Related Experiment Video
Updated: Aug 1, 2025
Determining heat and mechanical pain threshold in inflamed skin of human subjects
Published on: January 14, 2009
In Vitro-In Vivo Correlation of Buprenorphine Transdermal Systems Under Normal and Elevated Skin Temperature
Sherin Thomas1, Dana C Hammell1, Hazem E Hassan1,2
1Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, 21201, USA.
Purpose:
Application of external heat using a heating pad over buprenorphine transdermal system, Butrans® has been shown to increase systemic levels of buprenorphine in human volunteers. The purpose of this study was to perform in vitro permeation studies at normal as well as elevated temperature conditions to evaluate the correlation of in vitro data with the existing in vivo data.
Methods:
In vitro permeation tests (IVPT) were performed on human skin from four donors. The IVPT study design was harmonized to a previously published clinical study design and skin temperature was maintained at either 32 ± 1 °C or 42 ± 1 °C to mimic normal and elevated skin temperature conditions, respectively.
Results:
IVPT studies on human skin were able to demonstrate heat induced enhancement in flux and cumulative amount of drug permeated from Butrans® which was reasonably consistent with the corresponding enhancement observed in vivo. Level A in vitro-in vivo correlation (IVIVC) was established using unit impulse response (UIR) based deconvolution method for both baseline and heat arms of the study. The percent prediction error (%PE) calculated for AUC and Cmax values was less than 20%.
Conclusions:
The studies indicated that IVPT studies performed under the same conditions as those of interest in vivo may be useful for comparative evaluation of the effect of external heat on transdermal delivery system (TDS). Further research may be warranted to evaluate factors, beyond cutaneous bioavailability (BA) assessed using an IVPT study, that can influence plasma exposure in vivo for a given drug product.
Related Concept Videos
01:27Assessing Body Temperature - Rectal
Follow these steps for rectal temperature assessment:
Step 1: Perform hand hygiene and don clean gloves to prevent cross-infection.
Step 2: Position the patient in a side-lying position to better visualize the rectal...
01:14Assessing Body Temperature - Oral
Step 1:
Start by practicing proper hand hygiene to prevent the spread of microorganisms.
Step 2:
Take the thermometer out of the charging unit, switch it on, and wait for the ready sign.
Step 3:
Gently slide the probe cover until a click is heard. This simple action prevents cross-contamination and ensures the correct placement of the probe cover.
Step 4:
Instruct the patient to open their mouth and place...
01:19Assessing Body Temperature - Temporal Artery
Step 1: Perform hand hygiene and don a fresh pair of gloves to prevent cross-infection and ensure patient safety.
Step 2: Explain the procedure to the patient to establish trust. Clear communication establishes trust with the patient, ensures they understand what to expect, promotes cooperation, and enhances comfort during the procedure.
Step 3: Assess the patient's...
01:14Assessing Body Temperature - Axilla
Step 1: Perform hand hygiene and put on clean gloves to maintain infection control and prevent cross-contamination.
Step 2: Prepare the patient by explaining the procedure to ensure understanding and cooperation. Ensure privacy, expose the axilla, and inform the patient that minimal movement is crucial for an accurate reading.
Step 3: Adjust the patient’s clothing to expose only the axilla. It minimizes...
01:25Body Temperature
01:16Methods for Studying Drug Absorption: In vitro
The diffusion cell method uses a two-compartment cell, including a donor compartment with the drug solution, which simulates the environment where the drug is applied, and a receptor compartment with a buffer solution, which simulates the environment...