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Published on:November 2021
Indian Journal of Pharmaceutical Education and Research, 2021; 55(4):996-1007
Original Article | doi:10.5530/ijper.55.4.200

Formulation Development and Characterization of Nanoemulsion-based Gel for Topical Application of Raloxifene Hydrochloride


Authors and affiliation (s):

Tej Pratap Singh1,*, Farhan Jalees Ahmad2, Gaurav Kumar Jain3, Navneet Verma4

1School of Pharmaceutical Sciences, IFTM University, Moradabad, Uttar Pradesh, INDIA.

2Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, INDIA.

3Department of Pharmaceutics, Delhi Pharmaceutical Science and Research University, New Delhi, INDIA.

4Pharmacy Academy, IFTM University, Moradabad, Uttar Pradesh, INDIA.

Abstract:

Background: Nanoemulsion-gels are nanosized droplets, and thermodynamically stable oil-in-water dispersion. Raloxifene hydrochloride a selective estrogen receptor modulator currently its more research is being laid on in treatment of diseases in estrogen deficient postmenopausal women. Objectives: The objective of this research was to formulate nanoemulsion-gel of raloxifene for topical delivery. Materials and Methods: The oil, surfactant and cosurfactant were selected on the basis of maximal solubility of raloxifene. The screening of surfactant and cosurfactant were on the basis of their emulsification efficacy with oil to form homogenization mixture on gentle shaking. The nanoemulsions were prepared by ternary phase diagram method using different ratio of oil and surfactant-cosurfactant mixture (Smix) and nanoemulsion region obtained by excel sheet design triangular software. Results: The composition of the optimized nanoemulsion contains 0.072 %w/v raloxifene, 14.29 %v/v oil phase (Labrafil-M2125CS), 33.33%v/v Smix (Cremophor-RH40:Transcutol-P, 1:1), and 52.38%v/v distilled water. The optimized nanoemulsion was converted into gel form by addition of 1%w/v Carbopol-934. The formulation NEG2 possessed droplets size 56.73±0.58 nm, zeta-potential -22.20±0.02 mV, spreadability 18.35±0.45 gcm-1sec-1 and viscosity 98.54±0.39 mPas. The ex vivo permeation of NEG2 (22.38%) was comparatively lower to the permeation of NE3 (26.68%). Also, flux of NEG2 (11.96±0.4 μgcm-2h-1) significantly lower permeability than NE3(16.28±0.7μgcm-2h-1). But nanoemulsion-gel form is maintained more effective concentration within skin due to adhesive nature of gel form remain contact on the applied area for a long duration. Nanoemulsion-gel found stable during six months. Conclusion: The outcome of this study points out the nanoemulsiongel better than nanoemulsion because of adhesive nature and less permeability. Consequently, It maintain more raloxifene concentration at applied skin.

Key words: Raloxifene hydrochloride, Nanoemulsion gel, Ternary phase diagram, Zeta potential, Permeation.

 




 

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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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