Solution Engine: Bioavailability Enhancement for Oral Solid Dosage Forms
Click here to download the PDF version of our Solution Engine ASD screening, stability, and scale-up flyer. Our systematic approach, called our "Solution Engine", uniquely combines amorphous solid dispersion (ASD) technologies for screening, stability, and scale-up to ensure the drug candidate with the highest oral bioavailability is selected for further development and/or manufacturing.
In silico computer modelling
In vitro discriminant analysis
In vivo ADME and PK studies
Stability studies
Formulation screening
Process scale-up
cGMP manufacturing
CTM supply and clinical manufacturing
Specializations include lipid-based solution and suspension, self-microemulsifying drug delivery system (SMEDDS), nanosuspension and micronization
ASD Screening Studies: in silico and in vivo
Our ASD screening studies leverage in silico methods based on the Flory-Huggins solution theory to select drug-polymer combinations with the highest chance of miscibility based on estimated solubility parameters and potential for polar, dipole and ionic interactions. Subsequent in vivo PK studies determine drug-polymer combinations with the highest oral bioavailability.
ASD Stability Studies: SDD and HME
Next, ASD stability studies utilize small-scale spray dried dispersion (SDD) and/or hot melt extrusion (HME) to characterize drug-polymer combinations for amorphous content determination (XRPD), thermal properties (mDSC and TGA), assay/related substance and in-vitro non-sink dissolution before being staged in ICH accelerated stability chambers. The ASDs with the highest stability proceed to further in vivo PK studies and selected for process scale-up and manufacturing.
ASD Process Scale-Up and Manufacturing
Our ASD process development and cGMP manufacturing capabilities enable downstream process and manufacturing of finished oral solid dosage forms (tablets and capsules). The process of SDD and/or HME is scaled-up for engineering process development. Finally, cGMP manufacturing, packaging, labeling (open or blinded) and clinical site distribution completes full-service supply of clinical trial material (CTM).
Contact Us
Click here or email hello@bioduro.com to get in contact with a BioDuro representative. By combining in silico computer modeling, in vitro screening and in vivo PK with cGMP manufacturing, our unique approach optimizes ASDs for high oral bioavailability.
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