1. What are pharmaceutical pellets?

Pellets are small, spherical, or semi-spherical solid dosage forms used in pharmaceutical formulations to ensure controlled drug release, improve bioavailability, and facilitate drug delivery.

2. What are the advantages of pelletization in drug formulation?

• Uniform drug distribution.
• Improved flow properties.
• Controlled or modified drug release.
• Reduced risk of dose dumping.
• Enhanced patient compliance due to reduced irritation.

3. What methods are used for pellet production?

• Extrusion-spheronization.
• Layering techniques (solution or suspension layering).
• Spray drying or spray congealing.
• Compression.

4. What is extrusion-spheronization?

Extrusion-spheronization is a process used to produce uniform-sized pellets. It involves:

1. Preparing a wet mass.
2. Extruding it into cylindrical shapes.
3. Spheronizing to form pellets.

5. What are the critical parameters in extrusion-spheronization?

• Moisture content of the wet mass.
• Extrusion speed and diameter.
• Spheronization time and plate speed.

6. What types of drugs are suitable for pellet formulations?

• Drugs requiring controlled release.
• Drugs with high dose variability.
• Drugs causing local irritation or incompatibility in combination.

7. What excipients are commonly used in pellets?

• Binders (e.g., PVP, HPMC)
• Fillers (e.g., lactose, microcrystalline cellulose)
• Disintegrants (e.g., croscarmellose sodium)
• Coating materials (e.g., Eudragit, ethylcellulose).

8. What is multiparticulate drug delivery?

Multiparticulate drug delivery involves using multiple small units (e.g., pellets) in a single dosage form to provide controlled, sustained, or targeted drug release.

9. What are the common defects in pellet production?

• Irregular shapes or sizes.
• Cracking during coating.
• Agglomeration due to overwetting.
• Poor sphericity.

10. What is the importance of layering in pellet manufacturing?

Layering ensures uniform deposition of the active pharmaceutical ingredient (API) or excipient onto inert cores or other pellets to achieve desired drug release profiles.

11. What is the purpose of pellet coating?

Pellet coating protects the drug, masks taste, controls drug release, and targets specific regions in the gastrointestinal tract (e.g., enteric coating).

12. What tests are performed to evaluate pellets?

• Particle size distribution.
• Bulk and tapped density.
• Sphericity.
• Drug content uniformity.
• Dissolution testing.

13. What is the role of sphericity in pellets?

Sphericity ensures uniform coating, better flow properties, and consistent drug release.

14. What challenges are associated with pelletization?

• Maintaining sphericity during processing.
• Avoiding agglomeration.
• Controlling particle size.
• Ensuring uniform drug layering.

15. What is the significance of multiparticulate systems over single-unit systems?

Multiparticulate systems reduce the risk of dose dumping, provide uniform drug release, and offer better flexibility in drug formulation.