20- Development of a Novel Amoxicillin Tablet Using Ipomoea staphylina Extract as a Natural Binder: Enhancing Tablet Properties and Reducing Potential Side Effects

Background: Many of the excipients in pharmaceutical formulations can cause adverse effects like stomach irritation, skin issues, and nausea. Prolonged use of these synthetic excipients poses health risks, including potential renal failure. Higher doses (500 mg to 1200 mg) are often used for greater therapeutic efficacy, but they increase the likelihood of side effects. Additionally, the synthesis and purification of these excipients are costly and environmentally unfriendly. Aim and Objective: The objective is to decrease dosage levels while concurrently without reducing it release rate and mitigating potential side effects associated with Amoxicillin tablets. The selection of fully natural, non-synthetic excipients is integral to optimizing tablet activity. Materials and Method: Amoxicillin was combined with Ipomoea staphylina extract, and a preformulation study confirmed compatibility with excipients, ensuring no chemical interactions. The tablets (150, 200, 250 mg) were formulated using direct compression, followed by QA and QC assessments to verify quality and therapeutic efficacy. All studies adhered to standard guidelines, ensuring the formulation's integrity and effectiveness. Results: The formulation has undergone rigorous quality control and quality assessment procedures, successfully clearing all QA & QC tests. In dissolution testing, the plant-based amoxicillin exhibited a release rate of 96% within the expected time frame, indicating its effectiveness. The formulation has demonstrated excellence across various preformulation and evaluation tests (Powder flow, weight variation, friability, Dissolution test). Conclusion: In formulating a plant-based Amoxicillin tablet, we utilized I. staphylina extract as a natural binder, chosen for its flow properties that enhance the tablet's release profile. We deliberately selected a lower dosage than what is commonly available, aiming to reduce potential side effects associated with prolonged use, often linked to synthetic excipients. By incorporating only natural excipients, including I. staphylina extract, potato starch, and talc, we improved the tablet's effectiveness while minimizing adverse effects. The tablets passed all quality assessments, demonstrating excellent release properties and significant therapeutic activity.