Literature DB >> 34080101

Multiphysics Modeling and Simulation of Subcutaneous Injection and Absorption of Biotherapeutics: Sensitivity Analysis.

Peng Hou1, Fudan Zheng1, Clairissa D Corpstein1, Lei Xing2, Tonglei Li3.   

Abstract

PURPOSE: A multiphysics simulation model was recently developed to capture major physical and mechanical processes of local drug transport and absorption kinetics of subcutaneously injected monoclonal antibody (mAb) solutions. To further explore the impact of individual drug attributes and tissue characteristics on the tissue biomechanical response and drug mass transport upon injection, sensitivity analysis was conducted and reported.
METHOD: Various configurations of injection conditions, drug-associated attributes, and tissue properties were simulated with the developed multiphysics model. Simulation results were examined with regard to tissue deformation, porosity change, and spatiotemporal distributions of pressure, interstitial fluid flow, and drug concentration in the tissue.
RESULTS: Injection conditions and tissue properties were found influential on the mechanical response of tissue and interstitial fluid velocity to various extents, leading to distinct drug concentration profiles. Intrinsic tissue porosity, lymphatic vessel density, and drug permeability through the lymphatic membrane were particularly essential in determining the local absorption rate of an mAb injection.
CONCLUSION: The sensitivity analysis study may shed light on the product development of an mAb formulation, as well as on the future development of the simulation method.

Entities:  

Keywords:  Subcutaneous injection; computational fluid dynamics; modeling and simulation; protein absorption; tissue biomechanics

Mesh:

Substances:

Year:  2021        PMID: 34080101     DOI: 10.1007/s11095-021-03062-4

Source DB:  PubMed          Journal:  Pharm Res        ISSN: 0724-8741            Impact factor:   4.200


  44 in total

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Journal:  Nat Rev Drug Discov       Date:  2005-04       Impact factor: 84.694

Review 2.  Mechanistic determinants of biotherapeutics absorption following SC administration.

Authors:  Wolfgang F Richter; Suraj G Bhansali; Marilyn E Morris
Journal:  AAPS J       Date:  2012-05-23       Impact factor: 4.009

Review 3.  Current perspectives on stability of protein drug products during formulation, fill and finish operations.

Authors:  Nitin Rathore; Rahul S Rajan
Journal:  Biotechnol Prog       Date:  2008-05-17

4.  Tolerability of High-Volume Subcutaneous Injections of a Viscous Placebo Buffer: A Randomized, Crossover Study in Healthy Subjects.

Authors:  Clapton Dias; Bassam Abosaleem; Caroline Crispino; Bing Gao; Adam Shaywitz
Journal:  AAPS PharmSciTech       Date:  2015-02-19       Impact factor: 3.246

5.  Multiphysics Modeling and Simulation of Subcutaneous Injection and Absorption of Biotherapeutics: Model Development.

Authors:  Fudan Zheng; Peng Hou; Clairissa D Corpstein; Lei Xing; Tonglei Li
Journal:  Pharm Res       Date:  2021-04-02       Impact factor: 4.200

6.  Does needle size matter?

Authors:  Harvinder S Gill; Mark R Prausnitz
Journal:  J Diabetes Sci Technol       Date:  2007-09

Review 7.  High-dose monoclonal antibodies via the subcutaneous route: challenges and technical solutions, an industry perspective.

Authors:  Chakravarthy Narasimhan; Henryk Mach; Mohammed Shameem
Journal:  Ther Deliv       Date:  2012-07

8.  Understanding Subcutaneous Tissue Pressure for Engineering Injection Devices for Large-Volume Protein Delivery.

Authors:  Diane V Doughty; Corbin Z Clawson; William Lambert; J Anand Subramony
Journal:  J Pharm Sci       Date:  2016-06-07       Impact factor: 3.534

Review 9.  Challenges and Opportunities for the Subcutaneous Delivery of Therapeutic Proteins.

Authors:  Michael R Turner; Sathy V Balu-Iyer
Journal:  J Pharm Sci       Date:  2018-01-11       Impact factor: 3.534

Review 10.  Subcutaneous Injection of Drugs: Literature Review of Factors Influencing Pain Sensation at the Injection Site.

Authors:  Iris Usach; Rafael Martinez; Teodora Festini; José-Esteban Peris
Journal:  Adv Ther       Date:  2019-10-05       Impact factor: 3.845

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  1 in total

1.  Understanding Formulation and Temperature Effects on Dermal Transport Kinetics by IVPT and Multiphysics Simulation.

Authors:  Paige N Zambrana; Peng Hou; Dana C Hammell; Tonglei Li; Audra L Stinchcomb
Journal:  Pharm Res       Date:  2022-05-16       Impact factor: 4.200

  1 in total

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