Abstract
Current advancements in the research investigations focused at using natural products to generate novel dosage forms with a potential therapeutic impact. Silymarin is a natural product obtained from the herb Silybum marianum that has been shown to have remarkable hypoglycemic activity. Owing to the low enteral absorption, instability in stomach secretion, and poor solubility of Silymarin, it was better to be produced as a topical dosage form. A three-factor, three-level Box Behnken (33 BB) design was constructed to develop 15 formulations using three independent variables (phospholipid concentration, surfactant concentration, and sonication time) and two dependent variables (encapsulation efficiency and in vitro drug release). The optimized formula was added to HPMC gel and the resulting transfersomal gel was investigated for its characteristics, in vitro, ex vivo and hypoglycemic behaviors. The pH of the Silymarin-loaded transfersomal gel was 7.05, the spreadability was 55.35 mm, and the viscosity was 6.27 Pa. Furthermore, Silymarin loaded transfersomal gel had the greatest transdermal flux (92.41 µg/cm2·h), which was much greater than all other formulations. In vivo observations revealed that Silymarin loaded transfersomal gel significantly reduced blood glucose levels, compared to either Silymarin gel or oral Silymarin suspension. The findings show that the developed transfersomal gel could be an effective carrier for Silymarin transdermal delivery.
Highlights
Transdermal drug delivery systems (TDDS) have been exploited for many years to deliver drugs [1]
Transfersomes loaded with Silymarin were prepared using a conventional rotary evaporative sonication technique
This process was chosen because the formation of thin films occurs over a surface area sufficient for full vesicles hydration resulting in an enhancement of the encapsulation efficiency percentage [31]
Summary
Transdermal drug delivery systems (TDDS) have been exploited for many years to deliver drugs [1]. The transdermal bioactive agent has to pass through skin layers to reach the systemic circulation. Compared to other routes of administration, the transdermal route of administration exhibits potential benefits, such as evading first pass hepatic metabolism, extending drug duration of action, minimizing adverse effects, enhancing the pharmacological action, minimizing the fluctuation in drug concentrations, and improving patient’s convenience [2]. TDDS can be effectively implemented when drug therapy is essential for chronic uses or for a prolonged time. Transdermal therapy is restricted to certain types of bioactive agents, as the stratum corneum poses a barrier against the permeating substances [3]
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