FORMULA OPTIMIZATION AND IN VITRO RELEASE KINETIC STUDIES OF DILTIAZEM HYDROCHLORIDE MUCOADHESIVE BILAYER BUCCAL FILM
Objective: This research aims to determine the amount of hydroxypropyl methylcellulose (HPMC) and chitosan, which can produce the optimum buccal film formula and to determine the release kinetics of diltiazem hydrochloride in vitro.
Methods: The film was prepared by the solvent casting method. The formula's optimization was carried out using factorial design, which was processed using Design Expert 11.0.0 software, while the release kinetics was analyzed using the DDSolver program.
Results: The optimization results show that HPMC and chitosan (30 mg: 10 mg) is the amount of polymer that can produce the optimum formula. The buccal film formula has a swelling index of 2.92, a mucoadhesive strength of 64.40 gF, and a mucoadhesive residence time of 464 min. In vitro release study showed 97.64% release of Diltiazem hydrochloride after 480 min. The release kinetic’s of diltiazem hydrochloride follow the Korsmeyer Peppas model.
Conclusion: Thus, it can be concluded that the prepared formulation of the buccal mucoadhesive film can be a delivery system for diltiazem hydrochloride.
2. Sweetman SC. Martindale the complete drug reference. Thirty-Sixth Edition. London: Pharmaceutical Press; 2009.
3. Patel PS, Parmar AM, Doshi NS, Patel HV, Patel RR, Nayee C. Buccal drug delivery system: a review. Int J Drug Del Res 2013;5:35–48.
4. Khan SV, Trivedi, Boateng J. Functional Physico-chemical, ex vivo permeation and cell viability characterization of omeprazole loaded buccal films for paediatric drug delivery. Int J Pharm 2016;500:217–26.
5. Singh AUK, Sharma, Prajapati SK. A review on mucoadhesive buccal patches. Int J Res Dev Pharm Life Sci 2017;6:2654–60.
6. Mujariya R. A review on study of buccal drug delivery system a review on study of buccal drug delivery system. ISDE 2014;2:2–14.
7. Pawar HA, Surekha JM, Pravin JT, Geevarghese R. Development and evaluation of mucoadhesive patch using a natural polysaccharide isolated from Cordia dichotoma fruit. J Mol Pharm Org Process Res 2014;2:1–6.
8. Morales JO, Mcconville JT. European journal of pharmaceutics and biopharmaceutics manufacture and characterization of mucoadhesive buccal films. Eur J Pharm Biopharm 2011;77:187–99.
9. Mukherjee D, Bharath S. Comparative evaluation of risedronate sodium mucoadhesive films using different mucoadhesive. World J Pharm Pharm Sci 2015;4:1231–47.
10. Jaipal AMM, Pandey SY, Charde PP, Raut KV, Prasanth, Prasad RG. Effect of HPMC and mannitol on drug release and bioadhesion behavior on buccal discs of buspirone hydrochloride: in vitro and in vivo pharmacokinetic studies. Saudi Pharm J 2014;14:1–35.
11. Krampe RJC, Visser HW, Frijlink J, Breitkreutz HJ, Woerdenbag, Preis M, et al. Expert opinion on drug delivery oromucosal film preparations?: points to consider for patient-centricity and manufacturing processes. Expert Opin Drug Delivery 2016; 5247:1–41.
12. Kumria RBE, Al-dhubiab J, Shah, Nair AB. Formulation and evaluation of chitosan-based buccal bioadhesive films of zolmitriptan. J Pharm Innov 2018;13:133–43.
13. Averineni RKSG, Sunderajan, Mutalik S, Nayak U, Shavi G, Armugam K, et al. Development of mucoadhesive buccal films for the treatment of oral sub-mucous fibrosis: a preliminary study. Pharm Dev Technol 2009;14:199–207.
14. Zhang YM, Huo J, Zhou A, Zou W, Li C, Yao, et al. DDSolver: an add-in program for modeling and comparison of drug dissolution profiles. AAPS 2010;12:263–71.
15. Murtaza G, Ahmad M, Khan SA, Hussain I. Evaluation of cefixime-loaded chitosan microspheres: analysis of dissolution data using DDsolver. Dissolut Technol 2012;19:13–9.
16. Vaishali K, Nidhi S, Anwar D, Shruti H, Tushar G. Development of stable nanosuspension loaded oral films of glimepiride with improved bioavailability. Int J Appl Pharm 2017;9:28-33.
17. Zainab A, Sadeq, Nawal AR. Studying the effect of different variables on the formulation of mucoadhesive buccal patches of captopril. Int J Appl Pharm 2017;9:16-21.
18. Li W, He W, Gao P, Zhang C, Cai H, Chen Y. Preparation, in vitro and in vivo evaluations of compound calculus Bovis sativus and ornidazole film. Biol Pharm Bull 2016;39:1588–95.
19. Patel A, Shah D. Mucoadhesive buccal films based on chitosan and carboxymethylated Feronia limonia fruit pulp mucilage interpolymer complex for delivery of opioid analgesics. Asian J Pharm 2016;10:2–4.
20. Vergote GJ, Vervaet C, Remon JP, Haemers T, Verpoort F. Near-infrared FT-Raman spectroscopy as a rapid analytical tool for the determination of diltiazem hydrochloride in tablets. Eur J Pharm Sci 2002;16:63-7.
21. Tejada GM, Barrera G, Piccirilli GN, Sortino M, Frattini A, Salomón CG. Development and evaluation of buccal films based on chitosan for the potential treatment of oral candidiasis. AAPS PharmSciTech 2017;24:1–11.
22. Skulason SMS, Asgeirsdottir JP, Magnusson, Kristmundsdottir T. Evaluation of polymeric films for buccal drug delivery. Pharmazie 2009;64:197–201.
23. Patel VMB, Prajapati G, Patel MM. Design and characterization of chitosan-containing mucoadhesive buccal patches of propranolol hydrochloride. Acta Pharm 2007;57:61–72.
24. Kataria U, Jain C. Buccal films: design and in vitro characterization. Pharm Chem J 2015;2:16–26.
25. Dixit RP, Puthli SP. Oral strip technology: overview and future potential. J Controlled Release 2009;139:94–107.
26. Kathpalia HB, Sule A, Gupte H, Kathpalia B, Sule AG. Development and evaluation of orally disintegrating film of tramadol hydrochloride. Asian J Biomed Pharm Sci 2013;3:27–32.
27. Ghosal KS, Chakrabarty, Nanda A. Hydroxypropyl methylcellulose in drug delivery. Der Pharm Sin 2011;2:152–68.
28. Salamat N, Chittchang M, Johnston TP. The use of mucoadhesive polymers in buccal drug delivery. Adv Drug Delivery Rev 2005;57:1666–91.
29. Mohamed MI, Haider M, Ali MAM. Buccal mucoadhesive films containing antihypertensive drug: in vitro/in vivo evaluation. J Chem Pharm Res 2011;3:665–86.
30. Shah KUG, Khan M, Wahab A. Diltiazem hydrochloride microcapsules using ethyl cellulose ether derivative polymer as release retarding agent: in vitro chapter. Int J Res Granthaalayah 2015;3:78–93.
31. Zhang Y, Huo M, Zhou J, Zou A, Li W, Yao C, et al. DDSolver: an add-in program for modeling and comparison of drug dissolution profiles. AAPS J 2010;12:263-71.
32. Nugroho AK, Binnarjo A, Hakim AR, Ermawati Y. Compartmental modeling approach of Losartan transdermal transport in vitro. Indonesian J Pharm 2014;25:31-8.
33. Widiyastuti L, Nugroho AK. The release profile of granule consists of a combination of purifying extract of Centella asiatica and Andrographis paniculata. JFIKI 2016;3:58–61.
34. Iskandarsyah, Sutrio, Hayati D. Hydroxypropyl methylcellulose-release profile of theophylline controlled-release tablets. MIK 2010;3:58–70.
35. Dixit GR, Chavhan JI, Kanchan, Upadhye P, Misra S. Formulation and characterization of mucoadhesive buccal film of ranitidine hydrochloride using Sterculia Foetida gum as polymer. Asian J Pharm Clin Res 2015;8:68-71.
36. Peddapalli H, Chinnala KM, Banala N. Design and in vitro characterization of mucoadhesive buccal patches of duloxetine hydrochloride. Int J Pharm Pharm Sci 2017;9:52.
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