Application of surface area measurement for identifying the source of batch-to-batch variation in processability.

The primary goal of this study was to evaluate the use of specific surface area as a measurable physical property of materials for understanding the batch-to-batch variation in the flow behavior. The specific surface area measurements provide information about the nature of the surface making up the solid, which may include defects or void space on the surface. These void spaces are often present in the crystalline material due to varying degrees of disorderness and can be considered as amorphous regions.

Comprehensive validation scheme for in situ fiber optics dissolution method for pharmaceutical drug product testing.

There has been a growing interest during the past decade in the use of fiber optics dissolution testing. Use of this novel technology is mainly confined to research and development laboratories. It has not yet emerged as a tool for end product release testing despite its ability to generate in situ results and efficiency improvement.

Content uniformity determination of pharmaceutical tablets using five near-infrared reflectance spectrometers: a process analytical technology (PAT) approach using robust multivariate calibration transfer algorithms.

Near-infrared calibration models were developed for the determination of content uniformity of pharmaceutical tablets containing 29.4% drug load for two dosage strengths (X and Y). Both dosage strengths have a circular geometry and the only difference is the size and weight.

Strategy for identification of leachables in packaged pharmaceutical liquid formulations.

Drug stability is one of the key properties to be monitored in pharmaceutical drug development. Drug degradation products, impurities and/or leachables from the drug product and packages may have significant impacts on drug efficacy, safety profile and storage conditions. In the registration stability samples of an ophthalmic pharmaceutical drug product, an unknown compound was found at a level of 0.

Elimination of metformin-croscarmellose sodium interaction by competition.

During analytical method development and validation, a strong charge interaction between metformin and croscarmellose sodium was observed when the aqueous solution containing metformin was spiked with croscarmellose sodium. The charge interaction resulted in the retention of metformin in croscarmellose sodium and caused a serious drug recovery problem. The percent recovery of metformin in the solution was much lower than its theoretical values, especially in the low metformin concentration range.