In Vitro, In Compost, and In Vivo Assessment of Chitosan-Polyethylene Glycol as an Intravaginal Insert for Progesterone Delivery in Sheep

Abstract

In estrous synchronization, the hormone progesterone is an important element. Various hormone preparations currently available have limitations, especially those related to environmental impact issues. Various alternatives are being studied, and using biodegradable polymeric materials (chitosan-polyethylene glycol combination) to develop new devices is considered one of the solutions. This contribution aims to design and evaluate intravaginal implants that can release progesterone and be degraded in the body and the environment. Implants are made by melting and molding techniques. In vitro drug release studies using dyes as drug models. Implant degradation studies tested in compost. Changes in the shape of the implant, while it is in the vagina, are observed by ultrasound. Blood collection was performed three days before and during implantation to obtain a blood progesterone profile. In vitro drug release studies using dye as a drug model showed a chitosan-PEG profile that released the drug faster at first, then slowed down. Implant degradation studies in compost and vagina demonstrated a gradual degradation process. The blood progesterone profile increased during implantation, as high as 15 ng/mL on the third day. In conclusion, the chitosan-PEG intravaginal implant formulation designed using the melting and molding technique proved to be degraded in the compost environment. It released the hormone progesterone for four days according to the degradation period of the implant in the vagina.

The potential of biodegradable polymers: Chitosan, polyethylene glycol, and polycaprolactone as materials for progesterone intravaginal devices

“…The blood progesterone profile showed a significant increase during implantation, reaching a maximum of 15 ng/mL on the third day. The chitosan-PEG intravaginal implant formulation released progesterone for a period of four days, corresponding to the degradation time of the implant in the vagina [19].…”

“…Blood progesterone levels showed a significant increase during implantation, reaching a maximum of 15 ng/mL on the third day. The chitosan-PEG intravaginal implant formulation released progesterone for a period of four days, corresponding to the degradation time of the implant in the vagina [19]. The use of a simple melting and molding process for the combination of PCL-PEGchitosan implants has been observed to result in degradation in both simulated vaginal fluid and vaginal tissue of cows [20] .…”

Bioavailability properties of intravaginal implants made from chitosan-PEG-PCL in simulated vaginal fluid and vagina of cattle

“…Polyethylene glycol has been studied as a hydrogel base for the release of antimicrobial drugs via intravaginal application (Rajan et al 2014), and PCL has been investigated as a progesterone-releasing hormone in the form of intravaginal implants (Rathbone et al 2002). Even tough combinations of chitosan-PEG have been successfully developed and tested in sheep in previous study (Yessa et al 2023). However, the properties of the new chitosan-PEG-PCL combination as a promising hormone delivery material have not been reported.…”