Design space approach in the optimization of the spray-drying process

Fast-track to A Solid Dispersion Formulation Using Multi-way Analysis of Complex Interactions

“…Interpreting the effect of increasing the main terms for the PAC is straightforward. However, the presence of many second-and third order interaction terms makes the model complex and difficult to understand, a finding that is similar to the findings by Sertsou et al 5 and Lebrun et al 23 This illustrates the necessity for developing alternate model that is simpler to understand and interpret as compared with the traditional ANOVA model.…”

“…19 This issue is of importance if the GEMANOVA models are to be considered as potential model candidates to establish a design space fulfilling the requirements from the ICH Q8 guideline. 14,23 In a study by Riu and Bro,24 the authors employed a statistical resampling technique known as the jackknife in estimating parameter uncertainties of PARAFAC models. In another study by Liland and Faergestad 25 bootstrap resampling has been shown to be useful for estimating GEMANOVA model uncertainty, and similar findings of the usefulness of bootstrap in model error estimation was demonstrated by Hayashi et al 26 In the present study a data set from a complex formulation development 9 is used as a case for GEMANOVA model development to establish a design space according to the ICH Q8 guideline.…”

Statistical modeling, optimization and characterization of spray-dried solid self-microemulsifying drug delivery system using design of experiments

“…However, they imply fair flow as per the specification. 19) These results suggest that spray-dried SMEDDS powders are likely to produce poor flow due to the fine particle size and inter-particular cohesiveness, a constraint that must be considered in future experiments for prospective improvement.…”

“…For quality reasons, residual moisture of less than 1% must be attained in the spray-dried powder. 19) The average moisture content (Y 1 ) for all the factorial level combinations ranged between 0.64± 0.05% and 1.76± 0.12%. The effects of X 1 , X 2 and X 3 and their interactions on response Y 1 are given in Fig.…”

“…density The powder bulk density and tapped density were determined by a published method. 19) Due to the small amount of sample, a 10 mL graduated measuring cylinder was used. The bulk volume was directly recorded to determine its bulk density after placing approximately 5 g of powder in the measuring cylinder.…”