OR WAIT null SECS
January 01, 2004
This article reflects on the challenges that predicting powder flowability currently pose to the pharmaceutical manufacturing industry and considers some of the benefits that can accrue when companies overcome these issues.
December 01, 2003
The use of solid dispersion technology to increase the bioavailability of poorly water-soluble drugs has always been limited by processing and scale-up difficulties. A new approach may help to overcome some of the problems.
October 01, 2003
The aim of this study was to validate the automated clean-in-place (CIP) system installed on a capsule filling machine to determine its ability to adequately eliminate contaminants. The results obtained from the proposed cleaning validation trial showed that all the soluble tracer was removed after the washing procedure. At the end of the CIP procedure, the discharged water had the same pH, phosphate content and total organic content as the supplied water. Lack of cross-contamination in the product was also demonstrated and a recovery trial highlighted the complete elimination of the tracer from the machine.
June 01, 2003
This article describes a method for assessing the similarity of dissolution profiles using Hotelling's T2 statistic. The method applies a covariance structure that accounts for the heterogeneity of variance and correlation across time points. Comparing the method with the f2 criterion recommended in FDA's guidance on dissolution testing, the performance of the two methods was assessed on real examples, and simulation studies were also done to compare the method's performance with that of the f2 criterion.
May 01, 2003
Modern tablet production facilities are faced with two increasingly important, yet contradictory, demands - being able to handle more potent drugs and, at the same time, reduce costs. Additionally, batch sizes must become smaller and production planning more flexible. Until recently, these issues could only be dealt with individually and not as a whole; however, the exchangeable functional module (EFM) may provide a solution to this problem, as this article describes.
April 02, 2003
The authors provide a combined source of density data and show that denity can be used as an equipment-independent sclaing parameter in the manufacture of common pharmaceutical solids.
April 01, 2003
Oral dosage forms are the most popular way of taking medication, despite having some disadvantages compared with other methods. One such disadvantage is the risk of slow absorption of the active pharmaceutical ingredient (API), which can be overcome by administering the drug in liquid form and, therefore, possibly allowing the use of a lower dosage.
March 02, 2003
Binder properties of mucilage of starches extracted from breadfruit and cocoyam were investigated in paracetamol tablet formulations using tablet physical properties, disintegration times, and dissolution rates as assessment parameters.
March 01, 2003
The tabletting properties of a new coprocessed excipient for direct compression were compared with a physical mixture of its components (separately and with drugs) and the individual constituents. The compaction properties were also investigated. Results indicated that the new excipient has excellent flow properties and demonstrates enhanced compressibility.
January 01, 2003
Medicines and excipients are inseparable, with few exceptions - one cannot exist without the other. The Pharmaceutical Quality Group and other international bodies have developed good manufacturing practice (GMP) standards and guidelines to facilitate the effective supply of excipients. This article discusses the definition and significance of excipients, and highlights the importance of implementing the correct excipient manufacturing controls and standards.
