Hypromellose Excipient | Uses, Suppliers, and Specifications

Hypromellose, also known as hydroxypropyl methylcellulose (HPMC), is a versatile excipient commonly used in pharmaceuticals, cosmetics, food products, and various industrial applications. Here’s an overview of hypromellose excipient, including its uses, suppliers, and specifications:

Uses:

1. Pharmaceuticals: Hypromellose is widely used as a pharmaceutical excipient in oral solid dosage forms such as tablets, capsules, and granules. It serves as a binder, disintegrant, thickener, and film-forming agent, contributing to the physical and mechanical properties of the dosage forms.
2. Ophthalmic Solutions: In ophthalmic formulations, hypromellose is used as a lubricant and viscosity-enhancing agent in eye drops and ointments to improve ocular hydration and prolong drug residence time on the ocular surface.
3. Topical Preparations: Hypromellose is incorporated into topical formulations such as creams, gels, and lotions as a thickening agent, emulsifier, and stabilizer to enhance product consistency, spreadability, and shelf-life.
4. Controlled-Release Formulations: Hypromellose is utilized in controlled-release and sustained-release formulations to modulate drug release kinetics, providing extended drug release profiles and improved patient compliance.
5. Food Products: In the food industry, hypromellose is used as a thickening agent, stabilizer, and emulsifier in various food products, including sauces, dressings, desserts, and baked goods.
6. Cosmetics: Hypromellose is incorporated into cosmetic formulations such as creams, lotions, and makeup products as a thickening agent, film former, and moisture-retaining agent to enhance product texture and performance.

Suppliers:

Hypromellose excipient is available from numerous suppliers worldwide. Some prominent suppliers and manufacturers include:

1. Ashland Global Holdings Inc.: Ashland offers a wide range of hypromellose products under the brand names Benecel® and Aqualon™, catering to pharmaceutical and personal care applications.
2. Kima Chemical Co.,Ltd:Kima Chemical provides hypromellose-based products under the brand name KIMACELL, which are utilized in pharmaceuticals, food, and industrial applications.
3. Shin-Etsu Chemical Co., Ltd.: Shin-Etsu manufactures hypromellose-based products under the brand name Pharmacoat ™, serving pharmaceutical, food, and cosmetic industries.
4. Colorcon: Colorcon supplies hypromellose-based pharmaceutical excipients under the brand name Opadry®, designed for tablet film coating and formulation development.
5. JRS Pharma: JRS Pharma offers a range of hypromellose products under the brand name Vivapur®, specifically tailored for pharmaceutical applications such as tablet binding, disintegration, and controlled release.

Specifications:

Specifications for hypromellose excipient may vary depending on its intended application and regulatory requirements. Common specifications include:

• Viscosity: Hypromellose is available in various viscosity grades, typically ranging from low to high viscosity, to meet specific formulation needs.
• Particle Size: Particle size distribution may affect the flow properties and compressibility of hypromellose powders, impacting tablet manufacturing processes.
• Moisture Content: Moisture content is an important parameter that can affect the stability and performance of hypromellose-based formulations.
• Purity and Impurities: Specifications for purity, as well as limits for impurities such as heavy metals, residual solvents, and microbial contaminants, ensure the quality and safety of hypromellose products for pharmaceutical and food applications.
• Compatibility: Hypromellose should be compatible with other excipients and active ingredients in the formulation, as well as with processing methods and equipment used in manufacturing.

When sourcing hypromellose excipient, it is essential to obtain certificates of analysis (CoA) and compliance documentation from suppliers to verify that the product meets the required specifications and regulatory standards for the intended application. Additionally, collaboration with qualified suppliers and adherence to good manufacturing practices (GMP) are crucial for ensuring the quality, consistency, and regulatory compliance of hypromellose-based formulations.