In pharmaceutical manufacturing, excipients are not just “inactive ingredients” — they are functional components that directly impact product quality, stability, and patient compliance. Below is a structured overview of key excipient categories with their roles in GMP-driven tablet formulation:
1. Binders (Ensure Tablet Integrity)
Function: Promote cohesion among the API and other excipients, imparting mechanical strength and ensuring tablets withstand handling, packaging, and transport stresses.
Examples: Starch, polyvinylpyrrolidone (PVP)
2. Fillers / Diluents (Add Bulk for Accuracy & Handling)
Function: Provide the necessary tablet size and weight for accurate dosing and patient-friendly administration.
Examples: Lactose, Microcrystalline Cellulose (MCC), dicalcium phosphate
3. Disintegrants (Enable Rapid Breakdown in GI Tract)
Function: Facilitate quick disintegration into smaller particles upon contact with gastric fluids, ensuring timely dissolution and bioavailability of the API.
Examples: sodium starch glycolate, croscarmellose sodium, and crospovidone.
4. Lubricants (Prevent Manufacturing Defects)
Function: Reduce die-wall friction during compression, preventing sticking, picking, or capping while enabling smooth ejection.
Examples: Magnesium Stearate, Stearic Acid.
5. Glidants (Optimize Powder Flow)
Function: Improve powder blend flowability, ensuring consistent die filling, uniform tablet weight, and reproducibility during large-scale production.
Examples: Colloidal Silicon Dioxide
6. Coating Agents (Enhance Protection & Compliance)
Function: Provide stability against moisture/light, mask bitter taste/odor, improve swallowability, and aid in brand differentiation. Some coatings also enable modified release (e.g., enteric or sustained-release).
Examples: Hydroxypropyl methylcellulose (HPMC), Polyvinyl alcohol