Protheragen specializes in the development of innovative medical implant solutions through cutting-edge technology for in-situ forming implants (ISFIs). We offer advanced polymer in-situ forming implant system development services for the medical industry. Through our team of professionals, innovative technologies, and high-quality raw materials, we are able to meet the needs of our customers and provide individualized, safe, and reliable in-situ molded implant solutions for patients.

Introduction to ISFI

ISFI represents a simple, adjustable, and biodegradable polymer-based continuous drug delivery platform composed of biocompatible, water-miscible solvents and biodegradable polymers. It is an ideal drug delivery system for a variety of applications, especially for those that require frequent dosing regimens, as they are simple to manufacture, stable at room temperature for months, easy to administer, and can be removed to terminate therapy when needed.

Fig. 1 Schematic of ISFI formation and degradation. (Joiner J.B, et al. 2022)

Comprehensive ISFI Polymer System Development Services

Our full range of ISFI polymer system development services involves the design, development, and manufacture of implantable drug delivery systems based on polymer materials that form solid or gel-like implants in situ (at the implantation site) after drug administration. These systems can be used to provide controlled and sustained release of therapeutic agents over an extended period.

Specific services include, but are not limited to:

• Formulation Development: This involves selecting appropriate polymer materials and excipients based on the desired release profile, stability, and biocompatibility requirements. Our formulation development process is designed to optimize drug-polymer compatibility and achieve the desired drug release kinetics.
• Prototyping and Manufacturing: Once the formulation is finalized, a prototype design of the implant system can be created. This includes determining the appropriate shape, size, and geometry of the implant, as well as incorporating any necessary features such as drug reservoirs or channels. Prototypes are manufactured using specialized techniques such as molding, extrusion, or 3D printing.
• In Vitro and In Vivo Evaluations: The implant systems we develop undergo rigorous testing to assess their performance and biocompatibility. In vitro, studies evaluate drug release kinetics, degradation characteristics, mechanical properties, and stability. In vivo, studies involve implanting the systems in animal models to evaluate safety, efficacy, and tissue response.
• Regulatory Support: Our development services can provide guidance and support in preparing the necessary documentation (e.g., regulatory submissions) to facilitate the approval and commercialization of the implanted system.
• Scale-up and Manufacturing: This phase involves process optimization, quality control, and ensuring consistent and reproducible manufacturing.

In-situ Forming Polymer Formulations

In-situ forming polymer formulations are in the form of a sol prior to administration in the body, but once administered, gelation occurs in situ to form a gel. Gel formation is dependent on factors such as temperature regulation, pH changes, presence of ions, and UV irradiation, and the drug is released in a sustained and controlled manner.

The following materials are commonly used in our in situ gel formulations:

• Polymers: Gellan gum, alginate, xyloglucan, pectin, chitosan, poly(DL-lactic acid), poly(DL-propylene glycolide-ethylene glycolide), and polycaprolactone.
• Solvents: Water, dimethyl sulfoxide, N-methyl pyrrolidone, triacetin and 2-pyrrolidone. The choice depends on the solubility of the polymer used.

Fig. 1 Overview of the in situ hydrogel formation through biologically benign processes. (Ko D.Y, et al. 2013)

We will evaluate and characterize the in situ gel system by the following parameters:

• Viscosity and rheology.
• Sol-gel transition temperature and gelation time.
• Gel strength.
• In vitro drug release studies.
• Fourier transform infrared spectroscopy and thermal analysis
• Texture analysis of hydrogels.

Advantages of Protheragen

We have developed polymers that offer the following benefits:

• Customizability - achieve optimal shape, size and performance.
• Good biocompatibility with the human body - high-quality polymer material.
• Controllability - ensures accurate positioning and integrity of the implant.
• Convenience - reduces procedure time and patient discomfort.

If you are interested in our services or have any questions, please do not hesitate to contact us, we look forward to working with you to promote the development and advancement of the medical field.