EVALUATION OF PREFLO(R) MODIFIED STARCHES AS NEW DIRECT COMPRESSION EXCIPIENTS .1. TABLETTING CHARACTERISTICS

This investigation evaluated some new (Preflo(R)) and existing commerc ially available (Starch 1500, Star Tab) modified starches as direct co mpression excipients. Preflo(R) corn starches (CH-10, CH-20, CH-30) an d Preflo(R) potato starches (P-250, PI-10, PJ-20) were evaluated and c ompared with respect to their pharmaceutical properties such as partic le size, density, flowability, friability, and compression properties. Preflo(R) starches showed a high bulk density and good flowability. P reflo(R) com starches and Star Tab formed harder tablets than Preflo(R ) potato starches and Starch 1500. Data from the Athy-Heckel plots ind icated that the Preflo(R) starches are soft materials and, unlike Star ch 1500, undergo plastic deformation. Tablets containing acetaminophen were also compressed with the starches and disintegration and dissolu tion studies were conducted. Starch 1500 tablets disintegrated in 3.5 min, whereas none of the Preflo(R) starch tablets disintegrated in 30 min. While complete acetaminophen release occurred in 25 min from Star ch 1500 tablets, the drug dissolution time from Preflo(R) starch table ts varied from 4 to 12 hr, indicating a potential use for some of thes e starches in solid oral modified-release dosage forms.