FORMUALTION AND DEVELOPMENT OF MUCOADHESIVE SUSTAINED RELEASE BUCCAL TABLETS AND PATCHES OF 5-FLUOROURACIL USING DIFFERENT POLYMERS

Authors

  • Nitin Gawai Department of Pharmaceutics, Anuradha College of Pharmacy, Chikhli, Buldana, Maharashtra, India.
  • Zahid Zaheer Department of Quality Assurance, Y B Chavan College of Pharmacy, Aurangabad - 431 001, Maharashtra, India.

DOI:

https://doi.org/10.22159/ajpcr.2018.v11i5.20241

Keywords:

Mucoadhesive sustained release, 5-Fluorouracil, Carbopol 974p, Polyvinylpyrolidone-K 30, In-vitro drug release, In-vivo drug release

Abstract

 Objective: The present research study was undertaken to formulate mucoadhesive sustained release buccal tablets and patches of 5-fluorouracil (5-FU).

Method: For the research experiment work design expert software version 10, stat-ease, Inc. has been used. A 32 full factorial design was selected for the formulation of the buccal tablet as well as buccal patches. In this research work, formulated tablets and patches using different polymers such as carbopol 974p, polyvinylpyrrolidone-K 30, sodium deoxycholate, microcrystalline cellulose, and polyvinyl alcohol. An after formulation of batches formulated products studied for characterization, namely, Fourier transform infrared (FTIR) and differential scanning calorimeter (DSC). Evaluation parameters studied such as weight uniformity, thickness, hardness, friability, and content uniformity also carried out. For drug release purpose from the formulation of buccal tablet and patches in vitro drug released performed. In vivo drug releases study also carried out using Rabbit for drug reaction point of view.

Results: Design expert showed the significant results on independent and dependent variables. The R-Squared 0.9943 for drug release and 0.9985 for swelling index is in reasonable agreement with the formulations. FTIR and DSC indicating compatibility of the drug and polymers in the tablet formulation and patch formulations at the molecular level. The drug release of buccal tablet showed 75.10–99.34% and buccal patches showed 58.41–81.43%. These formulations showed good results when compared to the conventional tablet.

Conclusion: Formulation of mucoadhesive sustained release buccal tablets and patches of 5-FU successfully done using different polymers, which would definitely help in increasing bioavailability of the drug.

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Author Biography

Nitin Gawai, Department of Pharmaceutics, Anuradha College of Pharmacy, Chikhli, Buldana, Maharashtra, India.

Pharmaceutics

References

Mujoriya R, Dhamande K, Wankhede UR, Angure S. A review on study of buccal drug delivery system. Innov Syst Des Eng 2011;2:24-35.

Namita S, Garg MM. Current status of buccal drug delivery system: A review. J Drug Deliv Ther 2015;5:34-40.

Adhikari SN, Nayak BS, Nayak AK, Mohanty B. Formulation and evaluation of buccal patches for delivery of atenolol. AAPS Pharm Scitech 2010;11:1038-44.

Amul M, Meenakshi B, Deepak M, Harshna P. Buccal drug delivery system: A review. J Afr 2016;3:157-76.

Phanindra B, Moorthy BK, Muthukumaran M. Recent advances in mucoadhesive/bioadhesive drug delivery system: A review. Int J Pharm Med Biosci 2013;2:68-73.

Mamatha Y, Prasanth VV, Arunkumar S, Bhai MA, Yadav V. Buccal drug delivery a technical approach. J Drug Deliv Ther 2012;2:26-33.

Gavin A, Jimmy TH, Wang PD, Brownlow B, Bayoumi AT. Layered nano emulsions as mucoadhesive buccal systems for controlled delivery of oral cancer therapeutics. Int J Nano Med 2015;10:1569-84.

Godbole NN, Galgatte UC, Chaudhari PD. Development and in-vitro evaluation of quantum dots as a carrier for delivery of 5-fluorouracil. Int J Pharm Pharm Sci 2016;8:289-96.

Rajendran R, Balan R, Ganesan N, Thiruvengadam D. Recent modalities in drug delivery via inhalation therapy-an advanced treatment strategy for pulmonary carcinoma. Int J Pharm Pharm Sci 2015;7:8-21.

British Medical Association. British National Formulary: BNF 69. 69th ed. British Medical Association; 2015. p. 590.

Airley R. Cancer Chemotherapy: Basic Science to the Clinic. Chichester: John Wiley & Sons; 2009. p. 76.

Rossi S, editor. Australian Medicines Handbook. Adelaide: The Australian Medicines Handbook Unit Trust; 2013.

Joag MG, Sise A, Murillo JC, Sayed-Ahmed IO, Wong JR, Mercado C, et al. Topical 5-fluorouracil 1% as primary treatment for ocular surface squamous neoplasia. Ophthalmology 2016;12:1442-8.

Pendekal MS, Tegginamat PK. Development and characterization of chitosan-polycarbophil interpolyelectrolyte complex-based 5-fluorouracil formulations for buccal, vaginal and rectal application. DARU J Pharm Sci 2012;20:67.

Dhiman MK, Yedurkar PD, Sawant KK. Buccal bio adhesive delivery system of 5-fluorouracil: Optimization and characterization. Drug Dev Ind Pharm 2008;34:761-70.

Ghareeb MM, Mohammad HA. Study the effects of secondary polymers on the properties of buccoadhesive polyvinyl alcohol patches of 5-flourouracil. Int J Pharm Pharm Sci 2013;5:484-8.

Sharma YR. Elementary Organic Spectroscopy. 4th ed. Delhi: S Chand & Company Limited; 2007. p. 69-89.

Mutalik S, Naha A, Usha AN, Ranjith AK, Musmade P, Manoj K, et al. Preparation, in vitro, preclinical and clinical evaluations of once daily sustained release tablets of aceclofenac. Arch Pharm Res 2007;30:222-34.

Patel DM, Shah PM, Patel CN. Formulation and evaluation of bioadhesive buccal drug delivery of repaglinide tablets. Asian J Pharm 2012;6:171-9.

Duchene D, Ponchel G. Bioadhesion of solid oral dosage forms, why and how? Eur J Pharm Biopharm 1997;44:15-23.

Li XQ, Ye ZM, Wang JB, Fan CR, Pan AW, Li C, et al. Mucoadhesive buccal films of tramadol for effective pain management. Rev Bras Anestesiol 2017;67:231-7.21.

Rao TR, Hussain MA, Bharathi C, Shilpa A, Anjum M. Bioadhesive polymer buccal tablets for losartan potassium controlled delivery: Formulation, in-vitro and ex-vivo evaluation. Am J Alzheimer’s Dis Dement 2015;3:1-10.

Alagusundaram M, Chetty CM, Dhachinamoorthi D. Development and evaluation of novel trans-buccoadhesive bilayer tablets of famotidine: Asian J Pharm 2011;5:150-6.

Nafee NA, Ismail FA, Nabila A, Boraie LM. Mucoadhesive buccal patches of miconazole nitrate in vitro/in vivo performance and effect of ageing. Int J Pharm 2003;264:1-14.

Jaipal A, Pandey MM, Charde SY, Raut PP, Prasanth KV, Prasad RG. Effect of HPMC and mannitol on drug release and bioadhesion behavior of buccal discs of buspirone hydrochloride: In-vitro and in-vivo pharmacokinetic studies. Saudi Pharm J 2015;23:315-26.

Kaur A, Kaur G. Mucoadhesive buccal patches based on interpolymer complexes of chitosan-pectin for delivery of carvedilol. Saudi Pharm J 2012;20:21-7.

Bassi P, Kaur G. Polymeric films as a promising carrier for bioadhesive drug delivery: Development, characterization and optimization. Saudi Pharm J 2015;25:32-43.

Ikram MD, Gilhotra N, Gilhotra RM. Formulation and optimization of mucoadhesive buccal patches of losartan potassium by using response surface methodology. Adv Biomed Res 2015;4:239.

Reddy JR, Muzib YI, Chowdary KP. Development and in-vivo characterization of novel transbuccal formulations of amiloride hydrochloride. J Pharm Res 2013;6:647-52.

Shivanand K, Raju SA, Nizamuddin S, Jayakar B. In vivo bioavailability studies of sumatriptan succinate buccal tab. Daru 2011;19:224-30.

Gorle A, Patil P, Bhaskar R, Ola M. Development and evaluation of buccal film containing antihypertensive agent. Pharm Innov J 2015;4:53-60.

Giannola LI, De Caro V, Giandalia G, Siragusa MG, Paderni C. 5-Flurourocil buccal tablets for locoregional chemotherapy of oral squamous cell carcinoma: Formulation, drug release and histological effects on reconstituted human oral epithelium and porcine buccal mucosa. Curr Drug Deliv 2010;7:109.

Sharma GK, Sharma PK, Bansal M. A review on mucoadhesive buccal patch as a novel drug delivery system. Pharm Sci Monitor Int J Pharm Sci 2016;4:1378-86.

Puratchikody A, Prasanth VV, Mathew ST, Kumar BA. Buccal drug delivery: Past, present and future-a review. Int J Drug Deliv 2011;3:171-84.

Nakagawa T, Kondo SI, Sasai Y, Kuzuya M. Preparation of floating drug delivery system by plasma technique. Chem Pharm Bull 2006;54:514-8.

Published

01-05-2018

How to Cite

Gawai, N., and Z. Zaheer. “FORMUALTION AND DEVELOPMENT OF MUCOADHESIVE SUSTAINED RELEASE BUCCAL TABLETS AND PATCHES OF 5-FLUOROURACIL USING DIFFERENT POLYMERS”. Asian Journal of Pharmaceutical and Clinical Research, vol. 11, no. 5, May 2018, pp. 174-85, doi:10.22159/ajpcr.2018.v11i5.20241.

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Original Article(s)