Amit Kaushal, Sandeep Arora, Sukhbir Singh, Neelam Sharma
Amit Kaushal, Sandeep Arora, Sukhbir Singh, Neelam Sharma
Chitkara College of Pharmacy, Chitkara University, Punjab, India.
Volume - 13,
Issue - 5,
Year - 2020
In the present study, sustained release tablet of metformin hydrochloride were formulated and analyse the impact of material and process attributes on dissolution profile employing Quality by design (QbD) approach. Taguchi design was employed to screen the critical factors and amount of HPMC, amount of compritol and compression force was selected as critical factors. The effect of critical factors on the critical quality attributes (CQAs) of sustained, such as cumulative drug release at 2 hr (CDR 2), at 5 hr (CDR 5) and 8 hr (CDR8) was evaluated using Box-Behnken design. The optimised formulation was achieved with set of variable, such as a amount of HPMC (24.9 %), amount of compritol (6.93 %) and compression force (7.09 KN) and resulted into a tablet with a cumulative drug release 18.53%, 47.10 % and 85% at 2, 5 and 8 hr respectively which was close to predicted value .
Cite this article:
Amit Kaushal, Sandeep Arora, Sukhbir Singh, Neelam Sharma. Assessing the Impact of Formulation Variables on Dissolution Profile of Sustained Release Tablet of Metformin Hydrochloride by Quality by Design Approach. Research J. Pharm. and Tech 2020; 13(5): 2350-2358. doi: 10.5958/0974-360X.2020.00423.0
1. Rägo L, Santoso B. Drug regulation: history, present and future. In: C.J. van Boxtel, Santoso B, Edwards IR, editors. Drug benefits and risks: International Textbook of Clinical Pharmacology. 2ed: IOS Press and Uppsala Monitoring Centre; 2008; 65-77.
2. Yu LX. Pharmaceutical quality by design: product and process development, understanding, and control. Pharmaceutical Research. 2008; 25(4): 781-91.
3. Pallagi E, Ambrus R, Szabó-Révész P, Csóka I. Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation. International Journal of Pharmaceutics. 2015; 491(1): 384-92.
4. Mishal A, Rathod S. Quality by Design: A New Era of Development of quality in pharmaceuticals. Research Journal of Pharmacy and Technology. 2014; 7(5):581-591.
5. Jetani JM, K. GP. A comparative review of the USFDA guidelines on process validation focusing on the importance of quality by design (QbD). Research Journal of Pharmacy and Technology. 2017; 10(4):1257-1260.
6. Veni DK, Gupta NV. Quality by design approach in the development of solid lipid nanoparticles of linagliptin. Research Journal of Pharmacy and Technology. 2019; 12(9):4454-4462.
7. Zhang L, Mao S. Application of quality by design in the current drug development. Asian Journal of Pharmaceutical Sciences. 2017; 12(1):1-8.
8. Rathore AS, Winkle H. Quality by design for biopharmaceuticals. Nature Biotechnology. 2009; 27(1): 26-34.
9. Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, et al. Understanding pharmaceutical quality by design. The AAPS Journal. 2014; 16(4): 771-83.
10. Jain S. Quality by design (QBD): A comprehensive understanding of implementation and challenges in pharmaceuticals development. International Journal of Pharmacy and Pharmaceutical Sciences. 2013; 6(1): 29-35.
11. Guidance for industry: Q8 pharmaceutical development. US department of health and human service food and drug administration. 2010.
12. Sangshetti JN, Deshpande M, Zaheer Z, Shinde DB, Arote R. Quality by design approach: Regulatory need. Arabian Journal of Chemistry. 2017; 10: S3412-S25.
13. Shivhare U, Darakh V, Mathur V, Bhusari K, Godbole M. Preparation and evaluation of metformin hydrochloride microcapsules. Research Journal of Pharmacy and Technology. 2009; 2(3):559-56.
14. Mandal U, Gowda V, Ghosh A, Bose A, Bhaumik U, Chatterjee B, et al. Optimization of metformin HCl 500 mg sustained release matrix tablets using artificial neural network (ANN) based on multilayer perceptrons (MLP) model. Chemical and Pharmaceutical Bulletin. 2008; 56(2): 150-155.
15. Lee Y-L, Kim M-S, Park M-Y, Han K. Quality by design: understanding the formulation variables and optimization of metformin hydrochloride 750 mg sustained release tablet by box–behnken design. Journal of Pharmaceutical Investigation. 2012; 42(4): 213-220.
16. Asha Patel, Subhabrata Ray, Ram Sharnagat Thakur. Invitro evaluation and optimization of controlled release floating drug delivery system of metformin hydrochloride. Daru. 2006; 14(2): 57-64.
17. Roy A, Roy K, Roy S, Deb J, Ghosh A, Ali KA. Response surface optimization of sustained release metformin-hydrochloride matrix tablets: Influence of some hydrophillic polymers on the release. ISRN Pharmaceutics. 2012:1-10.
18. Nawaj SS, Khan M, Khan GJ, Sohel A. Design, development and evaluation of press coated floating pulsatile tablet of antihypertensive agent. Research Journal of Pharmacy and Technology. 2018; 11(3):921-929.
19. Thakkar V, Mahida H, Baldaniya L, Gohel M, Gandhi T, Raval H, et al. Risk based approach for design and optimization of novel tablet for type-II diabetes. Pharmaceutical and Biological Evaluations. 2015; 2(6): 21.
20. Nanjwade BK, Mhase SR, Manvi F. Formulation of extended-release metformin hydrochloride matrix tablets. Tropical Journal of Pharmaceutical Research. 2011; 10(4): 375-83.
21. Roy H, Brahma CK, Nandi S, Parida KR. Formulation and design of sustained release matrix tablets of metformin hydrochloride: Influence of hypromellose and polyacrylate polymers. International journal of applied basic medical research. 2013; 3(1): 55-63.
22. Nagarwal RC, A.Srinath, Pandit JK. In situ forming formulation: development, evaluation, and optimization using 33 factorial design. AAPS PharmSciTech. 2009; 10: 977.
23. He W, Li Y, Zhang R, Wu Z, Yin L. Gastro-floating bilayer tablets for the sustained release of metformin and immediate release of pioglitazone: Preparation and in vitro/in vivo evaluation. International Journal of Pharmaceutics. 2014; 476(1): 223-231.
24. Wadher KJ, Kakde RB, Umekar MJ. Study on sustained-release metformin hydrochloride from matrix tablet: Influence of hydrophilic polymers and in vitro evaluation. International journal of Pharmaceutical Investigation. 2011; 1(3): 157-63.
25. Albetran H, Dong Y, Low IM. Characterization and optimization of electrospun TiO2/PVP nanofibers using taguchi design of experiment method. Journal of Asian Ceramic Societies. 2015; 3(3): 292-300.
26. Bansal S, Beg S, Asthana A, Garg B, Asthana GS, Kapil R, et al. QbD-enabled systematic development of gastroretentive multiple-unit microballoons of itopride hydrochloride. Drug Delivery. 2016;23(2):1-15.
27. Jose S, Fangueiro JF, Smitha J, Cinu TA, Chacko AJ, Premaletha K, et al. Cross-linked chitosan microspheres for oral delivery of insulin: Taguchi design and in vivo testing. Colloids and Surfaces B: Biointerfaces. 2012; 92: 175-179.
28. Ashrini B. S., N. VK. Statistical optimization of media components by taguchi design and response surface methodology for enhanced production of anticancer metabolite by penicillium sp. JUFP2. Research Journal of Pharmacy and Technology. 2019; 12(2):463-471.
29. Garg NK, Sharma G, Singh B, Nirbhavane P, Katare OP. Quality by besign (QbD)-based development and optimization of a simple, robust RP-HPLC method for the estimation of methotrexate. Journal of Liquid Chromatography Related Technologies. 2015; 38(17): 1629-1637.
30. Negi LM, Jaggi M, Talegaonkar S. Development of protocol for screening the formulation components and the assessment of common quality problems of nano-structured lipid carriers. International Journal of Pharmaceutics. 2014; 461(1): 403-410.
31. Singh B, Rani A, Babita, Ahuja N, Kapil R. Formulation optimization of hydrodynamically balanced oral controlled release bioadhesive tablets of tramadol hydrochloride. Scientia Pharmaceutica. 2010; 78(2): 303-323.
32. Revision Bulletin: Metformin hydrochloride extended-release tablets. The United State Pharmacopeial Convention. 2010.
33. Patil P, Phanse M, Gaikwad V, Chaudhari P. Direct Spectrophotometeric Determination of metformin hydrochloride in pure form and in pharmaceutical formulations. Research Journal of Pharmacy and Technology. 2009; 2(4):874-875.
34. Dhar S, Pokharkar V. Formulation Development of mucoadhesive matrix tablet for metformin hydrochloride: in-vitro and in-vivo evaluation. Research Journal of Pharmacy and Technology. 2010; 3(2):483-489.