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Designing of zolmitriptan loaded nanosomes for the treatment of acute migraine

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In this work PC Nanosome of Zolmitriptan was formed by using the Ether injection method. Thin film hydration/probe method also used but its not the appropriate method for Nanosome preparation because larger particles size and more agglomerates were found by this method At the Preformulation study there was not any physical and chemical interaction between drug and Lipids had been evaluated by DSC and FTIR respectively. The standard curve of Zolmitriptan was prepared by using 0.1M HCl and lambda max at 274.8 nm.

Preformulation study carried out indicates that there is no drug Lipids interaction, and which is important for proceeding to further experimental work. The UV Spectrum of obtained of drug in 0.1 M HCl and indicate of λ max-274.8nm in 0.1M HCl.

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A full Factorial design was employed to statistically investigate the effect of different formulations variables on the properties of zolmitriptan loaded Nanosomes. The type of lipids X1, lipid to cholesterol ratios X2 were selected as the independent variables. The % Entrapment efficiency Y1, Particle size Y2, PDI Y3, Zeta Potential Y4 and zolmitriptan release y5 were selected as the dependent variable. Desirability was calculated for selection of optimized formula which was subjected for further investigation.

The size of the Nanosomes and the drug efficiency in Vesicles were highly dependent on the different types of Lipids i.e. PC, HPC & combination Formulations. Formulation F3 shows particles size The % entrapment efficiency is dependent upon the types and ratio of lipids concentration. %EE is found higher in Formulation prepared by PC as compare to Formulation prepared by HPC. Formulation F3 and shows the maximum entrapment efficiency (57%).

All the formulations show more than 90% release. Formulations prepared by PC shows rapid and maximum release within 8 hrs as compare to Formulation prepared by HPC & combination formulations prepared by HPC & PC. Formulations F3 followed the Higuchi model kinetics with regression value 0.961. The stability of Nanosomes is dependent upon surface charge on lipid vesicles. The PC Lipid formulation F3 shows good stability, having zeta -26.

S.No. Factors independent Variables Factors Dependent Variables

Variables X1-Type of lipids X2- Ratio OF Lipid:Chol Y1 (%EE) Y2 (Size nm) Y3 (PDI) Y4 (Zeta Potential) Y5 (% Release)

1 PC (40) 4:1 32 ± 0.56 138.1 ± 3.2 0.353 ± 0.23 -13.5 93.31 ±1.1

2 PC(80) 8:1 43 ± 0.83 149.2 ± 4.5 0.361 ± 0.4 -24 95.33.89 ±2.5

3 PC(120) 12:1 57 ± 0.45 182.8 ± 5.6 0.378 ± 0.2 -26 96.34.26 ±4.6

4 HPC (40) 4:1 29 ± 0.75 502.6 ± 7.8 0.415 ± 0.8 -9.51 94.43.25 ±3.2

5 HPC (80) 8:1 41 ± 0.86 701.7 ± 3.34 0.443 ± 0.5 -10.23 90.31 ±8.1

6 HPC (120) 12:1 52 ± 1.2 812.3 ± 9.2 0.462 ± 0.9 -12.32 95.12 ±4.5

7 PC:HPC (20:20) 2:2:1 28 ± 0.45 369.1 ± 5.66 0.423 ± 0.3 -6.56 91.11 ±2.3

8 PC:HPC (40:40) 4:4:1 39 ± 0.66 456.1 ± 8.56 0.406 ± 0.20 -8.23 93.21 ±5.6

9 PC:HPC (60:60) 6:6:1 49 ± 2.1 655.6 ± 10.23 0.430 ± 0.58 -10.45 93.23 ±

Ether injection method is selected for Nanosome preparation. Nanosome lipids enriched vesicles were successfully prepared and formulation F3 shows smaller particles size 182.8., higher entrapment efficiency 57% & 96% release in 8 hrs as compare to others & followed Higuchi release model with regression value 0.961. This formulation may be use to treat the acute migraine attacks.

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