FORMULATION AND EVALUATION OF FAST DISSOLVING TABLETS OF AMOXYCILLIN TRIHYDRATE AND POTASSIUM CLAVULANATE
Objective: The present work is aimed to formulate fast dissolving stable tablet formulation a preferred combination of Amoxycillin trihydrate (Beta-lactum antibiotic) and Potassium clavulanate (Beta-lactum inhibitor) by using various super disintegrants.
Methods: Fast dissolving tablets are prepared by direct compression method using super disintegrants i.e. sodium starch glycolate, crospovidone, croscarmellose sodium. Aspartame as a sweetener and trusil mango flavor were used to increase palatability. Reduction in the dose of Amoxycillin trihydrate and Potassium clavulanate tablet was possible by developing fast dissolving tablet.
Results: The powder blends were subjected to various pre-formulation evaluations such as, tapped density, bulk density, hausnerâ€™s ratio, the angle of repose and compressibility index. The prepared Amoxycillin trihydrate and Potassium clavulanate fast dissolving tablets were evaluated for thickness, weight variation, friability, disintegration time, hardness, wetting time and in vitro drug release. All fast dissolving tablet formulations shown uniform weight, hardness and friability data indicates the good mechanical resistance of the fast dissolving tablet. Fast dissolving tablets were disintegrated between 25-50 second and in vitro disintegration time of the best fast disintegrating tablets was found to be 25 second.
Conclusion: Amoxycillin trihydrate and Potassium clavulanate fast dissolving tablets were found to be of good quality fulfilling all the needs for fast dissolving tablets. The optimised (F-4) formulation had shown best disintegration time and released profile with a maximum in vitro drug release as compare to marketed preparation at all time intervals of in vitro drug release.
2. Prakash I, Chudasama J, Gupta P, Dev R, Shekhar S, Kumar M. Formulation and In-vitro bioequivalence study of amoxycillin and potassium clavulanate fast dispersible tablet. PharmaTutor Mag 2014;2;102-11.
3. Valera A, Upadhyay P, Deshpande J, Shah S, Patel J. Development of stable formulation and evaluation of the combination of amoxycillin trihydrate and clavulanic acid by dry granulation method. J Pharm Sci Biosci Res 2013;3:127-35.
4. Subbaiah S, Karuna DS, Grace R, Ubaidulla U. Formulation of fast disintegrating amoxicillin and potassium clavulanate tablets: in vitro evaluation and stability studies by direct compression method. Acta Biomed Sci 2015;2:23-31.
5. Singh ANK, Sekar M, Viswanath V, Hussan R. Formulation development and evaluation of amoxicillin trihydrate and Potassium clavulanate immediate release tablets by the wet granulation method, dry granulation method, and moist activated granulation method. Int J Univ Pharm Biosci 2013;1:71-80.
6. Saroha K, Kumar G, Paul Y. Formulation and evaluation of fast dissolving tablets of amoxicillin trihydrate using synthetic super disintegrants. Int J Pharm Biosci 2013;4:254-62.
7. Yadav VT, Jayswal BD, Patel KN, Patel BA, Patel PA. Formulation and evaluation of floating tablet of amoxicillin trihydrate. Int J Pharm Res Scholars 2012;1:2277-7873.
8. Bhavani D, Rao RNG. Formulation and evaluation Of Valsartan Fast disintegrating tablets by vacuum drying technique. Asian J Pharm Clin Res 2016;9:73-9.
9. Rao RSP, Rao CG, Mallikarjun V. Formulation and In-vitro evaluation of fast-disintegrating tablets of flupirtine by direct compression method. Int J Pharm Technol 2015;7:8289-301.
10. Bhowmik D, Chiranjib B, Krishnakanth, Pankaj, Chandira RM. Fast dissolving tablet: an overview. J Chem Pharma Res 2009;1:163-77.
11. Karia I, Ramesh Dr, Parmar B. Formulation and evaluation of fast dissolving tablets of olmesartan medoxomil by using coprocessed excipients technique. World J Pharm Pharma Sci 2015;4:1356-73.
12. Sridharbabu NY, Kumar D, Veesam V, Malathy PS, Sandeepthi B. Formulation and evaluation of fast dissolving tablets of carbamazepine by direct compression using super-disintegrants. Int J Pharm Sci Lett 2014;4:432-6.
13. Rane DR, Gulve HN, Patil VV, Thakare VM, Patil VR. Formulation and evaluation of fast dissolving tablet of albendazole. Int Curr Pharma J 2012;1:311-6.
14. Indian Pharmacopoeia. Controller of Publications, Govt. of India, Ministry of Health and Family Welfare, New Delhi; 2007:4;122-600.
15. Rao NGR, Patel T, Kumar R. Development of fast dissolving carbamazepine tablets: effect of the functionality of super-disintegrants. Int J Pharm Sci Nanotechnol 2010;3:824-33.
16. Shaikh TH, Bhise SD, Ligade DM, Patil MVK, Patankar RD. Formulation and evaluation of mouth dissolving tablets of metformin hydrochloride. Int Res J Pharm 2012;3:97â€“108.
17. Singh KS, Mishra ND, Jassal R, Soni P. Fast disintegrating combination tablets of omeprazole and domperidone. Asian J Pharm Clin Res 2009;2:74â€“82.
18. Mettu SR, Veerareddy PR. Formulation, evaluation and pharmacokinetics of flurbiprofen fast dissolving tablets. Br J Pharm Res 2013;3:617â€“31.
19. Sivakranth M, Althaf AS, Rajasekhar S. Formulation and evaluation of oral fast dissolving tablets of sildenafil citrate. Int J Pharm Pharma Sci 2011;3:112â€“21.
20. Rawat PK, Mote PB, Singh KS, Salunke AA, Rajendra VB, Zadbuke SN. Fast dissolving tablets of pioglitazone hydrochloride by use of various super disintegrants. Int J Adv Res Pharm Bio Sci 2013;3:74â€“9.
21. Masaki K. Orally disintegrating famotidine tablets. Academy of pharmaceutical science and tech; 1997. p. 79-84.
22. Nugrahani I, Sukmadja J, Sundani N. Solid state interaction between amoxicillin trihydrate and potassium clavulanate. Malays J Pharm Sci 2007;5:45â€“57.
23. Swamivelmanickam M, Valliappan K, Reddy PG. Preformulation studies for amoxicillin trihydrate and dicloxacillin sodium as mouth dissolve tablets. Int J ChemTech Res 2009;1:1032-5.
24. Bi Y, Sunada H, Yonezawa Y, Danjo K, Otsuka A, Iida K. Preparation and evaluation of a compressed tablet rapidly disintegrating in the oral cavity. Chem Pharm Bull 1996;44:2121-47.