浸漬工程)、
(2)カプセル調製液(浸漬液)からカプセル成型用ピンを引き上げて、当該ピンの外表面に付着したカプセル調製液をゲル化する工程(ゲル化工程)、
(3)カプセル成型用ピンの外表面に被覆形成されたゲル化カプセルフィルム(ゲル化皮膜)を乾燥する工程(乾燥工程)、
(4)乾燥したカプセルフィルム(皮膜)をカプセル成型用ピンから脱離する工程(脱離工程)。
なお、必要に応じて上記(4)の工程後に下記の加熱工程を行ってもよい。
(5)上記のゲル化工程(2)後の、乾燥工程(3)の前後若しくは同時に、又は脱離工程(4)後に、ゲル化カプセルフィルム(ゲル化皮膜)を30〜150℃で加熱処理する工程(加熱工程)。
硬質カプセルに内容物を充填する方法は、特に制限されない。
内容物の硬質カプセル内への充填は、特開2007−144014号公報、特開2000−226097号公報等に記載の公知のカプセル充填機、例えば全自動カプセル充填機(型式名:LIQFILsuper80/150、クオリカプス社製)、カプセル充填・シール機(型式名:LIQFILsuperFS、クオリカプス社製)等を用いて実施することができる。
本発明の硬質カプセルの用途は、特に制限されない。好ましくは、経口製剤、及び吸引製剤等を挙げることができる。
硬質カプセルの皮膜の強度(ヤング率、及び/又は破断伸び)を評価する場合、被験皮膜の厚みをそろえて比較することが重要である。このため、硬質カプセルの各成分組成に依存する皮膜の強度は、硬質カプセル調製液の各成分組成と同一成分組成である調製液を用いて、キャスト法によりフィルムを作製し、当該キャストフィルムを用いて評価することができる。
(1)カプセル組成液の調製
500mLのトールビーカーにイオン交換水144gを添加し、メカニカルスターラーでの攪拌下、基剤としてポリビニルアルコール(日本合成化学工業製、EG−48P)を35.7g添加し分散させた。湯浴にて溶液を85℃まで加熱した後、さらに1時間攪拌してポリビニルアルコールを溶解させた。ここに滴下漏斗を用いてシリカスラリ(富士シリシア化学製WA302、シリカ濃度約13質量%、シリカ平均粒子径0.2μm)120gを約40分かけて滴下した後、さらに1時間撹拌した。得られた溶液を55℃のオーブンにて一晩静置させることで脱泡し、カプセル組成液として用いた。皮膜形成時に、水分を除く皮膜成分合計に対するシリカ粒子の含有量が30質量%となるように調製した。
上記のように調製したカプセル組成液を、ボックス型アプリケータを用いてPETフィルム上に乾燥膜厚が約100μmになるように製膜した後、80℃の熱風オーブンに2時間静置して乾燥させた。乾燥後のフィルムは打ち抜き機を用いてダンベル型(JIS K−7161−2 1−BA)に打ち抜いて皮膜のサンプルとして用いた。
上記にて調製したサンプルは、飽和塩水溶液を備えたガラス製デシケータ内に静置し、デシケータを25℃の恒温槽にて一週間以上保管することで調湿を行った.低湿度条件(25℃、22%RH)として酢酸カリウムの飽和塩水溶液を、高湿度条件(25℃、60%RH)として硝酸アンモニウムの飽和塩水溶液を用いた。
上記の通りデシケータ中で調湿したダンベル状試験片(JIS K7161−2 1−BA)を用いて、引張速度10mm/min、チャック間距離59mmの条件にて引張試験を行った。装置は島津製作所製万能試験機EZ−LXを用いた。引張試験により、試験片の伸びと、その際にかかる試験力を評価した。試験力を初期断面積で除した公称応力σと、試験片の伸びを初期長さで除した公称ひずみをそれぞれ求めた。得られた応力−ひずみ曲線の初期の傾きによりヤング率(MPa)を求め、応力−ひずみ曲線下部の面積よりフィルムのタフネス(MJ/m3)を求めた。ヤング率の評価には25℃、60%RHにて調湿したサンプルを、タフネスの評価には25℃、22%RHにて調湿したサンプルをそれぞれ使用した。
シリカスラリとして、AEROSIL 90G(日本アエロジル株式会社製、シリカ平均粒子径0.02μm)25.5gをイオン交換水229.6gに添加し、超音波照射を4時間実施したものを使用した以外は実施例1と同様にして皮膜のサンプルを調製し評価を行った。水分を除く皮膜成分合計に対するシリカ粒子の含有量も実施例1と同様とした。
500mLのトールビーカーにイオン交換水258gを添加し、シリカ粒子(トクヤマ製サンシールSS10、平均粒子径1μm)を12.6g加え、超音波処理を2時間施した.メカニカルスターラーでの攪拌下ポリビニルアルコール(日本合成化学工業製、EG−48P)を29.4g添加し分散させた。湯浴にて溶液を85℃まで加熱した後、さらに1時間攪拌してポリビニルアルコールを溶解させた。得られた溶液を55℃のオーブンにて一晩静置させることで脱泡し、カプセル組成液として用いた。その他は実施例1と同様にして皮膜のサンプルを調製し評価を行った。水分を除く皮膜成分合計に対するシリカ粒子の含有量も実施例1と同様とした。
シリカ粒子として富士シリシア化学製サイロスフェアC−1504(平均粒子径4μm)を用いた以外は実施例3と同様にして皮膜のサンプルを調製し評価を行った。水分を除く皮膜成分合計に対するシリカ粒子の含有量も実施例1と同様とした。
シリカ粒子として富士シリシア化学製サイロスフェアC−1510(平均粒子径10μm)を用いた以外は実施例3と同様にして皮膜のサンプルを調製し評価を行った。水分を除く皮膜成分合計に対するシリカ粒子の含有量も実施例1と同様とした。
シリカスラリを添加しない以外は実施例1と同様に皮膜のサンプルを調製し評価を行った。
水分を除く皮膜成分合計に対するシリカ粒子の含有量が15.8質量%となるようシリカ粒子の添加量を調製したこと以外は、実施例3と同様にして皮膜のサンプルを調製し評価を行った。
水分を除く皮膜成分合計に対するシリカ粒子の含有量が42質量%となるようシリカ粒子の添加量を調製したこと以外は実施例3と同様にして皮膜のサンプルを調製し評価を行った。
水分を除く皮膜成分合計に対するシリカ粒子の含有量が42質量%となるようシリカスラリの添加量を調製したこと以外は実施例1と同様にして皮膜のサンプルを調製し評価を行った。
500mLのトールビーカーにイオン交換水174gを添加し、モンモリロナイト(クニミネ工業製、Kunipia−F)0.42gを添加した。この分散液に対し、ホモジナイザー(IKA製、使用ジェネレータ:S25N−25F)を用いて均一化処理(10000rpm、30分)を施した。メカニカルスターラーでの攪拌下ポリビニルアルコール(日本合成化学工業製、EG−48P)を28.2g添加し分散させた。湯浴にて溶液を85℃まで加熱した後、さらに1時間攪拌してポリビニルアルコールを溶解させた。ここに滴下漏斗を用いてシリカスラリ(富士シリシア化学製WA302、シリカ濃度約13質量%、シリカ平均粒子径0.2μm)97gを約40分かけて滴下した後、さらに1時間撹拌した。得られた溶液を55℃のオーブンにて一晩静置させることで脱泡し、カプセル組成液として用いた。その他は実施例1と同様にして皮膜のサンプルを調製し評価を行った。水分を除く皮膜成分合計に対するシリカ粒子の含有量も実施例1と同様とした。水分を除く皮膜成分合計に対するモンモリロナイトの含有量は1質量%となるよう調製した。
水分を除く皮膜成分合計に対するモンモリロナイトの含有量が2質量%となるよう調製したこと以外は実施例9と同様にして皮膜のサンプルを調製し評価を行った。水分を除く皮膜成分合計に対するシリカ粒子の含有量も実施例9と同様とした。
実施例1〜10及び比較例1について、皮膜成分と評価結果を表1にまとめた。
Claims (16)
- ポリビニルアルコール及びポリビニルアルコール共重合体からなる群から選ばれる少なくとも一種の基剤と、平均粒子径が0.01μm以上10μm以下のシリカ粒子とを含有する皮膜からなる硬質カプセル。
- 前記シリカ粒子の平均粒径が0.02μm以上1μm以下である、請求項1に記載の硬質カプセル。
- 水分を除く前記硬質カプセルの皮膜成分の合計を100質量%とした場合に、該皮膜成分に含まれる前記シリカ粒子の含有量が、1質量%以上45質量%以下である、請求項1又は2に記載の硬質カプセル。
- さらに、層状粘土鉱物を含む皮膜からなる、請求項1〜3のいずれか一項に記載の硬質カプセル。
- 前記層状粘土鉱物が、フィロケイ酸塩である、請求項4に記載の硬質カプセル。
- 前記フィロケイ酸塩が、ベントナイトである、請求項5に記載の硬質カプセル。
- 前記ポリビニルアルコールが、けん化度78%〜95%の範囲を有する部分けん化ポリビニルアルコールであり、及び前記ポリビニルアルコール共重合体が、けん化度78%〜95%の範囲を有する部分けん化ポリビニルアルコール共重合体である、請求項1〜6のいずれか一項に記載の硬質カプセル。
- ポリビニルアルコール及びポリビニルアルコール共重合体からなる群から選ばれる少なくとも一種の基剤と、平均粒子径が0.01μm以上10μm以下のシリカ粒子及び溶媒とを含有する硬質カプセル調製液。
- 前記シリカ粒子の平均粒径が0.02μm以上1μm以下である、請求項8に記載の硬質カプセル調製液。
- 前記硬質カプセル調製液の前記溶媒を除く固形分合計を100質量%とした場合に、前記シリカ粒子の含有量が、1質量%以上45質量%以下である、請求項8又は9に記載の硬質カプセル調製液。
- さらに、層状粘土鉱物を含む、請求項8〜10のいずれか一項に記載の硬質カプセル調製液。
- 前記層状粘土鉱物が、フィロケイ酸塩である、請求項11に記載の硬質カプセル調製液。
- 前記フィロケイ酸塩が、ベントナイトである、請求項12に記載の硬質カプセル調製液。
- 前記ポリビニルアルコールが、けん化度78%〜95%の範囲を有する部分けん化ポリビニルアルコールであり、及び前記ポリビニルアルコール共重合体が、けん化度78%〜95%の範囲を有する部分けん化ポリビニルアルコール共重合体である、請求項8〜13のいずれか一項に記載の硬質カプセル調製液。
- 下記工程を含む硬質カプセルの調製方法:
前記請求項8〜14のいずれか一項に記載の硬質カプセル調製液を使用して、硬質カプセルを調製する工程。 - 前記硬質カプセルの調製方法が、硬質カプセルの硬度を改善するためのものである、請求項15に記載の硬質カプセルの調製方法。
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PCT/JP2019/038838 WO2020071395A1 (ja) | 2018-10-02 | 2019-10-02 | 強度が改善された硬質カプセル、及びその製造方法 |
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EP (1) | EP3862022A4 (ja) |
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EP1752140A1 (en) | 2005-08-12 | 2007-02-14 | Warner-Lambert Company LLC | Method for banding hard capsules using hydroxypropylmethyl cellulose (HPMC) as a base |
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KR102296142B1 (ko) * | 2016-07-06 | 2021-08-31 | 쿠오리카프스 가부시키가이샤 | 경도가 개선된 경질 캡슐 및 그 제조 방법 |
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US20210369627A1 (en) * | 2018-10-02 | 2021-12-02 | Qualicaps Co., Ltd. | Improved-strength hard capsule and production method for same |
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- 2019-10-02 EP EP19869672.6A patent/EP3862022A4/en active Pending
- 2019-10-02 WO PCT/JP2019/038838 patent/WO2020071395A1/ja unknown
- 2019-10-02 US US17/282,085 patent/US20210369625A1/en active Pending
- 2019-10-02 JP JP2020550474A patent/JPWO2020071395A1/ja active Pending
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EP3862022A4 (en) | 2022-06-29 |
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EP3862022A1 (en) | 2021-08-11 |
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