PLGA Nanoparticle-Based Formulations to Cross the Blood–Brain Barrier for Drug Delivery: From R&D to cGMP

The blood–brain barrier (BBB) is a natural obstacle for drug delivery into the human brain, hindering treatment of central nervous system (CNS) disorders such as acute ischemic stroke, brain tumors, and human immunodeficiency virus (HIV)-1-associated neurocognitive disorders. Poly(lactic-<i>co...

Full description

Bibliographic Details
Main Authors: Kaining Zhi, Babatunde Raji, Anantha R. Nookala, Mohammad Moshahid Khan, Xuyen H. Nguyen, Swarna Sakshi, Tayebeh Pourmotabbed, Murali M. Yallapu, Harry Kochat, Erene Tadrous, Shelby Pernell, Santosh Kumar
Format: Article
Language:English
Published: MDPI AG 2021-04-01
Series:Pharmaceutics
Subjects:
Online Access:https://www.mdpi.com/1999-4923/13/4/500
_version_ 1797538645865922560
author Kaining Zhi
Babatunde Raji
Anantha R. Nookala
Mohammad Moshahid Khan
Xuyen H. Nguyen
Swarna Sakshi
Tayebeh Pourmotabbed
Murali M. Yallapu
Harry Kochat
Erene Tadrous
Shelby Pernell
Santosh Kumar
author_facet Kaining Zhi
Babatunde Raji
Anantha R. Nookala
Mohammad Moshahid Khan
Xuyen H. Nguyen
Swarna Sakshi
Tayebeh Pourmotabbed
Murali M. Yallapu
Harry Kochat
Erene Tadrous
Shelby Pernell
Santosh Kumar
author_sort Kaining Zhi
collection DOAJ
description The blood–brain barrier (BBB) is a natural obstacle for drug delivery into the human brain, hindering treatment of central nervous system (CNS) disorders such as acute ischemic stroke, brain tumors, and human immunodeficiency virus (HIV)-1-associated neurocognitive disorders. Poly(lactic-<i>co</i>-glycolic acid) (PLGA) is a biocompatible polymer that is used in Food and Drug Administration (FDA)-approved pharmaceutical products and medical devices. PLGA nanoparticles (NPs) have been reported to improve drug penetration across the BBB both in vitro and in vivo. Poly(ethylene glycol) (PEG), poly(vinyl alcohol) (PVA), and poloxamer (Pluronic) are widely used as excipients to further improve the stability and effectiveness of PLGA formulations. Peptides and other linkers can be attached on the surface of PLGA to provide targeting delivery. With the newly published guidance from the FDA and the progress of current Good Manufacturing Practice (cGMP) technologies, manufacturing PLGA NP-based drug products can be achieved with higher efficiency, larger quantity, and better quality. The translation from bench to bed is feasible with proper research, concurrent development, quality control, and regulatory assurance.
first_indexed 2024-03-10T12:34:23Z
format Article
id doaj.art-fefb54888c9548eea808ab02599ef367
institution Directory Open Access Journal
issn 1999-4923
language English
last_indexed 2024-03-10T12:34:23Z
publishDate 2021-04-01
publisher MDPI AG
record_format Article
series Pharmaceutics
spelling doaj.art-fefb54888c9548eea808ab02599ef3672023-11-21T14:25:02ZengMDPI AGPharmaceutics1999-49232021-04-0113450010.3390/pharmaceutics13040500PLGA Nanoparticle-Based Formulations to Cross the Blood–Brain Barrier for Drug Delivery: From R&D to cGMPKaining Zhi0Babatunde Raji1Anantha R. Nookala2Mohammad Moshahid Khan3Xuyen H. Nguyen4Swarna Sakshi5Tayebeh Pourmotabbed6Murali M. Yallapu7Harry Kochat8Erene Tadrous9Shelby Pernell10Santosh Kumar11Plough Center for Sterile Drug Delivery Solutions, University of Tennessee Health Science Center, 208 South Dudley Street, Memphis, TN 38163, USAPlough Center for Sterile Drug Delivery Solutions, University of Tennessee Health Science Center, 208 South Dudley Street, Memphis, TN 38163, USACovance Inc., Kinsman Blvd, Madison, WI 53704, USADepartment of Neurology, College of Medicine, University of Tennessee Health Science Center, 855 Monroe Avenue, Memphis, TN 38163, USADepartment of Pharmaceutical Sciences, University of Tennessee Health Science Center, 881 Madison Ave, Memphis, TN 38163, USADepartment of Pharmaceutical Sciences, University of Tennessee Health Science Center, 881 Madison Ave, Memphis, TN 38163, USADepartment of Microbiology, Immunology and Biochemistry, College of Medicine, University of Tennessee Health Science Center, 858 Madison Avenue, Memphis, TN 38163, USADepartment of Immunology and Microbiology, University of Texas Rio Grande Valley, McAllen, TX 78504, USAPlough Center for Sterile Drug Delivery Solutions, University of Tennessee Health Science Center, 208 South Dudley Street, Memphis, TN 38163, USADepartment of Pharmaceutical Sciences, University of Tennessee Health Science Center, 881 Madison Ave, Memphis, TN 38163, USADepartment of Pharmaceutical Sciences, University of Tennessee Health Science Center, 881 Madison Ave, Memphis, TN 38163, USADepartment of Pharmaceutical Sciences, University of Tennessee Health Science Center, 881 Madison Ave, Memphis, TN 38163, USAThe blood–brain barrier (BBB) is a natural obstacle for drug delivery into the human brain, hindering treatment of central nervous system (CNS) disorders such as acute ischemic stroke, brain tumors, and human immunodeficiency virus (HIV)-1-associated neurocognitive disorders. Poly(lactic-<i>co</i>-glycolic acid) (PLGA) is a biocompatible polymer that is used in Food and Drug Administration (FDA)-approved pharmaceutical products and medical devices. PLGA nanoparticles (NPs) have been reported to improve drug penetration across the BBB both in vitro and in vivo. Poly(ethylene glycol) (PEG), poly(vinyl alcohol) (PVA), and poloxamer (Pluronic) are widely used as excipients to further improve the stability and effectiveness of PLGA formulations. Peptides and other linkers can be attached on the surface of PLGA to provide targeting delivery. With the newly published guidance from the FDA and the progress of current Good Manufacturing Practice (cGMP) technologies, manufacturing PLGA NP-based drug products can be achieved with higher efficiency, larger quantity, and better quality. The translation from bench to bed is feasible with proper research, concurrent development, quality control, and regulatory assurance.https://www.mdpi.com/1999-4923/13/4/500poly(lactic-<i>co</i>-glycolic acid) (PLGA)blood–brain barrier (BBB)current Good Manufacturing Practice (cGMP)Food and Drug Administration (FDA)nanotechnology
spellingShingle Kaining Zhi
Babatunde Raji
Anantha R. Nookala
Mohammad Moshahid Khan
Xuyen H. Nguyen
Swarna Sakshi
Tayebeh Pourmotabbed
Murali M. Yallapu
Harry Kochat
Erene Tadrous
Shelby Pernell
Santosh Kumar
PLGA Nanoparticle-Based Formulations to Cross the Blood–Brain Barrier for Drug Delivery: From R&D to cGMP
Pharmaceutics
poly(lactic-<i>co</i>-glycolic acid) (PLGA)
blood–brain barrier (BBB)
current Good Manufacturing Practice (cGMP)
Food and Drug Administration (FDA)
nanotechnology
title PLGA Nanoparticle-Based Formulations to Cross the Blood–Brain Barrier for Drug Delivery: From R&D to cGMP
title_full PLGA Nanoparticle-Based Formulations to Cross the Blood–Brain Barrier for Drug Delivery: From R&D to cGMP
title_fullStr PLGA Nanoparticle-Based Formulations to Cross the Blood–Brain Barrier for Drug Delivery: From R&D to cGMP
title_full_unstemmed PLGA Nanoparticle-Based Formulations to Cross the Blood–Brain Barrier for Drug Delivery: From R&D to cGMP
title_short PLGA Nanoparticle-Based Formulations to Cross the Blood–Brain Barrier for Drug Delivery: From R&D to cGMP
title_sort plga nanoparticle based formulations to cross the blood brain barrier for drug delivery from r d to cgmp
topic poly(lactic-<i>co</i>-glycolic acid) (PLGA)
blood–brain barrier (BBB)
current Good Manufacturing Practice (cGMP)
Food and Drug Administration (FDA)
nanotechnology
url https://www.mdpi.com/1999-4923/13/4/500
work_keys_str_mv AT kainingzhi plgananoparticlebasedformulationstocrossthebloodbrainbarrierfordrugdeliveryfromrdtocgmp
AT babatunderaji plgananoparticlebasedformulationstocrossthebloodbrainbarrierfordrugdeliveryfromrdtocgmp
AT anantharnookala plgananoparticlebasedformulationstocrossthebloodbrainbarrierfordrugdeliveryfromrdtocgmp
AT mohammadmoshahidkhan plgananoparticlebasedformulationstocrossthebloodbrainbarrierfordrugdeliveryfromrdtocgmp
AT xuyenhnguyen plgananoparticlebasedformulationstocrossthebloodbrainbarrierfordrugdeliveryfromrdtocgmp
AT swarnasakshi plgananoparticlebasedformulationstocrossthebloodbrainbarrierfordrugdeliveryfromrdtocgmp
AT tayebehpourmotabbed plgananoparticlebasedformulationstocrossthebloodbrainbarrierfordrugdeliveryfromrdtocgmp
AT muralimyallapu plgananoparticlebasedformulationstocrossthebloodbrainbarrierfordrugdeliveryfromrdtocgmp
AT harrykochat plgananoparticlebasedformulationstocrossthebloodbrainbarrierfordrugdeliveryfromrdtocgmp
AT erenetadrous plgananoparticlebasedformulationstocrossthebloodbrainbarrierfordrugdeliveryfromrdtocgmp
AT shelbypernell plgananoparticlebasedformulationstocrossthebloodbrainbarrierfordrugdeliveryfromrdtocgmp
AT santoshkumar plgananoparticlebasedformulationstocrossthebloodbrainbarrierfordrugdeliveryfromrdtocgmp