Development of syringes and vials for delivery of biologics: current challenges and innovative solutions.

Expert Opinion on Drug Delivery
Saki YonedaSusumu Uchiyama

Abstract

Several new biopharmaceutical dosage forms have developed over time, such as lyophilized vial, liquid vial, and liquid prefilled syringe formulations. This review summarizes major pharmaceutical dosage forms and their advantages, disadvantages, and countermeasures against the shortcomings of each formulation. The appropriate combination of active pharmaceutical ingredients, excipients, and containers should be selected for the safe and less burdensome administration to the patients. Finally, we note certain opinions on the future development of not only therapeutic proteins but also gene therapeutics. This review is to discuss the challenges of the development of dosage forms to improve pharmaceutical stability and how they can be overcome. Silicone oil-free syringes are highly preferable for minimizing subvisible particles in the drug. It can be proposed that materials with less protein adsorption property are preferable for the suppression of protein aggregation. It is required to minimize adverse effects of biopharmaceuticals through proper quality control of the drug in a container, based on the understating of physicochemical stability of the protein in solution, the physicochemical properties of the container, and their c...Continue Reading

References

Nov 1, 1988·Diabetic Medicine : a Journal of the British Diabetic Association·R N Baldwin
Jul 4, 2001·Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan·T AsakuraR Abe
Sep 13, 2002·Journal of Pharmaceutical Sciences·Emily HaY John Wang
Jul 21, 2004·The Journal of Chemical Physics·Seishi Shimizu, Derek J Smith
Oct 19, 2004·Journal of Advanced Nursing·Stan T Preston, Kathleen Hegadoren
Mar 1, 2005·Journal of Pharmaceutical Sciences·Latoya S JonesC Russell Middaugh
Mar 12, 2005·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Hanns-Christian MahlerSusanne Matheus
Oct 10, 2006·The AAPS Journal·Amy S Rosenberg
Aug 16, 2008·Journal of Pharmaceutical Sciences·John F CarpenterBarry Cherney
Sep 11, 2008·Archives of Biochemistry and Biophysics·Erik SedlákPernilla Wittung-Stafshede
Jan 24, 2009·Protein Science : a Publication of the Protein Society·Hai PanGang Huang
Feb 21, 2009·Journal of Pharmaceutical Sciences·Jared S BeeTheodore W Randolph
Jan 27, 2010·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Hiroaki IkesueJill M Kolesar
Jun 25, 2010·Journal of Pharmaceutical Sciences·Matthew HoehneTheodore W Randolph
Aug 27, 2010·AAPS PharmSciTech·Ronald G IacoccaT Shelbourn
Jan 25, 2011·Molecular Immunology·Weirong WangRoxana Ionescu
Feb 15, 2011·Journal of Pharmaceutical Sciences·Sumit MajumdarAjit Joseph M D'souza
Nov 4, 2011·MAbs·Timothy T Kuo, Victoria G Aveson
Feb 7, 2013·PDA Journal of Pharmaceutical Science and Technology·Christopher SloeyJoseph Phillips
Mar 20, 2013·Expert Opinion on Drug Delivery·Jan JezekIain Simpson
Apr 30, 2013·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Kerstin HögerSarah Küchler
Sep 17, 2013·Protein Science : a Publication of the Protein Society·Jordan W Bye, Robert J Falconer
Feb 6, 2014·Journal of Pharmaceutical Sciences·Gayathri RatnaswamyDeirdre Murphy Piedmonte
Apr 15, 2014·Journal of Pharmaceutical Sciences·Alana GerhardtTheodore W Randolph
Jul 16, 2014·Expert Opinion on Drug Delivery·Helen L QuinnRyan F Donnelly
Aug 2, 2014·Expert Opinion on Drug Delivery·Rahul G Ingle, Aayush S Agarwal
Sep 27, 2014·Journal of Pharmaceutical Sciences·Elena KrayukhinaKiichi Fukui
Oct 23, 2014·PDA Journal of Pharmaceutical Science and Technology·Robert A SchautSusan L Schiefelbein
Feb 19, 2015·PDA Journal of Pharmaceutical Science and Technology·Koji NakamuraKevin Constable
Sep 29, 2015·Journal of Pharmaceutical Sciences·Alana GerhardtTheodore W Randolph
Oct 16, 2015·Journal of Pharmaceutical Sciences·Amano MasatoSusumu Uchiyama
Dec 15, 2015·PDA Journal of Pharmaceutical Science and Technology·Elinor H Zarour-ShalevNimrod Lev
Dec 15, 2015·PDA Journal of Pharmaceutical Science and Technology·Hideaki KiminamiShigeru Suzuki
Dec 19, 2015·International Journal of Pharmaceutical Investigation·Ansh Dev RaviL Chawla
Oct 25, 2016·Journal of Pharmaceutical Sciences·Stefanie FunkeWolfgang Friess
Nov 27, 2016·Journal of Pharmaceutical Sciences·Tetsuo TorisuSusumu Uchiyama
Apr 19, 2017·PDA Journal of Pharmaceutical Science and Technology·Christopher M WeikartJeff R Shallenberger
Jun 13, 2017·Journal of Pharmaceutical Sciences·Tetsuo TorisuSusumu Uchiyama
Sep 21, 2017·PDA Journal of Pharmaceutical Science and Technology·Robert A SchautRonald L Verkleeren

❮ Previous
Next ❯

Citations

Jul 27, 2021·Journal of Pharmaceutical Sciences·Saki YonedaSusumu Uchiyama

❮ 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.