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By Matthias Steiert, Cofounder, Afaf Translations
On average, more than 750 patents are granted each day, or about one patent every 2 minutes, and of those, more than half are of non-U.S. origin. The number of U.S. patents granted to foreign inventors has increased by nearly 10 percent per year during the past two decades. Every country has different patent laws and patent application requirements, so inventors must apply for a separate patent in every country in which they intend to make, use, or sell their product, or simply to maintain IP protection.
By Adrian Possumato, Multisorb Technologies
Pharmaceuticals are subject to a variety of degradation pathways that compromise drug safety and shelf life. By far the greatest degradation is caused by hydrolysis and oxidation. However, other mechanisms include racemization, photodegradation, elimination, and complexation.
By Fred Monsuur, Julia Poncher W. R. Grace & Co
An excipient’s role has traditionally been viewed as merely a filler or binder contributing to the stability of the end product. The full value that a formulation can bring to a final dosage form; or the real importance of ensuring an excipient’s quality and performance; are often underestimated, overlooked, misunderstood, or disregarded. In reality, the functionality of the excipient can help determine whether or not a drug succeeds or fails.
By Christine Banaszek, Charles Ross and Son Company
Creating an efficient mixing or blending system is a balancing act. Throughput must be balanced against batch size, agitator sizes, motor sizes, shear and tip speeds, viscosity, the thermal capacity of your product, energy costs, labor costs…and many other variables.
By Jeff Clark, President, 7PSolutions, LLC
Over the last several years, organizations such as the World Health Organization (WHO), Parenteral Drug Association (PDA), and the International Air Transport Association (IATA), along with most countries’ Ministries of Health or similar agencies, have written guidance and regulatory documents regarding the handling and management of time- and temperature-sensitive healthcare products during transport and in-transit storage.