1Research Scholar, Faculty of Pharmacy, Nootan Pharmacy College, Sankalchand Patel University, Visnagar, Gujarat, India.
2Associate Professor, Faculty of Pharmacy, Nootan Pharmacy College, Sankalchand Patel University, Visnagar, Gujarat, India.
*Corresponding Author E-mail: akashn.shah@zyduswellness.com
The Quality by Design (QbD) approach validates the formulation during development, ensuring optimization through the meticulous selection of herbal extracts.
Oral dosage forms, particularly fast- dissolving films containing various herbal extracts (such as turmeric, saffron, and ginger), were developed to achieve immediate therapeutic effects. The Quality by Design (QbD) approach emphasizes a science-based methodology in product development. Design of Experiments (DOE) and ANOVA are utilized to analyze highrisk Critical Quality Attributes (CQAs). Design Expert software aids in determining the optimal quantities of variables in the formulation by analyzing the effects of independent variables to establish the design space.
The effects of the identified independent variables, Pullulan and PEG 400, were investigated. Their impact on critical responses, Folding Endurance and Disintegration Time, were analyzed, revealing a significant influence on both responses. The optimized formulation, containing 50 mg/film of Pullulan and 20 mg/film of PEG 400, meets the desired QTPP and Pharmacopoeial standards for fast-dissolving films. ANOVA results indicated p-values of 0.0417 and 0.0448 for the respective variables, confirming the model's significance. The optimized fast-dissolving film (FDF) formulation with three natural extract combinations exhibited a Folding Endurance of 198±1.35 folds and a Disintegration Time (DT) of 35±3.48 kg/cm2, which are highly desirable from a formulation perspective.
The successful creation of a fast-dissolving film containing turmeric, saffron, and ginger using a QbD approach underscores the distinct challenges of formulation compared to other potent APIs. Additionally, achieving the desired folding endurance and disintegration time in a formulation with natural extracts at 17.75% potency is a groundbreaking achievement. There is no existing QbD methodology for a product that integrates three different natural extracts into a fast-dissolving film dosage form. Thus, applying QbD to develop and optimize the formulation and attain the desired outcomes is a significant accomplishment.
QbD - Quality by Design, Fast dissolving film, Natural extracts, QTPP-Quality Target Product Profile, DOE-Design of Experiments, CQA-Critical Quality Attributes
