Formulation and Evaluation of Itopride Hydrochloride Floating Beads for Gastroretentive Delivery

DOI:

https://doi.org/10.37285/ijpsn.2013.6.4.10

Authors

  • Nagratna Dhople
  • P N Dandag
  • A P Gadad
  • C K Pandey
  • Masthiholimath V S

Abstract

A gastroretentive sustained release system of itopride hydrochloride was formulated to increase the gastric residence time and modulate its release behavior. Itopride hydrochloride is a prokinetic drug used in the treatment of gastroeosophageal reflux disease, Non-ulcer dyspepsia and as an antiemetic. Hence, itopride hydrochloride beads were prepared by emulsion gelation method by employing low methoxy pectin and sodium alginate as sustained release polymers in three different ratios alone and in combination and sunflower oil was used to enable floating property to the beads. The effect of variation in polymer and their concentration was investigated. The beads were evaluated for production yield, particle size, swelling index, density measurement, buoyancy, drug content, drug entrapment efficiency, in vitro release characteristics and release kinetic study. Based on drug entrapment efficiency, buoyancy, swelling and in vitro release, F9 was selected as the optimized formulation. F9 was further subjected to surface morphology by SEM, in vitro release comparison with marketed formulation, in vivo floating study in rabbits and stability study for 90 days. In vitro release follows zero order and fitted in Korsmeyer peppas model (Non-Fickian release). Therefore, the rate of drug release is due to the combined effect of drug diffusion and polymer swelling. The in vivo X-ray studies revealed that the beads were floating in the rabbit stomach up to 10 hours. Thus, it was concluded that the sustained release formulation containing itopride hydrochloride was found to improve patient compliance, minimize the side effects and decrease the frequency of administration.

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Keywords:

Itopride hydrochloride, floating drug delivery system, low methoxy pectin, sodium alginate, sunflower oil, oil entrapped floating bead.

Downloads

Published

2013-12-31

How to Cite

1.
Dhople N, Dandag PN, Gadad AP, Pandey CK, V S M. Formulation and Evaluation of Itopride Hydrochloride Floating Beads for Gastroretentive Delivery. Scopus Indexed [Internet]. 2013 Dec. 31 [cited 2024 May 18];6(4):2269-80. Available from: https://www.ijpsnonline.com/index.php/ijpsn/article/view/690

Issue

Section

Research Articles

References

Amit K. Goyal and Goutam Rath (2010). Evaluation of anti-gerd activity of gastro retentive drug delivery system of itopride hydrochloride. Artificial Cells, Blood Substitutes, and Biotechnology 38(4): 200–207.

Badve SS, Sher P, Korde A and Pawar AP (2007). Development of hollow/ porous calcium pectinate beads for floating-pulsatile drug delivery. Eur J Pharma Biopharma 65: 85-93

Chandira RM, Debjit B, Chiranjib and Jayakar B (2010). Formulation and evaluation of gastroretentive drug delivery system of gastroprokinetic drug Itopride hydrochloride. IJPPS 2(1): 53-65.

Gangadharappa HV, Srirupa B, Getyala A, Gupta V N and Kumar T. M (2011). Development, in vitro and in vivo evaluation of novel floating hollow microspheres of rosiglitazone maleate. Der Pharmacia Lettre. 3(4): 299-316.

Higuchi T(1963). J. Pharm. Sci. 52: 1145–1149.

Kikuchi A, Kawabuchi M, Watanabe A, Sugihara M, Sakurai Y and Okano T (1999). Effect of Calcium alginate gel dissolution on release of Dextran with different molecular weights. J Cont Rel 58(1): 21–28.

Kim BH (2009). Handbook of Stability Testing in Pharmaceutical Development. Regulations, Methodologies, and Best Practices. In: Springer Science+Business Media.

Korsmeyer RW, R. Gurny, E. Doelker, P. Buri and N.A. Peppas (1983). Int J Pharm 15: 25–35.

Kumar GS, Sathish D and Rao MY (2012). Formulation and evaluation of gastroretentive floating tablets of cefuroxime axetil. IJRPBS 3(1): 187-195.

Kumar PD, Rathnam G, Prakash CR, Saravanan G, Karthick V and Selvam TP (2010). Formulation and characterization of bilayer floating tablets of ranitidine. RJC 3(2): 368-74.

Peppas NA, Koresmeyer RW and N.A. Peppas (Ed.) (1986). Hydrogels in Medicine and Pharmacy, 3rd edition, CRC Press, Boca Raton, pp 109–136.

Nimase PK and Vidyasagar G (2010). Preparation and evaluation of floating calsium alginate beads of Clarithromycin. Pelagiia Reasearch Library. Der Pharmacia Sinica 1(1): 29–35.

Parmar H, Bakliwal S, Gujarathi N, Rane B and Pawar S (2011). Formulation, optimization and In vitro characterization of mucoadhesive microparticle. IJPBA 2(3): 880-886.

Patel B, Patel J and Thakor R (2010). Improvement of solubility of cinnarizine by using solid dispersion technique. Int Res J Pharm 1(1): 127–131.

Patel FM, Patel ARAN and Rathore KS (2011). Release of metformin hydrochloride from ispaghula sodium alginate beads adhered cock intestinal mucosa. Int J Curr Pharm Res 3(3): 52-55.

Reddy G J, Potu A R, Reddy VP, Jukanti R and Bandari S (2011). Development and in vitro-in vivo Behaviour of Nizatidine Floating Tablets. Der Pharmacia Lettre 3(1):454-65.

Siddalingam PR and Mishra B (2007). Preparation and in vitro characterization of gellan based floating beads of acetohydroxamic acid for eradication of H. pylori. Acta Pharm 57: 413–427.