Often, I hear questions surrounding what are liquid dosage formulations. I thought I might take the opportunity to provide a short introduction to liquid dosage formulations. Liquid dosage formulations may be in the form of suspensions or syrups, metered dosed inhalers (MDIs), or creams or lotions. All of these systems would typically have particles present or droplets present in their formulations. There could also be parentals, such as injections or intravenous infusions, which may be particle free. Continue reading →
The 2010 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting will be held November 14 to 18 in New Orleans. As thousands of pharmaceutical scientists from around the world prepare to gather for the AAPS conference that is being held in conjunction with the International Pharmaceutical Federation’s (FIP) Pharmaceutical Sciences World Congress (PSWC), I wanted to highlight some papers that will discuss how to track particle distribution in real-time:
In an ideal world, you may want to directly measure the crystal population within the crystallizer (a critical product quality attribute) and measure the supersaturation which is driving the process (a critical process parameter). Today’s advanced Process Analytical Technology (PAT) allows you to measure both of these critical parameters in real time. But where should you begin – especially if budget constraints limit you to implementing only one advanced measurement. Continue reading →
Crystallization is a critical process for the purification and isolation of chemical compounds in the manufacture of many fine chemical and pharmaceutical products. The results of the crystallization step have far reaching impacts on overall process efficiency and final product quality. Crystallization is also a very difficult process to effectively optimize and control. Crystallization is inherently complicated simply by being a process involving the creation and formation of solid particles.
Timothy A. Bell, of DuPont Engineering Research and Technology, wrote a review of the challenges of scaling-up particulate processes where he stated: Continue reading →
METTLER TOLEDO FBRM and Opt Diss Fiber Optic UV for Dissolution Testing in Distek Evolution 6100
USP tablet dissolution testing is recognized as the standard analytical method used in the pharmaceutical industry.
Traditionally, dissolution has been performed in the analytical laboratory and tests were conducted with the final product. But in recent years dissolution testing has become a development tool for Quality by Design (QbD), and testing has expanded to include dissolution and disintegration tests which screen product performance during drug product development. Continue reading →
In 1969, the USA Congressional Joint Committee on Atomic Energy held a hearing at the head of the Fermi National Accelerator Laboratory and was being questioned on why build a new $250 million particle collider. What did a particle collider have to do with the security of the country? Physicist Robert Wilson replied “It has nothing to do directly with defending our country except to make it worth defending.” 1