OPTIMIZATION OF ROLL COMPACTOR VARIABLES AND FORMULATION OF ANTI-RETROVIRAL TABLET BY ROLL COMPACTION METHOD

  • SUHAS H. LAHANE Department of Pharmaceutics, MET’s Institute of Pharmacy, Pune University, Nasik 422003

Abstract

Objective: This study emphasis on roll compaction variable and how the processing parameters influence the formation of granules in process of formulations of antiretroviral IR Tablet with help of optimization technique.


Methods: In this present work we aimed to develop a stable pharmaceutical dosage form with anti-retroviral drug tenofovir disoproxil fumarate. % retention of granules over # 60 mesh in roll compaction method by sizing with 50G co-mill screen was assessed by optimization and results were evaluated by Design expert 12.0 software. Various parameters and optimization of the parameter for formulation for better product was done by using 23 factorial design and dry granulation technique for manufacturing tablets. Three operating parameters the roller speed, the hydraulic pressure and the gap width on the Chamunda CPMRC-200/150 Roll Compactor were varied. The planned response variable for study was % retention over #60 ASTM mesh. % retention of granules was calculated by weighing granules on digital electronic balance with respect to how much premix material was taken for compaction.


Results: Excipients compatibility study gave positive way showing no change in physical appearance of drug-excipients mix. It reviled that drug was compatible with excipients used.


By formation of granules with required ratio, the value of Compressibility index changed from 29 to 21.89, showed that flow properties were improved i.e. from poor to passable.


Design expert 12.0 gave optimized solution for formation of required quantity of granules. Pareto chart showed envaulted positive and negative impact of factors on response as explained in results.


The results clearly indicate that how granules manufacturing in roll compaction process are influenced by roller pressure, roller gap and speed. 70 % flakes formation and granules retention were observed with 4000 kg/cm2 pressure, 1 mm roller gap width and 6 rpm speed of roller.


Pareto chart clearly indicate major impact is of roller pressure. Comparative dissolution profile graph showed that drug release pattern is similar with the innovator tablet.


A stable, robust tablets were formed at the end of process.


Conclusion: In this study, by optimizing processing variables stable antiretroviral immediate release oral solid dosage form was formed.

Keywords: Dry granulation, Roll compactor, Optimization, Antiretroviral, Tenofovir disproxil fumarate (TDF), Immediate release tablet

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References

1. Poddar S, Shajahan A. A review on a flexible technology for modified release of drugs: multi layered tablets. J Controlled Release 2004;97:393-405.
2. Vijayalaxmi S, Umasri N. Formulation development and in vitro evaluation of tenofovir disproxil fumarate (TDF) immediate release tablets. Indo Am J Pharma Sci 2017;4:1229-41.
3. Kaur G, Sridhar D, Gera M. Optimization of roll compaction/Dry granulation (Rcdg) process for poorly flowable antiviral formulation. Am J Pharmtech Res 2012;2:2249-3387.
4. Sinka IC, Motazedian F, Cocks ACF, Pitt KG. The effect of processing parameters on pharmaceutical tablet properties. Powder Technol 2009;189:276-84.
5. Kannan K, Manikandan M, Selvamuthukumar S, Manavalan R. Formulation development and evaluation of emtricitabine and tenofovir disproxil fumarate tablets. Int J Drug Dev Res 2012;4:247-56.
6. Durghe N, Parida K, Roy H. Formulation development and characterization of antiretroviral agents. Int J Pharma Res Health Sci 2016;4:1517-26.
7. Baxter T, Bamum R, Prescott J. Flow: general principles of bulk solid handling. In: Augsburger L, Hoag S. editor. Pharmaceutical Dosage form: Tablets, Newyork, Informa healthcare; 2008. p. 77, 87, 128.
8. Yu S, Gururajan B, Reynolds G, Roberts R, Adams MJ, Wu CY. A comparative study of roll compaction of free-flowing and cohesive pharmaceutical powders. Int J Pharm 2012;428:39-47.
9. Armstrong N. Pharmaceutical experimental design and interpretation. 2nd Ed. Newyork, Taylor and fransis group; 2006. p. 83, 135.
10. Notari R. Biopharmaceutics and clinical pharmacokinetics, an introduction. 4th Ed. Newyork, Marcel Dekker; 1987. p. 176-8.
11. Bolton S, Bon C. Pharmaceuticals statistics: practical and clinical applications. 4th Ed. USA, Informa Healthcare Inc; 2004. p. 222-7.
12. United States Pharmacopoeia/National Formulary. 24th ed. Rockville MD: Pharmacopeial Convection; 2006. p. 242.
13. ICH, Q1A(R2), Stability Testing of New Drug Substances and Products, in: Proceedings of the International Conference on Harmonisation, Geneva; 2003.
14. Freeman T, Bey H, Hanish M, Brockbank K, Armstrong B. The influence of roller compaction variables on the rheological properties of granules. Asian J Pharma Sci 2016;11:516-27.
15. Banker G, Anderson N. Tablets. In: Lachman L, Lieberman H, Kanig J. editor. The theory and practice of industrial pharmacy. 3rd Ed. New Delhi, CBS publishers and distributors; 2009. p. 171-96, 293-345.
16. Podczeck F. Theoretical and experimental investigation into the delamination tendencies of bilayer tablets. Int J Pharm 2011;408:102-12.
17. Lachman L, Lieberman HA, Joseph LK. The theory and practice of industrial pharmacy. 4nd ed. India: Varghese Publishing house: 1991. p. 293-303, 311-317, 317-335, 442-443.
18. Lieberman HA, Lachman L, Schwartz JB. Pharmaceutical and dosage form: Tablet. 2th ed. Marcel Dekker, Inc; 1989. p. 188-190, 414, 564.
19. Bolton S, Bon C. Pharmaceutical statistics: practical and clinical applications. 4th ed. USA: Informa healthcare Inc; 2004-15. p. 16, 222-7, 265, 269.
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LAHANE, S. H. “OPTIMIZATION OF ROLL COMPACTOR VARIABLES AND FORMULATION OF ANTI-RETROVIRAL TABLET BY ROLL COMPACTION METHOD”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 12, no. 1, Dec. 2019, pp. 48-53, doi:10.22159/ijpps.2020v12i1.36016.
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