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
Highlights
The significant challenges in the preparation of nanoparticles are manufacturing variability due to a lack of understanding of the effect of critical material attributes (CMAs) and critical processing parameters (CPPs) to attain small size, narrow polydispersity index (PDI), and so on [1]
After identification of all the critical factors associated with the input materials (CMA), formulation (CFV), and manufacturing process (CPP), implement the quality by design (QbD) tools to optimize the potential factors to control the source of variability
Like the US FDA and European Medicine Agency, many regulatory agencies have accepted the use of Poly lactic-co-glycolic acid (PLGA) due to its biocompatibility and biodegradability
Summary
The significant challenges in the preparation of nanoparticles are manufacturing variability due to a lack of understanding of the effect of critical material attributes (CMAs) and critical processing parameters (CPPs) to attain small size, narrow polydispersity index (PDI), and so on [1]. The review aimed to describe the pharmaceuticals application of the double emulsion method for the PLGA loaded nanoparticles with the help of quality by design (QbD) approach to understanding the effect of CMAs and CPPs on critical quality attributes (CQAs) to reduce the manufacturing variability, control the manufacturing cost, and to improve the formulation safety and quality [2–4]. Hydrophilic drug shows a poor entrapment efficiency with a single emulsion technique because the water-soluble drug substances’ encapsulation generally results in diffusion or rapid partitioning of a drug from internal oil or organic dispersed into external/ continuous aqueous phase, leading to microparticles or nanoparticles with poor loading efficiency [20]. An attempt has been made to describe the systematic development of PLGA nanoparticles and the QbD elements and how to correlate the impact of CMA, CFV, and CPP with the CQAs of drug products to reduce the manufacturing variability [25]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
