Author(s): Surendra S Agrawal, Pravina N Gurjar, Ashwini Mutke


DOI: 10.52711/0974-360X.2022.00655   

Address: Surendra S Agrawal1, Pravina N Gurjar2*, Ashwini Mutke2
1Datta Meghe College of Pharmacy & Technology Management, DMIMS (DU) Wardha and Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM’S NMIMS, Mumbai.
2Sharadchandra Pawar College of Pharmacy, Savitribai Phule Pune University, Otur, Dist Junnar, India.
*Corresponding Author

Published In:   Volume - 15,      Issue - 9,     Year - 2022

Objective: The purpose of this study was to prepare pregabalin loaded niosomal dispersion for controlled release of drug and achieve therapeutic effect for longer duration than the available drug delivery. Methods: The niosome carriers were formulated using non-ionic surfactants and cholesterol ratio of 1:1. The effects of non-ionic surfactant and cholesterol on the average particle size and percent entrapment efficiency were studied. Optimization of the formulation was performed by factorial design using Design expert software 11.0. Results: Based on the solutions provided by the design expert software, the formulation resulted in the particle size of 490 nm and 92.4% EE as compared to the predicted values of 491.02nm for particle size and 90% EE. The optimized niosome carriers appeared as multilamellar vesicles, as evident by a scanning electron microscopy study. Anticonvulsant activity of the niosomal dispersion was determined by Pentylenetetrazol (PTZ) induced convulsions in mice. Pregabalin-loaded niosomal dispersion displayed a sustained and moderate anticonvulsant effect upto 24 h. Conclusion: Therefore, the present study revealed the possibility of using non-ionic surfactant niosomes as carrier systems for prolonged release of pregabalin.

Cite this article:
Surendra S Agrawal, Pravina N Gurjar, Ashwini Mutke. DOE based Formulation development and Evaluation of Niosomal dispersion of Pregabalin. Research Journal of Pharmacy and Technology. 2022; 15(9):3912-8. doi: 10.52711/0974-360X.2022.00655

Surendra S Agrawal, Pravina N Gurjar, Ashwini Mutke. DOE based Formulation development and Evaluation of Niosomal dispersion of Pregabalin. Research Journal of Pharmacy and Technology. 2022; 15(9):3912-8. doi: 10.52711/0974-360X.2022.00655   Available on:

1.    Yasuhara T, Agari T, Kameda M, Kondo A, Kuramoto S, Jing M, Sasaki T, Toyoshima A, Sasada S, Sato K, Shinko A. Regenerative medicine for epilepsy: from basic research to clinical application. International Journal of Molecular Sciences. 2013 Dec;14(12):23390-401.
2.    Hermann B, Seidenberg M, Jones J. The neurobehavioural comorbidities of epilepsy: can a natural history be developed?. The Lancet Neurology. 2008 Feb 1;7(2):151-60.
3.    Kshirsagar R, Shinde G, Kamble P, Mundade S, Mudda SM, inventors; MICRO LABS Ltd, assignee. Pharmaceutical compositions containing pregabalin. United States Patent Application US 12/818,060. 2011 Jun 9.
4.    Agrawal S, Gurjar P, Mazumdar A. Development of Pregabalin Loaded Solid Lipid Nano Particles, 22nd Dubai International Pharmaceuticals and Technologies Conference and Exhibition (DUPHAT), 2017, March 7-9, Dubai, UAE.
5.    Mozafari MR, Pardakhty A, Azarmi S, Jazayeri JA, Nokhodchi A, Omri A. Role of nanocarrier systems in cancer nanotherapy. Journal of Liposome Research. 2009 Dec 1;19(4):310-21.
6.    Agrawal S, Londhe V, Gaud R. Niosomes: Layered Delivery System For Drug Targeting. IJSR. 2014 Jan;3(1):213-17.
7.    Carafa M, Alhaique F, Marianecci C, Paolino D, Fresta M, inventors; Universita degli Studi" Magna Graecia" di Catanzaro, Universita degli Studi di Roma La Sapienza, assignee. Niosomes, freeze-dried powder thereof and their use in treatment. United States Patent Application US 13/519,200. 2012 Nov 15.
8.    Manosroi A, Chutoprapat R, Abe M, Manosroi J. Characteristics of niosomes prepared by supercritical carbon dioxide (scCO2) fluid. International Journal of Pharmaceutics. 2008 Mar 20;352(1-2):248-55.
9.    Kazi KM, Mandal AS, Biswas N, Guha A, Chatterjee S, Behera M, Kuotsu K. Niosome: a future of targeted drug delivery systems. Journal of Advanced Pharmaceutical Technology and Research. 2010 Oct;1(4):374.
10.    Lakavath Sunil Kumar. A Review on Novel vesicular systems for enhanced Oral bioavailability of Lipophilic drugs. Research Journal of Pharmaceutical Dosage Forms and Technology. 2021; 13(2):139-6.
11.    Nasir A, Harikumar SL, Amanpreet K. Niosomes: an excellent tool for drug delivery. international Journal of Research in Pharmacy and Chemistry. 2012;2(2):479-87.
12.    Pardakhty A, Varshosaz J, Rouholamini A. In vitro study of polyoxyethylene alkyl ether niosomes for delivery of insulin. International Journal of Pharmaceutics. 2007 Jan 10;328(2):130-41.
13.    Awate PS, Pimple TP, Pananchery JF, Jain AS. Formulation and Evaluation of Berberine HCl as Niosomal Drug Delivery System. Asian Journal of Pharmaceutical Research. 2020 Aug 4;10(3):149-59.
14.    Parmar RP, Parmar RB. Conceptual aspects of vesicular drug delivery system with special reference to niosome. Asian Journal of Pharmacy and Technology. 2013;3(2):52-9.
15.    Blazek–Welsh AI, Rhodes DG. SEM imaging predicts quality of niosomes from maltodextrin-based proniosomes. Pharmaceutical Research. 2001 May 1;18(5):656-61.
16.    Alsarra IA, Bosela AA, Ahmed SM, Mahrous GM. Proniosomes as a drug carrier for transdermal delivery of ketorolac. European Journal of Pharmaceutics and Biopharmaceutics. 2005 Apr 1;59(3):485-90.
17.    Marianecci C, Rinaldi F, Mastriota M, Pieretti S, Trapasso E, Paolino D, Carafa M. Anti-inflammatory activity of novel ammonium glycyrrhizinate/niosomes delivery system: human and murine models. Journal of Controlled Release. 2012 Nov 28;164(1):17-25.
18.    Kumar GP, Rajeshwarrao P. Nonionic surfactant vesicular systems for effective drug delivery—an overview. Acta Pharmaceutica Sinica B. 2011 Dec 1;1(4):208-19.
19.    Paolino D, Cosco D, Muzzalupo R, Trapasso E, Picci N, Fresta M. Innovative bola-surfactant niosomes as topical delivery systems of 5-fluorouracil for the treatment of skin cancer. International Journal of Pharmaceutics. 2008 Apr 2;353(1-2):233-42.
20.    Fang JY, Hong CT, Chiu WT, Wang YY. Effect of liposomes and niosomes on skin permeation of enoxacin. International Journal of Pharmaceutics. 2001 May 21;219(1-2):61-72.
21.    Devi SG, Udupa N. Niosomal Sumartriptan Succinate For Nasal Administration. Indian Journal of Pharmaceutical Sciences. 2000;62(6):479.
22.    Kishor BD, Darekar AB, Saudagar RB. An Overview a Novel Trend in Drug Delivery: Niosomes. Research Journal of Pharmaceutical Dosage Forms and Technology. 2016 Jul 1;8(3):211.
23.    Srinivas S, Kumar YA, Hemanth A, Anitha M. Preparation and evaluation of niosomes containing aceclofenac. Dig J Nanomater Bios. 2010 Mar 1;5(1):249-54.
24.    Girigoswami A, Das S, De S. Fluorescence and dynamic light scattering studies of niosomes-membrane mimetic systems. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2006 Jul 1;64(4):859-66.
25.    Hofland HE, Bouwstra JA, Verhoef JC, Buckton G, Chowdry BZ, Ponec M, Junginger HE. Safety aspects of non‐ionic surfactant vesicles: a toxicity study related to the physicochemical characteristics of non‐ionic surfactants. Journal of Pharmacy and Pharmacology. 1992 Apr;44(4):287-94.
26.    Moghassemi S, Hadjizadeh A. Nano-niosomes as nanoscale drug delivery systems: an illustrated review. Journal of Controlled Release. 2014 Jul 10;185:22-36.
27.    Ramadan WM, Singh AP. Preparation of Acyclovir Loaded Non ionic Surfactant Vesicles (Niosomes) Using Reverse Phase Evaporation Technique. Research Journal of Pharmacy and Technology. 2009 Dec 28;2(4):793-5.
28.    NVS M, Saini A. Niosomes: a novel drug delivery system. Int. J. Res. Pharm. Chem. 2011;1(3):498-511.
29.    Rogerson A, Cummings J, Florence AT. Adriamycin-loaded niosomes: drug entrapment, stability and release. Journal of Microencapsulation. 1987 Jan 1;4(4):321-8.
30.    Rogerson A, Cummings J, Willmott N, Florence AT. The distribution of doxorubicin in mice following administration in niosomes. Journal of Pharmacy and Pharmacology. 1988 May;40(5):337-42.
31.    Ghori SS, Qureshi MS, Khan MS, Khanam A, Patel J. Anticonvulsant Activity of Leaf Extracts of Anacardium occidentale. Linn. Research Journal of Pharmacology and Pharmacodynamics. 2011 Apr 28;3(2):72-6.
32.    Pandey P, Dua K, Dureja H. Erlotinib loaded chitosan nanoparticles: Formulation, physicochemical characterization and cytotoxic potential. International Journal of Biological Macromolecules. 2019 Oct 15;139:1304-16.
33.    Yogita M. Kolekar. Understanding of DoE and its advantages in Pharmaceutical development as per QbD Approach. Asian J. Pharm. Tech. 2019; 9 (4):271-275.
34.    Seelam Ramya Krishna, A. Ramu, S. Vidyadhara. Study of Influence of Formulation and process variables on entrapment efficiency and particle size of Floating microballoons of Clopidogrel bisulphate by DoE. Research J. Pharm. and Tech 2020; 13(9):4373-4380.
35.    R. Narayana Charyulu, Gautami Biswas, Travassos Pearl Wilma, Fiona Melreen Castelino, Ravi G. S. Development of Scopolamine Hydrobromide Orodispersible Films as an Anti-sialagogue in Dentistry: Optimization and in vitro Evaluation. Research J. Pharm. and Tech. 2020; 13(10):4570-4578.
36.    Firthouse PM, Halith SM, Wahab SU, Sirajudeen M, Mohideen SK. Formulation and evaluation of miconazole niosomes. Int J PharmTech Res. 2011;3(2):1019-22.
37.    Schreier H, Bouwstra J. Liposomes and niosomes as topical drug carriers: dermal and transdermal drug delivery. Journal of Controlled Release. 1994 Apr 1;30(1):1-5.
38.    Muzzalupo R, Tavano L, Cassano R, Trombino S, Ferrarelli T, Picci N. A new approach for the evaluation of niosomes as effective transdermal drug delivery systems. European Journal of Pharmaceutics and Biopharmaceutics. 2011 Sep 1;79(1):28-35.
39.    Cifter U, Turkyilmaz A, Oner L, inventors; Sanovel Ilac Sanayi ve Ticaret AS, assignee. Extended release gliclazide formulations. United States Patent Application US 12/171,932. 2009 Jan 15.
40.    Lashkarbolooki M, Ayatollahi S, Riazi M. Mechanistic study on the dynamic interfacial tension of crude oil + water systems: Experimental and modeling approaches. Journal of Industrial and Engineering Chemistry. 2016 Mar 25;35:408-16.
41.    Vader P, Mol EA, Pasterkamp G, Schiffelers RM. Extracellular vesicles for drug delivery. Advanced Drug Delivery Reviews. 2016 Nov 15;106:148-56.
42.    Hansen SL, Sperling BB, Sánchez C. Anticonvulsant and antiepileptogenic effects of GABAA receptor ligands in pentylenetetrazole-kindled mice. Progress in Neuro-Psychopharmacology and Biological Psychiatry. 2004 Jan 1;28(1):105-13.

Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

56th percentile
Powered by  Scopus

SCImago Journal & Country Rank

Recent Articles


Not Available