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Hardness : The hardness of prepared buccal tablets was found to be 4.2-5.8 kg/cm2.Formulation F12 showed maximum hardness. Hardness was found to increase with increasing carbopol proportion in the formulation. Thickness : Values were found to be in the range of 2.75 to 2.92 mm Friability : All formulations showed friability values less than 1% indicating good mechanical strength to withstand the rigors of handling and transportations. Weight Variation : Tablets ranged 149 to 152 mg respectively (i.e.) within the pharmacopoeial limit of 7.5 %. Drug Content:The average drug content of the buccal tablets was found to be within the range of 97.65 - 99.74 % indicating uniform distribution of the drug also within the compendial limits of 85 -115 %
Surface pH: Surface pH of all formulations was found to be in the range of 5.87 to 7.01 . Hence it is assumed that these formulations cause no irritation in the oral cavity. Swelling Index: All formulations showed good swelling profiles, Maximum swelling was seen with the formulation F12 Results indicate that as the concentration of carbopol 934p increases the swelling index increases. Mucoadhesive Strength : Values were found to be in the range of 4.5 -12.5 g.The mucoadhesivity of buccal tablets was found to be the maximum in case of formulation F12, i.e., 12.5g. This may be due to fact that positive charges on surface of carbopol could give rise to strong electrostatic interaction with mucous or negatively charged mucus membrane.
From dissolution data it is evident that designed formulations have displayed more than 87% drug release in 8 h. Formulations F9 and F12 showed optimum release . It is evident that all the formulations displayed zero-order release kinetics (r values from 0.9608 to 0.9992). Higuchi and Peppas data reveals that the drug is released by non-Fickian diffusion mechanism (r values from 0.9821 to 0.9996 and n values from 0.653 to 0.799).
Drug-excipient interactions were ruled out by FTIR spectroscopic studies on the samples (F9 and F12) stored for three months at 40 2 0 C / 75 5% RH. Stability studies indicate that the drug content, surface pH and cumulative percentage drug release of the formulations F9 & F12 was not significantly affected at 40 20 C / 75 5% RH after storage for three months. As per ICH Guidelines on stability studies, shelf life of the optimized formulations F9 and F12 was fixed to be 2 years