Integration of Smart Technologies and Data Mining Tools for the Customization of Film-Forming Sprays Containing the Epigallocatechin-3-Gallate:Dexolve Complex

Background: The present study aimed to develop a film-forming spray containing an epigallocatechin-3-gallate:Dexolve complex (FFS-EGCG:Dexolve) for site-specific treatment of throat cancer using newer excipients. Methods: EGCG was used to treat throat cancer. The permeability of EGCG was improved by amalgamating with Kleptose/Dexolve. The screened complex was loaded into a film-forming spray solution. Quality by design (QbD) was utilized to develop FFS-EGCG:Dexolve, including HPMC E5 and Lycoat. A risk estimation matrix (REM) was utilized to scrutinize critical quality attributes (CQAs) and critical material attributes (CMAs), and a correlation was developed via a Box–Behnken design (BBD). FFS-EGCG:Dexolve was characterized for its in vitro and ex vivo characteristics. Results: EGCG:Dexolve (1:3) had excellent physical properties and 90.83 ± 0.07% permeability. Through an REM, the film formation time and %EGCG released were screened as CQAs, whereas the amounts of HPMC E5, Lycoat, and Dexolve were chosen as CMAs. The amounts of HPMC E5, Lycoat, and Dexolve were considered crucial for designing FFS-EGCG:Dexolve, as determined by the BBD. FFS-EGCG:Dexolve formed instant films, covered a relatively large surface area, and had a long residence time, and controlled EGCG release was achieved for >6 h. The optimal batch comprising HPMC E5 (11.98 mg), Lycoat (10.09 mg), and Dexolve (163.5 mg) had excellent spray characteristics, formed a film in 82 s, and released 85.39% EGCG in a controlled manner. Conclusion: A novel FFS-EGCG:Dexolve complex was developed to explore the novel excipients Lycoat, HPMC E5, and Dexolve. The throat-targeted film-forming spray developed a film quickly and released >85% EGCG in 6 h. The novel FFS-EGCG:Dexolve complex was formulated for site specificity and intelligent technologies to achieve better therapeutic efficacy. Patient-centric formulations have excellent industrial and social impacts.