Formulation Development and Evaluation of New Albendazole Tablets with Integrated Quality by Design (QbD) Approach

  • Dnyaneshwar G Sitre Dept. of Pharmaceutics, Bhupal Nobles University, Maharana Pratap Station Road, Udaipur 313001, Rajstan, India
  • Ravindra K. Kamble Bhupal Nobles University, Maharana Pratap Station Road, Udaipur 313001, Rajasthan, India

Abstract

Hydatid disease occurs in most areas of the world and currently affects about one million people. Albendazole is an orally administered broad spectrum anthelmintic drug approved by US FDA in 1996. Literature review suggests Albendazole is low solubility compound and most of the studies were performed to improve the solubility with traditional approach of product development. The present study was aimed to apply Design of Experiments (DoE) in the development and optimization of drug release from new Albendazole tablets using three factor two level (23) full factorial designs with integrated Quality be Design (QbD) approach. New Albendazole tablets were formulated using micronized grade of the Albendazole active and excipients were selected inline with market reference product. Quality target product profile (QTPP) and Critical quality attributes (CQAs) were designed. Risk assessment was used to identify the Formulation variables impacting CQA dissolution. The amount of Formulation variables were optimized on the basis of drug release profiles at 15 minutes and 30 minutes of different formulation batches manufactured based on 23 full factorial design. Tablets were prepared by wet granulation technique and evaluated for various physicochemical parameters and in vitro drug release. Formulation trials dissolution results at 15 minutes and 30 minutes were evaluated to derive the concentration of Formulation variables which will achieve the release of more than 80%. Analysis of variance (ANOVA) analysis, Pareto chart and Contour plot were used to predict the values of formulation variables and their effect on dissolution.  Updated risk assessment of the Formulation Variables was performed and justification was provided for reduction of risk from medium to low level. Optimized formulation from DOE had comparable dissolution profile with market reference tablet. Stability studies of new Albendazole tablets 200 mg were conducted at ICH accelerated conditions and found to be stable. Thus studies revealed that full factorial experimental design could efficiently be applied for optimization of formulation variables affecting drug release. New Albendazole tablets 200 mg successfully formulated with application of the integrated quality by design (QbD) and design of experiment (DOE) approach and thereby achieved comparable release profile with market reference product.


 

Keywords: Albendazole, Experimental design, Full Factorial Design, Design of experiment & Dissolution

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Author Biographies

Dnyaneshwar G Sitre, Dept. of Pharmaceutics, Bhupal Nobles University, Maharana Pratap Station Road, Udaipur 313001, Rajstan, India

Bhupal Nobles University, Maharana Pratap Station Road, Udaipur 313001, Rajasthan, India

Ravindra K. Kamble, Bhupal Nobles University, Maharana Pratap Station Road, Udaipur 313001, Rajasthan, India

Bhupal Nobles University, Maharana Pratap Station Road, Udaipur 313001, Rajasthan, India

References

1. Sharma N, Pahuja S, Sharma N, Immediate Release Tablets: A Review, Int. J. Pharm. Sci. 2019; 11:3607-3618.
2. https://www.accessdata.fda.gov › label
3. Horton, J. "Albendazole: a review of anthelmintic efficacy and safety in humans." Parasitology 2000; 121(S1): S113-S132.
4. Nadpara, Nishendu P., et al. "Quality by design (QBD): A complete review." Int J Pharm Sci Rev Res 2012; 17(2):20-28.
5. Gujral, Gaurav, Devesh Kapoor, and Manish Jaimini. "An updated review on design of experiment (DOE) in pharmaceuticals." Journal of Drug Delivery and Therapeutics 2018; 8(3):147-152.
6. Wu, Zimei, et al. "Development and optimization of a rapid HPLC method for analysis of ricobendazole and albendazole sulfone in sheep plasma." Journal of pharmaceutical and biomedical analysis 2005; 39(1-2):225-232.
7. Lahane, Sandhya Bhimrao, and U. A. Deokate. "Development and validated UV spectrophotometric method for estimation of albendazole in tablet dosage form." World Journal of Pharmaceutical Research 2014; 3(4):1461-1467.
8. Nadpara, Nishendu P., et al. "Quality by design (QBD): A complete review." Int J Pharm Sci Rev Res 2012; 17(2):20-28.
9. Chowdary, K. P., K. Ravi Shankar, and P. Suneel Kumar. "Recent research on QbD approach in formulation development: A review." Int. J. Chem. Sci. & Tech 2014; 4(1):282-92.
10. Claycamp, H. Gregg, et al. "Quality-by-design II: application of quantitative risk analysis to the formulation of ciprofloxacin tablets." AAPS PharmSciTech 2016; 17(2):233-244.
11. Mehta, Samata, et al. "Effect of disintegrants on the properties of multiparticulate tablets comprising starch pellets and excipient granules." International journal of pharmaceutics 2012; 422(1-2):310-317.
12. Luis, Castillo Henríquez, et al. "Design of Experiments for the Establishment of the Dissolution Test Conditions of Rupatadine Fumarate 10 mg tablets." Journal of Drug Delivery and Therapeutics 2019; 9(1-S):331-336.
13. Kristensen, H. Gjelstrup, and T. Schaefer. "Granulation: A review on pharmaceutical wet-granulation." Drug development and industrial pharmacy 1987; 13(4-5):803-872.
14. Rane, Devendra Revanand, et al. "Formulation and evaluation of fast dissolving tablet of albendazole." International Current Pharmaceutical Journal 2012; 1(10):311-316.
15. United States Pharmacopoeia 32, national formulary 24, 12601, Twinbrook Parkway, Rockville, MD 20852, 2006.
16. The Indian Pharmacopoeia , Ministry of Health and Family welfare ,Govt. of India, Controller of Publications, New Delhi. 2007, 1996, 2, 973, 1377,144,736.
17. British Pharmacopeia, published by The Stationery Office on behalf of the Medicines and Healthcare Products Regulatory Agency (MHRA), 2007; 1384-1385.
18. Miao, P., et al. "Report on literature review of recent development in loss on drying method for moisture determination." (2014).
19. Aulton ME, Wells TI, Pharmaceutics, The Science of Dosage Form Design’ Churchill Livingstone, Vingstone, London: 1988, 168.
20. Krishnaiah, Y. S. R., et al. "Guar gum as a carrier for colon specific delivery; influence of metronidazole and tinidazole on in vitro release of albendazole from guar gum matrix tablets." J Pharm Pharm Sci 2001; 4(3):235-43.
21. Narayan, Suthar, and M. Choudhary. "A review on stability studies of pharmaceutical products." Int Jr of Appl Pharm & Bio Res 2017; 2(3):67-75.
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Sitre D, Kamble RK. Formulation Development and Evaluation of New Albendazole Tablets with Integrated Quality by Design (QbD) Approach. JDDT [Internet]. 15Mar.2021 [cited 20Apr.2021];11(2):123-34. Available from: http://jddtonline.info/index.php/jddt/article/view/4782