Evonik's Pharmaceutical-Grade AEROSIL® 200 Pharma: Nano-Scale Carrier Innovation for Global Drug and Food Industries

Evonik's Pharmaceutical-Grade AEROSIL® 200 Pharma: Nano-Scale Carrier Innovation for Global Drug and Food Industries

 

April 10, 2025, Hanau, Germany – Evonik, a global leader in specialty chemicals, today announced that its pharmaceutical-grade product AEROSIL® 200 Pharma (CAS No.: 112945-52-5) has obtained regulatory approvals in 12 countries, including the EU, U.S., and Japan, positioning it as the preferred carrier material for solid/liquid pharmaceuticals and food additives worldwide. This high-purity colloidal silica offers breakthrough solutions for drug stability and food safety through its nano-porous structure and multi-pharmacopeia compliance.

 

I. Product Highlights: Pharmaceutical-Grade Quality & Multifunctional Performance

 

AEROSIL® 200 Pharma is an amorphous anhydrous colloidal silicon dioxide produced via flame hydrolysis, featuring:

 

- Ultra-High Purity: SiO₂ content ≥99.0% (Ph. Eur. standard), with strict control of heavy metals (≤25ppm), arsenic (≤8ppm), and other impurities, compliant with EU E551 food additive requirements.

- Nano-Scale Network Structure: Specific surface area of 175-225 m²/g and tamped density of 50 g/L ensure efficient adsorption and uniform dispersion, enhancing drug bioavailability.

- Multi-Pharmacopeia Compliance: Certified by European Pharmacopeia (Ph. Eur.), U.S. Pharmacopeia (USP/NF), Japanese Pharmacopeia (JP), and Indian Pharmacopoeia (IP), supporting global drug registration.

 

II. Technical Parameters & Performance Comparison

 

Indicator AEROSIL® 200 Pharma Traditional Pharmaceutical Carriers

Specific Surface Area (BET) 175-225 m²/g 50-100 m²/g

Loss on Drying (105℃, 2h) ≤2.5% ≤5.0%

pH Value (Aqueous System) 3.5-5.5 6.0-7.0

Microbial Limits (TAMC/TYMC) ≤1000 CFU/g ≤1000 CFU/g

 

III. Application Scenarios & Industry Value

 

1. Pharmaceutical Industry

 

- Solid Dosages:

- Tablets/Capsules: Improves powder flowability (reducing angle of repose by 20-30%), prevents caking, and enhances tablet hardness (by 15-20%) and friability resistance.

- Direct Compression: Reduces lubricant usage and shortens production cycles.

- Liquid Formulations:

- Suspensions/Emulsions: Acts as a thickener and thixotropic agent to prevent drug sedimentation (sedimentation volume ratio >95%).

- Injectables: Compliant with IPEC-GMP standards for aseptic manufacturing.

 

2. Food & Nutraceuticals

 

- Anti-Caking Agent: Maintains flowability in powdered foods (e.g., milk powder, protein powder) without caking for 6+ months under ≤60% humidity.

- Active Ingredient Carrier: Adsorbs vitamins, probiotics, etc., extending shelf life (bioactivity retention increased by 30%).

 

IV. Global Footprint & Sustainability

 

Evonik ensures localized supply of AEROSIL® 200 Pharma through production facilities in Hanau, Germany and Shanghai, China, with an annual capacity of 5,000 metric tons. The manufacturing process adheres to GMP and HACCP systems, while sustainability initiatives include:

 

- Energy Recycling: Utilizes waste heat for power generation, reducing fossil fuel consumption.

- Packaging Optimization: Uses recyclable multi-layer paper bags (10 kg/bag) to minimize plastic waste.

 

V. Customer Support & Success Stories

 

- Technical Services: A global team of 200+ experts provides full-cycle support, including:

- Dispersion guidance (recommended high-shear mixing ≥30 minutes).

- Compatibility testing (adsorption isotherm data with APIs).

- Key Clients:

- Multinational Pharmaceutical Companies: Implemented in sustained-release tablets, achieving dissolution uniformity (RSD <5%).

- Food Conglomerates: Extended probiotic shelf life from 6 to 12 months as a carrier.

 

VI. Contact Information

 

- Global Website: www.silica-specialist.com

- Technical Inquiries: technical.service.aerosil@evonik.com

- China Hotline: +86 21 6119-1151

 

About Evonik

Evonik is a leading global specialty chemicals company with 50 years of experience in pharmaceutical carriers, serving 18 out of the world’s top 20 pharmaceutical companies. Its AEROSIL® series holds a 35% global market share in pharmaceutical-grade silica, driving continuous innovation in drug delivery technologies.

 

Note: Product performance may vary based on formulation and process conditions. Compatibility testing is recommended before use. Evonik reserves the right to modify technical parameters without prior notice.