Evaluation of Preflo® Modified Starches as New Direct Compression Excipients. I. Tabletting Characteristics

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Abstract

This investigation evaluated some new (Preflo®) and existing commercially available (Starch 1500, Star Tab) modified starches as direct compression excipients. Preflo® corn starches (CH-10, CH-20, CH-30) and Preflo® potato starches (P-250, PI-10, PJ-20) were evaluated and compared with respect to their pharmaceutical properties such as particle size, density, flowability, friability, and compression properties. Preflo® starches showed a high bulk density and good flowability. Preflo® corn starches and Star Tab formed harder tablets than Preflo® potato starches and Starch 1500. Data from the Athy-Heckel plots indicated that the Preflo® starches are soft materials and, unlike Starch 1500, undergo plastic deformation. Tablets containing acetaminophen were also compressed with the starches and disintegration and dissolution studies were conducted. Starch 1500 tablets disintegrated in 3.5 min, whereas none of the Preflo® starch tablets disintegrated in 30 min. While complete acetaminophen release occurred in 25 min from Starch 1500 tablets, the drug dissolution time from Preflo® starch tablets varied from 4 to 12 hr, indicating a potential use for some of these starches in solid oral modified-release dosage forms.

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