Drug Product Formulation Development Services
At Ardena, we guide our customers into making smarter formulation choices. Ultimately, this reduces the risk of clinical failure and ensures your product reaches the clinic rapidly via the most efficient route. Solving a problem and saving time Overcoming development challenges is our speciality. We work with customers to understand their product needs and develop the best possible formulation. We have the capabilities to develop formulations for a very broad range of administration routes, from oral and topical to intranasal, ocular and intravenous.
Lipid based formulations
Lipid-based delivery systems range from simple oil solutions to complex mixtures of oils, surfactants, co-surfactants and co-solvents. These formulations present the DS to the body in a pre-dissolved state and increase oral bioavailability primarily by enhancing the solubilising capacity of the gastrointestinal environment.
The wide variety of lipophilic excipients available and the intricacy of their interplay may render lipid formulation development complex.
At Ardena, lipid formulations are developed via a science-based approach, whereby considerations of solubilising capacity, in vitro performance and manufacturability are carefully balanced.
Nanosuspensions
Nanosuspensions accelerate drug substance dissolution rates by increasing surface area and reducing particle size.
The key to nanosuspension development is the identification of a suitable stabiliser system, such that crystal growth and agglomeration effects are suppressed during the lifetime of the formulation.
In addition to a broad range of milling systems, Ardena has technologies to convert (liquid) nanosuspensions into solid forms.
Solid Dispersions
Amorphous solid dispersions increase DS solubility through elimination of the impact of crystal lattice energy on the dissolution process.
The physical stabilisation of the amorphous state of the DS is accomplished via dispersion in a polymer matrix. The identification of a polymer with sufficient solid-state miscibility with the DS is key to preventing recrystallisation and to ensuring consistent performance over time.
We identify suitable carrier polymers via a combined approach of precipitation assays and solvent evaporation trials, both conducted at milligram scale. Formulation concepts with adequate performance and physical stability are subsequently scaled-up and GMP-produced via either spray-drying or bead-layering.
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