Formulation and Evaluation of Colchicine Sustained release tablet by using factorial designs
Abstract
The study on the effect of polymer concentration on in vitro drug release profile revealed that there is a change in vitro drug release parameters (t50, t80, and MDT) with a change in polymer concentration. Fraction of HPMC K4M, HPMC K 100 M, and Ethyl Cellulose were required to be 15, 10, and 7 mg respectively for designing optimized batch F7. The release rate of Colchicine decreased proportionally with an increase in the concentration of ethyl Cellulose and HPMC K100 M. Also the high amount of HPMC K4M leads to the less initial release and sustain effect. A theoretical drug release profile was generated using pharmacokinetic parameters of Colchicine. The value of t50 and t80 of theoretical drug release profile was found to be 242 min and 529 min respectively. The similarity factor f2 was applied between the in vitro drug release profile of optimizing batches and theoretical profile, which indicate a decent similarity between all in vitro drug release profiles (f2 = 68.28 for F7). All the batches except F1shows the value of f2 value within a range. Batch F7 showed the highest f2 (f2 = 68.28) among all the batches and this similarity was also reflected in t50 (≈ 256 min) and t80 (≈ 554 min) values. A 23 full factorial design was applied to systemically optimize in vitro drug release profile. The HPMC K4M (X1), Concentration of HPMC K100 M (X2), and concentration of EC (X3) were selected as independent variables. The time required for 50% drug released (t50), the time required for 80% drug release (t80), similarity factor f2, and mean dissolution time (MDT) were selected as dependent variables. The results of full factorial design indicate that the HPMC K4M (X1), Concentration of HPMC K100 M (X2), and concentration of EC (X3) have a significant effect on in vitro drug release profile. To find out the release mechanism the in vitro release data were fitted in the Korsmeyer-Peppas equation. All Batches except F1 and F3 show Anomalous diffusion-controlled release (combined mechanism of diffusion and case II transport).
Keywords:
Colchicine, Sustained release tablet, 23 full factorial design, Similarity factorDOI
https://doi.org/10.22270/jddt.v11i5-S.5028References
Siva C, Velazquez C, Mody A, Brasington R. Diagnosing acute monoarthritis in adults: a practical approach for the family physician. American Academy of Family Physicians, 2003; 1:68(1):83-90. PMID: 12887114.
Ramesh Y, Raghu Murthy V, Nagarjuna S, Viswanath Reddy M, Sudheer M, Manikanta M. Development and In-vitro Evaluation of Fast dissolving Tablets of Imipramine. International Journal of Research in Pharmaceutical Sciences, 2011; 2(3):344-347.
Khanvilkar KH, Huang Y, Moore AD. Influence of hydroxypropyl methylcellulose mixture, apparent viscosity, and tablet hardness on drug release using a 2(3) full factorial design. Drug Development and Industrial Pharmacy, 2002; 28(5):601-608. https://doi.org/10.1081/DDC-120003456
Dave BS, Amin AF, Patel MM. Gastroretentive drug delivery system of ranitidine hydrochloride: formulation and in vitro evaluation. AAPS PharmSciTech. 2004; 8:5(2):e34. https://doi.org/10.1208/pt050234
Savaser A, Ozkan Y, Isimer A. Preparation and in vitro evaluation of sustained release tablet formulations of diclofenac sodium. Farmaco, 2005; 60(2):171-177. https://doi.org/10.1016/j.farmac.2004.10.001
Jhansi reddy K Vijaya Suman Reddy D, Ramesh Y, Parameshwar K. Formulation and Evaluation of Mouth Dissolving Tablets of Metoprolol Tartrate by New Coprocessed Technique. Research journal of Pharmaceutical Biological & Chemical Science, 2011; 2(3):385-390.
Huang YB, Tsai YH, Lee SH, Chang JS, Wu PC. Optimization of pH-independent release of nicardipine hydrochloride extended-release matrix tablets using response surface methodology. International Journal of Pharmaceutics, 2005; 31; 289(1-2):87-95. https://doi.org/10.1016/j.ijpharm.2004.10.021
Aparna B, Kumar B, Gnanaprakash K, Gobinath M and Ramesh Y. Development and Evaluation of Sublingual Tablets of Aripiprazole, International Journal of Biopharmaceutics, 2014; 5(4):251-257.
Sankar Rao. K Madhavi C, Ramesh Y, Deepthi A, Gnana Prakash. K, Gobinath. M. Formulation and Evaluation of Sustained Release Matrix Tablets of Cefadroxil by Using Direct Compression Method. American Journal of PharmTech Research, 2015; 5(4):1-13.
Golwala D, santosh Kumar Vaidya. Formulation and Evaluation of Sublingual Tablet of Enalapril Maleate by 32 Full Factorial Designs. Aegaeum Journal, 2020; 776-3808, 8(4):894-910.
Bharath Kumar K R S C, Vijay Kumar Voleti, Dasthagiri Reddy Y, Madhusudhana Chetty C, Poluri Suresh, Naganjaneyulu R. Formulation and Evaluation of Cimetidine In-Situ Gelling System By Factorial Design. Future Journal of Pharmaceuticals and Health Sciences, 2021; 1(3):20-26.
Sadak Vali C, Siva Prasad S, Pradeep Kumar M, Vageesh NM, Vadduri Swathi and Nageswara Naik B. Formulation development and characterization of mouth dissolving tablets of rabeprazole containing sodium starch glycolate as super disintegrate. World Journal of Pharmaceutical Research, 2020; 9(6):1612-1619. DOI: https://doi.org/10.20959/wjpr20206-17569
Anu Hardenia, Arun Kumar Gupta. Development and optimization of gastroretentive mucoadhesive microspheres using 33 factorial design, international journal of pharmaceutical sciences and research, 2016; 7(5):2020-2030 DOI: https://doi.org/10.13040/IJPSR.0975-8232.7(5).2020-30
Khatri Upasana, Kamal Singh Rathore, Sunil Saini, Bharkatiya Meenakshi. Formulation and Evaluation of Ketorolac Tromethamine using 32 Factorial Design. Research Journal of Pharmaceutical and Technology, 2020; 13(6):2556-2562. https://doi.org/10.5958/0974-360X.2020.00455.2
Nagarwal RC, Srinatha A, Pandit JK. In situ forming formulation: development, evaluation, and optimization using 3(3) factorial design. American Association of Pharmaceutical Scientists. 2009; 10(3):977-84. https://doi.org/10.22159/ajpcr.2018.v11i11.28492
Published
Abstract Display: 580 
PDF Downloads: 639 PDF Downloads: 339 How to Cite
Issue
Section
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
How to Cite
.