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Drug Delivery Letters

Author(s): Jagdale Sachin*, Panbude Aishwarya and Navasare Priya

DOI: 10.2174/2210303108666181108120840

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Development, Characterization and Optimization of Mucoadhesive Tablet for Buccal Delivery of Domperidone

Page: [37 - 49] Pages: 13

  • * (Excluding Mailing and Handling)

Abstract

Background and Objective: Upon oral administration domeperidone is rapidly absorbed, but subjected to the first pass effect which lowers systemic bioavailability to 15%. Mucoadhesive tablet can remain attached to buccal mucosa and becomes capable of bypassing hepatic first-pass metabolism to improve absorption directly into systemic circulation. The present research work was carried with an aim to develop, evaluate and optimize mucoadhesive tablet containing domperidone (DOME) for buccal delivery using different bio-adhesive polymeric combinations.

Methods: The buccal tablets were formulated by wet granulation method using isopropyl alcohol. The preliminary formulations were prepared using combinations of HPMC K4, HPMC K15, HPMC K100, HPMC E5 as mucoadhesive polymers. 32 full factorial design was applied to determine the effect of independent variables like concentration of mucoadhesive polymers (HPMC K15 and HPMC K100) over dependent variables like mucoadhesive properties (swelling index, bioadhesive strength and in vitro drug release). The prepared mucoadhesive tablets were evaluated for their tablet properties and mucoadhesive properties. The interactions between drug and polymers were studied by Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC).

Results: All formulations of factorial design showed satisfactory physicochemical, mechanical and bioadhesive characteristics. The formulation F9 exhibited maximum cumulative drug release, mucoadhesive strength and swelling index.

Conclusion: The developed buccal tablet of domperidone might prove alternative to bypass the hepatic first pass metabolism and to avoid degradation which in turn may result in reducing the frequency of administration. Thus, mucoadhesive tablet of domeperidone may become viable alternative overcoming the side effects; achieving greater therapeutic effectiveness and improving the patient compliance.

Keywords: Domperidone, mucoadhesive buccal tablet, mucoadhesive strength, drug release kinetics, experimental design.

Graphical Abstract

[1]
Gavini, E.; Sanna, V.; Juliano, C.; Bonferoni, M.C.; Giunchedi, P. Mucoadhesive vaginal tablets as veterinary delivery system for the controlled release of an antimicrobial drug, Acriflavine. AAPS PharmSciTech, 2002, 3(3), E20.
[2]
Harris, D.; Robinson, J.R. Drug delivery via the mucous membranes of the oral cavity. J. Pharm. Sci., 1992, 81(1), 1-10.
[3]
Hani, U.; Shivakumar, H.G.; Osmani, R.A.M.; Srivastava, A.; Varma, N.S.K. Development of a curcumin bioadhesive monolithic tablet for treatment of vaginal candidiasis. Iran. J. Pharm. Res., 2016, 15(1), 23-34.
[4]
Patel, R.; Shardul, N.; Patel, J.; Baria, A. Formulation development and evaluation of mouth melting film of ondansetron. Arch. Pharm. Sci. Res, 2009, 1, 212-217.
[5]
Bremeckar, K.D.; Strempel, H.; Klein, G. Novel concept for a mucosal adhesive ointment. J. Pharm. Sci., 1984, 73(4), 548-552.
[6]
Shin, S.C.; Bum, J.P.; Choi, J.S. Enhanced bioavailability by buccal administration of triamcinalone acetonide from the bioadhesive gels in rabbits. Int. J. Pharm., 2000, 209(1-2), 37-43.
[7]
Rana, A.; Rana, M.O.; Kamal, S.; Yusuf, A.H. Formulation and in vitro evaluation of xanthan gum or carbopol 934-based mucoadhesive patches loaded with nicotine. AAPS PharmSciTech, 2011, 12(1), 21-27.
[8]
Makky, A.M.A.; El-Gendi, N.A.H.; El-Menshawe, S.F.; El-Akkad, Y.E. A buccoadhesive disc as a novel drug delivery system of tenoxicam: formulation and in vitro/in vivo evaluation. J. Drug Deliv. Sci. Technol., 2012, 22(2), 145-152.
[9]
Roh, J.; Han, M.; Kim, K.N.; Kim, K.M. The in vitro and in vivo effects of a fast-dissolving mucoadhesive bi-layered strip as topical anesthetics. Dent. Mater. J., 2016, 35(4), 601-605.
[10]
Parodi, B.; Russo, E.; Caviglioli, G.; Cafaggi, S.; Bignardi, G. Development and characterization of a buccoadhesive dosage form of oxycodone hydrochloride. Drug Dev. Ind. Pharm., 1996, 22(5), 445-450.
[11]
Reena, T.; Vandana, D. Enhancement of solubility and dissolution rate of domperidone using cogrinding and kneading technique. J. Drug Deliv. Ther., 2012, 2(4), 152-158.
[12]
Bennett, P.N.; Brown, M.J. Clinical Pharmacology, 9th ed; Churchill Livingstone: London, 2003.
[13]
Tripathi, K.D. Essentials of Medical Pharmacology, 5th ed; Jaypee Brothers Medical Publishers: New Delhi, 2004.
[14]
Kumar, P.; Singh, I. Formulation and characterization of tramadol-loaded IPN microgels of Alginate and glutraldehyde: Optimiztion using response surface methodology. Acta Pharm., 2010, 60(3), 295-310.
[15]
Singh, B.; Kumar, R.; Ahuja, N. Optimizing drug delivery systems using systematic design of experiments. Part I: Fundamental aspects. Crit. Rev. Ther. Drug Carrier Syst., 2005, 22(1), 27-105.
[16]
Singh, B.; Dahiya, M.; Saharan, V.; Ahuja, N. Optimizing drug delivery systems using systematic design of experiments. Part II: Retrospect and prospects. Crit. Rev. Ther. Drug Carrier Syst., 2005, 22(3), 215-293.
[17]
Chauhan, S.; Kumar, P.; Kothiyal, P. Validated method development for the estimation of domperidone by UV- Spectroscopy. Int. J. Pharma. Res. Rev., 2015, 4(10), 1-7.
[18]
Charde, S.; Mudgal, M.; Kumar, L.; Saha, R. Development and evaluation of buccoadhesive controlled release tablets of lercanidipine. AAPS PharmSciTech, 2008, 9(1), 182-190.
[19]
Pulak, D.; Suvakanta, D.; Padala, N. Development and statistical optimization of mucoadhesive drug delivery system of famotidine using hibiscus esculentus polysaccharide. Int. J. Drug Deliv., 2014, 6(3), 311-325.
[20]
Arora, G.; Malik, K.; Singh, I. Formulation and evaluation of mucoadhesive matrix tablets of taro gum: optimization using response surface methodology. Polim. Med., 2011, 41(2), 23-34.
[21]
Diasa, R.J.; Sakhare, S.S.; Malic, K.K. Design and development of mucoadhesive acyclovir tablet. Iran. J. Pharm. Res., 2009, 8(4), 231-239.
[22]
Stetsko, G. Statistical experimental design and its application to pharmaceutical development problems. Drug Dev. Ind. Pharm., 1986, 12(8-9), 1109-1123.
[23]
Gazzi, S.; Kumar, C.K.; Gonugunta, C.S.; Kumar, B.V.; Veerareddy, P.R. Formulation and evaluation of bioadhesive buccal drug delivery of tizanidine hydrochloride tablets. AAPS PharmSciTech, 2009, 10(2), 530-539.
[24]
Mandal, S.C.; Bhattacharyya, M.; Ghosal, S.K. In vitro release and permeation kinetics of pentazocine from matrix-dispersion type transdermal drug delivery system. Drug Dev. Ind. Pharm., 1994, 20(11), 1933-1941.
[25]
Shidhaye, S.S.; Thakkar, P.V.; Dand, N.M.; Kadam, V.J. Buccal drug delivery of pravastatin sodium. AAPS PharmSciTech, 2010, 11(1), 416-424.
[26]
Thombre, S.K.; Gaikwad, S.S. Design and development of mucoadhesive buccal delivery for pantoprazole with stability enhancement in human saliva. Int. J. Pharm. Pharm. Sci., 2013, 5(2), 122-127.
[27]
Bottenberg, P.; Cleymaet, R.; Muynek, C.D.; Remon, J.P.; Coomans, D.; Slop, D. Development and testing of bioadhesive, fluoride-containing slow-release tablets for oral use. J. Pharm. Pharmacol., 1991, 43, 457-464.
[28]
Gaikwad, S.S.; Kale, Y.K.; Gondkar, S.B.; Darekar, A.B. Buccal tablet as a promising mucoadhesive drug delivery. Invent. Rapid. Pharm. Tech., 2012, 3, 1-8.
[29]
Carvalho, F.C.; Bruschi, M.L.; Evangelista, R.C.; Gremiao, M. Mucoadhesive drug delivery systems. Braz. J. Pharm. Sci., 2010, 46(1), 1-17.
[30]
Gupta, A.; Garg, S.; Khar, R.K. Measurement of bioadhesive strength of muco-Adhesive buccal tablets: Design of an in-vitro assembly. Indian Drugs, 1992, 30, 152-155.
[31]
Akbari, J.; Saeedi, M.; Kelidari, H.; Lashkari, M. Formulation and characterization of cetyl pyridiniumchloride bioadhesive tablets. Adv. Pharm. Bull., 2014, 4(4), 385-390.
[32]
Nafee, N.A.; Boraie, M.A.; Ismail, F.A.; Mortada, L.M. Design and characterization of mucoadhesive buccal patches containing cetyl pyridinium chloride. Acta Pharm., 2003, 53(3), 199-212.
[33]
Huwaij, R.A.; Assaf, S.; Salem, M.; Sallam, A. Potential mucoadhesive dosage form of lidocaine hydrochloride: II. In vitro and in vivo evaluation. Drug Dev. Ind. Pharm., 2007, 33(4), 437-448.
[34]
Vaidya, V.M.; Manwar, J.V.; Mahajan, N.M.; Sakarkar, D.M. Design and in vitro evaluation of mucoadhesive buccal tablets of terbutaline sulphate. Int. J. Pharm. Tech. Res., 2009, 1(3), 588-597.
[35]
Majithiya, R.J.; Raval, A.J.; Umrethia, M.L.; Ghosh, P.K.; Murthy, R.S.R. Enhancement of Mucoadhesion by Blending Anionic, Cationic and Nonionic Polymers. Drug Deliv. Tech., 2008, 8, 40-45.
[36]
Heng, P.W.S.; Chan, L.W.; Easterbrook, M.G.; Li, X. Investigation of the influence of mean HPMC particle size and number of polymer particles on the release of aspirin from swellable hydrophilic matrix tablets. J. Control. Release, 2001, 76(1-2), 39-49.