Issues in PE (Pharmaceutical Equivalence) of the API Flashcards
How does particle size affect pharmaceutical equivalence (PE)?
Particle size differences can alter dissolution rates and bulk density. While the API is PE in solution, suspensions may face dissolution issues.
How do polymorphs impact pharmaceutical equivalence (PE)?
Different crystalline and amorphous forms have different dissolution rates. A polymorphic impurity in an IV solution may precipitate over time, affecting stability.
How do hydrate and anhydrous forms affect pharmaceutical equivalence (PE)?
Differences in water content impact dissolution rates and API potency, but in solution, the API remains PE.
How do impurities affect pharmaceutical equivalence (PE)?
Different synthesis and purification methods create variations in residual solvents and impurities, requiring qualification if above threshold levels.
How does stability impact pharmaceutical equivalence (PE)?
Crystal defects from synthesis or purification can shorten shelf life. Amorphous forms degrade faster, affecting efficacy.
How does chirality and racemic mixtures affect pharmaceutical equivalence (PE)?
Racemic APIs are PE if the isomer ratio remains the same. However, single isomers (e.g., esomeprazole vs. omeprazole) have different pharmacokinetics and pharmacodynamics.
How do biotechnology-derived drugs impact pharmaceutical equivalence (PE)?
Due to complex structures, identicality is impossible. Instead of PE, follow-on products are termed ‘biosimilars,’ which must show similarity in PE, pharmacokinetics, and pharmacodynamics. Immunogenicity may also differ.
