Prakash Rao B et al./ Formulation and Evaluation <strong>of</strong> <strong>Mucoadhesive</strong> Buccal Drug Delivery System <strong>of</strong> Metoprolol Tartrate by Using Central Composite Design Optimization Table 6: Summary <strong>of</strong> ANOVA results in analysing lack <strong>of</strong> fit and pure error Source Sum square d.f. Mean square F value Probability > F MT release at 8 hour Model 698.29 5 139.66 10.79
Prakash Rao B et al./ Formulation and Evaluation <strong>of</strong> <strong>Mucoadhesive</strong> Buccal Drug Delivery System <strong>of</strong> Metoprolol Tartrate by Using Central Composite Design Table 8: FT-IR spectrum <strong>of</strong> MT alone and excipients Interpretation IR absorption IR absorption band <strong>of</strong> metoprolol band <strong>of</strong> Pure Metoprolol Drug + Drug + HPC Tartrate(cm -1 ) -1 Carbopol (cm ) -1 (cm ) -NH 2 ,-OH,aliphatic 3610.79 – 2360.95 3608.93 – 2359.89 3611.83 – 2356.13 and aromatic CH Carboxylic acid salt 1573.97 1580.14 1580.57 Aromatic ring 1514.17 1515.14 1513.21 Isopropyl group 1179.51 1180.47 1174.69 Aliphatic ether, 1112.00 1112.00 1112.00 1,4 secondary alcohol di-substituted Benzene 824.24 826.53 824.60 Table 9: Result <strong>of</strong> stability studies according to ICH guidelines Parameter 0 Days 6 months Physical apperence White White Drug content 49.06 49.05 Bioadhesive strength 43.52 43.12 physical changes <strong>of</strong> the substance are recorded as a function <strong>of</strong> temperature or time as substance is heated at a liner rate. The DTA <strong>of</strong> the pure drug shows two endothermic peaks(Fig 0 11). The peak at 123.19 C indicates its melting point and the 0 other peak at 223.12 C may be the degredation peak. In the DTA studies there was no shift in the melting peak. So, the selected excipients for the formulation were found to be compatible with the active ingredients and having no physical interaction with the active pharmaceutical ingredient. Stabality Studies The optimized formula was evaluated for physical appearance, drug content and bioadhesive strength for every month. The values given were at end <strong>of</strong> the six months. It was found that optimized formula was stable. CONCLUSION The CCD was used to find out the effect <strong>of</strong> independent varibles on the dependable variables. The result <strong>of</strong> CCD revealed that the carbopol 934P and HPC have significant effect on the drug release at 8 hour, bioadhesive strength, T50% and release exponent(n). The observed independent variables were found to be very close to predicted values <strong>of</strong> optimized formulation which demonstrates the feasibility <strong>of</strong> the optimization procedure in successful development <strong>of</strong> buccal tablets containing MT by using carbopol 934P and HPC. 155 REFERENCES 1. Shojaei AH. Buccal mucosa as a route for systemic drug delivery: A review. J Pharm Sci 1998;1:15-30. 2. Patel VM, Prajapati BG, Patel MM. Formulation, evaluation and composition <strong>of</strong> bilayer and multilayered mucoadhesive buccal device <strong>of</strong> Propranolol hydrochloride. AAPS Pharm Sci Tech 2006;8:1-15. 3. Giunchedi P, Juliano C, Gavini E. Formulation and In-vivo evaluation <strong>of</strong> Chlorhexidine buccal tablets prepared using a drug loaded chitosan microspheres. Eur J Pharm Biopharm 2002; 53: 233-9. 4. Perioli L, Ambrogi V, Giovagnoli S, Ricci M, Blasi P, Rossi C. <strong>Mucoadhesive</strong> bilayered tablets for buccal sustained release Flurbipr<strong>of</strong>en. AAPS Pharm Sci Tech 2007; 8:1-9. 5. Desai KGH, Pramod kumar TM. Preparation and evaluation <strong>of</strong> a novel buccal adhesive system. AAPS Pharm Sci Tech 2004; 5:1-9. 6. Munasur AP, Pillay V, Chetty DJ, Govender T. Statistical optimization <strong>of</strong> the mucoadhesivity and characterisation <strong>of</strong> multipolymeric Propranolol matrices for buccal therapy. Int J Pharm 2006; 323:43-51. 7. Yong CS, Jung JH, Rhee JP, Kim CK, Choi HG. Physicochemical characterization and evaluation <strong>of</strong> buccal adhesive tablets containing Omeprazole. Drug Dev Ind Pharm 2001;27: 447-55. 8. Yan MO, Choi HG, Jung JK, Kim CK. Development <strong>of</strong> thermoreversible Insulin liquide suppository with sodium salicylate. Int J Pharm 1999; 189:137-45. 9. Yamsani VV, Gannu R, Kolli C, Rao ME, Yamsani MR. Development and In-vitro evaluation <strong>of</strong> buccoadhesive Carvedilol tablets. Acta Pharm 2007;57:185-97. 10. Khanna R, Agrawal SP, Ahuja A. Preparation and evaluation <strong>of</strong> bioerodible buccal tablets containing Clotrimazole. Int J Pharm 1996; 138:67-73. 11. Owens TS, Dansereau RJ, Sakr A. Development and evaluation <strong>of</strong> extended release bioadhesive Sodium fluoride tablets. Int J Pharm 2005;288:109-22. 12. th Tripathi KD. Essentials <strong>of</strong> medical pharmacology. 5 ed. New Delhi: Jaypee publishers. 2003;12913. Singh B, Chakkal SK, Ahuja N. Formulation and optimization <strong>of</strong> controlled release RJPS, Jul - Sep, 2011/ Vol 1/ Issue 2
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