JP7472028B2 - 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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- JP7472028B2 JP7472028B2 JP2020550472A JP2020550472A JP7472028B2 JP 7472028 B2 JP7472028 B2 JP 7472028B2 JP 2020550472 A JP2020550472 A JP 2020550472A JP 2020550472 A JP2020550472 A JP 2020550472A JP 7472028 B2 JP7472028 B2 JP 7472028B2
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- hard capsule
- capsule
- mass
- polyvinyl alcohol
- hard
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Images
Classifications
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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
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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
- A61K9/4816—Wall or shell material
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
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、両極性分子と結合した層状粘土鉱物とを含有する皮膜からなる硬質カプセル。
項2.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層状粘土鉱物の含有量が、1質量%以上10質量%以下である、項1に記載の硬質カプセル。
項3.前記両極性分子がアミノ酸である、項1又は2に記載の硬質カプセル。
項4.前記アミノ酸が炭素数2~11のアミノ酸である、項3に記載の硬質カプセル。項5.前記炭素数2~11のアミノ酸がグルタミン酸である、項4に記載の硬質カプセル。
項6.前記層状粘土鉱物が、フィロケイ酸塩である、項1~5のいずれか一項に記載の硬質カプセル。項7.前記フィロケイ酸塩が、ベントナイトである、項6に記載の硬質カプセル。
項8.さらに、平均粒子径が0.01μm以上10μm以下のシリカ粒子を含む皮膜からなる、項1~7のいずれか一項に記載の硬質カプセル。
項9.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1~8のいずれか一項に記載の硬質カプセル。
項10.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、両極性分子と結合した層状粘土鉱物及び溶媒とを含有する硬質カプセル調製液。
項11.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、前記層状粘土鉱物の含有量が、1質量%以上10質量%以下である、項10に記載の硬質カプセル調製液。
項12.前記両極性分子がアミノ酸である、項10又は11に記載の硬質カプセル調製液。
項13.前記アミノ酸が炭素数2~11のアミノ酸である、項12に記載の硬質カプセル調製液。
項14.前記炭素数2~11のアミノ酸がグルタミン酸である、項13に記載の硬質カプセル調製液。
項15.前記層状粘土鉱物が、フィロケイ酸塩である、項10~14のいずれか一項に記載の硬質カプセル調製液。
項16.前記フィロケイ酸塩が、ベントナイトである、項15に記載の硬質カプセル調製液。
項17.さらに、平均粒子径が0.01μm以上10μm以下のシリカ粒子を含む、項10~16のいずれか一項に記載の硬質カプセル調製液。
項18.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10~17のいずれか一項に記載の硬質カプセル調製液。
項19.下記工程を含む硬質カプセルの調製方法:前記項10~18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20.前記硬質カプセルの調製方法が、硬質カプセルの強度を改善するためのものである、項19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。
、AEROSILシリーズ(日本アエロジル株式会社製)、シリカ粒子(株式会社トクヤマ サンシール)、サイロスフェアC-シリーズ(富士シリシア化学株式会社)等を挙げることができる。
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。
強度改善剤は、2種、又は3種を組み合わせて使用してもよい。前記強度改善剤を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、組み合わせる強度改善剤の上述の含有量の下限値の中で最も低い値を採用することができる。また、前記強度改善剤を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上限値は、組み合わせる強度改善剤の上述の含有量の上限値の中で最も高い値を採用することができる。
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。
<実施例1>
(1)モンモリロナイトの表面修飾
1000mLのセパラブル三口フラスコにイオン交換水を800mL入れ、層状粘土鉱物としてベントナイト(クニミネ工業製Kunipia-F;モンモリロナイトを主成分とする)を8.01g加えてメカニカルスターラーにより撹拌した。滴下漏斗にL-グルタミン酸(東京化成工業製)を2.83g加えて70℃のイオン交換水148gで希釈した。ここに2mol/Lの希塩酸を10mL加えてpHを調整し、L-グルタミン酸をアンモニウムカチオンの状態とした.この酸溶液をモンモリロナイトの水分散液に約1時間かけて滴下した後、さらに1時間攪拌を続けて表面修飾を行った。得られた表面修飾モンモリロナイトの分散液を遠心分離(18000rpm、5分、日立製himac CR22G)により沈殿させた。沈殿物をイオン交換水に再分散させ、再度遠心分離により回収し精製した。沈殿物を減圧下、120℃で5時間乾燥させることで、両極性分子であるL-グルタミン酸分子と結合した表面修飾モンモリロナイトを得た。
500mLのトールビーカーにイオン交換水258gを添加し、ジェランガム(ケルコゲル、CPケルコ製)0.6gを加えて湯浴にて85℃まで溶液を加熱・撹拌し、ジェランガムを溶解させた。ここに、表面修飾モンモリロナイトを1.7g添加した後,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。この溶液を50℃程度まで冷却した後,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39.5g添加した。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。水分を除く皮膜成分中、表面修飾された層状粘土鉱物の含有量は4質量%である。
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)に打ち抜いてサンプルとして用いた。
上記にて調製したサンプルフィルムは,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1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)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、試験片が破断した時のひずみより破断伸び(%)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、破断伸びの評価には25℃、22%RHにて調湿したサンプルをそれぞれ使用した。
層状粘度鉱物を含有しない以外は実施例1と同様にしてフィルムを調製し評価を行った。
層状粘度鉱物として未修飾のモンモリロナイトを用いた以外は、実施例1と同様にしてフィルム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301gを添加し、層状粘土鉱物として未修飾モンモリロナイトを1.96g添加した後,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(10,000rpm、30分)を施した。メカニカルスターラーでの攪拌下、L-グルタミン酸0.38g及び基剤としてポリビニルアルコールを45.7g添加した。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と同様にしてフィルムを調製し評価を行った。
実施例1、比較例1~4についても実施例1と同様に表1に示す。
Claims (12)
- 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、グルタミン酸と結合した層状粘土鉱物とを含有する皮膜からなる硬質カプセルであって、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層状粘土鉱物の含有量が、2質量%~5質量%である、前記硬質カプセル。
- 前記層状粘土鉱物が、フィロケイ酸塩である、請求項1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2に記載の硬質カプセル。
- さらに、平均粒子径が0.01μm以上10μm以下のシリカ粒子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1~4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、グルタミン酸と結合した層状粘土鉱物及び溶媒とを含有する硬質カプセル調製液であって、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、前記層状粘土鉱物の含有量が、2質量%~5質量%である、前記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6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7に記載の硬質カプセル調製液。
- さらに、平均粒子径が0.01μm以上10μm以下のシリカ粒子を含む、請求項6~8のいずれか一項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6~9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6~10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、硬質カプセルの強度を改善するためのものである、請求項11に記載の硬質カプセルの調製方法。
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GB1598081A (en) | 1977-02-10 | 1981-09-16 | Allen & Hanburys Ltd | Inhaler device for dispensing medicaments |
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- 2019-10-02 EP EP19868462.3A patent/EP3862021A4/en active Pending
- 2019-10-02 WO PCT/JP2019/038836 patent/WO2020071393A1/ja unknown
- 2019-10-02 US US17/282,079 patent/US20210369627A1/en active Pending
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EP3862021A1 (en) | 2021-08-11 |
US20210369627A1 (en) | 2021-12-02 |
JPWO2020071393A1 (ja) | 2021-09-02 |
WO2020071393A1 (ja) | 2020-04-09 |
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