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High Quality Hydroxypropyl Methylcellulose Phthalate for Enteric Coating

Company: Hebei Tangzhi Technology Co., Ltd. | Website: https://www.tangzhihpmc.com | Email: admin@tangzhicellulose.com | Tel: +86-15032625168 | Address: Room 2308, Dongsheng Plaza 2, No. 508 Zhongshan East Road, Chang’an District, Shijiazhuang, Hebei, China

In the pharmaceutical and nutraceutical industries, the use of Hydroxypropyl Methylcellulose Phthalate (HPMCP) stands at the forefront of innovation for enteric coating materials. With enhanced control over pH-dependent drug release, exceptional film-forming capabilities, and significant global demand growth, Hydroxypropyl Methylcellulose Phthalate has become vital in advancing oral drug formulations.

This article, researched and compiled by Hebei Tangzhi Technology Co., Ltd., delivers an in-depth examination encompassing industry trends, authoritative technical standards, real-world application scenarios, and the latest data visualizations for Hydroxypropyl Methylcellulose Phthalate. All findings are referenced from leading pharmaceutical forums and journals, ensuring you rely on accurate, trustworthy, and actionable information.

High Quality Hydroxypropyl Methylcellulose Phthalate for Enteric Coating

1. What is Hydroxypropyl Methylcellulose Phthalate?

Hydroxypropyl Methylcellulose Phthalate (HPMCP) is a widely used enteric polymer primarily employed as a coating agent for pharmaceuticals and nutraceuticals. Developed for its outstanding solubility profile in alkaline environments, HPMCP is engineered to resist gastric acidity while allowing targeted drug release in the intestinal tract.

Product Name: Hydroxypropyl Methylcellulose Phthalate
Product Profile: HPMCP is an enteric film coating material with excellent performance. It is mainly used as an enteric coating material, sustained-release skeleton material for tablets and granules, microcapsule matrix, and other equipment. Its release rate is related to pH value.
Product URL: Hydroxypropyl Methylcellulose Phthalate

2. Industry Trends: Hydroxypropyl Methylcellulose Phthalate Market & Innovation

In recent years, global demand for Hydroxypropyl Methylcellulose Phthalate has surged, driven by:

Pharmaceutical Innovation: Demand for advanced controlled-release and enteric formulations is expanding rapidly (International Journal of Pharmaceutics).
Dietary Supplements: The nutraceutical sector increasingly adopts HPMCP for targeted delivery of sensitive ingredients.
Global Regulatory Recognition: Recognized by pharmacopeias including USP, EP, JP, and compliant with major regulatory requirements (ICH Guidelines).
Technical Progress: Constant improvement of processability, purity, and customization options.

As a result, HPMCP is now indispensable to formulation scientists worldwide.

3. Technical Parameters - Key Data Table

Parameter	Value / Range	Industry Standard / Source
Appearance	White to off-white, odorless powder	USP/NF, EP Monographs
Phthalyl Content (% w/w)	21.0 – 35.0%	EP, JP, Company COA
Methoxy Content (% w/w)	18.0 – 22.0%	USP/EP, Manufacturer data
Hydroxypropoxy Content (% w/w)	4.0 – 12.0%	Company COA
Viscosity (2% Solution @ 20°C)	50 – 150 mPa.s	EP, ASTM D1200
Moisture Content (%)	≤ 5.0	USP 921
Residue on Ignition (%)	≤ 0.2	USP/EP
pH of 1% Solution	5.0 – 7.0	Company COA
Solubility	Soluble in organic solvents; insoluble below pH 5.0; dissolves at pH ≥ 5.5	EP/USP, Literature
Heavy Metals (ppm)	≤ 10	USP/EP

Technical Trend Chart of Hydroxypropyl Methylcellulose Phthalate

Phthalyl & Methoxy Content Distribution (Pie)

Viscosity Specification Comparison (Bar)

Moisture & Residue Trends (Line)

4. Analysis: Why Hydroxypropyl Methylcellulose Phthalate is Indispensable

The popularity and adoption of Hydroxypropyl Methylcellulose Phthalate continue to grow due to its unparalleled chemical and functional characteristics:

pH-dependent Gastroresistance: Remains intact in acidic gastric environments, dissolves in the duodenum or higher pH zones, enabling precise drug release (Journal of Pharmacology and Experimental Therapeutics).
Film-former Reliability: Creates tough yet flexible coatings suited for high-speed industrial processing lines.
Compatibility: Compatible with most active ingredients and excipients without risk of interaction.
Functional Versatility: Widely used for enteric, sustained-release, and microencapsulated drug delivery.
Regulatory Safety: Non-toxic, non-mutagenic, and supported by long-term clinical and regulatory acceptance.

For manufacturers worldwide, these traits drive Hydroxypropyl Methylcellulose Phthalate demand.

5. Main Applications of Hydroxypropyl Methylcellulose Phthalate

Hydroxypropyl Methylcellulose Phthalate offers unmatched performance in:

Enteric Coatings for Tablets & Capsules – To protect acid-sensitive drugs or probiotics from stomach acid, ensuring release in the intestine.
Sustained-Release Matrix Systems – As a retarding polymer for gradual API release.
Microcapsule Matrix – Encapsulation of APIs, flavors, probiotics, or sensitive nutrients for improved stability and targeted release.
Nutritional & Functional Foods – Delivery of bioactive nutrients, flavors, or sensitive enzymes.
Research & Prototyping – Pharmaceutical R&D, including enhancing bioavailability and patient compliance.

Specific application design and regulatory compliance references can be found at leading industry forums such as Drugs.com Forum.

6. Regulatory, Safety, and Environmental Aspects

Pharmacopeia Recognition: Hydroxypropyl Methylcellulose Phthalate is listed in USP, EP, and JP monographs.
Toxicology: Extensively studied, shown to be safe for human consumption at approved levels (PubMed Study).
Environmental Impact: Inert, biodegradable in wastewater systems, with minimal environmental burden.
REACH & RoHS Compliance: Available in grades compliant with international environmental standards.

7. Frequently Asked Professional Questions About Hydroxypropyl Methylcellulose Phthalate

Q1: What is the chemical structure of Hydroxypropyl Methylcellulose Phthalate?: Answer: HPMCP is a cellulose derivative with methyl, hydroxypropyl, and phthalyl substituent groups, conferring both hydrophilicity and pH-dependent solubility capabilities.
Q2: What are the viscosity grades available for Hydroxypropyl Methylcellulose Phthalate?: Answer: Major viscosity grades include HP-50 (50–70 mPa.s), HP-55 (100–140 mPa.s), and HP-55S (over 140 mPa.s), per DIN EN ISO 2555 and USP/EP methods.
Q3: Which pharmacopeias recognize Hydroxypropyl Methylcellulose Phthalate?: Answer: It is recognized by United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP) for use in oral dosage forms.
Q4: How is HPMCP typically applied in tablet manufacturing?: Answer: HPMCP is dissolved in an organic solvent or water-organic mixture, then applied via pan or fluid-bed coating, followed by a drying phase under controlled conditions.
Q5: What are the standard installation and processing parameters?: Answer: Coating is typically performed at 40–60°C inlet air temperature, with a spray rate of 2–7 g/min, and a product temperature maintained between 35–45°C, to ensure film integrity.
Q6: What are the classifications based on dissolution pH for HPMCP?: Answer: Main grades include HP-50 (dissolves at pH ≥ 5.0), HP-55 (dissolves at pH ≥ 5.5), and HP-55S (enhanced performance at pH ≥ 5.5).
Q7: Are there specific storage and handling conditions for Hydroxypropyl Methylcellulose Phthalate?: Answer: Yes, HPMCP should be stored in tightly closed container111s, at 15–30°C, away from moisture and direct sunlight, as per manufacturer specifications.

8. Why Choose Hebei Tangzhi Technology Co., Ltd. for Your Hydroxypropyl Methylcellulose Phthalate Needs?

Hebei Tangzhi Technology Co., Ltd. is a global expert in the production and export of Hydroxypropyl Methylcellulose Phthalate. With a comprehensive R&D and quality system, our HPMCP meets and exceeds the strictest regulatory and technical standards.

Full Regulatory Documentation: DMF, GMP, COA, MSDS provided.
Customization: Tailored grades and viscosity ranges, water dispersible and powder formulations available.
Global Supply Chain: Efficient production with on-time worldwide delivery.
Technical Support: Highly qualified experts to assist with formulation and process development.
Competitive Advantage: Cost-effective, high-purity, and consistent product quality.

For detailed product data, regulatory support, or to request samples of Hydroxypropyl Methylcellulose Phthalate, please contact:
Company: Hebei Tangzhi Technology Co., Ltd.
Website: www.tangzhihpmc.com
Email: admin@tangzhicellulose.com
Phone: +86-15032625168
Address: Room 2308, Dongsheng Plaza 2, No. 508 Zhongshan East Road, Chang’an District, Shijiazhuang, Hebei, China