Abstract
Aim: The aim of this study was to Formulation and Evaluation of colon targeted pellets of Bumadizone Calcium
 Objective: Bumadizone Calcium is an acetic acid derivative, having irritation in stomach. Bumadizone Calcium has short half-life (4hrs) and undergoes first pass metabolism. It is pH-dependent. This research work was carried out to improve the bioavailability, patient compliance on oral colon targeted drug delivery. Bumadizone Calcium sustained release enteric coated pellets were prepared, which minimize the release of drug in stomach for treatment of IBD formulated by Extrusion Spheronization process.
 Experimental work done: Enteric coated pellets prepared by Extrusion Spheronization technique. Eudragit S100, HPMC, PVP K30, and Ethyl Cellulose were used as rate controlling polymers. In this study, a pH dependent colon targeted enteric coated pellets was established using 32 full factorial design by giving enteric coating with Eudragit S100. Different Concentration of Eudragit S100 as an enteric coating material (4%, 5%, & %6) and PVP K30 as a Binder (0.5%, 1% & 1.5%) are taken for the measurements of % Drug Release that are performed by using USP dissolution 1 (Basket type) at 50 rpm. The test is performed with gastric fluid (pH 1.2) at 37±0.5 for first 2 hours & then in phosphate buffer 6.8 for 4 hrs & finally in phosphate buffer pH 7.4 for 6 hrs. The prepared formulations were evaluated for drug-excipient compatibility study, flow property, drug content, and coating process efficiency.
 Results and Discussion: Optimized batch shown that less than 0.50% of the drug released at the end of 2 hrs in pH 1.2, less than 20% of drug released after end of 4 hrs in pH 6.8 and more than 85% at the end of 12 hrs in pH 7.4.
 Conclusion: Bumadizone Calcium Enteric Coated pellets can be successfully formulated by addition of PVP K-30 as a binder and Eudragit S100 as Coating polymer. It was also concluded that prepared formulation minimizes drug release in stomach and avoid side effect of the drug.
 Keywords: Bumadizone calcium, Eudragit S100, Enteric coating, extrusion spheronization technique, 32 full factorial designs.
Highlights
1.1 Introduction of Disease1.1.1 Inflammatory Bowel DiseaseCrohn’s disease and ulcerative colitis are inflammatory bowel diseases that cause chronic inflammation and damage in the gastrointestinal (GI) tract The GI tract is responsible for digestion of food, absorption of nutrients, and elimination of waste
In Crohn’s disease, the inflammation may extend through the entire thickness of the bowel wall. [1] 1.1.4 Ulcerative Colitis Ulcerative colitis is limited to the large intestine and the rectum
The inflammation occurs only in the innermost layer of the lining of the intestine. It usually begins in the rectum and lower colon, but may spread continuously to involve the entire colon. [1] 1.1.5 Indeterminate Colitis In some individuals, it is difficult to determine whether their IBD is Crohn’s disease or ulcerative colitis
Summary
1.1 Introduction of Disease1.1.1 Inflammatory Bowel DiseaseCrohn’s disease and ulcerative colitis are inflammatory bowel diseases that cause chronic inflammation and damage in the gastrointestinal (GI) tract (figure1) The GI tract is responsible for digestion of food, absorption of nutrients, and elimination of waste. The inflammation occurs only in the innermost layer of the lining of the intestine It usually begins in the rectum and lower colon, but may spread continuously to involve the entire colon. 69365-73-7 1399.723 g/mol Class-2 4 hours More than 90% absorbed Blood Stool, Urine 158 oc Carcinogenicity 50 mg to 300 mg, twice a day, once a day Octomotol tablet Oxidative degradation occurs in presence of direct sunlight or UV light at elevated temperature. It may be prevented by use of antioxidants.
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