The objective of the present study is to formulate and evaluate orally disintegrating taste masked drotaverine hydrochloride (HCl) tablets prepared by melt granulation technique. Taste masked drug polymer melt granules of drotaverine HCl were prepared by using either Compritol 888 ATO (glcerylbehenate) (hereafter referred as Compritol) or Precirol ATO 5 (glycerylpalmitostearate) (here after referred as Precirol) using varying drug-polymer ratios of 1:1,1:2,1:5 and 1:7. Prepared drug-polymer blends evaluated for taste masking and the ratio of drug-polymer is optimized. The granules and tablets prepared with optimized drug-polymer ratio were evaluated for pre and post compression parameters. The drug polymer ratios 1:7 with Compritol and 1:5 with Precirol were optimized based on taste evaluation. The pre-compression results showed that all the formulae have good flow properties. The post-compression evaluations resulted that some of the formulae met the specifications of orally disintegrating tablets. From all the prepared taste masked drotaverine HCl tablets CP9 formulation consisting of croscarmellose sodium 8% w/w, mannitol 8% w/w aspartame 3.2% w/w showed release of >50% of the drug in 5 mins and 100% of the drug in 45 mins. The formulation PF5 consisting of croscarmellose sodium 6.1% w/w, mannitol 8.1% w/w aspartame 3.39% w/w showed >50% of the drug release in 5 mins and 100% of the drug in 30 mins and this has been selected as optimized formulation. The optimised formulations were characterised by FTIR, DSC and XRD studies and found no incompatibility. The results demonstrated that the prepared drotaverine HCl ODT showed better taste masking and meeting the parameters of ODT formulations CP9 and PF5 ( PF5>CP9). The present melt granulation technique can be effectively used for taste masking.
Keywords: Drotaverine HCl, Compritol, Precirol, melt granulation, Taste masking.
Key words: Drotaverine HCl, Compritol, Precirol, melt granulation, Taste masking.
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