From Racemate to Single Enantiomer
Pharmacokinetic Differences, Clinical Context and MediPharm’s Process Expertise Gastric acid has long been recognised as a key factor in the physiology of the upper gastrointestinal tract, playing essential roles in protein digestion, mineral absorption and providing a natural defense against bacterial infections to a certain degree. However, inappropriate levels of gastric acid underlie several widespread […]
Lyophilization for Biologics and Parenteral Formulations: Development, Cycle Design and GMP Implementation
Lyophilization, or freeze‑drying, is a critical stabilization technology for biologics and labile parenteral formulations that converts a solution into a solid state by sequentially freezing, sublimating ice during primary drying and removing bound water during secondary drying. When appropriately designed, a lyophilized product maintains chemical integrity and conformational stability of the active substance, mitigates hydrolytic […]