Formulation Development and in Vitro Dissolution Evaluation of Chlorpheniramine Maleate,Ibuprofen,Phenylephrine HCl Tablet
Objective:To optimize formulation composition and process condition and evaluate the similarity of dissolution curve between tested formulation and reference formulation of chlorpheniramine maleate,ibuprofen,phenylephrine HCl tablet.Methods:The mixture of chlorpheniramine maleate and ibuprofen is granulated by wet method,and phenylephrine HCl is granulated by wet method separately.The percentage of the disintegrant croscarmellose sodium,the adhesive hypromellose,the lubricant magnesium stearate and particle size of ibuprofen on the dissolution are investigated,and the final formulation composition is determined.Results:After formulation screening,at a total tablet weight of 480 mg,the particle size range of ibuprofen is 170 μm≤D90≤190 μm,the amount of the disintegrant croscarmellose sodium is at 25.2 mg,the adhesive hypromellose 4.2 mg and the lubricant magnesium stearate 4.2 mg.The similarity factor(f2)value of dissolution curve between tested formulation and reference formulation is higher than 50 in the four dissolution media.Conclusion:Chlorpheniramine maleate,ibuprofen,phenylephrine HCl tablet are successfully developed,with simple formulation,robust process,and good similarity of dissolution behavior,which provided a solid foundation for the later manufacturing of chlorpheniramine maleate,ibuprofen,phenylephrine HCl tablet.
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