Product Name: Hydroxypropyl Methyl Cellulose Phthalate (HPMCP)
CAS Number: 9050-31-1
Date: March 01, 2025
General Description
Hydroxypropyl Methyl Cellulose Phthalate (HPMCP) is a white to off-white, free-flowing powder or granular material, derived from hydroxypropyl methylcellulose (HPMC) by esterification with phthalic anhydride. It is a pH-sensitive polymer, insoluble in acidic conditions (e.g., stomach pH), but soluble in neutral to alkaline environments (e.g., intestinal pH). HPMCP is widely used as an enteric coating agent in pharmaceuticals and as a matrix material for controlled-release formulations.
Typical Applications
- Pharmaceuticals: Enteric coating for tablets and granules, sustained-release matrices
- Nutraceuticals: Protective coating for acid-sensitive ingredients
- Biotechnology: Encapsulation of bioactive compounds
- Research: pH-dependent drug delivery systems
Technical Specifications
| Property | Value | |
| Appearance | White to off-white powder or granules | |
| Methoxyl Content | 20.0–24.0% (w/w) | |
| Hydroxypropoxyl Content | 5.0–9.0% (w/w) | |
| Phthalyl Content | 27.0–35.0% (w/w) (varies by grade) | |
| Moisture Content | ≤ 5.0% | |
| Ash Content | ≤ 0.5% | |
| Bulk Density | 250–450 g/L | |
| Particle Size | 95% passes through 100 mesh | |
| Viscosity(10% in acetone/ethanol, varies by grade) | 40–60 cP | 136-204 |
| pH (1% dispersion) | 4.0–6.0 | |
| Solubility | Insoluble in water (pH < 5); soluble in acetone, ethanol, and pH > 5.5 aqueous media | |
Performance Properties
- Enteric Properties: Insoluble below pH 5.0–5.5 (depending on grade, e.g., HP-50 at pH 5.0, HP-55 at pH 5.5); dissolves rapidly above these thresholds.
- Film Formation: Forms tough, flexible, transparent films resistant to gastric fluids.
- Stability: Stable in dry form; protects acid-sensitive drugs from degradation in the stomach.
- Compatibility: Compatible with plasticizers (e.g., triethyl citrate, diethyl phthalate) for coating applications.
- Thermal Properties: Softens at ~145°C; decomposes above 150°C.
Storage and Handling
- Storage Conditions: Store in a cool, dry place (5–30°C) in tightly sealed containers, away from moisture and heat.
- Shelf Life: Minimum 24–36 months under proper storage conditions.
- Packaging: 25 kg multi-layer paper bags or fiber drums with polyethylene lining.
Safety Information
- Non-hazardous under normal handling conditions.
- Avoid inhalation of dust; use a dust mask and gloves during handling.
- Consult the Safety Data Sheet (SDS) for detailed safety and disposal instructions.
Usage Guidelines
- Coating Application: Dissolve in organic solvents (e.g., acetone/ethanol 50:50) at 5–15% concentration with plasticizers (e.g., 10–20% triethyl citrate) for spray coating.
- Typical Dosage:
- Enteric coating: 5–15% of tablet weight
- Matrix systems: 20–40% of formulation
- Processing: Apply via spray coating in fluid-bed or pan coaters; ensure proper drying to avoid film splitting.
Notes
- Grades: Common grades include HP-50 (dissolves at pH > 5.0) and HP-55 (dissolves at pH > 5.5); higher phthalyl content increases pH threshold for dissolution.
- Regulatory: Included in USP/NF, EP, and FDA Inactive Ingredients Database for oral capsules and tablets.
- Excessive titanium dioxide (>10%) in coatings may reduce elasticity and gastric resistance.