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Indian Journal of Pharmaceutical Education and ResearchNOW IN
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IJPER · Lens · 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

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Article · Volume 57, Issue 1 · pp. 62–73

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

Regulagadda Suryanarayana1, Anjaneyulu Vinukonda2, Seema Saroj1, Neelu Jain3, Harish Pandey3, VSA Pavan Rudrabhatla4, Thrimurthulu Gode5

  1. 1Injectables R&D, Alembic Pharmaceuticals Limited, Vadodara, Gujarat, INDIA.
  2. 2MS&T Department, Gland Pharma Ltd., Visakapatnam, Andhra Pradesh, INDIA.
  3. 3Department of Pharmacy, Sri Satya Sai University of Technology and Medical Sciences, Sehore, Madhya Pradesh, INDIA.
  4. 4Department of Chemistry, GITAM Institute of Science, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.
  5. 5Inorganic and Physical Chemistry division, Indian Institute of Chemical Technology, Hyderabad, Telangana, INDIA.

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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