Abstract

Various levels of newer disintegrants were compared against 10% starch and 0% disintegrant in dicalcium phosphate-based hard gelatin capsules filled on an instrumented Zanasi machine at a constant compression force. Hydrochlorothiazide or acetaminophen were included for drug dissolution studies. Disintegration time, ejection force and overall running characteristics were also considered. In general, the modified celluloses were most effective in enhancing drug dissolution, followed, in order, by the modified starches, corn starch, cross-linked PVP and the control (0% disintegrant). Reducing the lubricant level (magnesium stearate) or using a more soluble drug (acetaminophen) required less modified cellulose (AcDiSol) to exert a similar effect on drug dissolution. Disintegration and dissolution data correlated best with the more soluble drug.

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