Implementation of quality by design principles in the development of microsponges as drug delivery carriers: Identification and optimization of critical factors using multivariate statistical analyses and design of experiments studies.

Autor: Simonoska Crcarevska M; Institute of Pharmaceutical Technology, Faculty of Pharmacy, University of Ss. Cyril & Methodius, Majka Tereza 47, 1000 Skopje, Macedonia; Center of Pharmaceutical Nanotechnology, Faculty of Pharmacy, University of Ss. Cyril & Methodius, Majka Tereza 47, 1000 Skopje, Macedonia. Electronic address: msimonoska@ff.ukim.edu.mk., Dimitrovska A; Institute of Applied Chemistry and Pharmaceutical Analysis, Faculty of Pharmacy, University of Ss. Cyril & Methodius, Majka Tereza 47, 1000 Skopje, Macedonia., Sibinovska N; Institute of Pharmaceutical Technology, Faculty of Pharmacy, University of Ss. Cyril & Methodius, Majka Tereza 47, 1000 Skopje, Macedonia; Center of Pharmaceutical Nanotechnology, Faculty of Pharmacy, University of Ss. Cyril & Methodius, Majka Tereza 47, 1000 Skopje, Macedonia., Mladenovska K; Institute of Pharmaceutical Technology, Faculty of Pharmacy, University of Ss. Cyril & Methodius, Majka Tereza 47, 1000 Skopje, Macedonia; Center of Pharmaceutical Nanotechnology, Faculty of Pharmacy, University of Ss. Cyril & Methodius, Majka Tereza 47, 1000 Skopje, Macedonia., Slavevska Raicki R; Institute of Pharmaceutical Technology, Faculty of Pharmacy, University of Ss. Cyril & Methodius, Majka Tereza 47, 1000 Skopje, Macedonia; Center of Pharmaceutical Nanotechnology, Faculty of Pharmacy, University of Ss. Cyril & Methodius, Majka Tereza 47, 1000 Skopje, Macedonia., Glavas Dodov M; Institute of Pharmaceutical Technology, Faculty of Pharmacy, University of Ss. Cyril & Methodius, Majka Tereza 47, 1000 Skopje, Macedonia; Center of Pharmaceutical Nanotechnology, Faculty of Pharmacy, University of Ss. Cyril & Methodius, Majka Tereza 47, 1000 Skopje, Macedonia.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2015 Jul 15; Vol. 489 (1-2), pp. 58-72. Date of Electronic Publication: 2015 Apr 17.
DOI: 10.1016/j.ijpharm.2015.04.038
Abstrakt: Microsponges drug delivery system (MDDC) was prepared by double emulsion-solvent-diffusion technique using rotor-stator homogenization. Quality by design (QbD) concept was implemented for the development of MDDC with potential to be incorporated into semisolid dosage form (gel). Quality target product profile (QTPP) and critical quality attributes (CQA) were defined and identified, accordingly. Critical material attributes (CMA) and Critical process parameters (CPP) were identified using quality risk management (QRM) tool, failure mode, effects and criticality analysis (FMECA). CMA and CPP were identified based on results obtained from principal component analysis (PCA-X&Y) and partial least squares (PLS) statistical analysis along with literature data, product and process knowledge and understanding. FMECA identified amount of ethylcellulose, chitosan, acetone, dichloromethane, span 80, tween 80 and water ratio in primary/multiple emulsions as CMA and rotation speed and stirrer type used for organic solvent removal as CPP. The relationship between identified CPP and particle size as CQA was described in the design space using design of experiments - one-factor response surface method. Obtained results from statistically designed experiments enabled establishment of mathematical models and equations that were used for detailed characterization of influence of identified CPP upon MDDC particle size and particle size distribution and their subsequent optimization.
(Copyright © 2015 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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