Hydroxypropyl methyl cellulose phthalate

Hydroxypropyl methyl cellulose phthalate (CAS 9050-31-1), commonly known as HPMCP, is a cellulose-based enteric polymer used in pharmaceutical manufacturing. It forms acid-resistant films that dissolve at defined pH thresholds in the intestinal tract.

This material enables controlled drug release without gastric degradation, ensuring the integrity of the dosage form. HPMCP is the primary enteric coating material for tablets and capsules where active ingredients must bypass the stomach.

It is essential for protecting acid-sensitive APIs such as proton pump inhibitors and certain biologics. In solid dosage form development, it is used in both film coating and hot-melt extrusion processes to engineer delayed-release profiles.

Formulators also incorporate it into enteric matrix granules and multiparticulate systems for modified-release oral drug products. Its defined dissolution pH range makes it a specification-critical excipient in generic drug development.

HPMCP is supplied as a white to off-white powder in standard pharmaceutical grades. Two primary grades are commercially recognized, HP-50 and HP-55, which are differentiated by their specific pH dissolution thresholds.

These grades offer thresholds of approximately 5.0 and 5.5 respectively to meet diverse formulation needs. Material is available to Ph.Eur., USP/NF, and JP specifications for global regulatory compliance.

The product is supported by comprehensive documentation packages suitable for IND and NDA filings. This ensures that manufacturers can meet the rigorous quality standards required for modern pharmaceutical applications.