DEVELOPMENT AND EVALUATION OF BILAYER MUCOAHESIVE GASTRORETENTIVE TABLET OF DILTIAZEM HYDROCHLORIDE
Keywords:
Diltiazem Hydrochloride, Mucoadhesive tablet, Sodium alginate, Mucoadhesive strength, In Vitro drug releaseAbstract
Objective: The objective of present study was to formulate an oral mcoadhesive tablet of diltiazem hydrochloride.
Methods: Investigate the effect of amount of HPMC K4M and sodium alginate on the sustained release and gastric residence time of dosage form. The mucoadhesive tablet prepared by direct compression method was used varying concentrations of HPMC K4M and Sodium alginate and (1:1, 1:1.5, 1:2) Drug and Polymer ratio.
Results: The formulations were evaluated and results revealed that FTIR studies showed no evidence of interactions between drug and excipients used. The mucoadhesive strength, residence time and drug content of formulation F3 was found to be 26.35 ± 1.15 mg, >7.5hrs, and 98.75 ± 0.05 % respectively. The formulation F3 exhibited sustained drug release i.e. 75.71% in 12 h. The In Vitro release kinetics studies reveal that formulations fit well with zero order kinetics and mechanism of drug release is Super case II transport.
Conclusion: The study was concluded that formulation of mucoadhesive tablets from the cumulative % drug release study reveals that increase in the concentration of adhesive polymers cause slow the drug release. Sustained release tablet of DTZ can be beneficial in treatment of hypertension.
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References
Jain N K. Progress in controlled and novel drug delivery system, 3rd ed. 2004;67-78.
Agyilirah G A, Green M, Ducret R. Evaluation of gastric retention properties of a cross linked polymer coated tablet versus those of a non-disintegrating tablet. Int J Pharm. 1991;75:241-5.
Garg S, Sharma S. Gastroretentive drug delivery systems. J Pharm Tech 2003;(5):129-41.
Deshpande, A A, Shah, N. H., Christopher, T. Development of a novel controlled release system for gastric retention. J Pharm Res 1997;14(6):815-9.
K Chowdary, B Suresh, B Sangeeta, G et al. Design And Evaluation of Diltiazem Mucoadhesive Tablets For Oral Controlled Release. J Saudi Pharm 2003;11(4):43-8.
S Sarojini, R Manavalan. An overview on various approaches to Gastroretentive dosage forms. Inte J of Drug Development and Res 2012;4(1):1-13.
Pranshu Tangri, N.V. Satheesh Madhav. Oral Mucoadhesive Drug Delivery Systems:a review. Int J of Biopharm 2011;2(1):36-46.
G C Rajput, F D Majmudar, J K Patel, K N Patel. et al. Stomach Specific Mucoadhesive Tablets As Controlled Drug Delivery System:a review. Int J Pharm and Bio Res 2010;1(1):30-41.
Amit Alexander, Ajazuddin, D K Tripathi, Tekeshwar Verma, et al. Mechanism Responsible For Mucoadhesion of Mucoadhesive Drug Delivery System:a review IJACPT 2011;2(1):434-45.
P Tangri, S Khurana, N Satheesh. Mucoadhesive Drug Delivery:mechanism and Methods of Evaluation. Int J Pharm Bio Sci 2011;2(1):458-67.
Rahamatullah Shaikh, Thakur Raghu Raj Singh, Martin James Garland et al. Mucoadhesive drug delivery systems. J Pharm Bioallied Sci 2011;3(1):89–100.
A Hoffman, D Stepensky, Pharmacodynamic aspects of modes of drug administration for optimization of drug therapy. J Crit Rev Ther Drug Carrier Sys 1999;16:571-639.
J K Vasir, K Tambwekar, S Garg. Mucoadhesive tablets as a controlled drug delivery system. Int J Pharm 2003;255:13-32.
Sudhakar Y, Kuotsu K Bandhoupadhyay. Buccal bioadhesive drug delivery a promising option for orally less efficient drugs. J Cont Rel 2006;114:15-40.
Hao J, Heng P. Buccal Delivery Systems. J Drug Dev Ind Pharm 2003;29:821-32.
Hoffman, A F, Pressman, J H, Code, C F. Controlled entry of orally administered drugs:Physiological considerations. J Drug Dev Ind Pharm 1983;9:1077-81.
Elmowafy, E M, Awad, G A, Mansour, S, El-Shamy, A E. Release mechanisms behind polysaccharides based Famotidine controlled release matrix tablets. AAPS J Pharm Sci Tech 2008;9(4):1230-9.
Lakshmana P, Shirwaikar A, Ravikumar G et al. Formulation and evaluation of oral sustained release of Diltiazem Hydrochloride using rosin as matrix forming. J Material Ars Pharm 2009;50(1):32-42.
Lubna A Sabri. Formulation and In Vitro Evaluation of Mucoadhesive Diltiazem Hydrochloride Buccal Tablets. AJPS 2011;10:254-67.
Shivanand Pandey, Viral Devmurari, Manish Goyani et al. Formulation, characterization and In Vitro evaluation of Diltiazem Hydrochloride matrix tablets. J Der Pharmacia Lettre 2010;2(1):482-8.
Dhara B Patel, Madhabhai M Patel. Formulation and Development of Mucoadhesive Tablet of Diltiazem Hydrochloride. Int J of Pharm and Bio Sci 2010;1(2):1-14.
Muhammad Rafiq, Abdul Wahab, Nisarur Rehman et al. In Vitro and in vivo evaluation of two sustained release formulations of diltiazem HCl. African J of Pharm and Pharmacology 2010;4(9):678-94.
Gurpreet Arora, Karan Malik, Inderbir Singh et al. Formulation and Evaluation of Controlled Release Mucoadhesive Matrix Tablets:Assessment of Myrrh Oleo Gum Resin as a Natural Pharmaceutical Excipient. Int J of Pharm Sci and Drug Res 2011;3(2):84-8.
Ashraful I, Asma A, Md Asaduzzaman. Md Rezowanur R. Development and evaluation of mucoadhesive ciprofloxacin bi-layer tablet for extended drug release. Asian J Pharm Res 2011;1(3):64-8.
Parthiban K, Kumar B, Manivannan R, Sanjeevi D. Once daily gastro retentive mucoadhesive cephalexin monohydrate tablet:formulation and in-vitro evaluation. Int J Pharm 2010;1(5):89-98.
Banerjee T, Muruganantham V, Venkateswarlu B, Jayker B. Formulation and evaluation of mucoadhesive tablets of NSAID combination with proton pump inhibitor. IJPRD 2011;3(8):160-9.
Umarji B, Rudragouda P, Ravindra B, Swati M. Formulation and in-vitro evaluation of mucoadhesive buccal tablets of furosemide. W J Pharm 2012;1(3):1041-63.
Lachman L, Liberman H. Theory and Practice of Industrial Pharmacy, Varghese Publishing House, Bombay, 1987;430.
Ketan Gulabrao Albhar, Vaibhav Sudhakar Wagh. Effect of HPMC K4M, HPMC K15M, sodium alginate and carbopol 934 in the formulation of carbonyl iron capsule. J Der Pharmacia Lettre 2012;4(1):367-94.
Ravouru Nagaraju, Rakurthi Satyasaroja, Rajesh Kaza, Formulation and Evaluation of Controlled Release Indomethacin Microparticles. Turk J Pharm Sci 2011;8(1):1-22.
Hiremath, P S, Saha, R N. Controlled release hydrophilic matrix tablet formulations of Isoniazid:Design and In Vitro Studies. AAPS Pharm Sci Tech 2008;9(4):1171-8.
Yeole, P G, Galgatte, U C, Babla, I B. Design and evaluation of xanthum gum-based sustained release matrix tablets of diclofenac sodium. IJPS 2006;68(2):185-9.
Dave B S, Amin A F, Patel M M. Gastroretentive drug delivery system of Ranitidine, Hydrochloride:Formulation and In Vitro Evaluation. J AAPS Pharm Sci Tech 2004;5(2):34-42.
Abubakr, O N, Zhang, J S. Captopril floating and/or bioadhesive tablets:Design and release kinetics. J Drug Dev Ind Pharm 2000;(29):965-9.
Chavanpatil, M D, Jain, P, Chaudhari, S. Novel sustained release, swellable and bioadhesive gastroretentive drug delivery system for ofloxacin. Int J Pharm 2006;(316):86-92.
Chawla, G, Gupta, P, Bansal, A K et al. Gastroretention a mean to address regional variability in intestinal drug absorption. J Pharm Tech 2003;50-68.
Cheuh, H R, Zia, H, Rhodes, C T, Optimization of Sotalol floating and bioadhesive
extended release tablet formulation. J Drug Dev Indian Pharm 1995;(21):1725-47.
Carstensen, J T, Drug stability:principle and practices, 2nd ed. Marcel Dekker, New York, 1995;538-50.