JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD Pharm. D III Year PHARMACEUTICAL FORMULATIONS Previous Question Paper (October/November - 2019 - R08)

Wet granulation involves the addition of a liquid binder to a powder mixture to form granules, whereas dry granulation involves compacting powder particles into larger masses (slugs or ribbons) without the use of liquid. Wet granulation is suitable for heat-stable, moisture-stable drugs, while dry granulation is preferred for moisture-sensitive or heat-labile substances.

Quality control tests for uncoated tablets ensure consistency, bioavailability, and stability. The primary tests include:

• General Appearance: Visual inspection for size, shape, color, surface texture, and markings (monograms/logos).
• Tablet Hardness: Measured using a hardness tester (e.g., Monsanto, Pfizer) to ensure the tablet can withstand mechanical stress during packaging and shipping.
• Friability: Evaluated using a friabilator to determine the tablet's resistance to abrasion and chipping during handling.
• Weight Variation: Determined by weighing 20 tablets individually and calculating the average weight to ensure dose uniformity.
• Tablet Thickness: Measured using a micrometer or vernier caliper to maintain uniformity across batches.
• Disintegration Time: Measured in a disintegration test apparatus to ensure the tablet breaks down into smaller particles within a specified time in a simulated gastric medium.
• Dissolution Test: Assesses the rate and extent of drug release from the tablet into a dissolution medium, which is critical for predicting in vivo performance.