Analysis

ABSTRACT
Dissolution testing is a key pharmaceutical QC test required for release of oral dosage forms. It is also commonly used
to predict in vivo behavior of the formulation. Filtration is a key sample preparation step that follows the drug dissolution
test before sample analysis. Because of the simplicity of the filtration process, the choice of filtration devices is often

INTRODUCTION
Dissolution testing has become a highly valuable in
vitro test performed for quality control and
regulatory purposes (1). According to the
biopharmaceutical classification system (BCS), dissolution
testing can be used to waive in vivo bioequivalence
studies (2), where it can be applied to replace expensive
pharmacokinetic studies and is suitable for the approval of

ABSTRACT
A simple, cost-effective, time-saving device has been invented to control the variability of a basket. This device not only
controls the parameters set in USP <711> (height, cylinder ID, and OD) but also controls the cylinder symmetry, which is
not defined in USP <711>.
INTRODUCTION
Dissolution testing is a requirement for all solid oral

ABSTRACT
Griseofulvin and carbamazepine were selected as model drugs to compare measurements of disk intrinsic dissolution
rate (IDR) by a traditional (Wood apparatus) USP method (500-mg pellet, 900 mL media) and a new miniaturized method
(5-mg pellet, 15 mL media) at 37 °C and 100 rpm. An in situ fiber optic UV instrument was used to collect dissolution data,

ABSTRACT
Myasthenia gravis is an autoimmune disease that destroys key components of the neuromuscular system. The most
common therapy uses reversible inhibitors of cholinesterase activity, such as pyridostigmine bromide (PB). The nature of
this illness implies that we must be sure that all available PB immediate-release tablets produce the same therapeutic
response.

INTRODUCTION
In vitro dissolution testing is an important
physicochemical tool used to measure drug release
rates during both early and late stages of drug
development. In both cases, a product-specific
discriminating dissolution method is utilized as a quality
control tool to evaluate batch-to-batch consistency and
as a predictive means to gain a post-market bio-waiver

ABSTRACT
The objective of these studies was to develop a discriminatory in vitro release test for assessing formulation factors
that may affect oxytocin (OT) release during formulation development studies of a Pluronic® F127 OT in situ gel-forming
parenteral dosage form. An appropriate release assessment method should be able to discriminate between the

INTRODUCTION
Simulation of gastrointestinal conditions is essential to
adequately predict the in vivo behavior of poorly
soluble drugs. Simulating small intestinal conditions
with biorelevant media such as fasted state simulated
intestinal fluid (FaSSIF) and fed state simulated intestinal
fluid (FeSSIF) has become standard practice in many

Face-to-Face Meeting
The second IVR DT focus group face-to-face meeting
was held on April 24th in Research Triangle Park, North
Carolina. About 40 people met in an offsite conference
room facility hosted by GSK. The main topic of
discussion was “Value of Dissolution throughout
Development.” The chain of the focus group, Qingxi
Wang, opened the meeting and moderated throughout.

Abstract
The purpose of this study was to compare the technical quality of commercial American and Japanese ranitidine
tablets. Five brands of 150-mg USP tablets and six brands of 150-mg JP tablets were compared on hardness, friability,
average weight, average content, content uniformity, and dissolution.