Biopharmaceutical formulations for pre-filled delivery devices

Abstract

We anticipate that there will be a significant move towards polymer primary packaging for most drugs in the longer term. The timescales for this will depend on a number of factors and hence will be hard to predict. Formulation will play a critical role in developing successful products in the pre-filled syringe format, particularly with the trend towards concentrated biotherapeutics. Development of novel, smart formulation technologies will, therefore, be increasingly important.

Subcutaneous Injection Volume of Biopharmaceuticals—Pushing the Boundaries

“…Particularly, combination products such as prefilled syringes and autoinjectors enable self-administration, shifting the point of care from the hospital to the patient's home. 4 Prefilled syringes also improve patient compliance and safety as well as minimize dosing errors and microbial contaminations. 4 Despite these benefits, several challenges associated with the SC administration route remain.…”

“…4 Prefilled syringes also improve patient compliance and safety as well as minimize dosing errors and microbial contaminations. 4 Despite these benefits, several challenges associated with the SC administration route remain.…”

In Vivo Analysis of the Potency of Silicone Oil Microdroplets as Immunological Adjuvants in Protein Formulations

“…Another source of subvisible particles is the lubricant used in prefilled syringes. Prefilled syringes are the primary container of choice for storage and delivery of parenteral drug products because of their ease of use, their compatibility with auto‐injectors, and the reduction in improper dosing and decreased contamination associated with their use . Prefilled syringes typically are composed of glass, which requires a lubricant to allow smooth movement of the plunger through the syringe during drug administration.…”

Silicone Oil Microdroplets Can Induce Antibody Responses Against Recombinant Murine Growth Hormone in Mice

“…Their reduced handling requirements, ease of administration, reduced risk of contamination, and elimination of the need for overfill make prefilled syringes a popular choice among producers and consumers. 17, 18 Because prefilled syringes function as a storage container as well as a delivery device, therapeutic proteins within these syringes are exposed to silicone oil for their entire shelf life. 19 During storage, shipping, and administration to the patient, silicone oil can be shed from the syringe barrel wall, forming microdroplets of silicone oil within the protein formulation.…”

“…19 During storage, shipping, and administration to the patient, silicone oil can be shed from the syringe barrel wall, forming microdroplets of silicone oil within the protein formulation. 18, 20 …”