Zeibun Ramtoola, Bakhaidar R. and Pabari R.

Program Director, MSc Industrial Pharmaceutical Science, School of Pharmacy, Royal College of Surgeons in Ireland, 123 St Stephens Green, Dublin 2, Ireland

Abstract:

Nanoparticle (NP) formulation development is a complex multidimensional system involving materials, manufacturing process and environmental effects [1]. As NPs are future therapeutic carriers, it is important to identify and understand the effect and interactions of these relationships on the final NP characteristics. Such studies can contribute to the concept of quality by design to meet future regulatory requirements [2].

The aim of this study was to apply gene expression programming (GEP) to model the effect of critical formulation and process factors and their interactions on final NP characteristics. The effect of polymer concentration, concentration of surface stabiliser and solvent to non-solvent ratio on size, polydispersity (PDI) and ZP of NPs were measured. NP size ranged between 111-2947nm with PDI ranging from 0.01 to 1, whilst ZP ranged from -33 to near neutral. The mathematical equations and the 3D graph generated by GEP modelling showed non-linear and interactive relationships of all 3 variables studied on the measured NP characteristics, confirming the complexity of NP formulation. The data showed excellent fit with the models generated as shown by the correlation coefficients of >90% observed. GEP modelling may be a useful and effective tool in establishing the design space during formulation development and optimization of NPs.

REFERENCES

[1]        Ramtoola Z et al. J Pharm Pharmacol. 2011 Jan;63(1):26-32
[2]        Landin, M. et al. Int J Pharm 2012 Sept;434(1-2):35–42
            
*Joint first authors, 1 PhD Funded by the Saudi Cultural Attachee Bureau