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HPMC
Phthalate 55

To guarantee the highest purity and efficacy, we adhere to strict global standards

Pharmaceutical Excipients

HPMC Phthalate 55

HPMC Phthalate is a chemically modified cellulose polymer primarily used as an Enteric Coating Agent in oral pharmaceutical formulations. Its vital function is to shield the Active Pharmaceutical Ingredient (API) from the harsh acidic environment of the stomach, or to protect the stomach from the irritating effects of the drug. The 55 grade is characterized by pH-Dependent Solubility, remaining intact in acidic gastric fluid ($\text{pH} < 5$) and beginning to dissolve rapidly upon entering the small intestine ($\text{pH} > 5.5$).

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).
A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.
A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.
Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).
Functional Class:
Enteric Polymer, Release Modifier.
Chemical Structure:
A cellulose ester, the $\text{Phthaloyl derivative}$ of $\text{HPMC}$.
Mechanism of Action:
Prevents erosion and dissolution in acidic media; then ionizes and dissolves in alkaline media (the intestines).
Function of Grade 55:
The number 55 indicates that the polymer is designed to start dissolving at a $\text{pH}$ of approximately 5.5, ensuring release in the upper small intestine.
Safety Note:
Effective at releasing the API without being degraded by gastric enzymes.
Tablets and Capsules

Enteric coating for acid-sensitive APIs (e.g., enzymes or certain antibiotics).

Provides superior protection from stomach acid with rapid dissolution in the intestines.

Pellets/Beads

As a coat for pellets within capsules.

Allows for the preparation of delayed enteric release formulations with precise control over the release site..

Irritating Formulations

Coating of gastric irritants (e.g., $\text{NSAIDs}$).

Prevents release in the stomach, minimizing nausea and ulceration.

Regulatory Compliance

he product fully complies with the requirements specified in the United States Pharmacopeia (USP), the European Pharmacopoeia (EP), and/or other relevant standards.

Viscosity

Strict control over viscosity is maintained to ensure easy spray application on tablets and consistency in film thickness.

Phthalate Content

Precise determination of the phthalate ratio is critical to guarantee the specific $\text{pH} 5.5$ performance and compliance with safety requirements.

Manufacturing Operations

Production is conducted in a rigorous cGMP environment, ensuring consistency in physical properties.

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