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Arshiya Shaikh, Alladi Saritha
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Abstract
nThe 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. 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. 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. Hence it was concluded that, bilayer tablet show no significant advantage over monolithic tablet on the basis of drug release and stability. So monolithic prototype formulation is chosen for the scale up process of fixed dose combination of Fenofibrate and Pravastatin sodium tablet.
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Keywords: Formulation, Evaluation, Fixed Dose Combination, Fenofibrate, Pravastatin Sodium
n[if 424 equals=”Regular Issue”][This article belongs to Research & Reviews: A Journal of Bioinformatics(rrjobi)]
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| Volume | 11 | |
| [if 424 equals=”Regular Issue”]Issue[/if 424][if 424 equals=”Special Issue”]Special Issue[/if 424] [if 424 equals=”Conference”][/if 424] | 01 | |
| Received | February 8, 2024 | |
| Accepted | February 12, 2024 | |
| Published | March 2, 2024 |
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