Tags

Type your tag names separated by a space and hit enter

Evaluation of novel starch acetate-diltiazem controlled release tablets in healthy human volunteers.
J Control Release. 2004 Mar 24; 95(3):515-20.JC

Abstract

Highly substituted starch acetate can be used to control drug release from directly compressed tablets in vitro. The aim of this study was to evaluate controlled release properties of starch acetate in vivo in humans. Three starch acetate tablet formulations with different in vitro release rates for diltiazem (fast, moderate and slow) were developed. An open, single dose, randomised, four treatment, four period, four sequence cross-over pharmacokinetic study was conducted in eight healthy volunteers. Diltiazem concentrations in plasma were determined by HPLC. Concentration-time profiles of the formulations differed: mean C(max) and AUC(0- infinity) values of the fast, moderate and slow formulations were 95, 69, 31 ng/ml and 610, 511, 231 ng h/ml, respectively. In vitro-in vivo correlation (IVIVC) was analysed according to the cumulative area under the curves and in vitro release profiles. Acceptable limits of prediction errors were achieved for C(max) and AUC(0-24 h). The moderate formulation and commercial reference tablet showed similar in vitro release profiles and diltiazem concentrations in plasma. In conclusion, direct compression starch acetate formulations control drug release in humans.

Authors+Show Affiliations

Department of Pharmaceutics, University of Kuopio,FIN-70211 Kuopio, Finland. Ossi.Korhonen@uku.fiNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15023462

Citation

Korhonen, Ossi, et al. "Evaluation of Novel Starch Acetate-diltiazem Controlled Release Tablets in Healthy Human Volunteers." Journal of Controlled Release : Official Journal of the Controlled Release Society, vol. 95, no. 3, 2004, pp. 515-20.
Korhonen O, Kanerva H, Vidgren M, et al. Evaluation of novel starch acetate-diltiazem controlled release tablets in healthy human volunteers. J Control Release. 2004;95(3):515-20.
Korhonen, O., Kanerva, H., Vidgren, M., Urtti, A., & Ketolainen, J. (2004). Evaluation of novel starch acetate-diltiazem controlled release tablets in healthy human volunteers. Journal of Controlled Release : Official Journal of the Controlled Release Society, 95(3), 515-20.
Korhonen O, et al. Evaluation of Novel Starch Acetate-diltiazem Controlled Release Tablets in Healthy Human Volunteers. J Control Release. 2004 Mar 24;95(3):515-20. PubMed PMID: 15023462.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of novel starch acetate-diltiazem controlled release tablets in healthy human volunteers. AU - Korhonen,Ossi, AU - Kanerva,Harri, AU - Vidgren,Mika, AU - Urtti,Arto, AU - Ketolainen,Jarkko, PY - 2003/06/24/received PY - 2003/12/23/accepted PY - 2004/3/17/pubmed PY - 2005/1/15/medline PY - 2004/3/17/entrez SP - 515 EP - 20 JF - Journal of controlled release : official journal of the Controlled Release Society JO - J Control Release VL - 95 IS - 3 N2 - Highly substituted starch acetate can be used to control drug release from directly compressed tablets in vitro. The aim of this study was to evaluate controlled release properties of starch acetate in vivo in humans. Three starch acetate tablet formulations with different in vitro release rates for diltiazem (fast, moderate and slow) were developed. An open, single dose, randomised, four treatment, four period, four sequence cross-over pharmacokinetic study was conducted in eight healthy volunteers. Diltiazem concentrations in plasma were determined by HPLC. Concentration-time profiles of the formulations differed: mean C(max) and AUC(0- infinity) values of the fast, moderate and slow formulations were 95, 69, 31 ng/ml and 610, 511, 231 ng h/ml, respectively. In vitro-in vivo correlation (IVIVC) was analysed according to the cumulative area under the curves and in vitro release profiles. Acceptable limits of prediction errors were achieved for C(max) and AUC(0-24 h). The moderate formulation and commercial reference tablet showed similar in vitro release profiles and diltiazem concentrations in plasma. In conclusion, direct compression starch acetate formulations control drug release in humans. SN - 0168-3659 UR - https://www.unboundmedicine.com/medline/citation/15023462/Evaluation_of_novel_starch_acetate_diltiazem_controlled_release_tablets_in_healthy_human_volunteers_ DB - PRIME DP - Unbound Medicine ER -