Wet Granulation: Recommended Excipients
Wet Granulation: Recommended ExcipientsWet granulation is a widely used granulation technique in the pharmaceutical industry, where a liquid binder (e.g., water, ethanol, or a solution) is used to agglomerate powder particles, improving flowability, compressibility, and uniformity. Below are recommended excipients and a technical breakdown.
Recommended Excipients
1. Fillers (Diluents)
Microcrystalline Cellulose (MCC): e.g., Avicel PH series, offers excellent compressibility and moisture absorption, suitable for direct compression or wet granulation.
Lactose: Spray-dried lactose (e.g., Fast-Flo) has good flowability; monohydrate lactose is stable but may be moisture-sensitive.
Mannitol: Suitable for chewable tablets, with good solubility but slight hygroscopicity.
Pregelatinized Starch: Partially pregelatinized starch (e.g., Starch 1500) acts as both a binder and disintegrant.
2. Binders
Hydroxypropyl Methylcellulose (HPMC): Low-viscosity grades (e.g., E5, E15) are suitable for wet granulation, producing strong granules.
Polyvinylpyrrolidone (PVP): PVP K30 is commonly used, soluble in water or ethanol, ideal for moisture-sensitive drugs.
Starch Paste: Traditional binder (e.g., corn starch paste), cost-effective but with weak binding capacity.
Sucrose Solution: High concentrations (50-70%) are used in traditional Chinese medicine pills but may prolong drying time.
3. Disintegrants
Croscarmellose Sodium (CCNa): Superdisintegrant, typically added externally (after granule drying).
Crospovidone (PVPP): Strong water absorption and swelling, suitable for moisture-sensitive formulations.
Sodium Starch Glycolate (CMS-Na): Rapid swelling but requires controlled usage (typically 1-5%).
4. Lubricants/Glidants
Magnesium Stearate: Standard usage 0.5-1%; excessive amounts may hinder disintegration.
Talc: Acts as both a glidant and lubricant but may affect content uniformity.
Silicon Dioxide (Colloidal SiO₂)**: e.g., Aerosil 200, improves granule flowability.
5. Other Excipients
pH Adjusters: e.g., citric acid, sodium bicarbonate (for drug release or stability control).
Wetting Agents: e.g., sodium lauryl sulfate (SDS), used for hydrophobic drug granulation.
Leave Your Inquiry