A novel superdisintegrating agent made from physically modified chitosan with silicon dioxide.

Disintegrants and fillers represent important excipients for immediate-release solid dosage forms in many pharmaceutical applications. A new excipient based on the coprecipitation of chitosan and silica has been achieved. The "intimate" physical association between chitosan and silica creates an insoluble, hydrophilic, highly absorbent material, consequently, resulting in superiority in water uptake, water saturation for gelling formation, and compactability among other superdisintegrants. The new excipient has an outstanding functionality that does not primarily depend on water wicking and swelling properties. In fact, it translates it into superior disintegration characteristics with improved powder flow and compaction properties. Thus, the new excipient could act as a superdisintegrant and pharmaceutical filler at the same time. Studies have shown that chitosan-silica delivers superior performance in wet granulation formulations and is the only disintegrant that is effective at all concentrations in tablet formulation.