Press Room

Article / May 31, 2010

Finding Solutions

C&EN, 31 May, 2010

Custom manufacturers take on drug solubility issues to help pharmaceutical firms move products through development

When they get together, pharmaceutical researchers call drug compounds by nicknames such as “brick dust” and “grease.” Whether compounds are crystalline rocks, lipophilic goo, or something in between, getting them to be water soluble can be a major hurdle for making therapies bioavailable in the body. If the bioavailability is low, meaning only a fraction of a dose gets into circulation, even the best molecule can fail as a drug.

About 40% of marketed drugs are thought to be poorly water soluble. Development efforts might have to be redoubled, however, because between 70 and 90% of drug candidates in the pipeline are believed to have low solubility. In fact, solving solubility problems is considered to be the leading challenge in drug development.

Read article here

Also in the Press Room

See All

Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

Article

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024