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Oral Biofilm Formation on Different Materials for Dental Implants

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Published on: June 24, 2018

Phase-Inversion In Situ Implants for Dental Drug Delivery: A QbD-Guided In Vitro Technological Evaluation.

Elena O Bakhrushina¹, Polina S Sakharova¹, Mariya V Kotilevskaya¹

¹Department of Pharmaceutical Technology, A.P. Nelyubin Institute of Pharmacy, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow 119048, Russia.

|June 26, 2026

Summary

This study optimized bleached shellac-based phase-inversion in situ implants (PIISIs) using a Quality by Design approach. Optimized PIISIs offer a promising platform for drug delivery, with further biological validation needed.

Keywords:

critical quality attributes periodontal drug delivery phase-inversion in situ implant quality by design shellac solvent screening

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Area of Science:

Polymer science and materials engineering.
Drug delivery systems.
Biomaterials science.

Background:

Phase-inversion in situ implants (PIISIs) are versatile polymer platforms where matrix formers and solvents dictate depot properties.
Bleached shellac, a natural, biodegradable resin, offers potential as a PIISI matrix former due to its functional groups.
A Quality by Design (QbD) approach is crucial for rationalizing PIISI formulation and understanding polymer-solvent interactions.

Purpose of the Study:

To apply a QbD approach to develop and rationalize a bleached shellac-based PIISI.
To investigate the physicochemical interactions between bleached shellac and various solvent systems.
To identify optimal solvent systems and shellac concentrations for PIISI formulation with desirable critical quality attributes.

Main Methods:

Screening of seven neat solvents and five binary solvent combinations for bleached shellac at 25% (m/m).
Evaluation of twelve formulations against critical quality attributes: injectability, phase-inversion kinetics, solvent diffusion, and implant structure.
Optimization of shellac concentration (20-35%) in selected lead solvent systems.

Main Results:

Three lead solvent systems identified: propylene glycol/N-methylpyrrolidone (PG+NMP), PG/dimethyl sulfoxide (PG+DMSO), and DMSO/benzyl alcohol (DMSO+BA).
Optimal formulation: 30% shellac in PG+NMP, exhibiting rapid phase inversion (~50 s), uniform structure, and low swelling (22%).
A mechanistic framework linking solvent properties (H-bond balance, water miscibility) to implant architecture was proposed.

Conclusions:

A QbD-driven approach successfully rationalized bleached shellac-based PIISIs.
The developed PIISI formulations represent a preliminary physicochemical platform for potential drug delivery applications.
Further in vitro and in vivo biological validation is necessary to confirm cytocompatibility and inflammatory response for dental applications.