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
1, 2, 1, 3, 3, 4, 5
- 1Injectables R&D, Alembic Pharmaceuticals Limited, Vadodara, Gujarat, INDIA.
- 2MS&T Department, Gland Pharma Ltd., Visakapatnam, Andhra Pradesh, INDIA.
- 3Department of Pharmacy, Sri Satya Sai University of Technology and Medical Sciences, Sehore, Madhya Pradesh, INDIA.
- 4Department of Chemistry, GITAM Institute of Science, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, INDIA.
- 5Inorganic and Physical Chemistry division, Indian Institute of Chemical Technology, Hyderabad, Telangana, INDIA.
CORRESPONDENCE
Mr. Regulagadda Suryanarayana
Head, Injectables ARD, Alembic Pharmaceuticals Limited, Vadodara-390003, Gujarat, INDIA.
Received: 23-04-2022; Accepted: 11-10-2022.
Volume 57, Issue 1 · pp. 62-73 · 2023 · 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.
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Suryanarayana, R., Vinukonda, A., Saroj, S., Jain, N., Pandey, H., Rudrabhatla, V. P., & Gode, T. (2023). 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, 57(1), 62-73. https://doi.org/10.5530/001954641874
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