EXPLORATORY QUALITY BY DESIGN STUDY OF LIDOCAINE HYDROCHLORIDE EMULGELS

Original scientific paper

Authors

  • Maja Dzepanova Faculty of Pharmacy, Ss. Cyril & Methodius University in Skopje, Majka Tereza 47, 1000 Skopje, Republic of North Macedonia https://orcid.org/0009-0008-0251-3906
  • Biljana Stefanovska Faculty of Pharmacy, Ss. Cyril & Methodius University in Skopje, Majka Tereza 47, 1000 Skopje, Republic of North Macedonia https://orcid.org/0009-0002-2937-7760
  • Angela Nastevska Faculty of Pharmacy, Ss. Cyril & Methodius University in Skopje, Majka Tereza 47, 1000 Skopje, Republic of North Macedonia https://orcid.org/0009-0000-3169-3194
  • Teodora Tasevska Faculty of Pharmacy, Ss. Cyril & Methodius University in Skopje, Majka Tereza 47, 1000 Skopje, Republic of North Macedonia https://orcid.org/0009-0002-9615-8322
  • Lina Livrinska Trpevska Faculty of Pharmacy, Ss. Cyril & Methodius University in Skopje, Majka Tereza 47, 1000 Skopje, Republic of North Macedonia https://orcid.org/0009-0007-7569-4448
  • Katerina Goracinova Faculty of Pharmacy, Ss. Cyril & Methodius University in Skopje, Majka Tereza 47, 1000 Skopje, Republic of North Macedonia https://orcid.org/0000-0002-8101-6359
  • Nikola Geskovski Faculty of Pharmacy, Ss. Cyril & Methodius University in Skopje, Majka Tereza 47, 1000 Skopje, Republic of North Macedonia https://orcid.org/0000-0002-2073-5632
  • Maja Simonoska Crcarevska Faculty of Pharmacy, Ss. Cyril & Methodius University in Skopje, Majka Tereza 47, 1000 Skopje, Republic of North Macedonia https://orcid.org/0000-0002-1927-7101

DOI:

https://doi.org/10.2298/CICEQ260303008D

Keywords:

quality by design, quality risk management, topical drug delivery, emulgel formulation

Abstract

A quality by design/quality risk management-driven early-stage screening was conducted for 4% lidocaine hydrochloride (LHCl) oil-in-water emulgels intended for topical use. A quality target product profile was established and critical quality attributes defined to ensure efficacy, safety, and patient acceptability. Nine formulations (B1–B9) were developed to evaluate the influence of key critical material attributes, Carbopol 940, Tween 80, cetostearyl alcohol (CA), and isopropyl myristate (IPM), on physicochemical properties, rheology, spreadability, and in vitro drug release. All formulations showed acceptable pH, homogeneity, and drug content. Droplet size and polydispersity depended strongly on excipient composition: higher Carbopol and CA increased droplet size, whereas Tween 80 reduced it. Amplitude sweep measurements demonstrated elastic-dominant behavior within the linear viscoelastic region; Carbopol and CA enhanced viscoelastic strength and yield stress, while Tween 80 and IPM exhibited a plasticizing effect. Spreadability was comparable across formulations and reflected shear-thinning behavior. In vitro dissolution revealed formulation-dependent LHCl release, with stronger gel networks associated with slower release. Correlation analysis confirmed significant relationships between CA content, rheological parameters, droplet size, and drug release. Overall, LHCl emulgels can be rationally designed using a quality by design (QbD) approach, with rheology and droplet size serving as key determinants of performance.

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12.07.2026

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Copyright (c) 2026 Maja Dzepanova, Maja Simonoska Crcarevska, Biljana Stefanovska, Angela Nastevska, Teodora Tasevska, Lina Livrinska Trpevska, Katerina Goracinova, Nikola Geskovski

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How to Cite

EXPLORATORY QUALITY BY DESIGN STUDY OF LIDOCAINE HYDROCHLORIDE EMULGELS: Original scientific paper. (2026). Chemical Industry & Chemical Engineering Quarterly. https://doi.org/10.2298/CICEQ260303008D

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