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Volumn 30, Issue 4, 1996, Pages 1071-1084

FIP guidelines for dissolution testing of solid oral products (final draft, 1995)

Author keywords

Dissolution testing; FIP; In vitro In vivo; Solid oral products

Indexed keywords


EID: 84993708213     PISSN: 21684790     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159603000424     Document Type: Article
Times cited : (8)

References (42)
  • 1
    • 0001419666 scopus 로고
    • FIP Guidelines for Dissolution Testing of Solid Oral Products. Pharm Ind. 1981; 43: 334–343.
    • (1981) Pharm Ind , vol.43 , pp. 334-343
  • 2
    • 6844230351 scopus 로고
    • Dissolution Methodology
    • Leeson LJ, Carstensen JT,(Eds.). Washington, DC; APhA
    • Pernarowski M. Dissolution Methodology. In Leeson LJ, Carstensen JT,(Eds.). Dissolution Technology. Washington, DC; APhA: 1974.
    • (1974) Dissolution Technology
    • Pernarowski, M.1
  • 3
    • 0017965932 scopus 로고
    • Kritischer Vergleich von Geräten und Methoden zur Bestimmung der Auflösungsgeschwindigkeit von Tabletten
    • Krowczynski L. Kritischer Vergleich von Geräten und Methoden zur Bestimmung der Auflösungsgeschwindigkeit von Tabletten. Pharmazie. 1978; 33: 241–247.
    • (1978) Pharmazie , vol.33 , pp. 241-247
    • Krowczynski, L.1
  • 4
    • 6844256426 scopus 로고
    • Dissolution Methology: an Overview
    • Dakkuri A Shak AC. Dissolution Methology: an Overview. Pharm Technol. 1982; 2: 41–53.
    • (1982) Pharm Technol , vol.2 , pp. 41-53
    • Dakkuri, A.1    Shak, A.C.2
  • 5
    • 0022608713 scopus 로고
    • Advances in Dissolution Technology: Design, pros and cons
    • Lathia CD Banakar WV. Advances in Dissolution Technology: Design, pros and cons. Drug Dev Ind Pharm. 1986; 12: 71–105.
    • (1986) Drug Dev Ind Pharm , vol.12 , pp. 71-105
    • Lathia, C.D.1    Banakar, W.V.2
  • 6
    • 6844219732 scopus 로고
    • Associations and Specifications
    • Blume H, Grundert-Remy U, Möller H,(Eds). Stuttgart: Wissenschaftliche Verlagsgesellschaft
    • Siewert M. Associations and Specifications. In Blume H, Grundert-Remy U, Möller H,(Eds). Controlled/Modified Release Products. Stuttgart: Wissenschaftliche Verlagsgesellschaft; 1991.
    • (1991) Controlled/Modified Release Products
    • Siewert, M.1
  • 7
    • 0019497850 scopus 로고
    • Effect of Sampling Probe Size on Dissolution of Tableted Drug Samples
    • Wells CE. Effect of Sampling Probe Size on Dissolution of Tableted Drug Samples. J Pharm Sci. 1981; 70: 232–233.
    • (1981) J Pharm Sci , vol.70 , pp. 232-233
    • Wells, C.E.1
  • 8
    • 0021153312 scopus 로고
    • Optimierung und Justierung der Versuchsbedingungen von in vitro-Tests: Feste perorale Arzneizubereitungen
    • Stricker H. Optimierung und Justierung der Versuchsbedingungen von in vitro-Tests: Feste perorale Arzneizubereitungen. Acta Pharm Technol. 1984; 30: 113–125.
    • (1984) Acta Pharm Technol , vol.30 , pp. 113-125
    • Stricker, H.1
  • 9
    • 0017276562 scopus 로고
    • In-vitro-Studien zum Auflöse- und Resorptionsverhalten oral verabreichter Arzneistoffe und die Korrelation mit der biologischen Verfügbarkeit
    • Stricker H. In-vitro-Studien zum Auflöse- und Resorptionsverhalten oral verabreichter Arzneistoffe und die Korrelation mit der biologischen Verfügbarkeit. Pharm Ind. 1976; 38: 232–234.
    • (1976) Pharm Ind , vol.38 , pp. 232-234
    • Stricker, H.1
  • 10
    • 6844219731 scopus 로고
    • Verfügbarkeitsprufung in vitro: Forderungen, Möglichkeiten, Grenzen
    • Dibbern HW. Verfügbarkeitsprufung in vitro: Forderungen, Möglichkeiten, Grenzen. Pharm Ind. 1984; 46: 381–385.
    • (1984) Pharm Ind , vol.46 , pp. 381-385
    • Dibbern, H.W.1
  • 11
    • 0023881733 scopus 로고
    • Simulation of physiological pH-time profile in in vitro dissolution study: Relationship between dissolution rate and bioavailability of controlled release dosage form
    • Das SK Gupta BK. Simulation of physiological pH-time profile in in vitro dissolution study: Relationship between dissolution rate and bioavailability of controlled release dosage form. Drug Dev Ind Pharm. 1988; 14: 537–544.
    • (1988) Drug Dev Ind Pharm , vol.14 , pp. 537-544
    • Das, S.K.1    Gupta, B.K.2
  • 12
    • 0007938726 scopus 로고
    • Zur pharmazeutischen Qualität von glibenclamidhaltigen Fertigarzneimitteln
    • Blume H Ali SL Siewert M. Zur pharmazeutischen Qualität von glibenclamidhaltigen Fertigarzneimitteln. Pharm Ztg. 1984; 129: 983–989.
    • (1984) Pharm Ztg , vol.129 , pp. 983-989
    • Blume, H.1    Ali, S.L.2    Siewert, M.3
  • 14
    • 84993719124 scopus 로고
    • Guidelines for Design and Evaluation of Oral Sustained Release Dosage Form
    • Yakuskin-1–5
    • Guidelines for Design and Evaluation of Oral Sustained Release Dosage Form. Ministry of Health and Welfare of Japan. Yakuskin-1–5; 1988.
    • (1988) Ministry of Health and Welfare of Japan
  • 15
    • 0025147050 scopus 로고
    • Workshop Report In Vitro and In Vivo Testing and Correlation for Oral Controlled/Modified-Release Dosage Forms
    • Workshop Report In Vitro and In Vivo Testing and Correlation for Oral Controlled/Modified-Release Dosage Forms. Pharm Res. 1990; 7: 975–982.
    • (1990) Pharm Res , vol.7 , pp. 975-982
  • 16
    • 0024396590 scopus 로고
    • In Vitro Dissolution Profile of Water-Insoluble Drug Dosage Forms in the Presence of Surfactants
    • Shah VP Konecny JJ Everett RL McCullough B Noorizadeh AC Skelly JP. In Vitro Dissolution Profile of Water-Insoluble Drug Dosage Forms in the Presence of Surfactants. Pharm Res. 1989; 6(7):612–618.
    • (1989) Pharm Res , vol.6 , Issue.7 , pp. 612-618
    • Shah, V.P.1    Konecny, J.J.2    Everett, R.L.3    McCullough, B.4    Noorizadeh, A.C.5    Skelly, J.P.6
  • 17
    • 0026657633 scopus 로고
    • Influence of Higher Rates of Agitation on Release Patterns of Immediate-Release Drug Products
    • Shah VP Gurbarg M Noory A Dighe S Skelly JP. Influence of Higher Rates of Agitation on Release Patterns of Immediate-Release Drug Products. J Pharm Sci. 1991; 81(6):500–503.
    • (1991) J Pharm Sci , vol.81 , Issue.6 , pp. 500-503
    • Shah, V.P.1    Gurbarg, M.2    Noory, A.3    Dighe, S.4    Skelly, J.P.5
  • 19
    • 0001262837 scopus 로고
    • Impact of Different Deaeration Methods on the USP Dissolution Apparatus Suitability Test Criteria
    • Qureshi SA McGilveray IJ. Impact of Different Deaeration Methods on the USP Dissolution Apparatus Suitability Test Criteria. Pharm Forum. 1994; 20(6): 8565–8566.
    • (1994) Pharm Forum , vol.20 , Issue.6 , pp. 8565-8566
    • Qureshi, S.A.1    McGilveray, I.J.2
  • 21
    • 84993767565 scopus 로고
    • Supplement 1: Drug Release 724
    • U.S. Pharmacopeia 23, Supplement 1: Drug Release 724 2535; 1995.
    • (1995) U.S. Pharmacopeia , vol.23 , Issue.2535
  • 22
    • 0020400710 scopus 로고
    • Numerical convolution/deconvolution as a tool for correlating in vitro with in vivo drug availability
    • Langenbucher F. Numerical convolution/deconvolution as a tool for correlating in vitro with in vivo drug availability. Pharm Ind. 1982; 44: 1166–1172.
    • (1982) Pharm Ind , vol.44 , pp. 1166-1172
    • Langenbucher, F.1
  • 23
    • 0001452477 scopus 로고
    • Improved algorithms correlating body response with drug input
    • Langenbucher F. Improved algorithms correlating body response with drug input. Pharm Ind. 1982; 44: 1275–1278.
    • (1982) Pharm Ind , vol.44 , pp. 1275-1278
    • Langenbucher, F.1
  • 24
    • 6844244808 scopus 로고
    • Percent absorbed time plots derived from blood level or urinary excretion data
    • Wagner JW Nelson F. Percent absorbed time plots derived from blood level or urinary excretion data. J Pharm Sci. 1963; 57: 918–928.
    • (1963) J Pharm Sci , vol.57 , pp. 918-928
    • Wagner, J.W.1    Nelson, F.2
  • 25
    • 0014297946 scopus 로고
    • New method for calculating the intrinsic absorption rate of drug
    • Loo JCK Riegelmann S. New method for calculating the intrinsic absorption rate of drug. J Pharm Sci. 1968; 57: 918–928.
    • (1968) J Pharm Sci , vol.57 , pp. 918-928
    • Loo, J.C.K.1    Riegelmann, S.2
  • 27
    • 0021279999 scopus 로고
    • Momenten-Analyse und in vitro/in vivo Korrelation
    • von Hattingberg HM. Momenten-Analyse und in vitro/in vivo Korrelation. Acta Pharm Technol. 1984; 30: 93–101.
    • (1984) Acta Pharm Technol , vol.30 , pp. 93-101
    • von Hattingberg, H.M.1
  • 28
    • 0027288496 scopus 로고
    • In vitro/in vivo Correlations: Scientific Implications and Standardisation
    • Cardot JM Beyssac E. In vitro/in vivo Correlations: Scientific Implications and Standardisation. Eur J Drug Metab Pharmacokinet. 1993; 18(1):113–120.
    • (1993) Eur J Drug Metab Pharmacokinet , vol.18 , Issue.1 , pp. 113-120
    • Cardot, J.M.1    Beyssac, E.2
  • 30
    • 0027473743 scopus 로고
    • Workshop Report: Scale-Up of Immediate Release Oral Solid Dosage Forms
    • Workshop Report: Scale-Up of Immediate Release Oral Solid Dosage Forms. Pharm Res. 1993; 10: 313–316
    • (1993) Pharm Res , vol.10 , pp. 313-316
  • 31
    • 10544226592 scopus 로고
    • Eur J Pharm Biopharm. 1993;39(1):40–43.
    • (1993) Eur J Pharm Biopharm , vol.39 , Issue.1 , pp. 40-43
  • 32
    • 0027144435 scopus 로고
    • Workshop II Report: Scale-Up of Oral Extended Release Dosage Forms
    • Workshop II Report: Scale-Up of Oral Extended Release Dosage Forms. Pharm Res. 1993; 10: 1800–1805
    • (1993) Pharm Res , vol.10 , pp. 1800-1805
  • 33
    • 0027291066 scopus 로고
    • Eur J Pharm Biopharm. 1993;39 (4):162–167.
    • (1993) Eur J Pharm Biopharm , vol.39 , Issue.4 , pp. 162-167
  • 35
    • 0022892810 scopus 로고
    • Influence of a high fat breakfast on the bioavailability of theophylline controlled-release formulations: an in vitro demonstration of an in vivo observation
    • Maturu PK Prasad VK Worsley W Shiu GK Skelly JP. Influence of a high fat breakfast on the bioavailability of theophylline controlled-release formulations: an in vitro demonstration of an in vivo observation. J Pharm Sci. 1986; 75: 1205–1206.
    • (1986) J Pharm Sci , vol.75 , pp. 1205-1206
    • Maturu, P.K.1    Prasad, V.K.2    Worsley, W.3    Shiu, G.K.4    Skelly, J.P.5
  • 36
    • 0023860810 scopus 로고
    • Food-Induced Theophylline Release/Absorption Changes from Controlled-Release Formulations: A Proposed in Vitro Model
    • Wearly L Karim A Pagone F Streicher J Wickman A. Food-Induced Theophylline Release/Absorption Changes from Controlled-Release Formulations: A Proposed in Vitro Model. Drug Devl Ind Pharm. 1988; 14: 13–28.
    • (1988) Drug Devl Ind Pharm , vol.14 , pp. 13-28
    • Wearly, L.1    Karim, A.2    Pagone, F.3    Streicher, J.4    Wickman, A.5
  • 38
    • 0025201504 scopus 로고
    • Theophylline-Controlled Release Preparations and Fatty Food: An in vitro Study Using the Rotating Dialysis Cell
    • El-Arini K Shiu GK Skelly JP. Theophylline-Controlled Release Preparations and Fatty Food: An in vitro Study Using the Rotating Dialysis Cell. Pharm Res. 1990; 7: 1134–1140.
    • (1990) Pharm Res , vol.7 , pp. 1134-1140
    • El-Arini, K.1    Shiu, G.K.2    Skelly, J.P.3
  • 39
    • 0023038127 scopus 로고
    • Drug dissolution studies in milk using the automated flow injection serial dynamic dialysis technique
    • Macheras P Koupparis M Tsaprounis C. Drug dissolution studies in milk using the automated flow injection serial dynamic dialysis technique. Int J Pharm. 1986; 33: 125–136.
    • (1986) Int J Pharm , vol.33 , pp. 125-136
    • Macheras, P.1    Koupparis, M.2    Tsaprounis, C.3
  • 40
    • 0025041478 scopus 로고
    • Eine neues in vitro-Modell zur Erkennung von Wechselwirkungen zwischen Retardarzneimitteln zur oralen Applikation und Nahrungsmitteln
    • Junginger HE Verhoeven J Peschier LJC. Eine neues in vitro-Modell zur Erkennung von Wechselwirkungen zwischen Retardarzneimitteln zur oralen Applikation und Nahrungsmitteln. Pharm Ztg Wiss. 1990; 2: 53–58.
    • (1990) Pharm Ztg Wiss , vol.2 , pp. 53-58
    • Junginger, H.E.1    Verhoeven, J.2    Peschier, L.J.C.3
  • 42
    • 6844224166 scopus 로고    scopus 로고
    • In vitro-Dissolution Testing of Oral Controlled Release Products
    • Gundert-Remy U Möller H. Stuttgart, Germany: Wissenschaftliche Verlagsgesellschaft
    • Siewert M. In vitro-Dissolution Testing of Oral Controlled Release Products. In: Gundert-Remy U Möller H. Oral Controlled Release Products Therapeutic and Biopharmaceutic Assessment. Stuttgart, Germany: Wissenschaftliche Verlagsgesellschaft: 139–154.
    • Oral Controlled Release Products Therapeutic and Biopharmaceutic Assessment , pp. 139-154
    • Siewert, M.1


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