Quality-By-Design-Based Development And Characterization Of Medicated Jellies For Micronutrient Delivery

Abstract

The oral route is the most widely utilized for medication administration since it is costeffective, simple to give, and has a high level of patient acceptability. Jellies are a semisolid, clear, non-greasy dosage form that may be utilized both internally and externally. Its matrix contains a lot of water and looks like mucilage but has a jelly-like appearance. Chewable formulations have the advantages of not requiring water for ingestion, having a pleasing look, and having a pleasant texture. Soft chew is a single-dose, solid formulation, because it is a mobile drug delivery method, it is employed as an acute medicine. They're made using a heating and congealing procedure. It may be used as a new dosage form in pharmaceuticals, nutraceuticals, and over-the-counter treatments. From childhood to old age, nutritional health problems have persisted at all stages of life. One major concern that has gotten worse over time is nutritional deficiency. The growth, maintenance, and repair of bone and tissue as well as oxygen delivery are all processes that the human body needs micronutrients for to function properly. A patient's lack of nutrition leads to a number of problems. Undoubtedly one of the most important issues is malnutrition. There are numerous formulations, including pills, syrups, and suspensions, in the market to address nutritional deficiency, malnutrition, and other problems. These foods either don't fit the bill for nutritional needs or have large dosages. The large dosage in these formulations makes them less than ideal for patient compliance. The development of such a potent dose form for patients is therefore necessary. The present study was embraced to develop jellies of minerals to fulfill the requirement of micronutrients. The objective of the proposed work was to develop new patient-compliant dosage forms, which help the patient to fulfill the requirements of micronutrients. Manufacturing premium jellies has seen successfully achieved with the application of the "Formulation by Design" philosophy. The objective of present study was to develop oral medicated jellies employing quality by design approach. Quality target product profile and critical quality attributes for jellies were identified. Potential factors affecting the quality of final formulation were identified by constructing fishbone diagram and risk assessment matrix. Screened factors were further optimized by employing the central composite design. 2D and 3D contour plots were drawn for determining the optimum concentration of selected critical parameters. The Ishikawa Fishbone diagram was created based on Abstract 2022 Department of Pharmaceutical Sciences & Technology, MRSPTU ix previous knowledge from the literature to identify potential risk factors (hardness, chewiness) affecting the critical quality attributes of medicated jellies. Ishikawa fish bone diagram depicts the interrelationship between potential, process parameters, material attributes, and all other elements involved in the manufacturing and analytical process. This along with understanding of quality risk management study helped us in determining the root-cause effect of these variables in order to achieve the desired quality attributes. The selection of the degree of optimum assessment tool is critical in order to understand the degree of impact of various parameters (concentration of gelatin, concentration of sugar) on the identified quality attribute. As a result, it's critical to choose factors that have a significant impact on jellies quality attributes. Risk identification and respective management was also done by preparing quality risk management report as per ICH Q 9 guidelines. A central composite design was used to optimize the provided input / independent variables. Design-Expert software (Version 11) was used to create an ANOVA-based statistical model, a 2D counter plot, and a 3D response surface plot for determining the relationship between the independent variables and selected responses (hardness and Chewiness). The created jellies underwent in-process and post-process quality control tests, and the results were found to be satisfactory. This study provides a wider understanding of implementing quality by design principles in lab scale pharmaceutical product development in practical manner. The proposed formulations may result in a new range of products that deliver essential micronutrients in a patient- and industry-friendly way