Development Of Formulation and Technology of Combined Generic Powder for Oral Solution in Sachets Based on the Quality by Design Approach

Abstract

Using quality by design approaches (dispersion analysis and random balance method), the formulation and technology of powder for oral solution in sachets were developed. It includes paracetamol, ascorbic acid, phenylephrine hydrochloride, and pheniramine maleate. The influence of 27 excipients from 5 functional groups on 11 quality attributes was established by the dispersion analysis. The preferred excipients were selected using the utility function. The quantities of preferable excipients (7 quantitative factors at three levels) were researched by the random balance method. Their influence on 11 pharmaco-technological parameters of the powder and the physical properties of the solution studied. The optimal composition of the powder for the oral solution established. 9 sequences of introducing components were analyzed by dispersion analysis. The optimal technology of the powder for oral solution in sachets byroll compaction is established.