Use of poloxamer polymers to stabilize recombinant human growth hormone against various processing stresses

Pharmaceutical Development and Technology
M Katakam, A K Banga

Abstract

Several processing and shipping stresses were investigated for their effect on the physical stability of recombinant human growth hormone (rhGH). These included exposure to air/water interfaces, adsorption to hydrophobic surfaces, freeze-thaw cycles, and temperature. The interfacially and thermally denatured hormone was evaluated for the presence of insoluble and soluble aggregates by spectrophotometry and by size-exclusion chromatography, respectively. Noncovalent aggregates were generated by either vortexing or multiple passages through a hypodermic needle, processes which exposed the protein to air/water interfaces. Thermal stress also resulted in the generation of aggregates. This aggregation was reduced or eliminated by the use of poloxamer polymers. Under the conditions employed, filtration through some commercially available filters, exposure to hydrophobic beads, or multiple freeze-thaw cycles did not produce any aggregates within the limitations of the analytical procedures used. Based on this study, Poloxamer 407 was found to be the most effective stabilizer for rhGH for protection against interfacial and thermal stress.

References

Nov 1, 1991·Pharmaceutical Research·B M EckhardtT A Bewley
Nov 1, 1991·Proceedings of the National Academy of Sciences of the United States of America·V SluzkyR Langer
Dec 1, 1987·Biotechnology and Applied Biochemistry·G W BeckerR M Riggin
Mar 1, 1983·Journal of Pharmaceutical Sciences·S SatoS W Kim
Jun 1, 1995·Journal of Pharmaceutical Sciences·M KatakamA K Banga
Jan 1, 1993·Pharmaceutical Biotechnology·R Pearlman, T A Bewley

❮ Previous
Next ❯

Citations

Aug 20, 2005·Journal of Interferon & Cytokine Research : the Official Journal of the International Society for Interferon and Cytokine Research·Simon N RobinsonJames E Talmadge
Jan 14, 2011·Journal of Pharmaceutical Sciences·Surinder M SinghKrishna M G Mallela
Nov 22, 2012·Journal of Pharmaceutical Sciences·Regina L HutchingsKrishna M G Mallela
Nov 16, 2011·Journal of Pharmaceutical Sciences·Andrea HaweWim Jiskoot
Jul 16, 2011·Advanced Drug Delivery Reviews·Satoshi OhtakeTsutomu Arakawa
Jun 2, 2007·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·K D F Vlugt-WensinkW E Hennink
May 20, 2005·The Journal of Pharmacy and Pharmacology·Camellia Zamiri, Michael J Groves
Mar 12, 2005·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Hanns-Christian MahlerSusanne Matheus
Jan 18, 2005·International Journal of Pharmaceutics·Wei Wang
Sep 1, 2004·Biochemical and Biophysical Research Communications·Samer SinghRakesh Bhatnagar
Mar 4, 2014·Journal of Orthopaedic Surgery and Research·Soung-Yon KimJuneyoung Lee
Jun 15, 2004·Vaccine·Claire M CoeshottM A Julie Westerink
Jan 11, 2011·Pharmaceutical Development and Technology·Nilanjana DasSenshang Lin
Nov 21, 2012·FEMS Immunology and Medical Microbiology·Neeta Jain-GuptaNammalwar Sriranganathan
Dec 17, 2011·International Journal of Pharmaceutics·Ge BaiW Thomas Leach
May 8, 2013·Journal of Controlled Release : Official Journal of the Controlled Release Society·Marie MorilleClaudia N Montero-Menei
Sep 1, 2010·Therapeutic Delivery·Andrew L Lewis, Lisbeth Illum
Jul 29, 2016·Pharmaceutical Development and Technology·Victoria J Valerón Bergh, Hanne Hjorth Tønnesen
Oct 23, 2003·Transfusion Medicine Reviews·Irina Bakaltcheva, Thomas Reid
Mar 4, 2000·Plastic and Reconstructive Surgery·C M Clokie, M R Urist
Nov 11, 2006·Pharmaceutical Research·Gilles DumortierJean Claude Chaumeil
Mar 15, 2011·Pharmaceutical Research·Sébastien DasnoyVéronique Préat
May 26, 2018·Pharmaceutical Research·Michael T JonesSatish K Singh
Apr 26, 2021·International Journal of Pharmaceutics·Gabriela Corrêa CarvalhoMarlus Chorilli
Aug 26, 1999·International Journal of Pharmaceutics·W Wang
Dec 26, 2001·Pharmaceutical Science & Technology Today·D A Parkins, U T Lashmar

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Clinics in Sports Medicine
Michael E Angeline, Scott Rodeo
European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
Chang Hun YuHwa Nam
Contact Dermatitis
Javier Ruiz-HornillosSonsoles Rojo Sánchez
The Journal of Bone and Joint Surgery. American Volume
Joseph P IannottiScott Rodeo
© 2022 Meta ULC. All rights reserved