A New Rapidly Absorbed Paracetamol Tablet Containing Sodium Bicarbonate. II. Dissolution Studies and In Vitro In Vivo Correlation

ABSTRACT The objective of this study was to compare the in vitro dissolution profile of a new rapidly absorbed paracetamol tablet containing sodium bicarbonate (PS) with that of a conventional paracetamol tablet (P), and to relate these by deconvolution and mapping to in vivo release. The dissolutio...

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Bibliographic Details
Published in:Drug development and industrial pharmacy 2002-01, Vol.28 (5), p.533-543
Main Authors: Rostami-Hodjegan, A., Shiran, M. R., Tucker, G. T., Conway, B. R., Irwin, W. J., Shaw, L. R., Grattan, T. J.
Format: Article
Language:English
Subjects:
Acetaminophen - chemistry
Acetaminophen - pharmacokinetics
Analgesics
Analgesics, Non-Narcotic - chemistry
Analgesics, Non-Narcotic - pharmacokinetics
Biological and medical sciences
Chemistry, Pharmaceutical
Deconvolution
Dissolution test
Excipients - chemistry
General pharmacology
Humans
In vitro-in vivo correlation
Medical sciences
Models, Biological
Neuropharmacology
Paracetamol
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Sodium Bicarbonate - chemistry
Solubility
Tablets
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Summary:ABSTRACT The objective of this study was to compare the in vitro dissolution profile of a new rapidly absorbed paracetamol tablet containing sodium bicarbonate (PS) with that of a conventional paracetamol tablet (P), and to relate these by deconvolution and mapping to in vivo release. The dissolution methods used include the standard procedure described in the USP monograph for paracetamol tablets, employing buffer at pH 5.8 or 0.05 M HCl at stirrer speeds between 10 and 50 rpm. The mapping process was developed and implemented in Microsoft Excel® worksheets that iteratively calculated the optimal values of scale and shape factors which linked in vivo time to in vitro time. The in vitro-in vivo correlation (IVIVC) was carried out simultaneously for both formulations to produce common mapping factors. The USP method, using buffer at pH 5.8, demonstrated no difference between the two products. However, using an acidic medium the rate of dissolution of P but not of PS decreased with decreasing stirrer speed. A significant correlation (r = 0.773; p
ISSN:0363-9045
1520-5762
DOI:10.1081/DDC-120003449