JP5289429B2 - 硬質カプセル剤 - Google Patents
硬質カプセル剤 Download PDFInfo
- Publication number
- JP5289429B2 JP5289429B2 JP2010507091A JP2010507091A JP5289429B2 JP 5289429 B2 JP5289429 B2 JP 5289429B2 JP 2010507091 A JP2010507091 A JP 2010507091A JP 2010507091 A JP2010507091 A JP 2010507091A JP 5289429 B2 JP5289429 B2 JP 5289429B2
- Authority
- JP
- Japan
- Prior art keywords
- capsule
- film
- hard capsule
- polyvinyl alcohol
- pva
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 239000007902 hard capsule Substances 0.000 title claims abstract description 148
- 229920002451 polyvinyl alcohol Polymers 0.000 claims abstract description 203
- 239000004372 Polyvinyl alcohol Substances 0.000 claims abstract description 202
- 239000002775 capsule Substances 0.000 claims abstract description 185
- 238000002360 preparation method Methods 0.000 claims description 88
- 239000002202 Polyethylene glycol Substances 0.000 claims description 44
- 229920001223 polyethylene glycol Polymers 0.000 claims description 44
- 238000000034 method Methods 0.000 claims description 37
- 150000007524 organic acids Chemical class 0.000 claims description 34
- 239000000203 mixture Substances 0.000 claims description 33
- -1 alkali metal salt Chemical class 0.000 claims description 25
- 238000004519 manufacturing process Methods 0.000 claims description 24
- 150000003839 salts Chemical class 0.000 claims description 24
- 238000007789 sealing Methods 0.000 claims description 21
- 239000003349 gelling agent Substances 0.000 claims description 20
- 238000000465 moulding Methods 0.000 claims description 20
- 238000011049 filling Methods 0.000 claims description 19
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 16
- 238000001035 drying Methods 0.000 claims description 15
- 239000000600 sorbitol Substances 0.000 claims description 15
- 239000004014 plasticizer Substances 0.000 claims description 7
- 229910052783 alkali metal Inorganic materials 0.000 claims description 4
- 238000000926 separation method Methods 0.000 claims 1
- 239000007788 liquid Substances 0.000 description 72
- 239000000243 solution Substances 0.000 description 37
- 235000002639 sodium chloride Nutrition 0.000 description 32
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 28
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 18
- 238000009864 tensile test Methods 0.000 description 18
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 16
- 238000007654 immersion Methods 0.000 description 16
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 15
- 239000007864 aqueous solution Substances 0.000 description 15
- 229960002920 sorbitol Drugs 0.000 description 15
- 239000000679 carrageenan Substances 0.000 description 14
- 229920001525 carrageenan Polymers 0.000 description 14
- 229940113118 carrageenan Drugs 0.000 description 14
- 239000003814 drug Substances 0.000 description 14
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 10
- 235000010418 carrageenan Nutrition 0.000 description 10
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 10
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerol Natural products OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 9
- 238000005259 measurement Methods 0.000 description 9
- 238000007127 saponification reaction Methods 0.000 description 9
- 239000003795 chemical substances by application Substances 0.000 description 8
- 229940079593 drug Drugs 0.000 description 8
- 238000010438 heat treatment Methods 0.000 description 8
- 238000002156 mixing Methods 0.000 description 8
- 239000001103 potassium chloride Substances 0.000 description 8
- 235000011164 potassium chloride Nutrition 0.000 description 8
- 239000000047 product Substances 0.000 description 8
- 239000002904 solvent Substances 0.000 description 8
- 229920002148 Gellan gum Polymers 0.000 description 7
- 235000013305 food Nutrition 0.000 description 7
- 238000009472 formulation Methods 0.000 description 7
- 239000000499 gel Substances 0.000 description 7
- 235000010492 gellan gum Nutrition 0.000 description 7
- 239000000216 gellan gum Substances 0.000 description 7
- 235000011187 glycerol Nutrition 0.000 description 7
- 238000006116 polymerization reaction Methods 0.000 description 7
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 description 6
- 235000011054 acetic acid Nutrition 0.000 description 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
- 150000001875 compounds Chemical class 0.000 description 6
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 6
- 239000000126 substance Substances 0.000 description 6
- 239000011975 tartaric acid Substances 0.000 description 6
- 235000002906 tartaric acid Nutrition 0.000 description 6
- 238000012360 testing method Methods 0.000 description 6
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 description 5
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 5
- 235000014113 dietary fatty acids Nutrition 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 239000000194 fatty acid Substances 0.000 description 5
- 229930195729 fatty acid Natural products 0.000 description 5
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 5
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 5
- 150000004667 medium chain fatty acids Chemical class 0.000 description 5
- 235000005985 organic acids Nutrition 0.000 description 5
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 description 5
- JUJWROOIHBZHMG-UHFFFAOYSA-N Pyridine Chemical compound C1=CC=NC=C1 JUJWROOIHBZHMG-UHFFFAOYSA-N 0.000 description 4
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 4
- 238000005336 cracking Methods 0.000 description 4
- 230000007423 decrease Effects 0.000 description 4
- 239000003205 fragrance Substances 0.000 description 4
- 239000001301 oxygen Substances 0.000 description 4
- 229910052760 oxygen Inorganic materials 0.000 description 4
- 229920001277 pectin Polymers 0.000 description 4
- 239000001814 pectin Substances 0.000 description 4
- 235000010987 pectin Nutrition 0.000 description 4
- 239000000546 pharmaceutical excipient Substances 0.000 description 4
- 229920000642 polymer Polymers 0.000 description 4
- 239000008213 purified water Substances 0.000 description 4
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 description 3
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 description 3
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 description 3
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 3
- 229920000604 Polyethylene Glycol 200 Polymers 0.000 description 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
- ZNOZWUKQPJXOIG-XSBHQQIPSA-L [(2r,3s,4r,5r,6s)-6-[[(1r,3s,4r,5r,8s)-3,4-dihydroxy-2,6-dioxabicyclo[3.2.1]octan-8-yl]oxy]-4-[[(1r,3r,4r,5r,8s)-8-[(2s,3r,4r,5r,6r)-3,4-dihydroxy-6-(hydroxymethyl)-5-sulfonatooxyoxan-2-yl]oxy-4-hydroxy-2,6-dioxabicyclo[3.2.1]octan-3-yl]oxy]-5-hydroxy-2-( Chemical compound O[C@@H]1[C@@H](O)[C@@H](OS([O-])(=O)=O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H]2OC[C@H]1O[C@H](O[C@H]1[C@H]([C@@H](CO)O[C@@H](O[C@@H]3[C@@H]4OC[C@H]3O[C@H](O)[C@@H]4O)[C@@H]1O)OS([O-])(=O)=O)[C@@H]2O ZNOZWUKQPJXOIG-XSBHQQIPSA-L 0.000 description 3
- 239000002671 adjuvant Substances 0.000 description 3
- 239000002585 base Substances 0.000 description 3
- 239000001110 calcium chloride Substances 0.000 description 3
- 229910001628 calcium chloride Inorganic materials 0.000 description 3
- 235000011148 calcium chloride Nutrition 0.000 description 3
- 229910001424 calcium ion Inorganic materials 0.000 description 3
- 239000003086 colorant Substances 0.000 description 3
- 230000002950 deficient Effects 0.000 description 3
- 238000007598 dipping method Methods 0.000 description 3
- 150000002148 esters Chemical class 0.000 description 3
- 238000011156 evaluation Methods 0.000 description 3
- 239000007903 gelatin capsule Substances 0.000 description 3
- 238000001879 gelation Methods 0.000 description 3
- 239000004310 lactic acid Substances 0.000 description 3
- 235000014655 lactic acid Nutrition 0.000 description 3
- 239000000178 monomer Substances 0.000 description 3
- 239000012476 oxidizable substance Substances 0.000 description 3
- 229920001451 polypropylene glycol Polymers 0.000 description 3
- 239000003352 sequestering agent Substances 0.000 description 3
- 238000003860 storage Methods 0.000 description 3
- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 description 3
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 description 3
- 229920002554 vinyl polymer Polymers 0.000 description 3
- 238000011179 visual inspection Methods 0.000 description 3
- GHOKWGTUZJEAQD-ZETCQYMHSA-N (D)-(+)-Pantothenic acid Chemical compound OCC(C)(C)[C@@H](O)C(=O)NCCC(O)=O GHOKWGTUZJEAQD-ZETCQYMHSA-N 0.000 description 2
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 2
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 description 2
- JAHNSTQSQJOJLO-UHFFFAOYSA-N 2-(3-fluorophenyl)-1h-imidazole Chemical compound FC1=CC=CC(C=2NC=CN=2)=C1 JAHNSTQSQJOJLO-UHFFFAOYSA-N 0.000 description 2
- 229920001817 Agar Polymers 0.000 description 2
- NLXLAEXVIDQMFP-UHFFFAOYSA-N Ammonia chloride Chemical compound [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 description 2
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
- SOGAXMICEFXMKE-UHFFFAOYSA-N Butylmethacrylate Chemical compound CCCCOC(=O)C(C)=C SOGAXMICEFXMKE-UHFFFAOYSA-N 0.000 description 2
- RGHNJXZEOKUKBD-SQOUGZDYSA-N D-gluconic acid Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O RGHNJXZEOKUKBD-SQOUGZDYSA-N 0.000 description 2
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 2
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 2
- 108010010803 Gelatin Proteins 0.000 description 2
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 2
- 229920000161 Locust bean gum Polymers 0.000 description 2
- CSNNHWWHGAXBCP-UHFFFAOYSA-L Magnesium sulfate Chemical compound [Mg+2].[O-][S+2]([O-])([O-])[O-] CSNNHWWHGAXBCP-UHFFFAOYSA-L 0.000 description 2
- BAPJBEWLBFYGME-UHFFFAOYSA-N Methyl acrylate Chemical compound COC(=O)C=C BAPJBEWLBFYGME-UHFFFAOYSA-N 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
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- REFJWTPEDVJJIY-UHFFFAOYSA-N Quercetin Chemical compound C=1C(O)=CC(O)=C(C(C=2O)=O)C=1OC=2C1=CC=C(O)C(O)=C1 REFJWTPEDVJJIY-UHFFFAOYSA-N 0.000 description 2
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- 238000000576 coating method Methods 0.000 description 2
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- 229910052751 metal Inorganic materials 0.000 description 2
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- 239000003921 oil Substances 0.000 description 2
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- 239000012466 permeate Substances 0.000 description 2
- KJFMBFZCATUALV-UHFFFAOYSA-N phenolphthalein Chemical compound C1=CC(O)=CC=C1C1(C=2C=CC(O)=CC=2)C2=CC=CC=C2C(=O)O1 KJFMBFZCATUALV-UHFFFAOYSA-N 0.000 description 2
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- MSWZFWKMSRAUBD-IVMDWMLBSA-N 2-amino-2-deoxy-D-glucopyranose Chemical compound N[C@H]1C(O)O[C@H](CO)[C@@H](O)[C@@H]1O MSWZFWKMSRAUBD-IVMDWMLBSA-N 0.000 description 1
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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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
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- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Medicinal Preparation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- General Preparation And Processing Of Foods (AREA)
Description
(I-1)PVA共重合体およびPVAを含有するフィルムからなる硬質カプセル。
(II-1)(I-1)乃至(I-10)のいずれかに記載する硬質カプセルに、ポリエチレングリコールまたはポリエチレングリコールを含む組成物が充填されてなる、硬質カプセル剤。
(III-1)PVA共重合体を含有するカプセルフィルムの破断伸び向上方法であって、フィルム成分としてPVA共重合体とPVAとを併用することを特徴とする方法。
本発明の硬質カプセルは、硬質カプセル皮膜(カプセルフィルム)を形成する成分としてポリビニルアルコール(PVA)とポリビニルアルコール共重合体(PVA共重合体)とを併用することを特徴とする。
(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)。
斯くして調製される硬質カプセルのボディ部とキャップ部は、前述する内容物をボディ部に充填したのち、該ボディ部にキャップ部を被覆して両者を嵌合させることにより硬質カプセル剤として提供することができる。
(a)12時間放置後、封緘硬質カプセル剤と接していた白色コピー用紙面に、内容物(PEG400)が付着しているか否か。
(b)12時間放置後、封緘硬質カプセル剤を白色コピー用紙上で転がしたときに、白色コピー用紙面に内容物(PEG400)が付着するか否か。
無水フタル酸42gをとり、新たに蒸留したピリジン300mLを正確に量って入れた1Lの遮光した共栓瓶に加え、強く振り混ぜて溶かした後、16時間以上放置する。この液25mLを正確に量り、約200mLの耐圧共栓瓶に入れ、これに測定するPEG試料約0.8〜15gを精密に量って加え、密栓し、これを丈夫な布で包み、あらかじめ98±2℃に加熱した水浴中に入れる。この際、瓶の中の液が水浴の液の中に浸るようにする。98±2℃で30分間保った後、水浴から瓶を取り出し、室温になるまで空気中で放冷する。次に0.5mol/L 水酸化ナトリウム液 50mLを正確に加え、更にフェノールフタレインのピリジン溶液(1→100)5滴を加え、この液につき、0.5mol/L 水酸化ナトリウム液で滴定する。但し、滴定の終点は液が15秒間持続する淡赤色を呈するときとする。同様の方法で空試験を行う。
本発明は、PVA共重合体を含有するカプセルフィルム(皮膜)について、破断伸びを向上させる方法を提供する。
ポリビニルアルコール共重合体(以下、「PVA共重合体」という)(POVACOAT Type L:大同化成社製、5%水溶液の25℃における粘度20mPa・s)7.2%、ポリビニルアルコール(以下、「PVA」という)(部分けん化型PVA、重合度1,000、けん化度86〜90mol%、和光純薬工業社製)10.8%、カッパカラギーナン(ゲル化剤)0.144%、および塩化カリウム(ゲル化補助剤)0.072%を含有するカプセル調製液を調製し、これをガラス板にフィルム作成用アプリケーターを用いて、乾燥厚が0.1mmとなるように、キャスティングした。これを60℃で2時間乾燥後、23℃、相対湿度40%の環境下で1週間保存したのち、長さ70mm、幅10mmの大きさのフィルムに裁断し、試験フィルムとした。
PVA共重合体、PVA、および有機酸塩の割合が、表2に記載する割合になるように調製したカプセルフィルムを作成した。具体的には、まず、表1に記載する処方に従って52℃のカプセル調製液を調製した。次いで、このカプセル調製液をガラス板にフィルム作成用アプリケーターを用いて、乾燥厚が0.1mmになるようにキャスティングした。60℃で2時間乾燥後、23℃、相対湿度40%の環境下で1週間保存したのち、長さ70mm、幅10mmの大きさのフィルムに裁断し、カプセルフィルム(試料番号1〜22)を調製した。
粘度は、B型回転粘度計(ローター番号3)を用いて、52℃、回転数12rpm、測定時間1分の条件で測定した。
上記で調製した各カプセルフィルムを23℃、相対湿度40%の環境下で1週間保存したものについて、カプセル水分(%)を求めた。具体的には、まずカプセルフィルムの重量(湿重量)を測定した後、105℃で2時間加熱乾燥し、再度各カプセルフィルムの重量(乾燥重量)を測定した。次いで、乾燥前の重量(湿重量)と乾燥後の重量(乾燥重量)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(カプセルフィルム水分量%)を算出した。
上記で調製した各カプセルフィルム(試料1〜22)について、実験例1の方法に従って、引張試験を実施した。測定した各フィルムの応力と引張ストロークから、実験例1に記載するように最大応力(N)と破断伸び(mm)を求めた。
カプセル調製液の粘度とカプセルの生産収率との関係を調べた。具体的には、PVA共重合体、PVA、ゲル化剤(カラギーナン)、ゲル化補助剤(塩化カリウム)、ゼラチン、HPMCおよび水などを用いて、カプセル調製液の粘度(52℃、B型回転粘度計、ローター番号3、回転数12rpm、測定時間1分)を500、1350、2000、3100および4000mPa・sに調整し、これらの各カプセル調製液でカプセルを作成した場合のカプセル生産収率を求めた。
カプセルの生産収率(%)は、作成した硬質カプセルについて、カプセル皮膜中の泡やカプセルの変形などの外観上の不良品を選別する外観検査機で良品と判断された単位時間当たりのカプセル数(外観検査後の良品数)と単位時間当たりの理論カプセル製造数(理論カプセル製造数)から下式に従って算出した。
(1)硬質カプセルの調製
40℃の精製水170LにPVA(部分けん化型PVA、重合度1000、けん化度86〜90mol%、和光純薬工業社製)を48kg加えて分散させ、82℃まで加温してPVAを溶解させた。これを60℃まで冷却し22%PVA水溶液を調製した。下記表4に示すカプセル調製液の処方に基づき、あらかじめ60℃に加温した22.9%のPVA共重合体(POVACOAT Type L、5%水溶液の粘度が25℃で20mPa・s、大同化成社製)の水溶液に、10%塩化カリウム水溶液、2%カラギーナン水溶液、22%PVA水溶液および精製水を所定量加えて攪拌し、試料番号23〜26のカプセル調製液を調製した。これらの溶液を24時間穏やかに攪拌しながら脱泡した。斯くして調製した水溶液(カプセル調製液)を浸漬液として、浸漬法による慣用のカプセル製造装置に仕込み、浸漬液の温度を50〜55℃に保持しながら、常法に従ってサイズ1号の硬質カプセル(キャップ、ボディ)を調製した。
上記で調製した各硬質カプセルを23℃、相対湿度12%、22%、33%、43%および53%の環境下で1週間保存したものについて、硬質カプセル水分量(%)を求めた。具体的には、まず上記保存後の硬質カプセルの重量(湿重量)を測定した後、105℃で2時間加熱乾燥し、再度各硬質カプセルの重量(乾燥重量)を測定した。次いで、乾燥前の重量(湿重量)と乾燥後の重量(乾燥重量)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(硬質カプセル水分量%)を算出した。
上記で調製した各硬質カプセルを23℃、相対湿度12%、22%、33%、43%および53%の環境下で1週間保存したものについて、硬質カプセルの割れ率(%)を求めた。具体的には、上記保存後の各硬質カプセルに対して、50gの錘を高さ10cmから自然落下させ、割れた硬質カプセル数を計数した。割れた硬質カプセル数から下式に従って硬質カプセルの割れ率(%)を算出した。
バンドシール原料として、PVA共重合体(大同化成社製のPOVACOAT Type F、5%水溶液の25℃の粘度5.5mPa・s)、PVA((日本酢ビ・ポバール社製のJP-05、平均重合度500、部分けん化型PVA:けん化度87-89mol%)、およびソルビトールを用いて表6の処方からなるバンドシール調製液(処方例1〜19)を作成した。なお、表中の括弧内は、乾燥後のバンドシールの重量(乾燥重量)を100重量%とした場合のPVA共重合体、PVAおよびソルビトールの重量比を示す。次いで、各バンドシール調製液(処方例1〜19)について、下記の方法に従って、粘度を測定するとともに、液だれ、曳糸性および流動性の点から硬質カプセルに塗布するうえでの取り扱い性を評価した。
粘度は、B型回転粘度計(粘度500mPa・s未満の場合はローター番号2、粘度500mPa・s以上2000mPa・s未満の場合はローター番号3、粘度2000mPa・s以上の場合はローター番号4)を用いて、23℃、回転数60rpm、測定時間1分の条件で測定した。
各バンドシール調製液について、液だれ、曳糸性および流動性の全ての点から硬質カプセルに塗布する取り扱い条件を満たしている場合を「適正:○」と評価し、一つでも条件を満たしていない場合を「不適正:×」と評価した。
上記で調製した封緘硬質カプセルを、23℃、RH43%の条件で1日間放置して、外観上の変化、特に嵌合部周囲に形成したバンドシールの状態を観察した。
(b) 12時間放置後、封緘硬質カプセル剤を白色コピー用紙上で転がしたときに、白色コピー用紙面に内容物(PEG400)が付着するか否か。
(1)硬質カプセルの調製
40℃の精製水170LにPVA(部分けん化型PVA、重合度は1000、けん化度86〜90mol%、和光純薬工業社製)を48kg加えて分散させ、82℃まで加温してPVAを溶解させた。これを60℃まで冷却しPVA水溶液を調製した。あらかじめ60℃に加温した22.9%のPVA共重合体(POVACOAT Type L、5%水溶液の粘度が25℃で20mPa・s、大同化成社製)の水溶液34.93kgに、10%塩化カリウム水溶液0.8kg、2%カラギーナン水溶液8kg、PVA水溶液54.55kgおよび精製水1.72kgを加えて攪拌した。この溶液を24時間穏やかに攪拌しながら脱泡した。斯くして調製した水溶液(カプセル調製液)を浸漬液として、浸漬法による慣用のカプセル製造装置に仕込み、浸漬液の温度を50〜55℃に保持しながら、常法に従ってサイズ1号または2号の硬質カプセル(キャップ、ボディ)を調製した。
全自動カプセル充填機(クオリカプス社製、LIQFILsuper40)を用いて、上記で調製したサイズ1号の硬質カプセルに、平均分子量400のポリエチレングリコール(PEG400)を470μL充填した。次いで、全自動カプセル充填・シール機(クオリカプス社製、LIQFILsuperFS)を用いて、上記でPEG400を充填した硬質カプセルのキャップとボディの嵌合部に、下記の処方からなるバンドシール液を塗布し、乾燥させて、内部にPEG400を充填してなる本発明の硬質カプセル剤を調製した。
Claims (17)
- ポリビニルアルコール共重合体およびポリビニルアルコールを含有するフィルムからなる硬質カプセルであって、フィルムに含まれるポリビニルアルコール共重合体とポリビニルアルコールとの重量比が70:30〜1:99である硬質カプセル。
- フィルムに含まれるポリビニルアルコール共重合体とポリビニルアルコールとの重量比が50:50〜1:99である、請求項1に記載する硬質カプセル。
- さらに、ゲル化剤を含有する請求項1または2に記載する硬質カプセル。
- さらに、ゲル化補助剤を含有する請求項3に記載する硬質カプセル。
- さらに、有機酸およびその塩からなる群から選択される少なくとも1種を含有する請求項1乃至4のいずれかに記載する硬質カプセル。
- フィルムの水分量が3〜5%であり、破断伸びが9.5〜20mmであることを特徴とする請求項1乃至5のいずれかに記載する硬質カプセル。
- 請求項1乃至6のいずれかに記載する硬質カプセルに、ポリエチレングリコールまたはポリエチレングリコールを含む組成物が充填されてなる、硬質カプセル剤。
- 上記ポリエチレングリコールが、平均分子量200〜600の低分子量ポリエチレングリコールである、請求項7記載の硬質カプセル剤。
- ボディ部とキャップ部の嵌合部が、ポリビニルアルコール共重合体、ポリビニルアルコールまたはこれらの混合物を含有するバンドシールで封緘されてなることを特徴とする、請求項7に記載する硬質カプセル剤。
- バンドシールが更に可塑剤としてソルビトールを含有するものである、請求項9に記載する硬質カプセル剤。
- ポリビニルアルコール共重合体およびポリビニルアルコールを含有するカプセル調製液に、カプセル成型用ピンを浸漬して引き上げ、当該成型用ピンに付着した上記カプセル調製液をゲル化、乾燥させ、これを成型ピンから脱離回収して硬質カプセルを得ることを特徴とする、請求項1乃至6のいずれかに記載する硬質カプセルの製造方法。
- 請求項1乃至6のいずれかに記載する硬質カプセル内に内容物を充填した後、キャップ部とボディ部を嵌合し、形成された嵌合部に、ポリビニルアルコール共重合体、ポリビニルアルコールまたはこれらの混合物を含有するバンドシール調製液を塗布し、乾燥して封緘することを特徴とする硬質カプセル剤の調製方法。
- 上記内容物がポリエチレングリコールまたはポリエチレングリコールを含む組成物である、請求項12に記載する硬質カプセル剤の調製方法。
- ポリビニルアルコール共重合体を含有するカプセルフィルムの破断伸び向上方法であって、カプセルフィルムの成分として、ポリビニルアルコール共重合体とポリビニルアルコールとを70:30〜1:99(重量比)の割合で併用することを特徴とする方法。
- 上記カプセルフィルムに配合するポリビニルアルコール共重合体とポリビニルアルコールとの重量比が、50:50〜1:99である、請求項14に記載するカプセルフィルムの破断伸び向上方法。
- カプセルフィルムの成分として、さらに、有機酸およびその塩からなる群から選択される少なくとも1種を併用することを特徴とする、請求項14または15に記載するカプセルフィルムの破断伸び向上方法。
- 上記有機酸の塩が、有機酸のアルカリ金属塩である請求項16に記載するカプセルフィルムの破断伸び向上方法。
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