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Abstract
The present work was based on the development and characterization of gastro retentive dosage form appropriate for controlled release of Famotidine, a drug with narrow therapeutic window. The drug loaded polymer film of biological macromolecules (Sapindus mukrossi) was folded into hard gelatin capsules. The polymeric film revealed a fast release during the first hour followed by a more gradual drug release during a 12-h period following a non-Fickian diffusion process. Tensile strength of polymeric film was optimized using different amount (0.2–0.7 ml) of polyethylene glycol (PEG 400). Various physical parameters were studied for evaluating their performance as a gastroretentive dosage form. Drug and polymers were found to be compatible as revealed by interaction study and scanning electron microscopy (SEM) study revealed uniform dispersion of Famotidine in polymeric matrices. The results indicate that gastro retentive film drug delivery system holds lots of potential for drug having stability problems in alkaline pH or are which mainly absorbed in acidic pH.
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References
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- Peppas, N., 1985. Analysis of fickian and non-fickian drug release from polymers. Pharm. Acta Helv. 60(4):110–111.
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- Sathish, D., Himabindu, S., Pavan K, P., Madhusudhan, R.Y., 2013.Preparation and evaluation of novel expandable drug delivery system. Br. J. Pharm. Res. 3(4):1079–1093.
- Shakuntla, V., Kalpana, N., Singh S.K. and Mishra,D.N.,2014. Unfolding type gastroretentive film of Cinnarizine based on ethyl cellulose and hydroxypropylmethyl cellulose. International Journal of Biological Macromolecules. 64:347– 352.
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- Sharad, S. D. and Pradeep, R.V., 2012. Design of a gastroretentive mucoadhesive dosage form of Furosemide for controlled release. Acta Pharm. Sin. B. 2 (5):509–517.
- Uttam K. M., Bappaditya C. and Faria, G.S., 2016.Gastro-retentive drug delivery systems and their in vivo success: A recent update. Asian Journal of Pharmaceutical Sciences.11 (5):575–584.
- Vipul, D. P. , Girish, K. J., Naresh, G.M. and Narayan, P.R., 2013. Review: Pharmaceutical applications of various natural gums, mucilages and their modified forms. Carbohydrate polymer. 92(2):1685-1699.
References
Arora, S., Ali, J., Ahuja, A., Khar, R.K. and Baboota, S., 2005. Floating drug delivery system: A review. AAPS Pharm. Sci. Tech. 6: 372-390.
Banerjee, N. Singh, S., 2013. Formulation, evaluation and optimization of effervescent granules to be reconstituted into suspension of levetiracetam for sustained release. Int. J. Pharm. Sci. Rev. Res. 20 (2): 181–186.
Barbara, L., Corinaldesi, R., Bianchi, P.G., 1985. Famotidine in the management of duodenal ulcer: experience in Italy. Digestion. 32(1):24–31.
Deshpande, A. A., Shah, N.H., Rhodes, C.T. and Malik, W., 1997. Development of a novel controlled release system for gastric retention. Pharm. Res. 14:815–819.
Deborah, M., and Campoli-Richards, S.P.C.,1986. Famotidine: Pharmacodynamics and Pharmacokinetic Properties and a Preliminary Review of its Therapeutic Use in Peptic Ulcer Disease and Zollinger-Ellison Syndrome. Drugs. 32(3):197–221.
Freny, H., Sujit, K. D. and Saisivam, S., 2013. Optimization & Screening of Different Film Forming Polymers and Plasticizers In Fast Dissolving Sublingual Film. Int J Pharm Pharm Sci. 6(6):41-42.
Huwaij, R.A., Obaidat, R.M. Sweiden, K. and Al Hiari, Y., 2011. Formulation and in vitro evaluation of Xanthan gum or Carbopol 934 based mucoadhesive patches loaded with nicotine. AAPS Pharm. Sci. Tech. 12(1):21–27.
Higuchi, T.,1963. Mechanism of sustained action medication, theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J. Pharm. Sci. 51:1145–1149.
Klausner, E.A., Lavy, E., Friedman, M. and Hoffman, A.,2003. Expandable gastroretentive dosage forms. J. Controlled Release. 90(2):143–162.
Klausner, E.A., Lavy, E., Borta, M., Cserepes, E., Friedman, M. and Hoffman, A., 2003. Novel gastroretentive dosage forms: evaluation of gastro retentivity and its effect on levodopa absorption in humans. Pharm. Res. 20(9):1466–1473.
Klauser, E.A., Lavy, E., Stepensky, D., Friedman, M. and Hoffman, A., 2002. Novel gastroretentive dosage forms: evaluation of gastroretentivity and its effect on riboflavin absorption in dogs. Pharm. Res. 19:1516–1522.
Korsmeyer, R., Gurny, R. and Peppas, N., 1983. Mechanism of solute release from porous hydrophilic polymers. Int. J. Pharm. 15:25–35.
Mohana, K. R. S., Lakshmia, P.K. and Balasubramaniamb, J., 2013. Design of a novel bilayered gastric mucoadhesive system for localized and unidirectional release of lamotrigine. Saudi Pharmaceutical Journal.21 (1):45–52
Noha, A.N., 2013. Design and characterization of mucoadhesive buccal patches containing cetyl pyridinium chloride. Acta Pharm. 53:199–212.
Nafee, N.A. and Ismail, F.A., 2004. Mucoadhesive drug delivery system, formulation and in -vitro evaluation of mucoadhesive tablets containing water soluble drugs. Drug Dev. Pharm. 30:995–1004.
Perioli, L., Ambrogi, V., Angelici, F., Ricci, M., Giovagnoli, S. and Capercel, M., 2004. Development of mucoadhesive patches for buccal administration of ibuprofen. J. Controlled Release.99(1):73–82.
Peppas, N., 1985. Analysis of fickian and non-fickian drug release from polymers. Pharm. Acta Helv. 60(4):110–111.
Rajamma, A.J., Yogesh, H.N. Sateesha, S.B., 2012. Natural gums as sustained release carriers: development of gastroretentive drug delivery system of Ziprasidone Hcl. DARU J. Pharm. Sci. 20 (58):1–9.
Rishikesh G., Prajapati S.K., Snigdha, P. and Peeyush, B., 2015. Design, Evaluation and Radiographic Study of a Novel Floating Film Bearing Famotidine as a Model Drug. Lat. Am. J. Pharm. 34 (5): 917-23.
Rishikesh, G., Sunil, K. P., Snigdha, P. and Peeyush, B., 2014. Formulation and evaluation of novel stomach specific floating microspheres bearing famotidine for treatment of gastric ulcer and their radiographic study. Asian Pacific Journal of Tropical Biomedicine. 4(9):729–735.
Singh, B.N. and Kim, K.H., 2000. Floating drug delivery systems: An approach to oral controlled drug delivery via gastric retention. Journal Controlled Release. 63: 235-259.
Sathish, D., Himabindu, S., Pavan K, P., Madhusudhan, R.Y., 2013.Preparation and evaluation of novel expandable drug delivery system. Br. J. Pharm. Res. 3(4):1079–1093.
Shakuntla, V., Kalpana, N., Singh S.K. and Mishra,D.N.,2014. Unfolding type gastroretentive film of Cinnarizine based on ethyl cellulose and hydroxypropylmethyl cellulose. International Journal of Biological Macromolecules. 64:347– 352.
Sivaneswari, S., Karthikeyan, E. and Chandana, P.J., 2017. Novel expandable gastro retentive system by unfolding mechanism of levetiracetam using simple lattice design– Formulation optimization and in vitro evaluation. Bulletin of Faculty of Pharmacy, Cairo University. (Article in press).
Sharad, S. D. and Pradeep, R.V., 2012. Design of a gastroretentive mucoadhesive dosage form of Furosemide for controlled release. Acta Pharm. Sin. B. 2 (5):509–517.
Uttam K. M., Bappaditya C. and Faria, G.S., 2016.Gastro-retentive drug delivery systems and their in vivo success: A recent update. Asian Journal of Pharmaceutical Sciences.11 (5):575–584.
Vipul, D. P. , Girish, K. J., Naresh, G.M. and Narayan, P.R., 2013. Review: Pharmaceutical applications of various natural gums, mucilages and their modified forms. Carbohydrate polymer. 92(2):1685-1699.