BioDuro has been the pioneer service provider of amorphous solid dispersion technologies since the inception of its formulation department in 1996. These platforms address solubility, permeability, and overall bioavailability issues with BCS II, III and IV compounds representing ~ 90% of current NCEs in the pipelines of the pharmaceutical industry. In addition, our team is made up of experts in conventional oral solid dosage forms (Immediate and Modified Release tablets and capsules)
Our formulation development decision tree benefits from integrated in-vivo animal studies early in development where within three to four weeks of starting a project, the lead formulations identified through in-vitro analytical data, are tested for PK profile under our Solution Engine 2.0 platform. Such early PK data has proven to save 12 to 15 months off formulation development timelines based on feedback from our customers
Additional formulation technologies and experience include:
Pediatric age appropriate dose development
Taste-masking/taste-evaluation (electronic tongue)
Orally disintegrating tablets (ODT)
Gastroretentive drug delivery systems (GRDDS)
Solutions
Suspensions, nanosuspensions, lipid based formulations and self-micro-emulsifying drug delivery systems (SMEDDS)
Micronization
We combine data driven decision making with years of formulation expertise to deliver the API to targeted site of action.