ABSTRACT
Objective: The intension of the present study includes fabrication and optimization of mouth dissolving film loaded with Chlorothalidone by solvent evaporation techniques using two components and their three levels as multilevel Categoric design. Methods: Major problem associated with the development of film loaded with BCS class II drug is to increase its solubility. Here the Chlorothalidone solubility achieved by co-solvents, such as methanol. After dissolving the drug in co-solvent, this drug solution is poured into an aqueous dispersion of Hydroxypropyl Methylcellulose E5 (HPMC E5) and Polyethylene glycol 400 (PEG 400). The two independent variables selected are factor A (concentration of HPMC E5) and factor B (concentration of PEG 400) was selected on the basis of preliminary trials. The percentage drug release (R1), Disintegration time in sec (R2) and folding endurance (R3) were selected as dependent variables. Here HPMC E5 used as a film former, PEG 400 as plasticizer, mannitol as bulking agent, Sodium starch glycolate as a disintegrating agent, tween 80 as the surfactant, tartaric acid as saliva stimulating agent, sodium saccharin as a sweetener and orange flavour etc. These fabricated films were evaluated for physicochemical properties, disintegration time and In vitro drug release study. Results: The formulation F6 has more favorable responses as per multilevel categoric design is % drug release about 98.95 %, average disintegration time about 24.33 second and folding endurance is 117. Thus formulation F6 was preferred as an optimized formulation. Conclusion: The present formulation delivers medicament accurately with good therapeutic efficiency by oral administration, this mouth dissolving films having a rapid onset of action than conventional tablet formulations.
ABSTRACT
Studies in pharmaceutical systems are used to pick up the physicochemical properties of drugs, one of them are solid dispersions requiring a carrier to achieve that purpose. Generally hydrophilic agents are used as a carrier, because they have high hydrophilicity and are used in the pharmaceutical industry as excipients. In this work the Urea merges with Cefuroxime Axetil (CFA) for the formation of three solid dispersions, the antibacterial drug (CFA) is insoluble in water, creating problems of bioavailability in the body. Solid Dispersion of CFA was prepared with a ratio of 1:1, 1:2 and 1:3 using Urea. The study of bioactivity of the solid solutions was performed by Differential Scanning Calorimetry (DSC) and showing that part of CFA is retained in the volume (structure) of Urea and some joins the surface. The data analyzed were for the absorbance of each sample that were applied a cubic interpolation to determine differences between the dispersions by using MATLAB software (V.No. R201 1b).