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Abstract QbD approach empowers the pharma researchers to minimize the number of experimental trials and time. It helps identify the significant, influential factors such as critical material attributes, critical formulation variables, and critical process parameters, which may significantly impact the quality of the products. Poly lactic-co-glycolic acid (PLGA), a biocompatible and biodegradable polymer, has gained an immense potential and wide range of applications as a carrier for manufacturing of polymeric nanoparticle drug delivery systems as per US-FDA and European Medicine Agency for drug delivery. The double emulsion method for preparing PLGA nanoparticles to encapsulate hydrophilic drugs has attracted interest in manufacturing processes. The double emulsion is a two-step process consisting of two different emulsification, making the process more complicated. The stability of nanoparticles obtained by a double emulsion method remains questionable due to the many formulations and process attributes. Currently, PLGA based nanoparticles prepared by a double emulsion technique are an alternative pharmaceutical manufacturing operation for getting the quality product by employing the Quality by Design approach. This present review has discussed the QbD elements to elucidate the effect of material attributes, formulation, and process variables on the critical quality attributes of the drug product, such as particle size distribution, encapsulation efficiency, etc. The components of a double emulsion, characteristics of drugs, polymers, and stabilizers used have been discussed in detail in this review. Graphic abstract
Panigrahi et al. (Mon,) studied this question.