EVALUATION OF INNOVATIVE CO-PROCESSED ADDITIVE FOR DIRECT COMPRESSION TABLETS USING ATORVASTATIN AND DIAZEPAM AS MODEL DRUGS
Keywords:Low-cost excipient, Direct compressible, In situ prepared additives
Objective: The aim of the present study is to prepare and evaluate a co-processed excipient from commercially available Avecil PH102 and silicon dioxide colloidal (SDC) using direct compression technique for preparation of tablets.
Methods: The effect of the ratio of the two components on the properties of the prepared co-processed excipient has been investigated. In addition, it was evaluated for flowability, compressibility, and compatibility utilizing Fourier transforms Infrared (FTIR) and Differential scanning calorimetry (DSC) analysis. Tablets were produced by direct compression utilizing the co-processed additive with diazepam or atorvastatin calcium as model drugs in addition to magnesium stearate and talc as a lubricant. The addition of super disintegrant croscarmellose sodium or tablets preparation by wet granulation was utilized for comparison regarding the properties of prepared tablets. The prepared tablets were characterized for the drug content, hardness, friability, disintegration, dissolution, and stability.
Results: Optimal physicochemical properties of the excipient from a manufacturing perspective were obtained using a co-processed Avecil PH102-with SDC (2% w/w) to get a mixture. The FTIR and DSC analysis showed no chemical interaction. The properties of tablets made using co-processed excipient showed good hardness, friability, acceptable tablet disintegration time, dissolution rate, and stability comparable to that obtained by the multistep method of wet granulation. Although the addition of super disintegrant more shorten the disintegration time but the obtained value without croscarmellose sodium is still satisfied the requirement.
Conclusion: The Avecil PH102-SDC co-processed excipient produced was found to be promising as a valuable industrial, pharmaceutical excipient for the production of compressed tablets with good physical properties and fast dissolution.
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