Fabrication and Evaluation of Diclofenac Sodium Enteric Coated Pellet Dosage Form.

Aiswarya, R (2012) Fabrication and Evaluation of Diclofenac Sodium Enteric Coated Pellet Dosage Form. Masters thesis, J K K Nattraja College of Pharmacy, Komarapalayam.

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The present research study is to develop Diclofenac sodium enteric coated pellets using Kollicoat MAE 100 P and Eudragit L 100 by Extrusion-Marumerisation technique. Objective Diclofenac sodium is a water insoluble non steroidal anti inflammatory drug used in the treatment of chronic rheumatoid arthritis and osteoarthritis. Diclofenac sodium was enteric coated and presented as enteric coated Diclofenac sodium pellet in a capsule dosage form. The key target of our study is to fabricate a Diclofenac pellets with uniform size and shape which increases the gastrointestinal transit time. In order to protect Diclofenac sodium release in the stomach, pellets were enteric coated and made available in the small intestine for release in the range of 6 – 7.5pH. Rationale for the selection of dosage form is to minimize large variation in gastric emptying / residence time, less susceptible to dose dumping, facilitate accurate delivery of small quantity of potent drugs, reduced drug concentration at sites other than target organ, and maximizes drug absorption in small intestine, reduced potential side effects without lowering drug bio availability. Rationale for the selection of enteric coating Diclofenac sodium has been reported with GI bleeding, ulceration and perforation can be fatal. So, Diclofenac sodium was enteric coated with enteric coating polymer such as Kollicoat MAE 100P , Eudragit L 100 and minimized the release in the stomach. The present research work was carried out to prepare enteric coating pellet dosage form using Diclofenac sodium for the effective therapy in Osteoarthritis and Rheumatoid Arthritis. Diclofenac sodium pellets were fabricated and enteric coated with two different polymers namely Eudragit L 100 and Kollicoat MAE 100P with different ratios. Diclofenac sodium enteric coated pellet formulation C8 with 2% seal coat of ethyl cellulose and 15% of Eudragit L l00 showed 0.59% in acid medium (0.1N HCL) and 98.24% in Buffer medium (Phosphate buffer PH 6.8). From this research work it is evident that the formulated pellet formulation has ability to retard the release of diclofenac sodium in stomach and made available in intestine, which shows similar drug release profile when compared to the marketed formulation.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Diclofenac Sodium; Enteric Coated Pellet Dosage; Extrusion Marumerisation
Subjects: PHARMACY > Pharmaceutics
Depositing User: Ravindran C
Date Deposited: 23 Aug 2017 10:39
Last Modified: 23 Aug 2017 10:39
URI: http://repository-tnmgrmu.ac.in/id/eprint/2812

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