Mechanistic Model of in vitor Intraoral Absorption of Buprenorphine for the Buccal and Gingival Mucosa

Authors: Kalra P, Lukacova V, Dwivedi P, Alam K, Tsakalozou E, Pauletti GM, Zhou H, Zhou HU
Conference: AAPS
Keywords: AAPS2024, in silico model, in vitro, oral cavity
Software: MembranePlus™
Division: PBPK

Purpose

  • Long-term use of buprenorphine oral cavity drug products (DP) poses risks of dental issues [1] and the underlying reason is not well understood
  • This study investigates the buccal and gingival permeability of buprenorphine active pharmaceutical ingredient (API) and buprenorphine generic drug product (DP) using in vitro permeability assays, with a focus on assessing tissue specific retention in different mucosal regions [2,3], and evaluating the impact of formulation excipients on buprenorphine permeation
  • Mechanistic in silico model in MembranePlus software (beta version, Simulations Plus Inc., Lancaster, CA) was employed to deconvolute in vitro permeation data from EpiOral and EpiGingival tissue models, yielding in vitro diffusivity (Dm) and fraction unbound (fut) (cf Poster # T0930-04-22).
  • Future work will determine whether differences in the oral mucosal regions can provide

By  Priyata Kalra, Viera Lukacova1, Pankaj Dwivedi, Khondoker Alam, Eleftheria Tsakalozou, Giovanni Pauletti, Haiying Zhou

American Association of Pharmaceutical Scientists (AAPS) PharmSci 360, October 20-23, 2024, Salt Lake City, Utah