Abstract
The goal of this research was to provide critical evaluation of the physicomechanical performance of Starch-MCC-Povidone (SMP) composites engineered via co-processing strategy. Aqueous dispersions of the primary excipients at predetermined combination levels were subjected to physical agglomeration at controlled subgelatinization (55 °C) temperature followed by drying at 60 °C for 48 h. Under scanning electron microscope, the materials appeared as enlarged porous composites of starch-MCC bound by solid bridges of povidone. Powder fluidity indicators suggested acceptable flow properties (Angle of repose 5 gs-1). Compact weight variation studies revealed reproducible volumetric die filling capacity. Analysis of powder compaction indices shows appreciable densification and total volume reduction in both Heckel and Kawakita models. The dilution capacity of the composites was up to 40% using L-ascorbic acid as the model drug. Analysis of post compression tablet properties indicated extensive elastic recovery at low MCC content. All the novel composites were characterised by rapid in-vitro disintegration and efficient in-vitro drug release (t50% <1 min; t80% < 2 min). In comparison to Ludipress® and Prosolv®, moderate to high MCC containing Starch-MCC-Povidone composites (SMP3 and SMP5) could be employed as alternative cost effective direct compression diluents in tablet formulation.
Highlights
The wide therapeutic coverage of tablets as drug delivery systems coupled with the dynamic nature of tablet technology have prioritized considerable attention on development of novel materials required to meet up the 21st century’s expectations in formulation design and manufacture with special focus on excipients development and optimization.Production of tablets via direct compression (DC) method, which involves only mixing and compression, confers myriads of merits because it bypasses preliminary granulation stages which are associated with multiple unit operations, complex manufacturing challenges and huge economic implications (Armstrong, 2007; Alderborn, 2013)
By co-processing, interparticular agglomeration resulted in size enlargement and the resulting coprocessed structure appeared as enlarged porous mass of maize starch-microcrystalline cellulose (MCC) composites synergized by Polyvinyl pyrrolidone (PVP) solid bridges at their interfaces (Figure 1b-1d)
The surface characteristics of the composites were defined by starch-MCC ratio and this affected the nature of interaction with other molecules
Summary
Production of tablets via direct compression (DC) method, which involves only mixing and compression, confers myriads of merits because it bypasses preliminary granulation stages which are associated with multiple unit operations, complex manufacturing challenges and huge economic implications (Armstrong, 2007; Alderborn, 2013). Limited availability of cost effective ready-tocompress raw materials In DC, these excipients suffer numerous setbacks that hamper their applicability as cost efficient raw materials in tabletting. The poor fluidity and compressibility, low dilution capacity, production of friable tablets, low mechanical quality and high chances of wear and tear to press are among the myriads of mitigating factors that limits the usefulness of starch when it comes to direct compression tableting especially in modern high speed tablet press (Bolhuis and Armstrong, 2006)
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