Comparing the dissolution rates and pellet fine structure of branded Zovirax® with three similar acyclovir generic products marketed across the world, all containing the same API itraconazole. Raman spectroscopy revealed recrystallizing API slowed the dissolution rate.
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Characterizing an API’s different salt forms and polymorphs is an essential drug development task. The successful preclinical assessment and product development can…
FormaDose® Design Solution is a comprehensive drug design assessment consisting of a holistic review of the molecule, patient, and market considerations. Led…
Quality by Design (QbD) is a well-known pharmaceutical industry strategy for enhancing production processes, including active pharmaceutical ingredients and medicinal products. Companies…
If scientific literature indicates that elements are not likely to be present in drug product components, and no additional elements are added…