Abstract
This article reports the development of a pharmaceutical product containing vegetable actives from a Brazilian medicinal plant. The possibility of forming a microemulsion using Pterodon emarginatus ("sucupira") oil was evaluated and the anti-inflammatory potential of this microemulsion was also examined. A formulation was developed using P. emarginatus oil, a mixture of ethoxylated Castor Oil (Ultramone(r) R-540/propylene glycol 2:1) (surfactant/cosurfactant) and distilled water at a ratio of 10:15:75, respectively. The microemulsion which was selected was then subjected to the preliminary stability test and analyzed in terms of average diameter of droplets, pH, zeta potential, and polydispersity index, on the 1st, 7th, 15th, and 30th days after preparation and stored at different temperatures (5 ± 2 °C, 25 ± 2 °C, and 40 ± 2 °C). The anti-inflammatory in vivo activity of both oil and formulation were evaluated, using the experimental model of croton oil-induced ear edema. The preliminary stability test showed that the microemulsion stored at 5 and 25 °C retained its original features throughout the 30-day period. The anti-inflammatory potential of both oil and formulation was shown to be statistically significant (p < 0.001), when compared to the control group, however, the microemulsion proved to be more effective (p < 0.05) than the oil when applied directly to the ear.
Highlights
The technological development of research on pharmaceutical forms containing herbal materials has expanded over recent decades and contributed to innovation in the pharmaceutical sector (Bassani, González, Petrovick, 2005; Calixto, 2005; Rocha et al, 2008; Araújo-Júnior et al, 2013; Beringhs et al, 2013; Couto et al, 2013; Klein et al, 2013; Quintão et al, 2013).Emulsified systems are characterized by their capacity to deliver drugs, and depending on the size of the globule and the process used, they can be classified as macroemulsions, microemulsions or nanoemulsions (Jafari, He, Bhandari, 2007)
The required Hydrophilic-Lipophilic Balance (HLB) values were evaluated for the first time
The HLB parameter is an important tool for the technological development of phytopharmaceuticals and can be successfully employed in the formulation of natural products such as those based on vegetable oils (Fernandes et al, 2013)
Summary
The technological development of research on pharmaceutical forms containing herbal materials has expanded over recent decades and contributed to innovation in the pharmaceutical sector (Bassani, González, Petrovick, 2005; Calixto, 2005; Rocha et al, 2008; Araújo-Júnior et al, 2013; Beringhs et al, 2013; Couto et al, 2013; Klein et al, 2013; Quintão et al, 2013).Emulsified systems are characterized by their capacity to deliver drugs, and depending on the size of the globule and the process used, they can be classified as macroemulsions, microemulsions or nanoemulsions (Jafari, He, Bhandari, 2007). An average diameter of droplets in a microemulsion generally ranges from 10-100 nm (1001000Å) (Shakeel, Ramadan, 2010; Jadhav, Shetye, Kadam, 2010). Several hypotheses have been put forward for the mechanism of drug permeation enhancement. These include increased drug solubility, which fosters a high concentration gradient towards skin, small droplet size and low viscosity which facilitates permeation, increased drug thermodynamic activity in the microemulsion vehicle, and the disruption of the stratum corneum lipid order by microemulsion components (Kreilgaard, 2002; Zhao et al, 2006; Biruss, Kählig, Valenta, 2007; Gupta, Moulik, 2008; Vicentini et al, 2008; Moniruzzaman, Kamiya, Goto, 2010; Shakeel, Ramadan, 2010)
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