Abstract
FORMULATION AND EVALUATION OF FIXED DOSE COMBINATION OF FENOFIBRATE AND PRAVASTATIN SODIUM IN TABLET DOSAGE FORM

Dr. H. Padmalatha*, B. Anvesh, B. Divya, G. Sharmitra, M. Manisha and M. Saikiran

ABSTRACT

The aim of this is study is to formulate and evaluate fixed dose combination of Fenofibrate and Pravastatin sodium in tablet dosage for the treatment of Dyslipidemia. Monolithic and Bilayer tablets prototype formulation were investigated because there is a compatibility in between Fenofibrate and Pravastatin sodium based on Infrared spectroscopy studies, So a monolithic tablet is possible. For the formulation and optimization of fenofibrate layer, two factor three level factorial design was used as experimental design for optimization with a minimum of nine run. All the nine trial (F1 – F9) has been formulated according to the experimental design by wet granulation method. The independent variable studied were amount of HPMC (X1) and amount of crospovidone (X2). Drug release at 45 minutes (Y1) and disintegration time (Y2) was chosen as dependent variable. The software generated the optimized formulation and predict the response based on the constraint and the response of the dependent variable of the nine trial. Then batch was formulated based on the suggested formulation and response were obsereved. The observed pre and post compression parameter of the suggested trial was within the acceptable limit. Hence it has chosen as optimized formulation and used for formulating fixed dose combination of bilayer and monolithic tablets. For the formulation and optimization of Pravastatin sodium layer, Trial and error method was employed. Total three trial (P1-P3) has been formulated. Trial P1 was formulated by direct compression, the results of this trial indicates that it has extremely poor flow property and lower hardness and high %friability. So it is concluded that direct compression is not feasible. So trial P2 is formulated using wet granulation all the post compression parameter was within the acceptable range but trial P2 show poor flow property. Hence trial P3 was formulated as like trial P2 but with increased quantity of cellulose microcrystalline in extragranular material. The observed precompression parameter of trial P3 shows it has good flow property and weight variation, hardness, friability and assay where within the limit. The disintegration time of Trial P3 was found to be optimum. The In-vitro drug dissolution of the Trial P3 was 91.74%. Hence trial P3 was chosen as optimized formulation. Thus for the further formulation of Fixed dose combination of bilayer and monolithic tablet, the blend of trial P3 was used.

Keywords: Formulation, Evaluation, Fixed Dose Combination, Fenofibrate And Pravastatin Sodium, Tablet Dosage Form.


[Full Text Article]   [Download Certificate]

Login





Forgot Password  |  Register

Indexing

Best Paper Awards

European Journal of Biomedical and Pharmaceutical Sciences (EJBPS) will give best paper award in every issue in the form of money along with certificate to promote research activity of scholar.

Best Article of current issue :

Dr. Dhrubo Jyoti Sen

Download Article : Click here

News & Updation

  • EJBPS: JUNE ISSUE PUBLISHED

    JUNE 2024 Issue has been successfully launched on 1 JUNE 2024.

  • EJBPS New Impact Factor

    EJBPS Impact Factor has been Increased to 7.482 for Year 2024.

  • Index Copernicus Value

    EJBPS Received Index Copernicus Value 77.3, due to High Quality Publication in EJBPS at International Level

  • Journal web site support Internet Explorer, Google Chrome, Mozilla Firefox, Opera, Saffari for easy download of article without any trouble.

    .

  • Article Invited for Publication

    Dear Researcher, Article Invited for Publication  in EJBPS coming Issue.

     

UG/PG/Ph.D Research Publication

Research Scholar of UG/PG/Ph.D can Submit their Research Article/Review Article/Case Study/Short Communication for Publication in EJBPS

Downloads

Copyright From

Covering Letter

                        Author Instruction 
 

PLAGERLUM REPORT