Topical ocular protein delivery based on protein powder suspensions in semifluorinated alkanes.

The field of ocular diseases, specifically retinal diseases is a successful target area for protein drugs with various marketed products. Besides the intraocular treatment of the retina, the topical treatment of corneal or conjunctival diseases is a promising approach. Topical ocular protein formulations face the challenges of poor penetration and potentially low stability.

Drug Product Characterization of High Concentration Non-Aqueous Protein Powder Suspensions.

High concentration protein formulations for subcutaneous injection represent a substantial number of development projects in the pharmaceutical industry. Such concentrated aqueous protein solutions face some specific challenges such as increased viscosity and aggregation propensity. Protein powder suspensions in non-aqueous vehicles could be an alternative providing lower viscosity than the respective aqueous solution.

Preparation of high concentration protein powder suspensions by milling of lyophilizates.

Pharmaceutical formulations utilizing protein drugs as powders can be used as drug delivery systems in various ways. Besides powders for inhalation, another promising approach is their use as suspensions in non-aqueous liquids for subcutaneous administration providing high protein stability and good injectability. In this study protein powder suspensions were prepared using a swing-mill.

Powder suspensions in non-aqueous vehicles for delivery of therapeutic proteins.

Formulating biopharmaceuticals is a challenging task due to their complex and sensitive nature. Protein drugs are typically marketed either as an aqueous solution or as a lyophilizate. Usually aqueous solutions are preferred as neither drying nor reconstitution are required.