madman
Super Moderator
Conclusion
Based on a BIO-PSA® AC 7-4302 silicone matrix, EA as an anastrozole solvent, and the use of glycerol as a crystallization inhibitor, a homogeneous drug wet mix was produced, capable of building up TDDS as ready-to-use formulation. This anastrozole drug-in-adhesive patch was found to be stable after drying and stored over months. In Franz diffusion cell experiments, a continuous anastrozole release profile, as well as permeation of 65% of TDDS drug loading within 48 h, was found, providing the basis for a proof of functioning study in an experimental TDDS exposure to animals. In vivo data showed a favorable plasma anastrozole concentration–time course following application of the final anastrozole transdermal system to beagle dogs, comparable to plasma concentrations 24–72 h following oral administration in humans. The study attests to the eligibility of the API anastrozole (drug) for transdermal application route and shows the feasibility of anastrozole TDDS in a proof of principle design, which demands expanded confirmatory animal studies, predicting the convenient alternative use of anastrozole to treat BC in women with expected better therapeutic index and patient compliance.
Based on a BIO-PSA® AC 7-4302 silicone matrix, EA as an anastrozole solvent, and the use of glycerol as a crystallization inhibitor, a homogeneous drug wet mix was produced, capable of building up TDDS as ready-to-use formulation. This anastrozole drug-in-adhesive patch was found to be stable after drying and stored over months. In Franz diffusion cell experiments, a continuous anastrozole release profile, as well as permeation of 65% of TDDS drug loading within 48 h, was found, providing the basis for a proof of functioning study in an experimental TDDS exposure to animals. In vivo data showed a favorable plasma anastrozole concentration–time course following application of the final anastrozole transdermal system to beagle dogs, comparable to plasma concentrations 24–72 h following oral administration in humans. The study attests to the eligibility of the API anastrozole (drug) for transdermal application route and shows the feasibility of anastrozole TDDS in a proof of principle design, which demands expanded confirmatory animal studies, predicting the convenient alternative use of anastrozole to treat BC in women with expected better therapeutic index and patient compliance.
