Formulation Development

Advanced Formulation Technologies

BioDuro applies a range of formulation technologies to address the solubility, permeability, and bioavailability challenges commonly associated with modern drug candidates. Our teams develop tailored formulation strategies designed to improve oral exposure, optimize drug delivery, and support efficient progression toward clinical development.

Capabilities include:

• Amorphous Solid Dispersions (ASD) via hot‑melt extrusion and spray‑dried dispersion
• Particle engineering (micronization included)
• Immediate & modified‑release oral solids
• Injectable formulations
• Ophthalmic formulations
• Lipid‑based and SMEDDS formulations
• Topical drug delivery
• Oral peptide delivery
• Nanoparticle technology

From early feasibility studies through clinical manufacturing, BioDuro combines formulation expertise with analytical evaluation and PK-informed decision making to help identify scalable approaches for challenging compounds.

Bioavailability Enhancement & ASD Platform

Poor solubility remains one of the biggest challenges in oral drug development. BioDuro applies amorphous solid dispersion (ASD) strategies to improve exposure and help advance poorly soluble compounds toward clinical development.

Our formulation scientists evaluate each molecule to determine the most appropriate approach across Spray Dried Dispersion (SDD) and Hot Melt Extrusion (HME) technologies, combining predictive screening, analytical evaluation, and early PK data to guide formulation selection.

Workflows can include:

• ASD screening using minimal API quantities
• Molecular modeling and polymer compatibility evaluation
• Thermal stability and miscibility assessment
• Early PK-informed formulation selection
• Scale-up and clinical trial material manufacturing

Additional formulation approaches such as lipid-based systems, SMEDDS, nanosuspensions, and micronization may also be applied depending on compound-specific challenges.

Modified Release & Oral Dosage Expertise

BioDuro develops oral solid dosage formulations designed to address stability, release profile, and patient dosing challenges across a wide range of compounds. Our experience spans immediate release, delayed release, sustained release, and custom release approaches for tablets, capsules, and multiparticulate systems.

Formulation activities may include:

• Modified and controlled release formulations
• Enteric-coated dosage forms
• Matrix and multiparticulate systems
• Taste masking approaches
• Pediatric dosage considerations
• Tablets, mini-tablets, and capsules
• Clinical-to-commercial manufacturing scalability

Our teams apply formulation, granulation, coating, and processing expertise to help achieve consistent release profiles and downstream manufacturability.