Vivian Gray
Dissolution is an ever-evolving test with the development of novel dosage forms and increased quality expectations from regulators.
Rajesh Krishnan, Hao Chen
Over the last ten years, single-use (SU) technologies have been successfully implemented for the development and manufacturing of large, complex biologics, including monoclonal antibodies (MAbs) and recombinant proteins (Figure 1).
Joelle M. Onorato, Ph.D, Robert Langish, Samuel Hellings, Petia Shipkova, Ph.D, Peter S. Gargalovic, Ph.D
Accumulation of lipid-laden macrophages in the arterial wall is an early characteristic of atherosclerotic lesion formation. Lipid uptake by macrophages can be studied in vitro by treating macrophages with modified (i.e. acetylated) low-density lipoprotein (LDL) and measuring the accumulated free cholesterol and cholesterol esters. Initially, a commercially available enzymatic assay for the determination of total and free cholesterol was investigated.
In general, there is an industry trend toward the need for increased capacity, efficiency, uptime, and utilization – and this trend is certainly prevalent in most tablet production environments. Increasing overall capacity with fewer machines and fewer operators is driving requirements for fast change strategies, which involve multiple turrets, multiple sets of change parts, and streamlined procedures.
Melgardt M. de Villiers, Ph.D., Daniel P. Otto, Ph.D, Yuri M. Lvov, Ph.D
Since layer-by-layer (LbL) polyelectrolyte assembly was introduced in the nineteen nineties, it has found application in various fields that study and apply nanotechnology. LbL nanoassembly is based on the sequential adsorption of positively and negatively charged polymers on a surface to form a nano-thick film of coating. The process involves resaturation of polyion adsorption, resulting in the reversal of the terminal surface charge of the film after deposition of each layer. The method provides the possibility of designing ultrathin multilayer films with a precision better than one nanometer of defined molecular composition. These films can be applied to surfaces or can be used to coat micro- and nanoparticles. This coating process can be used to control the release of drugs, increase the stability of drugs and to improve the properties of commonly used excipients. Since no covalent binding is involved in the shell formation it allows the drug or excipient to remain intact. Therefor
Bei Chen, Ph.D., Jack Nottingham, Brian C Anderson, Ph.D.
Size reduction is one of the most common unit operations for both active pharmaceutical ingredient (API) and drug product manufacturing. The resulting particle size distribution (PSD), in most cases, is believed to have great impact on bioavailability and/or downstream processes. However, the fundamental understanding of the process is still limited.
Yanqiao Xiang, Ph.D, John Lucas, John VanAlsten, Ph.D, Bryan Li, Ph.D, Brian Preston, Mike Lovdahl, Ph.D, Cheryl M. Hayward, Ph.D
FTIR (Fourier Transform Infrared Spectroscopy) process analyzers have been shown to be a convenient and versatile analytical tool for monitoring reactions in real-time during flow chemistry development and manufacture. In this example, on-line FTIR is first applied to a Curtius rearrangement reaction in a batch mode, which provides the chemist with insight into both the mechanisms and kinetics of the chemistry being developed. The results from the experiments conducted in batch mode are then applied to enable the development of the flow chemistry process
Sara E. Andria, Ph.D.,, Moseley Fulcher, Mark R. Witkowski, Ph.D., S. Frank Platek, MS
The production and sale of counterfeit pharmaceutical products is a global problem. The products can be brand-name or generic and range from expensive life saving medications to lifestyle drugs.
Mikhail N. Slipchenko, Ph.D, Bo Zhou, Rodolfo Pinal, Ph.D, M. Teresa Carvajal, Ph.D, Ji-Xin Cheng, Ph.D
Process Analytical Technologies (PAT) for pharmaceutical manufacturers requires the development of new tools for identification and measurement of Critical Process Parameters (CPPs) meant to be further used for process control in a quality-by-design (QbD) approach to drug manufacturing [1]. One of the CPPs demanding for a non-invasive chemically-selective tool is intermediate and end-product content uniformity.
Edwin Chan, Yuh-Fun Maa, Ph.D, David Overcashier
A study was conducted to investigate the effect of headspace pressure within the prefilled syringe system where liquid leakage (dripping) was observed from the syringe needle upon removal of needle shield. Drip tests were performed to measure the expelled quantity on syringes manually filled with 0.5 or 1.0 mL of various aqueous solutions.
Donald C. Singer
A new official chapter about microbiological sampling will appear in the USP 35 NF 30 (United States Pharmacopeia), which represents a global collaborative effort between industry, regulators and USP expert committees. The intent of the chapter, <610> Alternative Sampling Methods for Non-sterile Inhaled and Nasal Products, is to offer methods for sampling of pharmaceutical products in complex packaging that are difficult to sample in an aseptic manner, which is the necessary microbiological approach.
Ann Newman, Ph.D., Eric Munson
Amorphous solid dispersions are being used more frequently in the pharmaceutical industry to address bioavailability problems with poorly soluble drugs.
Vineet Kumar, Ph.D., Shubhadra N. Singh, Ph.D, Devendra S. Kalonia, Ph.D.
Polyols (aka polyhydroxy co-solvents aka osmolytes) such as sucrose have long been known to impart thermodynamic stability to proteins in solution. Recent advances in biotechnology and in the development of proteins for therapeutic applications has led to an increased interest in these neutral co-solvents (more than 60 % of mAb formulations currently in market have polyhydroxy alcohols as excipients).