Preliminary studies of the development of a direct compression cellulose excipient from bagasse.
Bagasse is an unused by-product in cane sugar manufacture. Bagasse from sugar cane manually harvested in Indonesia was transformed to pulp by mechanical means and repeated autoclaving in 1.4% NaOH. It was then subjected to cycles of bleaching with hypochlorite and acid hydrolysis with 2.5 M HCl to produce 'microcrystalline' cellulose (MCC). Extraction of waxes by petroleum ether was necessary in order to improve the disintegration properties of tablets made from this material, DICEB III. When the bagasse-derived cellulose was reconstituted by recombining different proportions of selected sieve cuts to have a similar sieve size distribution as the commercially available MCC, Avicel PH102, it was found that the latter and DICEB III also had similar crystallinity as measured by X-ray powder diffraction (degree of crystallinity 2.8 +/- 0.2). The crystallinity and flow index were also relatively insensitive to most of the changes in the manufacturing procedure, indicating that the production process was quite robust. Directly compressed tablets were made containing 50 mg of caffeine and 500 mg of either Avicel PH102 or DICEB III to approximately the same hardness (11.6 +/- 1.1 and 13.7 +/- 0.5 kPa, respectively). They displayed similar satisfactory disintegration and dissolution behavior. However, DICEB III required greater compaction pressures than Avicel PH102, perhaps because the former was not spray dried to give spherical agglomerates of particles of uniform size as the commercial product. Rather, DICEB III consisted mainly of single irregular particles. Further work is required to improve the new excipient and to explore if the bagasse from mechanically harvested sugar cane (often contaminated by soil) could also be used for production of MCC.
Padmadisastra
Y
Y
Department of Pharmacy, University of Sydney, NSW, Australia.
Gonda
I
I
D002110:Caffeine / Q000032:analysis; D002482:Cellulose / Q000032:analysis*; D003460:Crystallization; D004339:Drug Compounding; D005079:Excipients; D006244:Hardness; D008855:Microscopy, Electron, Scanning; D011208:Powders; D012995:Solubility; D013607:Tablets; D014867:Water / Q000032:analysis
D005079:Excipients; D011208:Powders; D013607:Tablets; D014867:Water; D002110:Caffeine; D002482:Cellulose; C027433:bagasse