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Formulation and evaluation of taste-masked paracetamol-lipid sachets and chewable tablets
Wessam M. El-Refaie,Magda A. EL-Massik,Ossama Y. Abdallah,Nawal M. Khalafallah 한국약제학회 2014 Journal of Pharmaceutical Investigation Vol.44 No.6
The use of lipids as taste-masking excipients inparacetamol sachets and chewable tablets without compromisingdrug release was investigated. Twelve paracetamolgranule formulations were prepared by meltgranulation, using Precirol (glyceryl palmitostearate),cetyl alcohol and stearic acid, at different paracetamol-lipidratios. Based on efficient taste-masking results coupledwith minimum retardation of drug release, paracetamol-Precirol (1:1), paracetamol-cetyl alcohol (1:2) and paracetamol-stearic acid (1:2) granules were selected forpreparation of chewable tablets and sachets. Formulationswere evaluated for the effect of storage, at 40 C and 75 %RH for 6 months, on their performance. Results inferredthat paracetamol sachets, after reconstitution in 100 mlwater, showed efficient taste-masking compared to controlsachets (without lipids). The sachets released more than90 % of their drug content in 30 min, when tested in900 ml of phosphate buffered saline, pH 5.8. Chewabletablets exhibited comparable taste-masking effect to areference product, Tylenol 80 mg chewable tablets, andyielded similar drug dissolution profiles (similarity factorf2[50). Differential scanning calorimetry indicated theabsence of interaction between paracetamol and lipids. Scanning electron micrographs supported the obtainedresults. Upon storage at 40 C and 75 % RH for 6 months,all the prepared sachets and chewable tablets were found tobe stable except cetyl alcohol-based tablets that showeddecrease in the efficiency of taste masking with increase inrelease rate. In conclusion, selected lipids, Precirol, cetylalcohol and stearic acid, could be efficiently used in formulationof taste masked paracetamol sachets and chewabletablets without adversely delaying drug release.