Optimizing Drug Delivery Systems Using Systematic "Design of Experiments." Part II: Retrospect and Prospects

Abstract

The first study on application of Design of Experiments (DoE) in optimizing drug formulation appeared in 1967. Since then the number of literature reports on the use of DoE optimization in development of drug delivery technologies has been piling up steadily. Such systematic techniques find their use in every type of conventional dosage form and modern drug delivery system. The drug delivery devices investigated for optimization using response surface methodology include controlled release compressed matrices, microparticulates, macroparticulates, vesicular systems, floating systems, bioadhesive systems, semisolids, transdermals, and inhalations. The optimized processes mainly include extrusion-spheronization, pelletization, microencapsulation, coating, granulation, and tableting. Part I of this article [Crit Rev Ther Drug Carrier Syst 2005; 22(1):27-106] dealt with the salient steps involved in the DoE optimization methodology using diverse experimental designs. Part II deals with various retrospective literature findings as well as the prospective application of such DoE procedures while optimizing varied drug delivery technologies. A vast account of various DoE reports on optimization of diverse drug delivery system and processes along with the critical graphical analysis of various designs, input, and response variables have been presented here in a categorical form. Such an explicit and updated review on drug delivery optimization has not been published anywhere else in the recent past.

Enhancing biopharmaceutical attributes of phospholipid complex-loaded nanostructured lipidic carriers of mangiferin: Systematic development, characterization and evaluation

“…Further, design space within the overlay plot also demarcates the optimized formulation (Singh et al, 2005). …”

Polymers in Small-Interfering RNA Delivery

“…However, the conventional PLGA formulation prepared by double emulsion solvent evaporation method is expected to have little practical applicability due to the low loading and encapsulation efficiency which could be attributed to the accumulative effects comprising of siRNA leakage owing to its small molecular weight, hydrophilic character, and the electrostatic repulsive forces developed between the phosphate backbone of siRNA and the anionic acid groups in PLGA polymers. Foged group prepared and evaluated various formulations and preparative processes of siRNA-loaded PLGA nanoparticles following design of experiments (Singh et al, 2005a(Singh et al, , 2005bCun et al, 2011). The parameters under consideration for optimization were (1) the siRNA load, (2) the PLGA concentration, (3) the volume ratio between the inner water phase and the oil phase, (4) the sonication time for the primary emulsification and (5) the amount of acetylated bovine serum albumin (Ac-BSA) added to the inner water phase to stabilize the primary emulsion.…”

A Design of Experiment Approach for Optimization and Characterization of Etodolac Ternary System Using Spray Drying

“…A CCD with α=1 was employed as per standard protocol [25,26]. The amount of HPB (B) and PVP K30 (A) were selected as experimental factors and studied at three levels each.…”

“…Optimization using DoE is a cost-effective analytical tool, quick and best solution to a particular defined problem. This approach provides an ability to explore and determines ranges of polymer [25,26].…”