Research Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Design, Development and Characterization of Flash Release Wafers Containing Levocetrizine Hydrochloride and Montelukast Sodium


Affiliations
1 Department of Pharmaceutics, PSG College of Pharmacy, Coimbatore - 641004, Tamil Nadu,, India
     

   Subscribe/Renew Journal


The main objective of the current research investigation was to develop and characterize flash release wafers containing Levocetrizine hydrochloride and Montelukast sodium. The formulation of flash release wafers was done by the solvent casting method. HPMC E5 LV, HPMC E50 LV, HPMC Lab grade polymer and plasticizer like glycerol, di-butyl phthalate were screened for wafers formation. Amongst them, HPMC lab-grade as polymer basis and glycerol as plasticizer showed good smooth wafers, acceptable thickness, clear and easy to peel off from the Petri plate. There was no interaction found between drug-drug and drug-excipients by FT-IR spectral analysis and shown that the ingredients used for the formulation of wafers were highly compatible. Then the optimized flash release wafers were evaluated for main parameters like disintegration time, drug content, surface pH, thickness and percentage drug release. Batch ML-7 was found to be optimized formulation of wafers which showed the satisfactory acceptable results of drug content 99.56±1.03of Levocetrizine hydrochloride and 98.92±2.33 of Montelukast sodium, least disintegration time of about 15±0.68 seconds, surface pH was 6.78± 0.010 and percentage drug release of Levocetrizine hydrochloride and Montelukast sodium was 96% and 97.5% at 5th minute. Hence it was found that the optimized formulation ML-7 showed much faster drug release than the oral marketed immediate-release tablet formulation in a 5th minute. This depicted that the formulation containing a lower concentration of polymer and a higher concentration of superdisintegrates showed a positive effect on disintegration time and drug release.

Keywords

Flash release wafers, Levocetrizine hydrochloride, Montelukast sodium, Solvent casting method.
Subscription Login to verify subscription
User
Notifications
Font Size


  • Seema VP, et al. A New self micro emulsifying mouth dissolving film. Indian Journal Pharmaceutical Education and Research. 2016; 50(3): 191-199.

  • Irfan M, et al. Orally disintegrating films: A modern expansion in drug delivery system. Saudi Journal of Pharmacy. 2015; 24(5): 537-546.

  • Aliaa N, et al. Characterisation and optimization of oro dispersible mosapride film formulations. AAPS PharmSci Tech.2011; 12(4): 1384-1392.

  • Arya A, et al. Fast dissolving oral films: An innovative drug delivery system and dosage form. Int J Chem Tech Res.2010; 2(1): 576-583.

  • Kai BL, et al. Characterisation of oral disintegrating film containing Donapezil for Alzheimer disease. AAPS PharmSci Tech.2012; 13(1): 134-142.

  • Sunil KB, et al. Dynamic release of Amoxicillin from orally dissolving film composed of casein and sodium alginate. J Drug Res Dev.2017; 3(2): 1-7.

  • Mahajan A, et al. A short review on novel approach in oral fast dissolving drug delivery system and their patents. Adv biological Res.2011; 5(6): 291-303.

  • Elibary AA, et al. Enhanced dissolution of meloxicam from orodispersible tablets prepared by different methods. Bulletin of Faculty of Pharmacy.2012; 50(2): 89-97.

  • Saini S, et al. Fast dissolving films: Innovative drug delivery systems. Pharmacology Online Newsletter.2011; 1(2): 919-928.

  • Malke M, et al. Formulation and evaluation of oxacarbazine fast dissolving tablet. Indian J PharmSci.2007; 69(2): 211-214.

  • Duaa SA, Hind EZ. Solid state compatibility studies between montelukast sodium and levocetrizine. Asian J Pharm Clinc Res.2018;11(3):368-374.

  • Y.M. Issa, et al. Methods of determination of levocetrizine hydrochloride: A Review. Egypt. J. Anal. Chem.2014;23:1-22. https://www.researchgate.net/publication/313442946.

  • Vipan G, et al. Efficacy of montelukast and levocetrizine as treatment for Allergic rhinitis. Journal of Allergy and Therapy.2010;1(1):2-4.

  • Kapp A, Pichler WJ. Levocetrizine is an effective treatment in patients suffering from chronic idiopathic urticaria: A randomized double-blind, placebo-controlled, parallel, multi center study. Int J Dermatol.2006;45(4):469-474.

  • Syed A, et al. Formulation and invitro evaluation of levocetrizinedihydrochloride and montelukast sodium bilayered tablet for bi model drug release. Indian J Res Pharm and Biotech.2014;2(6):1460-1464.

  • Ali S, Quadir A. High molecular weight povidone polymer based films for fast dissolving drug delivery applications. Drug Del Technol.2007;7(6):36-43.

  • Gupta MM, et al. Enhancement of dissolution rate of rapidly dissolving oral film of meclizine hydrochloride by complexation of meclizine hydrochloride with beta-cyclodextrine. J Applied PharmSci.2011;1(9): 150-153.

  • MD Khaja A, et al. Development and evaluation of fast dissolving oral film of losartan potassium. Int J Pharm Sci Rev Res.2015;35(1):108-113.

  • Kamalesh U, et al. Formulation and evaluation of mouth dissolving films of paracetamol. Int J Pharm PharmSci.2014;6(5):200-202.

  • KM Maheswari, et al. Development and evaluation of mouth dissolving films of amlodipine besylate for enhanced therapeutic efficacy. Available from: URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4590810/.

  • Bura S, et al. Oral fast disintegrating films of alfuzosin Hydrochloride. Int J Recent Sci Res.2019;10(12):36577-36581.

  • Nagendrakumar D, et al. Formulation and evaluation of fast dissolving oral films of metoprolol succinate. Int J Eng Applied Sci.2015;6(4):28-38.

  • Sneha J, et al. Solubility enhancement techniques: A review. J Pharm Sci Res.2018;10(9):2205-2211.

  • Sandeep K, Pritam S. Various techniques for solubility enhancement: An overview. Pharm Inv J.2016;5(1):23-28.

  • Naranyana PR, et al. Formulation and evaluation of fast dissolving films of Loratidine by solvent casting method. J Pharm Inv.2013;2(2):31-35.

  • Choudhary D, et al. Formulation and evaluation of fast dissolving films of Levocetrizinedihydrochloride using different grades of methocel. J Pharm Res.2014;4(9):2919-24.

  • Dinge A, Nagarsenkar M. Formulation and evaluation of fast dissolving films for delivery of triclosan to the oral cavity. Available from: URL: https://pubmed.ncbi.nlm.nih.gov/18431674/

  • Bhujan B, Jangra S. Formulation and evaluation of fast dissolving sublingual films of rizatriptan benzoate. Int J Drug Dev Res.2012;4(1):97-107.

  • Heer D, et al. Development of fast dissolving oral films and tablets of Cinnarizine: effect of superdisintegrants. Int J Pharm PharmSci.2014;6(2):186-191.

  • Setouhy D, Malak N. Formulation of a novel Tianeptine sodium Orodispersible film. AAPS PharmSciTech.2010;11(3):1018-25.

  • Keshari A, et al. Fast dissolving oral film: A novel and innovative drug delivery system. Int J PharmSci Res.2014;5(3):92-95.

  • Swapna K, et al. Formulation and evaluation of montelukast sodium and levocetrizinedihydrochloride sublingual tablets. Asian J Pharm Clinc Res.2015;8(1):171-175.

  • Desai P, Basu B. Design and evaluation of fast dissolving film of domperidone. Int Res J Pharm.2012;3(9):134-145.

  • Richard W. Koresmeyer, et al. Mechanisms of solute release from porous hydrophilic polymers. International Journal of Pharmaceutics. 1983; 15(1): 25-35.


Abstract Views: 101

PDF Views: 0




  • Design, Development and Characterization of Flash Release Wafers Containing Levocetrizine Hydrochloride and Montelukast Sodium

Abstract Views: 101  |  PDF Views: 0

Authors

S. Subramanian
Department of Pharmaceutics, PSG College of Pharmacy, Coimbatore - 641004, Tamil Nadu,, India
P. Mani
Department of Pharmaceutics, PSG College of Pharmacy, Coimbatore - 641004, Tamil Nadu,, India

Abstract


The main objective of the current research investigation was to develop and characterize flash release wafers containing Levocetrizine hydrochloride and Montelukast sodium. The formulation of flash release wafers was done by the solvent casting method. HPMC E5 LV, HPMC E50 LV, HPMC Lab grade polymer and plasticizer like glycerol, di-butyl phthalate were screened for wafers formation. Amongst them, HPMC lab-grade as polymer basis and glycerol as plasticizer showed good smooth wafers, acceptable thickness, clear and easy to peel off from the Petri plate. There was no interaction found between drug-drug and drug-excipients by FT-IR spectral analysis and shown that the ingredients used for the formulation of wafers were highly compatible. Then the optimized flash release wafers were evaluated for main parameters like disintegration time, drug content, surface pH, thickness and percentage drug release. Batch ML-7 was found to be optimized formulation of wafers which showed the satisfactory acceptable results of drug content 99.56±1.03of Levocetrizine hydrochloride and 98.92±2.33 of Montelukast sodium, least disintegration time of about 15±0.68 seconds, surface pH was 6.78± 0.010 and percentage drug release of Levocetrizine hydrochloride and Montelukast sodium was 96% and 97.5% at 5th minute. Hence it was found that the optimized formulation ML-7 showed much faster drug release than the oral marketed immediate-release tablet formulation in a 5th minute. This depicted that the formulation containing a lower concentration of polymer and a higher concentration of superdisintegrates showed a positive effect on disintegration time and drug release.

Keywords


Flash release wafers, Levocetrizine hydrochloride, Montelukast sodium, Solvent casting method.

References