Parenteral
Oral Vs Parenteral Dosage Form | Formulation Challenges
Oral dosage form formulation challenges A) Poor Bioavailability Many drugs face challenges in being absorbed through the gastrointestinal (GI) tract due to poor solubility, gastrointestinal pH, or presence of enzymes that degrade the drug before it can be absorbed into the bloodstream. B) Solubility and Stability 1) solubility: Drugs with ... Read More
Difference Between Extractables and Leachables
In the intricate world of biopharmaceutical manufacturing, the presence of extractables and leachables poses a significant challenge, potentially tarnishing the purity of invaluable drug products. The FDA offers precise definitions for these two critical terms: Extractables These are compounds that can be meticulously drawn out from the container closure system ... Read More
Product Quality Tests for Injections and Implanted Drug Products
Parenteral drug products include both injections and implanted drug products that are injected through the skin or other external boundary tissue, or implanted within the body to allow the direct administration of the active drug substance(s) into blood vessels, organs, tissues, or lesions. Injections may exist as either immediate- or ... Read More