Implementing the Design of Experiments (DoE) Concept into the Development Phase of Orodispersible Minitablets (ODMTs) Containing Melatonin

Abstract

Development of orodispersible minitablets (ODMTs) requires consideration of aspects related to small dimensions, while ensuring short disintegration time with sufficient mechanical stability. In order to meet these and other critical quality attributes (CQAs), quality by design is encouraged. According to this approach, formulation and compression process factors were systematically studied using design of experiments (Plackett-Burman for screening purposes, full and fractional factorial design for in-depth characterization) to understand their influence on CQAs of orodispersible minitablets containing melatonin. Mathematical models describing the relationships between processing variables and attributes such as resistance to crushing and disintegration time were successfully developed, characterized by high coefficients of determination (R2adj = 0.90–0.97) and prediction errors in the range (+2.4 to −10.8%). In conclusion, based on these models, the design space was created for melatonin ODMTs, ensuring the product’s quality and process robustness. Moreover, the study demonstrated the suitability of texture analysis as an alternative to compendial measurement methods of resistance to crushing and disintegration time.

Orally Dispersible Dosage Forms for Paediatric Use: Current Knowledge and Development of Nanostructure-Based Formulations

“…Out of the European Pharmacopoeia monographs [8,58], several research articles in the fields of orodispersible dosage form development [25,55,59,78,79,81,82] and paediatric formulations [70,77,80], respectively, have led to the development of a model QTPP for ODTs, presented in Table 1.…”

Application of Response Surface Methodology in the Formulation of an Eco-friendly Degreaser using Rhamnolipid Biosurfactant

“…The R 2 and R 2 Adj values were assigned to determine how well the model explained the variability of the dependent variables. The lack of fit parameter was examined for all models to ensure its non-significance, indicating model validity [21].…”

“…The PBD was chosen to identify the significant factors in developing the eco-friendly degreaser formulation. This design identifies the main effects based on the outcomes of tests performed according to a matrix where high and low levels of factors are investigated [21]. This PBD generated 12 formulations (PBD-1 to PBD-12); the findings are shown in Table 4.…”

“…Since the RSM approach, particularly the PBD and BBD, has been widely used in product optimization, it was adopted in this study [20][21][22]. This study aimed to determine factors that have a significant effect on the formulation of eco-friendly degreaser using the PBD, followed by optimizing the formulation by BBD.…”

Development of Aceclofenac Loaded Microsponge Gels: A Statistical Quality by Design (Qbd) Approach Towards Optimization and Evaluation

“…Finally, as the formulation was targeted to treat pain associated with Rheumatoid arthritis, the Aceclofenac microsponge was incorporated into gel to make it easier for application. The transformation of Microsponges into gel resulted in considerably greater retention of drug on the skin [12].…”