Design of Experiments (DoE) manipulation in the formulation and optimization of a traditional Ayurvedic medicine derived from dried extract of Senegalia catechu enhanced through statistical analysis

Abstract

Introduction: In India, the regulatory body for catechu is the Food Safety and Standards Authority of India (FSSAI). The FSSAI is responsible for regulating the manufacture, sale, and distribution of food in India, including catechu. The FSSAI has set standards for the purity and quality of catechu, and it also monitors the market for adulterated catechu. The FDA (The Food and Drug Administration) is responsible for regulating the safety and efficacy of drugs and dietary supplements in the United States (US). The FDA has not approved catechu as a drug or dietary supplement, but it does regulate catechu as a food additive. The FDA has set limits on the amount of catechu that can be added to food Objective: The primary objective of this research was to involvement of design of experiments (DoE) manipulation in the formulation and optimization of a traditional Ayurvedic medicine derived from dried extract of Senegalia catechu enhanced through statistical analysis. Methodology: The dried extract of Senegalia catechu was collected and identified at the botanical herbarium garden. Subsequently, it underwent a drying process and was ground into a powder. This powder was then subjected to extraction using the digestion method, utilizing water as the solvent at a temperature of 70 °C. The resulting extract underwent phytochemical screening. Following this, the extract was utilized in the pharmaceutical development process. The optimization of the formulation for the dried extract of Senegalia catechu began with the establishment of the Quality Target Product Profile (QTPPs) for the final product. The desired outcome was an oral dispersible tablet (ODTs) that would enhance patient compliance and ensure rapid disintegration. These QTPPs served as the foundation for identifying the Critical Quality Attributes (CQAs), which included hardness, disintegration time, and mass uniformity. These attributes were utilized in all subsequent experiments. The experimental phase was divided into two main manufacturing processes is first one is direct compression and another one is wet granulation techniques. Each process was thoroughly investigated to optimize the drug product. To assess the potential risks and their impact on product quality, a comprehensive risk assessment was conducted. For the direct compression technique, a 32 full factorial Design (FFD) of DoE was employed to analyze the influence of the super disintegrant (26%) and lubricant range (ranging from 0.32% to 6%) on the characteristics of powder flow. On the other hand, the wet granulation technique utilized a 32 FFD, DoE to investigate the effects of the super disintegrant (Ranging from 1.5% to 4.8%) and binder (ranging from 4% to 9%) on both flow properties and tablet properties. Results: The successful optimization of an Enhanced Traditional Medicine (ETM) was achieved through the design and evaluation of formulations in this study. The utilization of DoE proved to be an exceptional approach in optimizing ETM formulations, offering a range of tools that enhance comprehension of the formulation and manufacturing process. Additional research on this DoE methodology is necessary to assess the impact of additional process variables, including compression force and speed, as well as formulation variables such as palatability. Conclusion: The influence of formulation variables on disintegration time, wetting time, and hardness was demonstrated through the development of optimization models. Consequently, employing DoE for the formulation optimization of a category for ETM containing dried extract of Senegalia catechu is a viable strategy to enhance drug product understanding while saving both time and money.