Description

Simethicone USP

Simethicone USP is a high-purity, pharmaceutical-grade antifoaming agent used in oral formulations to relieve symptoms of excess gastrointestinal gas, including bloating, pressure, and discomfort. As a chemically inert silicone compound, Simethicone acts by reducing surface tension, enabling the coalescence and dispersion of gas bubbles in the gastrointestinal (GI) tract without systemic absorption. Simethicone

• Is USP-compliant, non-systemic antifoaming agent
• Is used in oral suspensions, chewable tablets, capsules, and pediatric drops
• Is chemically inert and physiologically inactive—displaying no absorption or metabolism
• Exhibits rapid onset of action for relief of gas-related discomfort and bloating

Simethicone is a silicone-based mixture of fully methylated linear siloxane polymers stabilized with silica. Its unique surface-active properties break down gas bubbles in the stomach and intestines, allowing them to be eliminated more easily through normal peristalsis. It is odorless, tasteless, and suitable for use in both adult and pediatric populations.

In pharmaceutical applications, Simethicone USP is used in:

• Chewable tablets and capsules for over-the-counter relief of gas symptoms
• Oral suspensions and emulsions for infants, children, and sensitive populations
• Antacid combinations for dual-action GI relief
• Coatings or suspensions in radiologic imaging to reduce air interference during abdominal scans

Simethicone is classified as an excipient in some regulatory frameworks and as an API in others, depending on therapeutic intent. Its non-systemic profile makes it ideal for long-term use, including in pediatric and geriatric formulations.

CarboMer supplies Simethicone USP as either a 100% active fluid or in standardized emulsions (e.g., 30%, 40%) suitable for direct incorporation into aqueous formulations. The material is produced under GMP processes ensuring homogeneity, particle uniformity, and microbial control.

Product is packaged in tamper-evident, moisture-resistant containers for optimal stability and ease of handling. Bulk and research pack sizes are available, with full technical and regulatory support. Minimum order quantities (MOQ), lead times, and formulation guidance are available upon request.

Each batch is tested to USP monograph specifications for assay, identity, viscosity, pH (in emulsions), microbial limits, and silica content. Regulatory documentation includes CoA and SDS.

As with all CarboMer pharmaceutical ingredients, Simethicone USP is supported by comprehensive formulation assistance, regulatory expertise, and global supply chain reliability to help manufacturers bring safe, effective GI relief products to market.