Although not listed on the United States Pharmacopeia (USP), like standard USP 2, small volume USP 2 dissolution apparatus has gained a great deal of attention, especially for cases where small amount of drug product is available for testing in research and design step or evaluations are to be made on a tablet containing trace amounts of the active pharmaceutical ingredient. In this work, first...

This study explored the application of 400-DS dissolution apparatus 7 for individual pellet dissolution methodology by a design of experiment approach and compared its capability with that of the USP dissolution apparatus 1 and 2 for differentiating the coat quality of sustained release pellets. Drug loaded pellets were prepared by extrusion-spheronization from powder blends comprising 50%, w/w...

Introduction Soft gelatin capsule (SGC) formulations are becoming more popular in recent years (1,2). These formulations can mask odors and unpleasant tastes,and are easy to swallow. They are suitable for encapsulation of lipid solutions,suspensions,or paste-like formulations,making them a useful option when formulating poorly water-soluble drugs. Due to the unique properties of SGC formulation...

Standardized in-vitro dissolution testing of suppositories has been of interest to the pharmaceutical industry since the early works of Giabaldi and Gundhofer in 1975.(1) Anthony Palmieri exam ined standard izin g suppository dissolutions in his work at the University of Wyoming (2). Palmieri developed a slotted dissolution basket for suppositories that is ---------widely used by many individua...

Corresponding author. ABSTRACT 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 used to st...

INTRODUCTION Nifedipine is a calcium-channel blocking agent that is widely used in the treatment of angina pectoris and systemic hypertension (1). The pharmacokinetics and pharmacodynamics of nifedipine have been investigated in numerous studies (2–4). Clinical experiences gained with oral nifedipine formulations with immediate-release (IR) characteristics clearly show that a steep rise in the ...

Introduction Dissolution testing is routinely carried out in the pharmaceutical industry to determine the rate of dissolution of solid dosage forms. In addition to being a regulatory requirement, in-vitro dissolution testing is used to assist with formulation design, process development, and the demonstration of batch-to-batch reproducibility in production. The most common of such dissolution t...

This report summarizes some trends observed in drug dissolution testing, based upon the United States Pharmacopeia (USP) dissolution Apparatus Suitability Test results and the preliminary data obtained from an international collaborative study to assess the pharmaceutical quality of furosemide products in different countries. Based on the USP calibrator data submitted by the participants, repre...

Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) that is widely used for the treatment of mild-to-moderate pain. Mefenamic acid belongs to the Biopharmaceutical Classification System (BCS) class II drug which has lower water solubility but high permeability. There are two different compendial methods available for dissolution tests of mefenamic acid solid dosage forms, i.e. meth...