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Pharmaceutics. 2020 Dec 18;12(12). doi: 10.3390/pharmaceutics12121226.

Pharmacokinetic Characterization and External Evaluation of a Quantitative Framework of Sublingual Buprenorphine in Patients with an Opioid Disorder in Puerto Rico.

Pharmaceutics

Darlene Santiago, Victor Mangas-Sanjuan, Kyle Melin, Jorge Duconge, Wenchen Zhao, Raman Venkataramanan

Affiliations

  1. Pharmaceutical Sciences Department, School of Pharmacy, University of Puerto Rico, 00936-5067 San Juan, Puerto Rico.
  2. Department of Pharmacy and Pharmaceutical Technology and Parasitology, University of Valencia, 46100 Valencia, Spain.
  3. Interuniversity Research Institute for Molecular Recognition and Technological Development, Polytechnic University of Valencia, University of Valencia, 46100 Valencia, Spain.
  4. Pharmacy Practice Department, School of Pharmacy, University of Puerto Rico, 00936-5067 San Juan, Puerto Rico.
  5. Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA 15261, USA.
  6. Department of Pathology, MWRI, UPCI, MIRM, Thomas Starzl Transplantation Institute, School of Medicine, University of Pittsburgh, Pittsburgh, PA 15261, USA.

PMID: 33352843 PMCID: PMC7766849 DOI: 10.3390/pharmaceutics12121226

Abstract

BACKGROUND: The aim of this analysis was to characterize the pharmacokinetics (PK) of sublingual buprenorphine (BUP) and its metabolites (buprenorphine glucuronide; BUP-g, norbuprenorphine; Nor-BUP, and norbuprenorphine glucuronide; Nor-BUP-g) in opioid use disorder (OUD) patients in Puerto Rico (PR) as a first step of evidence-based BUP dosing strategies in this population.

METHODS: BUP and metabolites concentrations were measured from 0 to 8 h after the administration of sublingual buprenorphine/naloxone films in 12 stable OUD subjects.

RESULTS: PK non-compartmental characteristics showed considerable variability in parameters between the subjects over the 8-h sampling time (

CONCLUSIONS: Although limited in sampling time and number of recruited subjects, this study presents specific BUP PK characteristics that evidenced the need for additional PK studies and subsequent modeling of the data for the development of evidence-based dosing approaches in Puerto Rico.

Keywords: Puerto Ricans; Suboxone; buprenorphine/naloxone sublingual film; compartmental modeling; opioid use disorder (OUD); pharmacokinetics; popPK; population pharmacokinetics

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