Pharmaceutics and Pharmaceutical Technology
Pharmaceutics and Pharmaceutical Technology tests how formulation design, manufacturing controls and stability determine whether a dosage form delivers the drug safely and reproducibly. Expect applied calculations, excipient/process selection and GMP reasoning, not definitions alone.
Core rules
- Solid oral forms depend on disintegration, dissolution and content uniformity; semisolids on uniformity and microbial quality; parenterals on sterility, pyrogen control and particulate limits.
- Excipients are functional: binders change hardness, disintegrants change release, surfactants change wettability, preservatives change microbial limits.
- Stability is product-specific. Hydrolysis, oxidation, photolysis and polymorph conversion all matter. Use accelerated and long-term data together; do not extrapolate beyond supported conditions.
- Compounding needs a master formula, verified calculation, clean equipment and a final identity/strength/quality/label check.
Worked example
A first-order degradation constant is 0.015 month⁻¹ at 25 °C. Then t90 = −ln(0.90)/k = 0.1054/0.015 = 7.0 months. If the specification is 90–110% label claim, the supported shelf-life at that condition is about 7 months, not 12; confirm with real-time data and batch variability.
Traps
- Using zero-order t90 (0.1C0/k) for a first-order reaction.
- Omitting dilution factors in assay or uniformity calculations.
- Treating accelerated data alone as proof of shelf-life.
- Confusing %w/w, %w/v and mg/mL.