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Amorphous Solid Dispersions

Developing your poorly soluble compounds into dosage forms

Download our amorphous dispersions fact sheet

Amorphous Solid Dispersions Fact Sheet

Overcoming Challenging Drug Formulations

Low bioavailability in poorly soluble drug candidates often results in suboptimal drug delivery. There are a range of approaches to enhancing solubility, but amorphous solid dispersions 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 employs a suite of bioavailability enhancement 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.

BioDuro Solution Engine: Our technology experts will guide your compound through our Solution Engine to determine the right dosage form for engineered success

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

Methods of Bioavailability Enhancement

Spray Dried Dispersion

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.

Hot Melt Extrusion

Hot melt extrusion (HME) 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.

Upstream Processing

Improving dissolution of poorly soluble compounds

  • Micronization
  • Nano Milling
  • High Shear Granulation

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