Design and Assessment of Fixed Dose Combination Containing Fenofibrate and Pravastatin Sodium in Tablet Formulation: A Bioinformatics Approach

Year : 2024 | Volume : 11 | Issue : 01 | Page : 1 20
    By

    Arshiya Shaikh,

  • Alladi Saritha,

  1. Student, Department of Pharmaceutics, SSJ College of Pharmacy, Hyderabad, Telangana, India
  2. Associate Professor, Department of Pharmaceutics, SSJ College of Pharmacy, Hyderabad, Telangana, India

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. 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.

Keywords: Formulation, Evaluation, Fixed Dose Combination, Fenofibrate, Pravastatin Sodium

[This article belongs to Research & Reviews: A Journal of Bioinformatics ]

How to cite this article:
Arshiya Shaikh, Alladi Saritha. Design and Assessment of Fixed Dose Combination Containing Fenofibrate and Pravastatin Sodium in Tablet Formulation: A Bioinformatics Approach. Research & Reviews: A Journal of Bioinformatics. 2024; 11(01):1-20.
How to cite this URL:
Arshiya Shaikh, Alladi Saritha. Design and Assessment of Fixed Dose Combination Containing Fenofibrate and Pravastatin Sodium in Tablet Formulation: A Bioinformatics Approach. Research & Reviews: A Journal of Bioinformatics. 2024; 11(01):1-20. Available from: https://journals.stmjournals.com/rrjobi/article=2024/view=150903


References

  1. Gautam CS, Saha L. Fixed dose drug combinations (FDCs): rational or irrational: a viewpoint. Br J Clin Pharmacol. 2008;65(5):795–6.

  2. Sreedhar D, Subramanian G, Udupa N. Combination drugs: are they rational? Curr Sci. 2006;91:406.

  3. European Medicines Agency (EMA). Guideline on clinical development of fixed combination medicinal products. 2017 [cited 2019 Oct 10]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-development-fixed-combination-medicinal-products-revision2_en.pdf

  4. Auwal F, Dahiru MN, Abdu-Aguye SN. Availability and rationality of fixed dose combinations available in Kaduna, Nigeria. Pharm Pract (Granada). 2019;17(2):1470.

  5. Sawicki-Wrzask D, Thomsen M, Bjerrum OJ. An analysis of the fixed-dose combinations authorized by the European Union, 2009–2014: a focus on benefit-risk and clinical development conditions. Ther Innov Regul Sci. 2015;49(4):553–9.

  6. Duconge J, Ruano G. Fixed-dose combination products and unintended drug interactions: urgent need for pharmacogenetic evaluation. Pharmacogenomics. 2015;16(15):1685–8.

  7. Bangalore S, Kamalakkannan G, Parkar S, Messerli FH. Fixed-dose combinations improve medication compliance: a meta-analysis. Am J Med. 2007;120(8):713–9.

  8. Blaszczyk B, Miziak B, Czuczwar P, Czuczwar SJ. A viewpoint on rational and irrational fixed-drug combinations. Expert Rev Clin Pharmacol. 2018;11(8):761–71.

  9. Fortin A, Verbeeck RK, Jansen FH. Comparative oral bioavailability of non-fixed and fixed combinations of artesunate and amodiaquine in healthy Indian male volunteers. Eur J Clin Pharmacol. 2011;67(3):267–75.

  10. Dubey R. Bioequivalence challenges in development of fixed-dose combination products: looking beyond reformulation. Expert Opin Drug Deliv. 2012;9(3):325–32.

  11. McGettigan P, Roderick P, Kadam A, Pollock AM. Threats to global antimicrobial resistance control: centrally approved and unapproved antibiotic formulations sold in India. Br J Clin Pharmacol. 2019;85(1):59–70.

  12. ReAct. Why are fixed dose combinations of antibiotics generally not a good idea? 2018 [cited 2019 Oct 15]. Available from: https://www.reactgroup.org/news-and-views/news-and-opinions/year-2018/why-are-fixed-dose-combinations-of-antibiotics-generally-not-a-good-idea/

  13. Menditto E, Orlando V, De Rosa G, Barlocco D, Tari DU, Borrelli A, et al. Patient centric pharmaceutical drug product design–the impact on medication adherence. Pharmaceutics. 2020;12(1):44.

  14. Gupta YK, Ramachandran SS. Fixed dose drug combinations: issues and challenges in India. Indian J Pharmacol. 2016;48(4):347–9.

Regular Issue Subscription Original Research
Volume 11
Issue 01
Received 08/02/2024
Accepted 12/02/2024
Published 02/03/2024
Publication Time 23 Days
283

Login


My IP

PlumX Metrics