Salcaprozate Sodium-GMP

Salcaprozate Sodium is the sodium salt form of salcaprozate, an oral absorption promoter. Salcaprozate sodium may be used as a delivery agent to promote the oral absorption of certain macromolecules with poor bioavailability such as insulin and heparin.
It is a white to off-white crystalline powder, and its solubility in water is approximately 33 mg/mL.
Salcaprozate Sodium (SNAC) is a synthetic N-acetylated amino-acid derivative of salicylic acid. SNAC is a weak acid that display amphiphilicity and surface activity. It was discovered as part of a screen to identify carrier-based PEs that could “chaperone” poorly permeable payloads across the intestine. This compound is the most extensively tested carrier and the only PE approved in an oral formulation designed to improve oral BA, albeit with a small molecule, cyanocobalamin/SNAC. In other preclinical studies, it also improved intestinal permeation of peptides (salmon calcitonin (sCT) and insulin), along with poorly permeable small molecules (e.g., cromolyn). SNAC was tested in many formats: taste-masked liquids, tablets, and soft gelatin capsules. Similar to C10, SNAC can be blended with the active pharmaceutical ingredient (API) using conventional processes, which makes manufacturing uncoated oral tablet dosage forms economic and relatively easy to scale[1].