Pharmacopeial Specifications:
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Identification: Positive for aluminum and sulfate
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Assay (on dried basis): 98.0%–102.0%
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Loss on Drying: ≤10%
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pH (1% suspension): 3.5–4.5
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Aluminum Content: 15.5%–18.5%
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Microbial Limits: Meets pharmacopeial requirements
Applications in Pharmaceutical Formulation:
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Used in oral suspensions and tablets for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease (GERD), and mucosal injuries.
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Acts by forming a protective barrier over damaged mucosa, preventing further injury from acid, pepsin, and bile salts.
Comments:
Sucralfate is non-systemic and acts locally at ulcer sites. It does not significantly alter gastric pH and has minimal drug interactions compared to traditional antacids. However, it may adsorb certain drugs (e.g., fluoroquinolones, tetracyclines), so spacing of administration is recommended.
