Will using TiO₂-free coatings make my tablets easier to approve globally?
Yes, especially in the EU, where TiO₂ is under review for pharmaceuticals. Moreover, it demonstrates proactive compliance and reduces the risk of reformulation later.
Are TiO₂-free coatings as easy to apply as traditional ones?
Yes, they are generally as easy to apply as traditional TiO₂-based coatings
Will my tablet’s appearance change without TiO₂?
Slightly, yes. Without TiO₂, tablets may appear off-white or somewhat translucent, depending on the coating system used.
What are TiO₂-free coatings made of?
TiO₂-free coatings are usually made from alternative white pigments and fillers instead of titanium dioxide. Common substitutes include zinc oxide, zinc sulfide, barium sulfate, calcium carbonate, and synthetic opacifiers.
Can coating defects be repaired?
Minor defects may sometimes be corrected by re-coating, but often, significant defects require discarding the batch to avoid risks.
Can all drugs be enteric-coated?
No. Some drugs are unstable in the intestine, poorly soluble, or require immediate release. Enteric coating works only for drugs that benefit from delayed release.
What is the main purpose of enteric coating in pharmaceuticals?
Enteric coating protects the drug from stomach acid and ensures it dissolves in the intestine, where it can be absorbed effectively.
What quality control tests are essential for enteric-coated tablets?
Disintegration tests, dissolution testing in simulated gastric and intestinal fluids, and stability studies are crucial to confirm performance.
Can tablet coating affect how quickly a drug works?
Yes. Some coating are designed to delay or prolong drug release. For example, film coating for immediate release.
How is tablet coating applied in manufacturing?
Tablet coating is typically done in coating pans where coating solutions are sprayed onto rotating or fluidised tablets, followed by drying.