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Preparation, characterization and stability study of dutasteride loaded nanoemulsion for treatment of benign prostatic hypertrophy.

Ali MS, Alam MS, Alam N, Siddiqui MR - Iran J Pharm Res (2014)

Bottom Line: It was found that droplet size, viscosity and refractive index were slightly increased at refrigerator and room temperature in 3 months period.The shelf-life of optimized nanoemulsion A1 was found to be 2.18 years at room temperature.These results indicated that both physical as well as chemical stability of dutasteride in nanoemulsion formulation.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmaceutics, College of Pharmacy, Jazan University, Jazan, K.S.A.

ABSTRACT
Benign prostatic hyperplasia (BPH)is the most common condition in aging men, associated with lower urinary tract symptoms. It is caused due to the augmented levels of the androgen dihydrotestosterone. Dutasteride, a 5α-Reductase inhibitor has been recommended for the treatment of BPH upon oral administration. However, long term oral administration of dutasteride may cause sexual problem in man. Therefore the main objective of this study was to develop transdermal patch having nanoemulsion gel of dutasteride in order to enhance physical and chemical stability and eliminate adverse effect of dutasteride. Optimized nanoemulsion was prepared by aqueous phase-titration method and characterized by droplet size, viscosity and refractive index. In-vitro skin permeation of dutasteride through rat abdominal skin was determined by the Franz diffusion cell.Significant increase in the steady state flux (J ss), permeability coefficient (K p) and enhancement ratio (E r) was observed in optimized nanoemulsion formulation A1 (p < 0.05). The Er of optimized nanoemulsion A1 was found to be 1.52 times with respect to control which indicates transdermal delivery may be better approach for BPH. Stability studies were performed for the period of 3 months. It was found that droplet size, viscosity and refractive index were slightly increased at refrigerator and room temperature in 3 months period. However, the changes in these parameters were not statistically significant (p ≥ 0.05). The shelf-life of optimized nanoemulsion A1 was found to be 2.18 years at room temperature. These results indicated that both physical as well as chemical stability of dutasteride in nanoemulsion formulation.

No MeSH data available.


Related in: MedlinePlus

Solubility of dutasteride in different surfactants and co-surfactants at 25 °C (mean ± SD, n = 3).
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Figure 2: Solubility of dutasteride in different surfactants and co-surfactants at 25 °C (mean ± SD, n = 3).

Mentions: After finalizingeucalyptus oil: oleic acid (1.5:1) as oil phase, the main aim remains is to identify the surfactant that has the highest solubilization capacity for the oil. In the present study, five surfactants including lecithin, brij35, tween-20, tween-60 and tween-80 were selected for screening. Nonionic surfactants were selected because of they are known to be less affected by pH and changes in ionic strength. They are also regarded as safe, and biocompatible. During the study ionic surfactants were omittedbecause of their toxicological concerns. The selection of the surfactant was based on solubility of drug without addition of co-surfactant. It was observed that tween-20 has greatest solubility for the drug (Figure 2).


Preparation, characterization and stability study of dutasteride loaded nanoemulsion for treatment of benign prostatic hypertrophy.

Ali MS, Alam MS, Alam N, Siddiqui MR - Iran J Pharm Res (2014)

Solubility of dutasteride in different surfactants and co-surfactants at 25 °C (mean ± SD, n = 3).
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4232777&req=5

Figure 2: Solubility of dutasteride in different surfactants and co-surfactants at 25 °C (mean ± SD, n = 3).
Mentions: After finalizingeucalyptus oil: oleic acid (1.5:1) as oil phase, the main aim remains is to identify the surfactant that has the highest solubilization capacity for the oil. In the present study, five surfactants including lecithin, brij35, tween-20, tween-60 and tween-80 were selected for screening. Nonionic surfactants were selected because of they are known to be less affected by pH and changes in ionic strength. They are also regarded as safe, and biocompatible. During the study ionic surfactants were omittedbecause of their toxicological concerns. The selection of the surfactant was based on solubility of drug without addition of co-surfactant. It was observed that tween-20 has greatest solubility for the drug (Figure 2).

Bottom Line: It was found that droplet size, viscosity and refractive index were slightly increased at refrigerator and room temperature in 3 months period.The shelf-life of optimized nanoemulsion A1 was found to be 2.18 years at room temperature.These results indicated that both physical as well as chemical stability of dutasteride in nanoemulsion formulation.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmaceutics, College of Pharmacy, Jazan University, Jazan, K.S.A.

ABSTRACT
Benign prostatic hyperplasia (BPH)is the most common condition in aging men, associated with lower urinary tract symptoms. It is caused due to the augmented levels of the androgen dihydrotestosterone. Dutasteride, a 5α-Reductase inhibitor has been recommended for the treatment of BPH upon oral administration. However, long term oral administration of dutasteride may cause sexual problem in man. Therefore the main objective of this study was to develop transdermal patch having nanoemulsion gel of dutasteride in order to enhance physical and chemical stability and eliminate adverse effect of dutasteride. Optimized nanoemulsion was prepared by aqueous phase-titration method and characterized by droplet size, viscosity and refractive index. In-vitro skin permeation of dutasteride through rat abdominal skin was determined by the Franz diffusion cell.Significant increase in the steady state flux (J ss), permeability coefficient (K p) and enhancement ratio (E r) was observed in optimized nanoemulsion formulation A1 (p < 0.05). The Er of optimized nanoemulsion A1 was found to be 1.52 times with respect to control which indicates transdermal delivery may be better approach for BPH. Stability studies were performed for the period of 3 months. It was found that droplet size, viscosity and refractive index were slightly increased at refrigerator and room temperature in 3 months period. However, the changes in these parameters were not statistically significant (p ≥ 0.05). The shelf-life of optimized nanoemulsion A1 was found to be 2.18 years at room temperature. These results indicated that both physical as well as chemical stability of dutasteride in nanoemulsion formulation.

No MeSH data available.


Related in: MedlinePlus