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The Pharmacokinetics and Relative Bioavailability of Mepolizumab 100 mg Liquid Formulation Administered Subcutaneously to Healthy Participants: A Randomized Trial.

Author: AlbayatyMuna, BentleyJane H, BradfordEric S, C KaisermannMorrys, PouliquenIsabelle J, ShabbirShaila

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

This study compared the pharmacokinetic (PK) profile of a new liquid formulation of mepolizumab to the established lyophilized formulation in healthy participants. Participants received a single 100 mg subcutaneous dose of mepolizumab as liquid (prefilled syringe or autoinjector) or lyophilized formulation. All PK parameters were similar across the three groups. The 90% confidence intervals for maximum plasma concentration, AUC<sub>0-t</sub>, and AUC<sub>0-&#8734;</sub> treatment ratios (liquid prefilled syringe or autoinjector vs lyophilized formulation) were within conventional bioequivalence bounds (0.80-1.25), demonstrating statistical PK comparability. The on-treatment adverse event incidence was 29% to 38%. These findings suggest that the liquid formulation of mepolizumab has similar PK properties to the lyophilized formulation with no identified safety concerns.
Paper Details　
Original Abstract of the Article :
This study compared the pharmacokinetic (PK) profile of a new liquid formulation of mepolizumab with the established lyophilized formulation. In this open-label, parallel-group, single-dose study (NCT03014674; GSK ID: 204958), healthy participants were randomized (1:1:1) to receive a single mepolizu...See full text at original site
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引用元：
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7187405/

データ提供：米国国立医学図書館（NLM）

Mepolizumab Liquid Formulation: A New Option for Treatment

Mepolizumab is a medication used to treat certain inflammatory conditions. It is usually administered as a lyophilized (freeze-dried) formulation. This study explores the pharmacokinetic profile of a new liquid formulation of mepolizumab, comparing it to the established lyophilized formulation. The researchers conducted a randomized trial with healthy volunteers, evaluating the absorption and distribution of the drug in the body. The findings suggest that the liquid formulation is bioequivalent to the lyophilized formulation, meaning it produces similar levels of the drug in the blood. This is good news, as it suggests that the liquid formulation could be a convenient and safe alternative for patients.

Liquid Formulation Shows Promise

The study demonstrates that the liquid formulation of mepolizumab is bioequivalent to the lyophilized formulation. This means that the two formulations produce comparable levels of the drug in the blood, suggesting that the liquid formulation could be a viable option for patients. The study also found that the liquid formulation was well-tolerated, with no significant safety concerns identified.

Exploring New Treatment Options

The development of new formulations, like the liquid formulation of mepolizumab, can offer patients greater flexibility and convenience. This research suggests that the liquid formulation is a promising option that may provide similar benefits to the lyophilized formulation while offering increased convenience. Remember, it's crucial to discuss treatment options with your healthcare provider to determine the best approach for your individual needs.

Dr. Camel's Conclusion

This study suggests that the liquid formulation of mepolizumab is a safe and effective alternative to the lyophilized formulation, providing a potentially more convenient option for patients. The findings demonstrate the commitment to innovation in medication delivery, which can lead to better treatment experiences for patients.

Date :
  1. Date Completed 2021-05-28
  2. Date Revised 2021-05-28
Further Info :

Pubmed ID

31317668

DOI: Digital Object Identifier

PMC7187405

Related Literature

Article Analysis
・Effects of mepolizumab injection
SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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