Dispersible Tablets Manufacturing Process — Formulation, Equipment & Quality Control

Dispersible Tablets Manufacturing: Complete Process Guide

Manufacturing dispersible tablets requires specialized knowledge, advanced equipment, and strict quality control protocols. This comprehensive guide covers the entire manufacturing process from formulation development through final quality testing, with insights from Aarise Pharmaceuticals’ WHO-GMP certified production facility.

in Dispersible Tablet Formulation

Active Pharmaceutical Ingredient (API)

The API must be compatible with rapid disintegration technology. Particle size distribution is critical — micronized APIs (particle size <10 μm) are preferred for uniform distribution in the dispersed suspension.

Superdisintegrants

These are the key differentiating excipients in dispersible tablets. Common superdisintegrants include:

• Croscarmellose Sodium (Ac-Di-Sol): Swelling mechanism, typically used at 2-5% w/w
• Sodium Starch Glycolate (Primojel): Rapid swelling, used at 2-8% w/w
• Crospovidone (Polyplasdone): Wicking and swelling mechanism, used at 2-5% w/w
• Low-substituted Hydroxypropyl Cellulose (L-HPC): Both swelling and wicking action

Other Essential Excipients

• Diluents: Microcrystalline cellulose (MCC), mannitol, or lactose
• Binders: PVP K30, HPMC (used sparingly to avoid slowing disintegration)
• Glidants: Colloidal silicon dioxide (Aerosil) for powder flow
• Lubricants: Magnesium stearate (at minimal concentration — excess retards disintegration)
• Sweeteners: Aspartame, sucralose, or saccharin for taste masking
• Flavoring agents: Orange, strawberry, or mint flavors for patient acceptability

Manufacturing Methods

1. Wet Granulation Method

The most common method for dispersible tablets. Involves blending API with excipients, adding granulating fluid (PVP in isopropanol or water), wet massing in a rapid mixer granulator (RMG), drying in a fluid bed dryer (FBD) to 1-3% moisture, and sizing through a multi-mill or oscillating granulator.

2. Direct Compression Method

Suitable for APIs with good flow and compressibility. Involves simply blending and compressing directly. Requires excipients with excellent compressibility like spray-dried mannitol (Pearlitol SD) or directly compressible MCC (Avicel PH-102).

3. Dry Granulation (Roller Compaction)

Used for moisture-sensitive APIs. The blend is compacted into ribbons using a roller compactor, then milled into granules for compression.

Quality Control Tests

Third-Party Manufacturing at Aarise Pharmaceuticals

Aarise Pharmaceuticals offers comprehensive third-party manufacturing services for dispersible tablet formulations at our WHO-GMP certified facility in Haridwar, Uttarakhand. Our capabilities include formulation development, stability studies, regulatory documentation support, and large-scale commercial manufacturing. With 58+ product formulations and state-of-the-art quality control laboratories, we deliver consistent, pharmacopeial-grade dispersible tablets. Learn about our third-party manufacturing services or request a quote.