We demonstrate the use of modeling and simulation to investigate bioequivalence (BE) concerns raised about generic warfarin products. To test the hypothesis that the loss of isopropyl alcohol and slow dissolution in acidic pH has significant impact on the pharmacokinetics of warfarin sodium tablets, we conducted physiologically based pharmacokinetic absorption modeling and simulation using form...

©2010 Particle Sciences, Inc. All rights reserved. the drug substance and involves two steps: dissolution and absorption (or permeability). Understanding the multi-step dissolution process is essential to proper in vitro method development. Dissolution is the process of extracting the API out of the dosage form solid-state matrix into solution within the gastrointestinal tract. Absorption is th...

− Fenofibrate has been used for many years to lower cholesterol levels and its pharmacokinetic profile is well understood. However, due to its low solubility in water, it has low bioavailability after oral administration. In order to improve the dissolution rate, fenofibrate was formulated into a self-microemulsifying drug delivery systems (SMEDDS). We used pseudo-ternary phase diagrams to eval...

In vitro dissolution behaviors of CaTiO3 thin films deposited with ion beam assisted deposition (IBAD) and sputter-deposition techniques were investigated using Rutherford backscattering spectrometry (RBS) and Auger electron spectroscopy (AES). In vitro test was carried out by immersion in a simulated body fluid at 37 C for 5, 24, and 888 h. The dissolution of titanium ions from CaTiO3 film was...

The effect of formulation parameters on the in vitro release profile of a poorly soluble drug was investigated using rimonabant as model drug. A dissolution test was developed to evaluate the release profile of rimonabant from both 20mg film-coated tablet and capsule dosage forms. The test was applied to compare dissolution profiles of different dosage forms and to evaluate the effect of formul...

Drug dissolution (or release) testing is an analytical technique used to assess release profiles of drugs in pharmaceutical products,generally solid oral products such as tablets and capsules (1). This test gains its significance from the fact that if a drug from a product is to produce its effect, it must be released from the product and should generally be dissolved in the fluids of the gastr...

The FDA Biopharmaceutical Classification System guidance allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms only for BCS class I. Extensions of the in vivo biowaiver for a number of drugs in BCS class III and BCS class II have been proposed, in particular, BCS class II weak acids. However, a discrepancy between the in vivo BE resu...

in the current study, floating dosage form containing acyclovir was developed to increase its oral bioavailability. effervescent floating tablets containing 200 mg acyclovir were prepared by direct compression method with three different rate controlling polymers including hydroxypropyl methylcellulose k4m, carbapol 934, and polyvinylpyrrolidone. optimized formulation showed good floating prope...

The use of natural polymers in the drug delivery continues to be an area of intensive research despite the advent of several new synthetic polymers. The present study envisages pharmaceutical utility of Assam glutinous rice as natural biopolymeric matrix for microfabricated controlled DDS. Microcarriers were prepared using an industrially feasible ionic gelation method using the blends of propo...