Conventional and Novel Container Closure and Delivery Systems

Recent years have seen continued growth in the area of biologics with a majority of pharmaceutical companies developing a pipeline in next-generation biologic products. Most biologics are administered via injectable routes of administration and often require frequent injections. Hence, delivery devices that can reduce discomfort associated with injectable delivery (both to the caregiver and the patient) are of interest as part of lifecycle management of biologic products. This chapter attempts to discuss some key features of these delivery devices for biologics (both conventional and novel) that are important for consideration in product development. Keywords: biologics delivery technologies; combination products; device delivery packaging

[1]  T. Masuzawa,et al.  Synthetic polymer–tissue adhesion using an ultrasonic scalpel , 2011, Surgical Endoscopy.

[2]  Sung Chul Kim,et al.  Chemical structure and physical properties of cyclic olefin copolymers (IUPAC Technical Report) , 2005 .

[3]  R. Albrecht,et al.  Biomaterials with permanent hydrophilic surfaces and low protein adsorption properties. , 1994, Journal of biomaterials science. Polymer edition.

[4]  E. Cevher,et al.  Nasal Delivery of High Molecular Weight Drugs , 2009, Molecules.

[5]  Karen M. Alsante,et al.  A critical assessment of the ICH guideline on photostability testing of new drug substances and products (Q1B): Recommendation for revision. , 2010, Journal of pharmaceutical sciences.

[6]  J L Whittingham,et al.  Interactions of phenol and m-cresol in the insulin hexamer, and their effect on the association properties of B28 pro --> Asp insulin analogues. , 1998, Biochemistry.

[7]  Qi Wang,et al.  Surface modification of linear low‐density polyethylene film by amphiphilic graft copolymers based on poly(higher α‐olefin)‐graft‐poly(ethylene glycol) , 2011 .

[8]  D. Volkin,et al.  The adsorption of proteins to pharmaceutical container surfaces , 1992 .

[9]  F. C. Raggon,et al.  Promotion of Attack on Glass and Silica by Citrate and Other Anions in Neutral Solution , 1959 .

[10]  J. Tamada,et al.  Kinetics of insulin aggregation in aqueous solutions upon agitation in the presence of hydrophobic surfaces. , 1991, Proceedings of the National Academy of Sciences of the United States of America.

[11]  M. Weert,et al.  Immunogenicity of Biopharmaceuticals: Causes, Methods to Reduce Immunogenicity, and Biosimilars , 2008 .

[12]  R. Iacocca,et al.  Corrosive attack of glass by a pharmaceutical compound , 2007 .

[13]  T. J. Roseman,et al.  Glass for parenteral products: a surface view using the scanning electron microscope. , 1976, Journal of pharmaceutical sciences.

[14]  Theodore W Randolph,et al.  Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution. , 2009, Journal of pharmaceutical sciences.

[15]  V. Hlady,et al.  Protein adsorption on solid surfaces. , 1996, Current opinion in biotechnology.

[16]  H. Toguchi.  Sterility assurance of microspheres. , 1999, Journal of controlled release : official journal of the Controlled Release Society.

[17]  R. Campbell,et al.  Lispro Insulin: Adsorption and Stability in Selected Intravenous Devices , 1999, The Diabetes educator.

[18]  R. Iacocca,et al.  Factors Affecting the Chemical Durability of Glass Used in the Pharmaceutical Industry , 2010, AAPS PharmSciTech.

[19]  Bethan Hughes,et al.  2007 FDA drug approvals: a year of flux , 2008, Nature Reviews Drug Discovery.

[20]  Bethan Hughes,et al.  2008 FDA drug approvals , 2009, Nature Reviews Drug Discovery.

[21]  Joey Pollastrini,et al.  Tungsten-induced protein aggregation: solution behavior. , 2009, Journal of pharmaceutical sciences.

[22]  M. Wiedmann,et al.  Microtiter Plate Assay for Assessment of Listeria monocytogenes Biofilm Formation , 2002, Applied and Environmental Microbiology.

[23]  Pavlos Papadopoulos,et al.  Effect of terminal sterilization by irradiation on amber Type I and Type III glass containers containing veterinary oxytetracycline suspension. , 2004, PDA journal of pharmaceutical science and technology.

[24]  M. Duncan,et al.  Influence of surfactants upon protein/peptide adsorption to glass and polypropylene , 1995 .

[25]  J. Kling.  Fresh from the biologic pipeline—2010 , 2011, Nature Biotechnology.

[26]  C. R. Middaugh,et al.  Silicone oil induced aggregation of proteins. , 2005, Journal of pharmaceutical sciences.

[27]  A. Klibanov,et al.  Inhalation delivery of proteins from ethanol suspensions , 2001, Proceedings of the National Academy of Sciences of the United States of America.

[28]  S. Havelund,et al.  Adsorption of insulin on solid surfaces in relation to the surface properties of the monomeric and oligomeric forms , 1991 .

[29]  A. Albisser,et al.  Insulin aggregation in artificial delivery systems , 1980, Diabetologia.

[30]  KJ Lauritsen,et al.  Combination Products Regulation at the FDA , 2009, Clinical pharmacology and therapeutics.

[31]  P. Byron.  Drug delivery devices: issues in drug development. , 2004, Proceedings of the American Thoracic Society.