Amorphous Solid Dispersions (ASD) Formulation Services
Low bioavailability in poorly soluble drug candidates often results in suboptimal drug delivery. There are a range of approaches to enhancing solubility, but ASD are a sophisticated solution because they provide increased bioavailability, have applications across the drug discovery and development process and are highly suitable for manufacturing solid dose forms.
BioDuro-Sundia employs a suite of ASD solutions, with extensive experience in spray drying and hot melt extrusion. The selected approach depends on the properties of the active pharmaceutical ingredient (API).
We understand that API availability may be challenging or costly at any stage of development. Our goal is to combine innovation with efficiency in dosage form selection so that material requirements are minimized, but the solution generated is of highest value.
ASD Technologies for Bioavailability Enhancement: SDD and HME
Our technology experts will guide your compound through the process of ASD bioavailability enhancement to determine the right dosage form for engineered success. Services include:
Molecular modeling software for predictive screening
Microscale dispersions for performance evaluation using our MiniPrep technology
Thermal screening for stability and polymer miscibility by mDSC
In-house DMPK capabilities for dosage assessment and real-time feedback
Spray Dried Dispersion (SDD):
Spray drying is an established processing technology for the pharmaceutical industry that improves dissolution rates and bioavailability of poorly soluble compounds. The drug and a polymer matrix are dissolved in a solvent and atomized into a hot gas that evaporates the solvent. The result is a dry, compressible powder. This provides a physically stable drug form that enables processing of the dispersion into solid dosage forms with improved therapeutic efficacy. Read more.
Hot Melt Extrusion (HME):
Hot melt extrusion has proven to be a robust and viable method for pharmaceutical applications capable of creating a diverse range of dosage forms with clinical benefits. HME is the process of embedding drug in a thermoplastic carrier. The mixture is processed at elevated temperatures and pressures, which disperses the drug in the matrix at a molecular level to form a solid solution. Extruded material can be further processed into a variety of dosage forms, including capsules, tablets and transmucosal systems. Read more.
ASD Upstream Processing:
Improving dissolution of poorly soluble compounds
Micronization
Nano Milling
High Shear Granulation
ASD Downstream Processing:
Optimizing physical properties of solid dispersions for solid oral dosage forms
Roller Compaction using Gerteis MINI-PACTOR®
Blending (1-100 kg scale)
Tablet Compression
Encapsulation
Coating
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Amorphous Solid Dispersions (ASD)
