Statistically Optimized Facile Development, Characterization and Evaluation of Niosomal Nasal Drug Delivery System of Ropinirole Hydrochloride: In vitro Drug Release, Cytotoxicity and ex vivo Permeability Studies

Indian Journal of Pharmaceutical Education and Research

  • Regulagadda Suryanarayana1Injectables R&D, Alembic Pharmaceuticals Limited, Vadodara, Gujarat, INDIA.
  • Anjaneyulu Vinukonda2MS&T Department, Gland Pharma Ltd., Visakapatnam, Andhra Pradesh, INDIA.
  • Seema Saroj1Injectables R&D, Alembic Pharmaceuticals Limited, Vadodara, Gujarat, INDIA.
  • Neelu Jain3Department of Pharmacy, Sri Satya Sai University of Technology and Medical Sciences, Sehore, Madhya Pradesh, INDIA.
  • Harish Pandey3Department of Pharmacy, Sri Satya Sai University of Technology and Medical Sciences, Sehore, Madhya Pradesh, INDIA.
  • VSA Pavan Rudrabhatla4Department of Chemistry, GITAM Institute of Science, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.
  • Thrimurthulu Gode5Inorganic and Physical Chemistry division, Indian Institute of Chemical Technology, Hyderabad, Telangana, INDIA.

Volume 57 Issue 1 Pages 62-73

DOI: 10.5530/001954641874

Abstract

Introduction: Nasal route is an alluring route for direct drug delivery to the central nervous system (CNS), owing to its avoidance of the hepatic first-pass metabolism and deciphering the blood–brain barrier passage issues. ROP-HCl has a lower experimental BBB permeability therefore ROP-HCl freighted niosomes were fabricated by ethanol injection method and served two purposes one being a novel Niosomal formulation impacting the permeability and other obtaining a sustained release property which likely would lead to an improved bioavailability of ROP-HCl. Objectives: The present study is aimed to develop a stable non-ionic surfactant vesicle; Niosomes embodying Ropinarole Hydrochloride (ROP-HCl) for ameliorated treatment of Parkinson’s disease (PD) by statistical optimization employing a 3-level factorial design using Design Expert® software. Materials and Methods: All the formulations were characterized physiochemically and morphologically. Additionally, the drug and excipients interaction studies were evaluated using Differential scanning calorimetry (DSC), X-ray diffraction (XRD) and Fourier-transform infrared spectroscopy (FTIR). Further, in vitro release kinetics using DD solver excel add-in and mechanism was studied for developed Niosomal formulation. Cytotoxicity study was studied in Raw 264.7 cells. in a concentration dependent manner and ex vivo, permeability was done using sheep mucosa. Toxicity was studied by histological examination. Results: The IC50 value of developed Niosomes was lower than drug itself and further the permeability of developed Niosomes was considerably enhanced compared to ROP-HCl alone. Histological examination revealed safe nature of developed formulation. Conclusion: These results conveyed that, Niosomes can be a valuable carrier for the nasal delivery of ROP-HCl to CNS.

Keywords

  • Ropinirole hydrochloride
  • Statistical approach
  • Niosomes
  • Nasal drug delivery
  • cytotoxicity
  • Release kinetics
  • Ex-vivo permeability
  • Toxicity study
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