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[PSCI-03] Sterile Dosage Forms: Parenterals (SVP/LVP), Isotonicity, Pyrogens, Lyophilization & Ophthalmics
PSCI-03 • 4. PharmaceuticsLearning Objectives
Classify ISO cleanroom grades (Grade A/ISO 5, B, C, D), HEPA filtration (99.97% at 0.3 µm), and USP Type I, II, III, NP pharmaceutical glass containers.; Calculate isotonicity adjustments using Freezing Point Depression (ΔTf = 0.52°C) and Sodium Chloride Equivalent (E-value) methods.; Compare moist heat sterilization (F0 value, 121°C/15 psi), dry heat depyrogenation (250°C), membrane filtration (0.22 µm), and LAL vs Rabbit pyrogen testing.
Chapter Overview & Core Explanation
Injections and eye drops bypass the body's natural skin and gut barriers, so they must be completely free of viable microbes (sterile), bacterial endotoxins (pyrogen-free), visible particles, and matched to blood osmotic pressure (isotonic).
Key Exam & Clinical Takeaways
- 0.9% w/v Sodium Chloride ([10.1]) and 5% w/v Dextrose ([10.3]) have a freezing point depression (ΔTf) of 0.52°C and osmolarity ~285–308 mOsm/L, making them isotonic with human plasma and tears.
- Benzyl alcohol preservative is strictly contraindicated in neonates due to 'Fatal Gasping Syndrome' (metabolic acidosis, CNS depression, cardiovascular collapse).