A NEW ENHANCED SORBITOL: CALCIUM DIPHOSPHATE COMPOSITE AS A DIRECT COMPRESSION EXCIPIENT: A COMPARATIVE STUDY
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2016, Vol 8, Issue 4
Abstract
Objective: To evaluate and compare the particle and tableting properties of a new sorbitol (SOR) and anhydrous calcium diphosphate (ACD) composite with common excipients used for the preparation of tablets by direct compression such as polyvinylpyrrolidone (Ludipress®), lactose (Cellactose 80®) and microcrystalline cellulose (Prosolv SMCC 90®).Methods: All materials were tested for lubricant sensitivity, ejection force, and elastic recovery, dilution potential and reworking ability. Further, compressibility and compactibility were determined using the Heckel and Leuenberger models, respectively.Results: This new excipient offered more benefits in terms of functionality than commercial direct compressive co-processed excipients and showed better compressibility than other commercial excipients and its compactibility was ranked third after SOR and Prosolv SMCC 90®. However, this composite material was more susceptible to reprocessing than commercial products. Further, it showed a low lubricant sensitivity due to a combination of a plastic and brittle behavior. Moreover, the loading capacity of poorly compressible materials such as gemfibrozil was comparable to that of commercial direct compression excipients. It also showed the fastest in-vitro dissolution of gemfibrozil, whereas commercial products failed to fulfill the US pharmacopoeial requirements.Conclusion: This new composite material showed potential for use as a direct compression excipient.Keywords: Agglomeration, Sorbitol, Anhydrous calcium diphosphate, Composites, Direct compression
Authors and Affiliations
Edward Echeverri, Jhon Rojas, Mauricio Bedoya
Keywords
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