Description

Sucralfate USP

Sucralfate USP is a pharmaceutical-grade gastrointestinal protectant used in oral formulations for the treatment and prevention of duodenal ulcers, gastroesophageal reflux disease (GERD), and mucosal irritation. As a basic aluminum salt of sulfated sucrose, Sucralfate forms a viscous, adhesive complex at ulcer sites, creating a physical barrier against acid, pepsin, and bile salts. Sucralfate

• Is a USP-compliant gastroprotective agent and mucosal coating agent
• Forms a localized barrier to promote ulcer healing and protect inflamed tissues
• Is indicated for duodenal ulcers, GERD, stomatitis, and mucositis
• Is suitable for oral suspensions and solid dosage forms (e.g., tablets, powders)

Chemically, Sucralfate is an Aluminum hydroxide complex of the sulfated disaccharide Sucrose. In the presence of gastric acid, it undergoes polymerization and cross-linking to form a cytoprotective gel that selectively binds to ulcerated epithelium and damaged mucosa. It has minimal systemic absorption, making it ideal for localized, site-specific therapy.

In pharmaceutical development, Sucralfate USP is used in:

• Oral tablets and suspensions for treating active duodenal ulcers and maintenance therapy
• Formulations for radiation-induced mucositis and stomatitis
• Pediatric GI therapies where non-systemic treatment is preferred
• Veterinary applications in gastric ulcer management in large and small animals

Sucralfate is well tolerated and suitable for chronic use. It does not neutralize gastric acid but protects mucosal surfaces while promoting epithelial regeneration.

CarboMer supplies Sucralfate USP with tightly controlled specifications on particle size, sulfate content, aluminum levels, and loss on drying to ensure formulation consistency and regulatory compliance.

The API is packaged in sealed, moisture-resistant containers. Standard and bulk quantities are available with minimum order quantities (MOQ) and flexible lead times. The material is offered as a fine, off-white powder suitable for direct compression or suspension formulation.

Each batch is tested per USP monograph standards for identification, assay (sucrose sulfate and aluminum), pH, loss on drying, and microbial purity. Documentation includes CoA, SDS, and technical specifications.

As with all CarboMer APIs, Sucralfate USP is supported by technical formulation expertise, regulatory assistance, and full lifecycle documentation to help developers bring safe, effective, and patient-centric GI therapies to market.