STUDYING THE EFFECT OF DIFFERENT VARIABLES ON THE FORMULATION OF MUCOADHESIVE BUCCAL PATCHES OF CAPTOPRIL
Objective: The objective of this research was to formulate the captopril as mucoadhesive buccal films for hypertension treatment and studying the effect of different variables on the physical and mechanical behavior of the prepared films.
Methods: The bucco-adhesive patches were prepared using hydroxyl propyl methyl cellulose K4 (HPMC) as film forming a polymer with secondary polymer included carbopol 934 and eudragit RL100. The patches were prepared by a solvent casting method and evaluated for the weight variation, surface pH, mechanical properties, content, uniformity, ex-vivo mucoadhesive strength, ex-vivo permeation study and drug release study.
Results: Formula F5 containing HPMC as primary polymer with carbopol 934 as secondary polymer was chosen to be the best formulation for the following parameters: surface pH6.44, tensile strength (16.06), percentage elongation at break (34.14), swelling index(18.85), mucoadhesive strength(26.2 gm) and the folding endurance was>300 with an in vitro drug release about 94.73% during 6 h.
Fourier transforms infrared spectroscopy (FT-IR) and differential scanning calorimetric studies (DSC) showed no interaction between the drug and polymers.
Conclusion: It can be concluded that oral mucoadhesive buccal film of captopril, an antihypertensive agent can be prepared utilizing HPMC as a film forming a polymer with carbopol as a secondary polymer which extended the drug release through the buccal mucosa for 6 h.
2. Sangeetha S, Venkatesh DN, Krishan PN, Saraswathi R. Mucosa as a route for systemic drug delivery. Res J Pharm Bio Chem Sci 2010;1:178-87.
3. Shojaei AH. Buccal mucosa as a route for systemic drug delivery. J Pharm Pharm Sci 1998;1:15-30.
4. Sravanthi RR, Rajalakshmi R, Krishna MSB, Rupangada V, Ramya SE. A review on Mucoadhesive buccal films. Int J PharmTech Res 2014;6:1665-78.
5. James MR., Lionel DL, Timothy GK M, Albert F. 5th ed. A textbook of clinical pharmacology and therapeutics; 1999. p. 187-8.
6. Jones, Bartlett. Nurseâ€™s drug handbook. Tenth ed; 2011. p. 173-4.
7. Swectman SS. Martindale: the complete drug reference. 36th ed. Pharmaceutical Press: London; 2009. p. 1239.
8. Jackson JV, Moss MS, Widdp B. Clarkâ€™s Isolation and Identification of drugs. Second ed. pharmaceutical Press: London; 1986. p. 426.
9. Panigrahi L, Pattnaik S, Chosal S. Design and characterization of mucoadhesive buccal patches of salbutamol sulphate. Acta Pol Drug Res 2004;61:350-60.
10. Naffe NA, Roralie NA, Ismail FA, Mortada LM. Design and formulation of mucoadhesive buccal patches containg cetylpyridium chloride. Acta Pharm 2003;53:199-212.
11. Bansal S, Bansal M, Gavg G. Formulation and evaluation of fast dissolving film of an antihypertensive drug. Int J Pharm Chem Biol Sci 2013;3:1097-108.
12. Rasool BK, Khan SA. In vitro evaluation of miconazole mucoadhesive buccal film. Int J Appl Pharm 2010;2:23-6.
13. Manubolu K, Chandana AV, Prakash P, Sujatha B, Rani SV, Radhika KV. Formulation and in vitro characterization of amitriptyline buccal films. World J Pharm Pharm Sci 2014;3:1547-55.
14. Velmurugan S, Srinivas P. Formulation and in vitro evaluation of losartan potassium mucoadhesive buccal tablets. Asian J Pharm Clin Res 2013;2:125-30.
15. Kshirasagar N, Thamada N, Naik BK, Gopal MS. Design and evaluation of chitosan containing a mucoadhesive buccal patch of fluoxetine HCl. Int J Sci Public 2012;2:1-5.
16. Nagendrakumar D, KeshavshettiG G, Mogule P, Swamti S, Swami H. Formulation and evaluation of fast dissolving oral films of metoprolol succinate. Int J Eng Appl Sci 2015;6:28-38.
17. Viswanadhan PV, Padole A, Abraham A, Mathew ST. Buccal tablets of lisinopril by direct compression method for buccal drug delivery. Int Res J Pharma 2012;2:30-8.
18. Jagdale SC, Mohanty P, Aniruddha R, Chabukswar AR, Kuchekar BS. Development of buccal patches for delivery of darifenacin from beta-cyclodextrin complexes. J Basic Appl Pharm Sci 2014;35:29-39.
19. Saritha T, Balaji A. Design and evaluation of forskolin buccal mucoadhesive microspheres. Int J Cur Pharm Res 2015;7:17-21.
20. Muthukumaran M, Dhachinamoorthi D2, Chandra SKB. Development and Optimisation of hydralazine HCl sustained released mucoadhesive buccal tablets using 23 factorial design. Int J Adv Pharm Gen Res 2013;1:20-32.
21. Raju KU, Kumar A, Deepika B, Eswaraiah MC, Rao AS. Formulation and in vitro evaluation of buccal tablets of captopril. Int Res J Pharm Appl Sci 2012;2:21-43.
22. Parmar VJ, Lumbhani AN, Vijayalakshmi P, Sajal J. Formulation development and evaluation of buccal films of carvedilol. Int J Pharm Sci Res 2010;1:149-56.
23. Patil DA, Patil GB, Deshmukh PK, Belgamwar VS, Fursule RA. Chitosan-coated mucoadhesive multi particulate drug delivery system for gliclazide. Asian J Pharm Clin Res 2009;2:62-8.
24. Kuma BV, Kumar AA, Sudheer B, Kumar SK, Srinirasa RV, Kirtindhi K, et al. Formulation design, invitro evaluation and stability studies on mucoadhesive buccal Films of antianginal calcium channel. J Appl Pharm Sci 2011;1:136-42.
25. Chambi HNM, Grosso CRT. Mechanical and water vapor permeability, properties of biodegradable films based on methylcellulose, glucomannan, pectin and gelatin. Cienc Tecnol Ali Comp 2011;31:739-46.
26. Sobral PJA, Menegalli FC, Hubinger MD, Roques MA. Mechanical, water vapor barrier and thermal properties of gelatin based edible film. Food Hydrocolliods 2001;15:423-32.
27. Abu-Huwaij R, Assaf S, Salem M, Sallam A. Mucoadhesive dosage form of lidocaine hydrochloride: mucoadhesive and physicochemical characterization. Drug Dev Ind Pharm 2007;33:855-64.
28. David SRN, Rajabalaya R, Aand Zhia ES. Development and in vitro evaluation of the self-adhesive matrix-type transdermal delivery system of ondansetron hydrochloride. Trop J Pharm Res 2015;14:211-8.
29. Vishnu YV, Chandrasekhar K, Ramesh G. Development of mucoadhesive patches for buccal administration of carvedilol. Curr Drug Delivery 2007;4:27-39.
30. Puratchikody A, PrasanthVV, Mathew ST, Kumar BA. Mucoadhesive patch of salbutamol sulphate for unidirectional buccal drug delivery: development and evaluation. J Cur Drug Delivery 2011;8:416-25.
31. Mohamed MI, Afify EA, Mekhel MKG. Formulation and evaluation of antiasthmatic drug montelukast in the mucoadhesive buccal patch. J Coast Life Med 2014;2:907-14.
32. Yousif NZ, Mariae KN. Optimization and evaluation of metoclopramide HCl as a mucoadhesive buccal patch. World J Pharm Res 2015;4:79-99.
33. Deore VA, Kumar RS, Gide PS. Development and statistical optimisation of mucoadhesive buccal patches of indomethacin: in vitro and ex vivo evaluation. Int Int J Adv Pharm Biol Chem 2013;2:405-22.
34. El-shabouri MH, Abdelâ€“Aleen HM, Soliman OM, Eldahhan MS. Formulation and evaluation of buccoadhesive captopril tablet. Bull Pharm Sci 2009;32:45-64.
35. Thadkala K, Kumari NPP, Prathyush R, Raju A. Formulation, development, optimization and characterization of floating beads of captopril. Int J Pharm Res All Sci 2013;2:32-46.
36. Sunitha HS, Parthiban S, Vikneshwiri A, Seuthil KGP, Tamiz MT. Development and evaluation of Captopril fast dissolving a tablet by complexation techniques using guar gum as a super disintegrant. Int J Res Pharm Nanosci 2015;4:72-84.