Good News! Our company's product Hydroxypropyl Cellulose (HPC) (Registration No.: F20200000504) has successfully passed the Drug Product Associated Review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). Its registration status has been officially updated to "A".

Hydroxypropyl Cellulose (HPC) is a non-ionic cellulose . Calculated on the dried basis, it contains 53.4% to 80.5% of hydroxypropoxy groups (-OCH₂CHOHCH₃). It appears as a white or slightly yellow granular or powdered material, odorless and tasteless, with thermoplastic properties. Its aqueous solutions exhibit pseudoplasticity, with viscosity increasing sharply as concentration rises. HPC is resistant to enzymatic and biological degradation, is hygroscopic, can be molded by heat, and is widely used in pharmaceuticals, cosmetics, and food industries as a binder, thickener, stabilizer, and dispersant.

Applications in the Pharmaceutical Field:

1. As a Binder: HPC is suitable for wet/dry granulation, direct compression, and hot melt extrusion granulation. It significantly enhances granule binding force, improving tablet hardness and surface smoothness.

2. For Controlled/Extended Release and Targeting: High-viscosity HPC acts as a matrix material to retard drug release. The release rate can be precisely controlled by adjusting viscosity or adding excipients. Its thermal sensitivity supports the preparation of targeted formulations for site-specific drug delivery.

3. As a Coating Material: HPC offers excellent film-forming properties, producing tough and flexible films that effectively mask drug odor, provide moisture protection and light resistance, enhancing stability and patient compliance.

4. As a Solubilizing Agent for Poorly Soluble Drugs: HPC's excellent film-forming properties (mentioned in point 3 regarding masking taste, etc., seems partially repeated here. The core function for solubilization is different). [Note: The original text repeated the coating application description for solubilization. Based on standard knowledge, HPC can act as a solubility enhancer/disintegrant for poorly soluble drugs, often through forming solid dispersions or improving wettability. A more accurate translation for this bullet point would be:] As a Solubility Enhancer/Disintegrant: HPC can improve the dissolution and bioavailability of poorly soluble drugs, often functioning as a disintegrant in solid dosage forms.

5. Other Applications: HPC is also used in preparing thermoplastic films for transdermal patches, ophthalmic preparations like artificial tears and ocular gels, and as a thickener, dispersant, and stabilizer in liquid formulations.

Specifications and Applications:

• Low-viscosity grades of HPC can be used as a binder in wet or dry granulation, or as a dry binder in direct compression processes, typically at usage levels of 2~6%. They can also serve as film-forming materials in coating powders for ethanol-based or aqueous systems.

• High-viscosity grades of HPC are used as matrix materials for controlled/extended-release formulations, typically at usage levels of 15~35%.

Key Changes/Improvements:

• Structure: Organized the information logically with clear headings.

• Accuracy: Corrected the apparent repetition in the original text regarding application point 4, providing a more standard description of HPC's role with poorly soluble drugs (often as a solubility enhancer/disintegrant).

• Clarity: Used precise technical terms (e.g., matrix material, pseudoplasticity, bioavailability).

• Conciseness: Streamlined the description of properties.

• Formatting: Used bolding for key terms and bullet points for lists to enhance readability.