FORMULATION DEVELOPMENT AND OPTIMIZATION OF MEDICATED LOZENGES FOR PEDIATRIC USE

Paracetamol was formulated as lozenges to provide slow release medicament for the management of fever and pain. There are many dosage forms like syrups, tablets, inhalers are available in the market but still there is a need for new dosage forms which acts effectively and locally. So the present investigation has been taken up to design, prepare and evaluated tablet lozenges to meet the need of improved bioavailability and hence avoid hepatic toxicity. The benefits of these prepared lozenges showed increase in bioavailability, reduction in gastric irritation by passing of 1st pass metabolism and increase in onset of action. The lozenges were prepared using sucrose as base; Sodium Carboxy Methyl Cellulose (NaCMC) and Methyl Cellulose(MC) are used as polymers. Eudragit is used as taste masking agent. All the formulations prepared were subjected to various physicochemical parameters like hardness, content uniformity, friability, weight variation etc. The prepared formulations have a hardness of 9-10 Kg/cm2, not gritty, mouth feel freshness taste. Stability studies of selected formulations were also carried out at 30oC & 40°C for a period of six months. Some selected formulations were tested for drug excipients interactions subjecting to IR Spectral analysis. In-vitro drug dissolution studies showed least of 70.012% for PL3 and maximum of 90.648% for PL4 release of drug in 30 minutes. The moulded lozenges can provide an attractive alternative formulation in the alleviation of pain and fever.