DESIGN, OPTIMIZATION AND EVALUATION OF ACECLOFENAC FAST DISSOLVING TABLETS EMPLOYING STARCH VALERATE–A NOVEL SUPERDISINTEGRANT
Keywords:Superdisintegrant, Fast dissolving, Optimization, Starch valerate
Objective: To synthesize, characterize and evaluate starch valerate as a superdisintegrant in the formulation of aceclofenac fast dissolving tablets by employing 23 factorial design.
Methods: Starch valerate was synthesized and its physical and micromeritic properties were performed to evaluate it. The fast dissolving tablet of aceclofenac was prepared by employing starch valerate as a superdisintegrant in different proportions in each case by direct compression method using 23 factorial design for evaluation of tablet parameters like disintegration and dissolution efficiency in 5 min.
Results: The starch valerate prepared was found to be fine, amorphous and free flowing. Starch valerate exhibited good swelling in water with swelling index (125.2%). The study of starch valerate was shown by fourier transform infrared spectra (FTIR). The drug content (200±5%), hardness (3.5–4 kg/sq. cm), and friability (<0.15%) has been effective with regard to all the formulated fast dissolving tablets employing starch valerate. The disintegration time of all the formulated tablets was found to be in the range of 14±0.04 to 25.7±0.02 sec. The optimized formulation F4 had the least disintegration time i.e., 12.8±0.02 sec. The wetting time of the tablets was found to be in the range of 76±0.21 to 217±0.17s. The In vitro wetting time was less (i.e., 28±0.02s) in optimized formulation F4. The water absorption ratio of the formulated tablets was found to be in the range of 46±0.12 to 100±0.27%. The percent drug dissolved in the optimized formulation F8 was found to be 99.93% in 5 min.
Conclusion: Starch valerate, when combined with sodium starch glycolate, croscarmellose sodium, with aceclofenac, was found to be an effective super disintegrant which improved the dissolution efficiency and could therefore be used in the formulation of quick dissolving tablets to provide immediate release of the contained drug within 5 min.
Sanket Kumar, Shiv KR Garg. Fast dissolving tablets (Fdts): current status, new market opportunities, recent advances in manufacturing technologies and future prospects. Int J Pharm Pharm Sci 2014;6:22-35.
Ashish Masih, Amar Kumar, Shivam Singh, Ajay Kumar Tiwari. Fast dissolving tablets: a review. Int J Curr Pharm Res 2017;9:8-18.
Anupam Roy. Orodispersible tablets: a review. Asian J Pharm Clin Res 2016;9:19-26.
Sundeep Mupparaju, Vidyadhara Suryadevara, Sailaja Yallam, Sandeep Doppalapudi, Sasidhar Reddyvallam LC, Ramu Anne. Formulation and evaluation of dolutegravir sodium solid dispersions and fast dissolving tablets using poloxamer-188 and jack fruit seed starch as excipients. Asian J Pharm Clin Res 2019;12:181-90.
Kalindi Chauhan, Rakesh Solank, Shivani Sharma. A review on fast dissolving tablets. Int J Appl Pharm 2018;10:1-7.
Aher Smita S, Saudagar RB, Shinde Mayuri S. Review: fast dissolving tablet. Int J Curr Pharm Res 2018;10:5-12.
Hazarika JNR, P Deb. Formulation evaluation and optimization of immediate release tablet of aceclofenac by direct compression method. Int J Curr Pharm Res 2017;9:118-22.
Shaikh Siraj, Syyed Nazim, Gomase Pravin, Shaikh Afasar, Quazi Majaz. Formulation and evaluation of aceclofenac fast dissolving tablets. Int Res J Pharm 2011;2:100-5.
Shailendra Singh Solanki, Rashmi Dahima. Formulation and evaluation of aceclofenac mouth-dissolving tablets. J Adv Pharm Technol Res 2011;2:128–31.
R Santosh Kumar, T Naga Satya Yagnesh, V Goutham Kumar. Optimisation of ibuprofen fast dissolving tablets employing starch xanthate using 23factorial design. Int J Appl Pharm 2017;9:51-9.
R Santosh Kumar, T Naga Satya Yagnesh. Synthesis, characterization and evaluation of starch xanthate as a superdisintegrant in the formulation of fast dissolving tablets. Int J Appl Pharm 2018;10:249-58.
R Santosh Kumar, Ankita Gosh. Design, optimisation and evaluation of piroxicam fast dissolving tablets employing starch tartrate-a new superdisintegrant. Int J Appl Pharm 2019;11:89-90.
R Santosh Kumar, Sahithi Mulidi. Optimization of statistically designed aceclofenac fast dissolving tablets employing starch glutamate as a novel superdisintegrant. Int J Appl Pharm 2020;12:77-88.
Vivek Dave, Sachdev Yadav, Swapnil Sharma, Pushpendra Vishwakarma, Nasir Ali. Novel approach of aceclofenac fast dissolving tablet. Pak J Pharm Sci 2015;28:37-41.
C Mallikarjuna Setty, DVK Prasad, VRM Gupta, B Sa. Development of fast dispersible aceclofenac tablets: effect of functionality of superdisintegrants. Indian J Pharm Sci 2008;70:180–5.
Keshav R Deshmukh, Sunil K Jain. Development of aceclofenac mouth dissolving tablets using solid dispersion technique: in vitro evaluation. Ind J Pharm Edu Res 2012;46:97-104.
Jyotsana Madan, AK Sharma, Ramnik Singh. Fast dissolving tablets of Aloevera gel. Trop J Pharm Res 2009;8:63-70.
Kalpesh Gaur A, Lalit K, Tyagi A, ML Kori, CS Sharmab, RK Nema. Formulation and characterization of fast disintegrating tablet of aceclofenac by using sublimation method. Int J Pharm Sci Drug Res 2011;3:19-22.
Anas Bahnassi, Diana Zidanb. Formulation and evaluation of aceclofenac fast dissolving tablets using foam granulation technique. Indo Global J Pharm Sci 2012;2:342-7.
Garala Kevin C, Ekshinge Vinit B, Jarag Ravindra J, Shinde Anil J. Fast-disintegrating aceclofenac tablets: formulation development using simplex lattice design. Thai J Pharm Sci 2008;32:77-81.