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Application of Thermal Analysis in Lyophilization Development and Optimization

Lyophilization (or freeze-drying) is a process that removes the water from a product in order to impart higher stability, broader temperature tolerance, and longer shelf-life to pharmaceutical formulations that are unstable in aqueous solution. Lyophilization works by freezing the material and then reducing the surrounding pressure and adding enough heat to allow the frozen water in the material to sublime directly from the solid phase to the gas phase. While the demand for lyophilization is growing due to the introduction of new products, specifically biologics such as monoclonal antibodies (Mabs) and recombinant proteins, there are also several disadvantages to lyophilization. The principle disadvantages of lyophilization are:

  • High capital cost of equipment (about three times more than traditional sterile solution or sterile dry powder fill technology).
  • High energy costs (two to three times more than conventional methods)
  • Long process time (typically a minimum of 24-hours per drying cycle).

However, it should be pointed out that for many products, including the vast majority of high-value proteins, peptides, and vaccines, lyophilization is the only way to deliver stable, biologically active products with a commercially viable shelf-life. With the growing number of drugs in development requiring lyophilization, finding methods to shorten lyophilization development and ensuring optimization of lyophilization cycles can significantly impact the time and cost to develop and produce lyophilized product.

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A Technical Report in Counterfeit Drug Detection Using X-Ray Powder Diffraction (XRPD)

The FDA, over the years, has changed the Food Drug and Cosmetic Act by making amendments to the Prescription Drug Marketing Act of 1987. These amendments establish requirements related to the wholesale distribution of prescription drugs, and have a primary purpose of preventing the introduction of substandard ineffective and counterfeit drugs into the U.S. drug supply chain. While these amendments have increased awareness and vigilance at all levels of the distribution chain, the number of counterfeit drug cases has steadily increased over the years. Since 2001, the FDA’s Office of Criminal Investigations (OCI) has observed a steady increase in the number of counterfeit drug cases initiated. In 2001, the agency initiated six separate cases for suspected counterfeit drugs. By 2004, the number of cases initiated rose to fifty-eight. The agency recognized this increasing threat to the nation’s drug supply, and on February 18th, 2004, issued a report entitled Combating Counterfeit Drugs: A Report of the Food and Drug Admnistration. This report highlighted several measures that can be taken in six critical areas to better secure the nation’s drug supply against counterfeit medications. A large part of this initiative involves ensuring that drug products have a “pedigree,” or documentation of the chain of custody of the drug product throughout the distribution system (from manufacturer to end user).

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