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Published on:July 2017
Indian Journal of Pharmaceutical Education and Research, 2017; 51(4):758-764
Original Article | doi:10.5530/ijper.51.4.110

Development of Proniosomal Gel: in-vitro, ex-vivo and in-vivo Characterization


Authors and affiliation (s):

Nadeem Ahmed Farooqui1*, Mousumi Kar2, Ravindra Pal Singh3, Sanjay Jain4

1Department of Pharmaceutics, Suresh Gyan Vihar University, Jaipur, Rajasthan, INDIA.

2Department of Pharmaceutics, College of Pharmacy, IPS Academy, Indore, Madhya Pradesh, INDIA.

3Department of Pharmaceutics, Indore Institute of Pharmacy, Indore, Madhya Pradesh, INDIA.

Abstract:

The aim of the present research work was to characterize the ex-vivo, in-vitro and in-vivo studies of proniosomal (PN) gel of ketorolac tromethamine (KT). Experimental work: Proniosomal suspension was prepared by rotatory flask evaporator with addition of nonionic surfactant (Sodium Cholate) at concentration ranges (3%, 2% and 1%). Co-solvent like isopropanol, butanol and ethanol as well as dimethyl sulphoxide (DMSO), was later added which act as permeability enhancers in gel formulations. Carbopol 940 was added as the gelling agent in proniosomal suspension. Characterization: PN gel acts as percutaneous enhancers on the transdermal permeability hence were investigated for ex-vivo (Franz Diffusion Cell), in-vitro (Membrane Diffusion Technique) and in-vivo (Estimation of KT in serum at different time intervals by RP-HPLC) studies. Effect of KT on acute inflammation was evaluated in rat carrageenan-induced edema model. Results: Proniosomal gel formulation F1 consisting of sodium cholate, isopropanol and soya lecithin, showed highest drug release of 94.048 % in 24 hrs and formulation F9 showed lowest drug release of 73.789 % in 16 hrs. Transdermal flux (J) of formulation F1 was found to be high (7.518±0.041μg/cm2.hr) as compared to other formulations and marketed preparation. Proniosomal formulation (F1), consisting of sodium cholate (concentration 3%) and cosolvent (isopropanol) attained highest penetrability effect, where sodium cholate and isopropanol induced significant changes in membrane permeability as they completely solubilised membrane phospholipids by sodium cholate micelles. In case of F1 formulation, percent inhibition was found to be 66.84%. Serum estimation of Ketorolac Tromethamine (KT) revealed that application of F1formulation produced 4-fold increase in peak plasma concentration within 12 hours and was maintained upto 24 hours as compared to marketed formulation. Eventually a significant in-vitro-in-vivo correlation was achieved and PN formulation of KT shows significant improvement in bioavailability of KT in systemic circulation when applied via topical route as compared to marketed gel preparation.

Key words: Ketorolac Tromethamine, Carbopol 940, Proniosomal Gel, Permeability, inflammation.

 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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