FDA

WHY MANAGING VARIABILITY MATTERS? Pharmaceutical ingredients play a key role in drug formulation. Variations in their composition and physicochemical properties...

Abstract Enteric coating ensures a targeted release of active pharmaceutical ingredients (APIs) by protecting them from premature dissolution in the...

Abstract Posaconazole (PCZ) is a broad spectrum anti-fungal drug approved by FDA and currently used off-label for the treatment of...

Abstract Similar to other routes of administration, pulmonary formulations typically contain excipients. The panel of substances that can be used...

Abstract Pulmonary drug delivery is a form of local targeting to the lungs in patients with respiratory disorders like cystic...

Abstract The recent advancement of 3D-printed drugs is an emerging technology that has the potential for effective and safe oral...

Abstract Nitrosamine impurities have garnered recent attention due to their presence in pharmaceuticals and their mutagenic risks. Recent studies have...

Abstract The integration of Process Analytical Technology (PAT) into pharmaceutical process development has become a critical focus since the issuance...

Abstract Sulfur and phosphorus are elements that can be found in various FDA-approved drugs, either as part of the active...

Abstract Film-forming solution (FFS) implies a novel formulation strategy for liquid preparations for cutaneous application with numerous advantages in comparison...