PMID: 8453024Mar 1, 1993Paper

In vitro/in vivo correlation of prolonged release dosage forms containing diltiazem HCI

Biopharmaceutics & Drug Disposition
C CaramellaM R Galmozzi

Abstract

Six preparations were considered: three multiple unit dosage forms (micropellets in capsules) (D, E and G) and one matrix tablet (B) were experimental prolonged release formulations, two non-disintegrating tablets (A and C) were commercial products. The in vitro dissolution behaviour of the differing formulations was investigated using the USP XXII paddle apparatus. The in vivo study was effected on a panel of 12 healthy volunteers. The two commercial tablets (A and C) showed mean dissolution time (MDT) of 1.34 and 1.44 h and td of 91 and 92 min, respectively; for prolonged release formulations (B, E, D, and G) MDT ranged between 2.28 and 4.23 h and td between 149 and 291 min. The mean residence time (MRT) was 8.68 and 6.47 h for tablets A and C, respectively; it ranged between 9.62 and 10.24 h for the multiple unit formulations E, D, and G and was 11.27 h for matrix B. Formulation B also showed the higher apparent elimination half-life t1/2 (7.12 h), while apparent t1/2 for all the other formulations were very similar, ranging between 5.04 and 5.28 h. High variability between the various formulations was found for Cmax and AUC values, and no relationships could be established with the type of formulation. An in vitro/in vivo c...Continue Reading

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Citations

Oct 31, 1998·Journal of Controlled Release : Official Journal of the Controlled Release Society·M RodríguezD Torres
Jan 13, 2001·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·A AinaouiJ M Vergnaud
Jan 20, 2004·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Cristián TapiaMehrdad Yazdani-Pedram
Jun 29, 2000·Drug Development and Industrial Pharmacy·G ErtanT Güneri
Jul 7, 2007·Drug Development and Industrial Pharmacy·Cristián TapiaMehrdad Yazdani-Pedram
Jul 1, 1996·Journal of Pharmaceutical Sciences·J E PolliG L Amidon
Dec 31, 1997·Journal of Pharmaceutical Sciences·A DunneJ Devane
Mar 14, 2002·Biopharmaceutics & Drug Disposition·Nattee SirisuthNatalie D Eddington

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