Analysis

Q What tolerance is allowed between results obtained with manual and automatic sampling?

On October 23–24, 2008, the Shanghai University
of Traditional Chinese Medicine sponsored a
workshop on the pressing issue of performance
and quality benchmarks for conventional and traditional
medicines. Dr. Gordon Amidon from the College of
Pharmacy at the University of Michigan, who is the father
of the Biopharmaceutical Classification System (BCS), gave

As the editors indicate in the forward, this book is
intended to continue in the fine tradition of
Lieberman, Lachman, and Schwartz, editors of
previous editions of Pharmaceutical Dosage Forms: Tablets.
This edition expands upon the last edition, published in
1990, and devotes many pages to new technologies and
emerging trends in pharmaceutical development. The 311

The objective of this work was to develop floating levofloxacin tablets and to understand the kinetics of drug release
by applying mathematical and model-dependent approaches. Nine formulations of floating tablets were prepared by the
direct compression method using Gelucire 43/01 (hydrophobic) and hydroxypropyl methylcellulose (hydrophilic) as

Official compendia lack in vitro dissolution guidelines for simulated fed conditions. The goal of this project was to
compare disintegration times and drug release characteristics for Polygel CR tablets using USP dissolution Apparatus 1
and the USP disintegration apparatus. Calcium tablets plus vitamin D with different deaggregation properties were also

The concept of small-volume dissolution arises from the need to determine the dissolution rate from low-dose,
generally high potency drugs or drugs with analytical techniques that are not very sensitive. Novel drug delivery
products including subcutaneous implants, ocular systems, microspheres, nanospheres, and combination products such

The purpose of this research was to monitor in situ the drug release of ambroxol hydrochloride sustained-release
tablets using a fiber-optic dissolution test system. A control experiment with a UV-vis spectrophotometer was performed
simultaneously. Within 4 h, a real-time drug release profile was obtained. The average drug release at 60 min, 120 min,

ABSTRACT
As part of its evaluation of the performance verification tests used periodically to affirm the integrity of the USP
Performance test when General Chapter Dissolution <711> is relied upon, the Biopharmaceutics Expert Committee of the
Council of Experts, working with staff, decided to change the form of the accept/reject decision from one based on the

Q We have the following situation: a product releases about 90% of label claim in 7 min in pH 6.8 phosphate buffer, about 40% of label claim in 60 min in 0.1 N hydrochloric acid, and about 50% of label claim in 7 min and about 90% in 60 min in pH 4.6 acetate buffer. Which of these media is the most appropriate for this formulation?

ABSTRACT
The aims of this study were (1) to compare the in vitro dissolution profiles of oxcarbazepine-HP b-CD tablet
formulations with those of marketed oxcarbazepine tablets, (2) to apply statistical models to evaluate each method in
terms of easy application and usefulness, and (3) to identify the advantages and disadvantages of each method. The