Quality by Design-based Formulation of Fizzy Granules Containing Probiotics

Introduction: Probiotics have proven to have a strong potential for treating and/or preventing a wide range of diseases and also aid in maintaining a healthy gut microbial ecology and are effective against pathogens that are resistant to many drugs. As a result, the probiotics industry is expanding fast on a global scale, and research to explore probiotics into medicinal adjuvants has been intensified across the globe. However, due to the lack of an attractive dosage form, probiotics are not very compliant among patients. The present study aimed to formulate fizzy granules of probiotics (Lactobacillus sporogenes) by involving the concept of quality by design for industrial acceptance. Methods: For this, critical formulation attributes and various risks involved during the formulation have been identified through the Ishikawa fishbone diagram and risk assessment studies in compliance with relevant ICH guidelines. Selected significant variables involved during the formulation were further analyzed through a central composite design to analyze the optimum level of variables. Further, 2D contour plots and 3D response surface plots have been designed to define the relationship between the quality attributes and input variables. Results and Discussion: The developed statistical model was further validated and found appropriate to define the quality parameters at an acceptable level. Final quality profiling of the developed probiotics fizzy granules was performed to validate compliance with the quality target product profile and results were found to be satisfactory. Conclusion: This study involved the development of a novel fizzy probiotic formulation, incorporating the concept of quality by design to enhance acceptance among patients, pharmaceutical companies, and regulatory bodies.