Formulation Development and Evaluation of Deferasirox Dispersible Tablets

Karumanchi, Sateesh Babu (2014) Formulation Development and Evaluation of Deferasirox Dispersible Tablets. Masters thesis, Arulmigu Kalasalingam College of Pharmacy, Krishnankoil.

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The present study treatment of iron storage disease is to remove from the body the excess iron that has accumulated. This can be done by employing iron Chelators. Iron Chelators can be classified using a number of criteria such as their origin (synthetic versus biologically produced molecules), their interaction with solvents such as water (hydrophobic versus hydrophilic) or their stoichiometric interaction (bidentate versus hexadentate). Some of these properties have an important impact on the clinical utility of the chelator. One of the key clinical features is the degree to which they are absorbed from the gastrointestinal tract. The topic for the present study is “Formulation Development and Evaluation of Deferasirox dispersible tablets”. Introduction is presented in chapter 1 which gives details about chronic iron overload and its mode and choice of drugs for the treatment of chronic iron overload. This chapter also gives the overall view about dispersible tablets and their methods of development. Aim and Objective is presented which gives the information regarding the present study. Literature of review is presented in which provides an extensive detail of the related research work pertaining to the present study. Drug profile is presented which gives details about the mechanism of action, pharmacodynamics, dosage and administration, precautions and side effects of the drug selected. Excipient profile which gives details about the different excipients used in the formulation development. Materials and methods which gives details about the list of chemicals, equipments used for the study. This chapter also gives information about the methods involved in the development of formulation. Experimental investigation which gives information about different formulas developed in the formulation of dispersible tablets and the comparative evaluation of the developed formulation with that of the innovator product. Results and discussion which deals with the completed information regarding physical and chemical analysis of the present study with suitable tables, graphs and figures. Summary and conclusion which provides detailed information about each chapter. Deferasirox is indicated in for the treatment of chronic Iron overload due to blood transfusions in adult and pediatric patients (aged 2 years and over). Pre-formulation studies were performed for the drug and excipients as per the standard procedures. The innovator product characterization was performed. Formulation 1 was made by direct compression method. In this poor flow property was observed and also hardness and friability values were not satisfactory. Formulations 2,3,4,6,7,8,9 were made by using wet granulation method. In formulaton2 hardness was found to be less and the friability value does not comply with the specifications. In formulations 3, 4, 6 in order to get a better dispersion the concentration of superdisintegrant was increased. Here the disintegration time, dispersion time and percentage of drug release does not comply with the innovator product. In formulations 7,8,9 the disintegration time, dispersion time and percentage of drug release were found to match with the innovator product. All the physicochemical characteristics of the finished product were found to be satisfactory. Formulation 5 was also made by wet granulation method with a different formula. Here the disintegration time, dispersion time and percentage drug release does not match with the innovator. All the formulations were subjected to physicochemical analysis and out of them Formulation 8 was found to be satisfactory when compared to other formulations. The disintegration time (35 sec), dispersion time (67 sec) and percentage of drug release (98.3%) were found to be satisfactory and it matches with the innovator. So, the batch size was increased in further trial to check the reproducibility (Formulation 9). Finally loaded for stability as per the ICH guidelines.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Deferasirox Dispersible Tablets; ICH guidelines
Subjects: PHARMACY > Pharmaceutics
Depositing User: Ravindran C
Date Deposited: 09 Oct 2017 06:04
Last Modified: 09 Oct 2017 06:04

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