Difficult to Develop Products

Insoluble Compound Formulation Development - IRISYS

IRISYS creates new formulations that are tailored to a drug’s physical and chemical characteristics; each formulation is unique to the compound. We provide world-class dosage form development services, both classical and proprietary. We specialize in working with a variety of poorly soluble and insoluble compounds, including water insoluble drug formulations.

Poorly soluble compounds

IRISYS is a pioneer in the development of liquid-filled hard gelatin and HPMC (hydroxypropyl methylcellulose) capsule formulation technologies. We create solutions for issues related to the unique physical and chemical characteristics of a drug compound. These characteristics may include:

  • Insolubility (insoluble compounds)
  • Poor solubility
  • Poor bioavailability
  • Lack of content uniformity
  • Hygroscopicity

Wide range of dosage forms

IRISYS’ team develops formulations for dosage forms that are appropriate for small molecules, peptides and proteins.


  • Small organic molecules
  • Peptides and biologics
  • Proteins
  • Synthetic polymers
  • Inorganic compounds
  • Cytotoxic and potent compounds

Dosage forms:

  • Tablets
  • Capsules, powder-filled
  • Capsules, liquid-filled
  • Oral solutions and suspensions
  • Topical products
  • Injectables
  • Controlled release products
  • Sustained release products
  • Pellets
  • Microspheres
  • Microemulsions
  • Nanoemulsions
  • Nanoparticles


  • Moving from multiple daily doses to once daily
  • Controlled release of highly water soluble drugs
  • Immediate release of highly lipophilic drugs


  • Increased circulating half-life, optimized bio-distribution
  • Improved safety and efficacy
  • Decreased immune recognition
  • Targeted delivery
  • Discriminative release (location and environment)
  • Pharmacodynamically optimized formulations
  • Long-acting formulations
  • Lyophilized products


  • Increased bioavailability
  • Enhanced stability
  • Optimized viscosity
  • Optimized polymer network for high electrolyte content

BCS Class II drugs

The Biopharmaceutical Classification System (BCS) is a tool for regulation of drug products worldwide. BCS class II (BCS II) drugs are poorly soluble and highly permeable. IRISYS has experience working with BCS class II drugs and other insoluble compounds. We can address the specific needs of developing your BCS II drugs, including water insoluble drug formulations.

For help with your Difficult to Develop Product, contact us below: