Preparation and quality evaluation of a novel multi-unit dosage form by compaction of enteric pellets

PAN Xin; LIU Yang; XIAO Yu-jun; CHEN Mei-wan; CHEN Bao; WU Chuan-bin

Abstract：Objective:To develop and evaluate in vitro a new multi-unit dosage form prepared by compressing the mixture of different excipients and pellets. Methods:Pellets containing paracetamol were coated with Eudragit NE30D or Eudragit FS30D mixed with Eudragit L30D-55. The combinations of coated pellets and cushioning pellets by different excipients were compressed into tablets, and the compressibility and fragility of the compressed and uncompressed pellets were evaluated in vitro by comparing the similarity f_2 of the drug release profiles in the re-lease medium. Cast films prepared by the same formulations of coating were tested for their mechanical properties and the values of elongation indicated their flexibility. Results:The elongation of films prepared by Eudragit NE30D was superior to Eudragit FS30D without or with little Eudragit L30D-55, pellets coated with these two acrylic poly-mers was protected. The values of f_2 of drug release profiles for the compressed and uncompressed pellets coated with combination of Eudragit FS30D or Eudragit NE30D and Eudragit L30D-55 at the ratio of 2:1,1:1 and 1:2 were 82,70,65 and 70,58,41 respectively. The release profiles of tablets prepared by different excipients showed no distinguished difference with uncompressed pellets both in acid and PBS medium, but the drug release was increased with the increasing of pellets content. Conclusion:Both Eudragit NE30D and Eudragit FS30D have good flexibility and could protect pellets during compaction, pellets coated with higher amount of Eudragit NE30D or Eudragit FS30D in the coating combination have better compressibility. The differences of excipients provide little contribution to the quality of tablets but the influence of excipients content is profound.