製剤のバイオアベイラビリティの変動とそれに及ぼす要因解析
医薬品は, 薬物の持つ生理活性を病気の治療のために, 適用できる剤形に製剤したものである. 固形製剤を経口投与した場合, 薬物は吸収され, 作用点に到達しなければ薬効の発現は期待できない. 一般に医薬品は製剤間で製剤処方並びに剤形の特性などにおいて異なることが多く, そのために消化管内での製剤の崩壊性並びに製剤からの薬物の溶出速度が変化し, 製剤間でBA(Bioavailability)の変動が生じる. 1)特に難水溶性薬物の製剤のBAが臨床上問題となってからは, 製剤間におけるBAの相違に関して注意が払われるようになってきた. 2) 製剤のBAに及ぼす要因としては, 製剤要因, 3)生理的要...
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Published in | YAKUGAKU ZASSHI Vol. 123; no. 7; pp. 477 - 493 |
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Main Authors | , , |
Format | Journal Article |
Language | Japanese |
Published |
公益社団法人 日本薬学会
01.07.2003
日本薬学会 |
Online Access | Get full text |
ISSN | 0031-6903 1347-5231 |
DOI | 10.1248/yakushi.123.477 |
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Abstract | 医薬品は, 薬物の持つ生理活性を病気の治療のために, 適用できる剤形に製剤したものである. 固形製剤を経口投与した場合, 薬物は吸収され, 作用点に到達しなければ薬効の発現は期待できない. 一般に医薬品は製剤間で製剤処方並びに剤形の特性などにおいて異なることが多く, そのために消化管内での製剤の崩壊性並びに製剤からの薬物の溶出速度が変化し, 製剤間でBA(Bioavailability)の変動が生じる. 1)特に難水溶性薬物の製剤のBAが臨床上問題となってからは, 製剤間におけるBAの相違に関して注意が払われるようになってきた. 2) 製剤のBAに及ぼす要因としては, 製剤要因, 3)生理的要因, 4)併用薬物5)並びに食事の影響6)などが挙げられる. そこで, 著者らが研究した3種の難水溶性医薬品, フェニトイン散, メフェナム酸カプセル剤, スルピリド(SP)フィルムコーティング錠のBA, BAの改善並びにBAに及ぼす要因について概説する. |
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AbstractList | 医薬品は, 薬物の持つ生理活性を病気の治療のために, 適用できる剤形に製剤したものである. 固形製剤を経口投与した場合, 薬物は吸収され, 作用点に到達しなければ薬効の発現は期待できない. 一般に医薬品は製剤間で製剤処方並びに剤形の特性などにおいて異なることが多く, そのために消化管内での製剤の崩壊性並びに製剤からの薬物の溶出速度が変化し, 製剤間でBA(Bioavailability)の変動が生じる. 1)特に難水溶性薬物の製剤のBAが臨床上問題となってからは, 製剤間におけるBAの相違に関して注意が払われるようになってきた. 2) 製剤のBAに及ぼす要因としては, 製剤要因, 3)生理的要因, 4)併用薬物5)並びに食事の影響6)などが挙げられる. そこで, 著者らが研究した3種の難水溶性医薬品, フェニトイン散, メフェナム酸カプセル剤, スルピリド(SP)フィルムコーティング錠のBA, BAの改善並びにBAに及ぼす要因について概説する. |
Author | 新熊, 傳治 水野, 亘恭 濱口, 常男 |
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DOI | 10.1248/yakushi.123.477 |
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Pharmaceut., 21, 187-200 (1984). 37) Mizuno N., Morita E., Nishikata M., Shinkuma D., Yamanaka Y., Arch. Int. Pharmacodyn. Ther., 283, 79-87 (1986). 51) Katchalsky A., Spitnik P., J. Polymer Sci., 2, 432-446 (1947). 38) Shinkuma D., Hamaguchi T., Kobayashi M., Yamanaka Y., Mizuno N., Yakuzaigaku, 48, 106-113 (1988). 12) Glazko A. J., Chang T., "Antiepileptic Drugs," ed. by Woodbury D. M., Penry J. K., Schmidt R. P., Raven Press, New York, 1972, pp. 127-136. 26) Hamaguchi T., Shinkuma D., Irie T., Yamanaka Y., Morita Y., Iwamoto B., Miyoshi K., Mizuno N., Int. J. Clin. Pharmacol. Ther. Toxicol., 31, 326-330 (1993). 36) Gouda M. W., Al-Angary A. A., El-Hofy S. A., Mahrous G. M., Int. J. Pharmaceut., 37, 227, (1987). 46) Iinuma R., Toyama T., Yakuzaigaku, 21, 48-52 (1961). 45) Shinkuma D., Hamaguchi T., Kobayashi M., Yamanaka Y., Mizuno N., Int. J. Clin. Pharmacol. Ther. Toxicol., 29, 303-309 (1991). 22) Stewart J. J., Bass P., Gastroent., 70, 371-376 (1976). 52) Akaiwa H., Tsuge S., Tsunoda K., Haraguchi K., "Bunsekikagaku," Maruzen, Tokyo, 1991, pp. 24-26. 39) Banker G. S., Rhodes C. T., "Modern Pharmaceutics," Marcel Dekker, New York, 1990 pp. 47-48. 6) Sennello L. T., Sonders R. C., Friedman N., Clin. Pharmacol. Ther., 23, 414-420 (1978). 9) Aird R. B., Woodbury D. B. "The Managemen of Epilepsy," ed. by Thomas C. C., Springfield, 1974, pp. 162-167. 21) Shinkuma D., Hamaguchi T., Yamanaka Y., Mizuno N., Yata N., Chem. Pharm. Bull., 33, 4989-4994 (1985). 20) Kabasakalian P., Katz M., Rosenkrantz B., Townley E., J. Pharm. Sci., 59, 595-600 (1970). |
References_xml | – reference: 27) Tall A. R., Mistilis S. P., J. Int. Med. Res., 3, 176-182 (1975). – reference: 24) Bates T. R., Gibaldi M., Kanig J. L., J. Pharm. Sci., 55, 191-199 (1966). – reference: 30) Bates T. R., Sequerira J. A., Tembo A. V., Clin. Pharmcol. Ther., 16, 63-68 (1974). – reference: 29) Finholt P., "Influence of Formulation on Dissolution Rate," eds. by Leeson L. T., Carstensen J. T., The Dissolution Technology, The Industrial Pharmaceutical Technology Section of the Academy of Pharmaceutical Science, Washington, 1974, pp. 106-146. – reference: 38) Shinkuma D., Hamaguchi T., Kobayashi M., Yamanaka Y., Mizuno N., Yakuzaigaku, 48, 106-113 (1988). – reference: 40) Reynolds J. E. F., "Martindale: The Extra Pharmacopeia," 29th ed., The Pharmaceutical Press, London, 1989, pp. 1073-1079. – reference: 22) Stewart J. J., Bass P., Gastroent., 70, 371-376 (1976). – reference: 25) Sekikawa H., Nakano M., Takada M., Arita T., Chem. Pharm. Bull., 28, 2443-2449 (1980). – reference: 20) Kabasakalian P., Katz M., Rosenkrantz B., Townley E., J. Pharm. Sci., 59, 595-600 (1970). – reference: 37) Mizuno N., Morita E., Nishikata M., Shinkuma D., Yamanaka Y., Arch. Int. Pharmacodyn. Ther., 283, 79-87 (1986). – reference: 43) Yadomae T., Farumashia, 28, 52-55 (1992). – reference: 13) Yamamoto K., Nakano M., Arita T., Takayama Y., Nakai Y., J. Pharm. Sci., 65, 1484-1488 (1976). – reference: 12) Glazko A. J., Chang T., "Antiepileptic Drugs," ed. by Woodbury D. M., Penry J. K., Schmidt R. P., Raven Press, New York, 1972, pp. 127-136. – reference: 28) Shinkuma D., Hamaguchi T., Yamanaka Y., Mizuno N., Int. J. Pharmaceut., 21, 187-200 (1984). – reference: 47) Koch P. A., Schultz C. A., Wills R. J., Hallquist S. L., Welling P. G., J. Pharm. Sci., 67, 1533-1535 (1978). – reference: 19) Shinkuma D., Hamaguchi T., Yamanaka Y., Mizuno N., Yata N., Chem. Pharm. Bull., 33, 4981-4988 (1985). – reference: 17) Chakrabarti S., Belpaire F. M., J. Pharm. Pharmacol., 30, 330-331 (1978). – reference: 14) Shinkuma D., Hashimoto H., Yamanaka Y., Morita Y., Mizuno N., Yakuzaigaku, 39, 121-128 (1979). – reference: 41) Henn R. M., Isenberg J. I., Maxwell R. A. L., N. Engl. J. Med., 293, 371-375 (1975). – reference: 7) Bochner F., Hooper W. D., Tyrer J. H., J. Neurol. Sci., 16, 481-487 (1971). – reference: 11) Miyamoto K., Nou To Hattatsu, 6, 444-455 (1976). – reference: 42) Shinkuma D., Hamaguchi T., Kobayashi M., Yamanaka Y., Mizuno N., Int. J. Clin. Pharmacol. Ther. Toxicol., 27, 499-502 (1989). – reference: 39) Banker G. S., Rhodes C. T., "Modern Pharmaceutics," Marcel Dekker, New York, 1990 pp. 47-48. – reference: 9) Aird R. B., Woodbury D. B. "The Managemen of Epilepsy," ed. by Thomas C. C., Springfield, 1974, pp. 162-167. – reference: 5) Greenblatt D. J., Shader R. I., Harmatz J. S., Franke K., K-Weser J., Clin. Pharmacol. Ther., 19, 234-239 (1976). – reference: 33) Ogata H., Shibazaki T., Inoue T., Ejima A., J. Pharm. Sci., 68, 712-715 (1979). – reference: 16) Carrigan P. J., Bates T. R., J. Pharm. Sci., 62, 1476-1479 (1973). – reference: 2) Manninen V., Melin J., Reissel P., Lancet, 1, 490-491 (1972). – reference: 1) Yakatan G. J., Frome E. L., Leonard R. G., Shah A. C., Doluisio J. T., J. Pharm. Sci., 67, 253-256 (1978). – reference: 23) Shinkuma D., Hamaguchi T., Yamanaka Y., Mizuno N., Yata N., Chem. Pharm. Bull., 33, 5023-5027 (1985). – reference: 6) Sennello L. T., Sonders R. C., Friedman N., Clin. Pharmacol. Ther., 23, 414-420 (1978). – reference: 44) Shinkuma D., Hamaguchi T., Kobayashi M., Yamanaka Y., Mizuno N., Int. J. Clin. Pharmacol. Ther. Toxicol., 28, 440-442 (1990). – reference: 52) Akaiwa H., Tsuge S., Tsunoda K., Haraguchi K., "Bunsekikagaku," Maruzen, Tokyo, 1991, pp. 24-26. – reference: 4) Greenblatt D. J., Divoll M., Harmats J. S., Shader R. I., J. Pharmacol. Exp. Ther., 215, 86-91 (1980). – reference: 35) Welling P. G., Lyons L. L., Tse F. L. S., Craig W. A., Clin. Pharmacol. Ther., 19, 559-565 (1976). – reference: 50) Oosawa F., Biopolymers, 6, 135-144 (1968). – reference: 21) Shinkuma D., Hamaguchi T., Yamanaka Y., Mizuno N., Yata N., Chem. Pharm. Bull., 33, 4989-4994 (1985). – reference: 3) Prescott L. F., Steel R. F., Ferrier W. R., Clin. Pharmacol. Ther., 11, 496-504 (1970). – reference: 34) Hamaguchi T., Shinkuma D., Yamanaka Y., Mizuno N., J. Pharm. Sci., 75, 891-893 (1986). – reference: 18) Shinkuma D., Hamaguchi T., Muro C., Oota F., Yamanaka Y., Mizuno N., Int. J. Pharmaceut., 9, 17-28 (1981). – reference: 46) Iinuma R., Toyama T., Yakuzaigaku, 21, 48-52 (1961). – reference: 49) Hamaguchi T., Shinkuma D., Yamanaka Y., Miyake M., Tamura S., Mizuno N., Chem. Pharm. Bull., 43, 2205-2210 (1995). – reference: 10) Shinkuma D., Hashimoto H., Yamanaka Y., Morita Y., Acta Med. Hyogo, 1, 141-147 (1976). – reference: 31) Welling P. G., Huang H., Hewitt P. F., Lyons L. L., J. Pharm. Sci., 67, 764-766 (1978). – reference: 8) Manaka S., Nawata H., Izawa M., Hashimoto T., Sugiyama H., Saitoh Y., Nou To Shinkei, 27, 583-590 (1975). – reference: 26) Hamaguchi T., Shinkuma D., Irie T., Yamanaka Y., Morita Y., Iwamoto B., Miyoshi K., Mizuno N., Int. J. Clin. Pharmacol. Ther. Toxicol., 31, 326-330 (1993). – reference: 48) Hamaguchi T., Shinkuma D., Yamanaka Y., Miyake M., Tamura S., Mizuno N., Chem. Pharm. Bull., 43, 1204-1211 (1995). – reference: 32) Hamaguchi T., Shinkuma D., Yamanaka Y., Mizuno N., J. Pharmacobio-Dyn., 10, 21-25 (1987). – reference: 36) Gouda M. W., Al-Angary A. A., El-Hofy S. A., Mahrous G. M., Int. J. Pharmaceut., 37, 227, (1987). – reference: 51) Katchalsky A., Spitnik P., J. Polymer Sci., 2, 432-446 (1947). – reference: 15) Takeda K., Ozaki E., Matsushita R., Ichimura F., TDM Kenkyu, 17, 279-284 (2000). – reference: 45) Shinkuma D., Hamaguchi T., Kobayashi M., Yamanaka Y., Mizuno N., Int. J. Clin. Pharmacol. Ther. Toxicol., 29, 303-309 (1991). |
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Snippet | 医薬品は, 薬物の持つ生理活性を病気の治療のために, 適用できる剤形に製剤したものである. 固形製剤を経口投与した場合, 薬物は吸収され, 作用点に到達しなければ薬効の... |
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Title | 製剤のバイオアベイラビリティの変動とそれに及ぼす要因解析 |
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