INTRODUCTION Dissolution testing is an in vitro technique of great importance in formulation and development of pharmaceutical dosage forms,as it can be used as a substitute for in vivo studies under strictly defined and specified conditions (1). For the comparison of in vitro dissolution data and for use of such data for in vivo bioequivalence testing and in vitro-in vivo correlations (IVIVC) ...

The most common pharmaceutical formulations for antibiotics are the tablets and hard gelatin capsules. The typical shelflife of these dosage forms is five years. In the most countries of the world it is required by the law that the expired medications have to be disposed following the respective regulations. Furthermore, it is common sense not to use the expired medications. The present study w...

Introduction A modified release drug delivery system with prolonged residence time in the stomach is of particular interest for drugs: (a) that are locally acting in the stomach, (b) that have an absorption window in the stomach or in the upper part of small intestine, (c) that are unstable in the intestinal or colonic environments, or (d) have low solubility at high pH values. Systems that pro...

Purpose: With the introduction of combinatorial chemistry and high throughput screening, the properties of new chemical entities shifted towards higher molecular weight and increasing lipophilicity that results in decreasing aqueous solubility. It is not surprising that many drug candidates have poor water solubility since the initial selection of drug candidates are based on activity alone. Ot...

Poorly water-soluble drugs often suffer from limited or irreproducible clinical response due to their low solubility and dissolution rate. In this study, organic solvent-free solid dispersions (OSF-SDs) containing telmisartan (TEL) were prepared using polyvinylpyrrolidone K30 (PVP K30) and polyethylene glycol 6000 (PEG 6000) as hydrophilic polymers, sodium hydroxide (NaOH) as an alkalizer, and ...

©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...

The aims of the present study were to evaluate the performance of the main methods proposed for the comparison of percentage dissolved versus time curves and to recommend a more biorelevant combined approach for the comparison of dissolution profiles of multisource drug products. In vitro dissolution tests of four brands of oxcarbazepine (OxCBZ) tablets were performed, and the resulting profile...

poorly water-soluble drugs often suffer from limited or irreproducible clinical response due to their low solubility and dissolution rate. in this study, organic solvent-free solid dispersions (osf-sds) containing telmisartan (tel) were prepared using polyvinylpyrrolidone k30 (pvp k30) and polyethylene glycol 6000 (peg 6000) as hydrophilic polymers, sodium hydroxide (naoh) as an alkalizer, and ...