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Development and Characterization of Stomach Targeted Floating Alginate Nano Beads of Anticancer drug 5 Flurouracil Using QbD Approach for Gastric Cancer

Faculty of Pharmacy Supervisor: Dr. Jakir Ahmed Chowdhury

Md. Hafez Ahmed

63,000

Ongoing

University of Dhaka

Start: December 1, 2025
End: June 30, 2026

Abstract

Outline of the project with background information: Introduction Globally, gastric cancer is one of the primary causes of cancer-related deaths. It develops when cells lining the digestive tract acquire mutations that cause uncontrolled growth (1). Main risk factors include a history of chronic Helicobacter pylori infection, smoking, excessive alcohol consumption, obesity, infections like Epstein-Barr virus, a person's genetic makeup, and advanced age. More than 1,089,000 people were diagnosed with stomach cancer in 2020, and around 769,000 people lost their lives to this disease (2). Treatment option for stomach cancer (I) Chemotherapy Chemotherapy uses drugs that fight cancer, like cisplatin, or docetaxel, to kill cancer cells that are growing quickly. It is effective at inhibiting cancer from growing, but it has some big problems. These include non-specific toxicity that harms healthy cells, a short plasma half-life for drugs like 5-FU, and serious adverse effects like vomiting, hair loss, nausea, and bone marrow suppression. (II) Surgery Surgery refers to eliminating out part of the stomach and nearby lymph nodes. It is best for stomach cancer that is still in its early stages. But there are some drawbacks such as the chance of infection, bleeding, and problems with nutrition after surgery. In addition, surgery doesn't work for cancer that has spread or is in an advanced stage. (III) Radiation therapy In this treatment high-energy rays are used to destroy cancer cells. Normally these are combinedly used with chemotherapy. Radiation therapy shrink tumours cell but it can also damage some nearest healthy cell, which can cause side effects such as loss of fatigue, appetite, vomiting nausea etc. (IV) Immunotherapy Immunotherapy helps the immune system find and kill cancer cells. Some kinds of stomach cancer can be treated with drugs like pembrolizumab. This treatment works only for people with certain biomarkers, and it can also cause problems with the immune system (3-4). (V) Targeted therapy Target therapies are used to kill cancer cells by using molecular targets. For example, HER2 positive gastric cancer is one type of cancer that are treated by targeted therapy. The major drawback of this therapy is that it only effective for some types of cancer and is very expensive. Cancer cells can also become resistant to targeted drugs over time. There are some limitations to all of the current treatments for stomach cancer. Surgery is invasive and only effective in the early stages. Chemotherapy has a short half-life and can cause serious side effects throughout the body. Radiation therapy can hurt healthy tissues nearby, and targeted therapy and immunotherapy are costly and only work for some patients. Because of these problems, a more effective drug delivery system will be needed.5-Fluorouracil floating beads will be selected to overcome these limitations because cconventional chemotherapy of 5 flurouracil is often limited by poor absorption, rapid gastric emptying and systemic side effect(5) . Floating beads Floating drug delivery system has emerged as a promising strategy to prolong gastric residence time. The retention of a drug delivery system in the stomach extends the overall gastrointestinal transit time. Floating nano beads are less dense, so they can float on stomach fluids and stay in the stomach for 8 to 12 hours, while the normal time for the stomach to empty is only 3 to 4 hours. This prolonged gastric retention allows for controlled and sustained drug release, higher absorption bioavailability, and lower systemic toxicity (6). Alginate nano and micro beads Alginate, a biocompatible and biodegradable polymer, can form Nano beads through emulsion techniques, providing a nano-scale carrier for controlled drug release. Alginate beads are nano scale carriers that encapsulated the drug in alginate polymer matrix(8).Combining alginate nano beads with floating system offers an effective strategy for stomach targeted chemotherapy. Study Design The process can be divided into three main stages: preparation of alginate nano beads formulations, optimization by DoE, and characterization of optimized formulations (morphological and compatibility studies).

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