Next Article in Journal
A Novel Hybrid Additive Manufacturing Process for Drug Delivery Systems with Locally Incorporated Drug Depots
Next Article in Special Issue
Monitoring the Clinical Response to an Innovative Transdermal Delivery System for Ibuprofen
Previous Article in Journal
Comparison of In Vitro and In Vivo Results Using the GastroDuo and the Salivary Tracer Technique: Immediate Release Dosage Forms under Fasting Conditions
Previous Article in Special Issue
Mechanistic Evaluation of Enhanced Curcumin Delivery through Human Skin In Vitro from Optimised Nanoemulsion Formulations Fabricated with Different Penetration Enhancers
Open AccessArticle

Investigation of Silicone-Containing Semisolid in Situ Film-Forming Systems Using QbD Tools

Institute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged, 6720 Szeged, Hungary
*
Author to whom correspondence should be addressed.
Pharmaceutics 2019, 11(12), 660; https://doi.org/10.3390/pharmaceutics11120660
Received: 12 November 2019 / Revised: 4 December 2019 / Accepted: 5 December 2019 / Published: 7 December 2019
The aim of our research work was to develop dermally applicable, semisolid film-forming systems (FFSs) containing silicones, which form a film on the skin in situ, with suitable mechanical properties for skin application. FFSs were developed and investigated by means of the Quality by Design (QbD) methodology. With this QbD approach, the initial risk assessment defines the critical quality attributes (CQAs), the critical material attributes (CMAs) and the critical process parameters (CPPs) to ensure the required quality. Different semisolid systems were formed with or without silicones. During the initial risk assessment, three CQAs, namely skin adhesion, film flexibility and burst strength, were found to be critical attributes, while film appearance, film integrity and the drying time of the semisolid system, were found to be medium attributes. These parameters were investigated. The initial risk assessment also showed that there are three high CMAs: the type of silicones, film-forming excipients, drying excipients, and that there was one medium CMA: viscosity-enhancing excipients. Based on our results, the silicone content had a great effect on the film-forming systems. Different silicones affected the mechanical properties of the films in varying ways, decreased the drying time and showed promising results regarding the drying mechanism. View Full-Text
Keywords: in situ dermal film; film forming system; quality by design; silicones in situ dermal film; film forming system; quality by design; silicones
Show Figures

Figure 1

MDPI and ACS Style

Kis, N.; Kovács, A.; Budai-Szűcs, M.; Gácsi, A.; Csányi, E.; Csóka, I.; Berkó, S. Investigation of Silicone-Containing Semisolid in Situ Film-Forming Systems Using QbD Tools. Pharmaceutics 2019, 11, 660.

Show more citation formats Show less citations formats
Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Article Access Map by Country/Region

1
Back to TopTop