Formulation Research & Development

IriSys’ R&D services span all stages of formulation development including pre-formulation studies and analytical methods development, as well as qualification and validation. We have specialized technologies for development and optimization of oral, topical and parenteral formulations. Our innovative solutions are unique to each compound and may allow our clients to expand their intellectual property portfolios.

Difficult to Develop Products

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.

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, 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.

Applications:

  • 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

Oral:

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

Parenteral:

  • 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

Topical:

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

Novel drug delivery technologies

IriSys develops formulations for new chemical entities and ANDA/generic products. We also have experience developing formulations with 505(b)(2) product candidates, which can rely in part on data from existing reference drugs. Our formulations can support the expansion of our clients’ intellectual property portfolios.

Micronization technologies

Micro and nanoparticles

Encapsulation technologies

Liposomes, microspheres and micelles

Controlled release formulations

Controlled release solid dosages

Analytical Support Services

IriSys has developed and validated analytical methods for hundreds of products. Such methods enable the quantification of drug level in novel formulations. Analytical methods are also a requirement for drug product release in cGMP clinical and commercial manufacturing.

Method transfer & qualification

IriSys develops, validates, qualifies and transfers methods used to quantify drug substance purity and the percentage of drug content in a dosage form.

Full method development & validation

We design and conduct studies to determine the physical and chemical characteristics of the compound of interest, including small organic molecules, peptides and proteins.

Microbiology testing

IriSys conducts the testing needed to ensure the sterility and stability of finished drug products.

IriSys provides the following analytical chemistry services:

  • Reference standard characterization
  • Analytical methods development
  • Stability-indicating method development
  • Impurity profile generation
  • Degradation product identification
  • Analytical methods qualification
  • Analytical methods validation

IriSys provides the following preformulation development studies:

  • Dissolution testing according to USP
  • Dosage unit analysis for potency, purity and content uniformity
  • Excipient testing
  • Physical accelerated stress testing
  • Chemical accelerated stress testing
  • Specification development
  • Chromatographic system development
  • Identification of conditions required for optimal stability
  • Container/closure testing and selection
  • Pka and pI
  • Partition coefficient and distribution coefficient as a function of pH
  • pH-solubility profile
  • Intrinsic solubility
  • pH-stability profile at accelerated temperatures
  • Accelerated stability studies
  • Dissociation constants
  • Hygroscopicity analysis
  • Lipophilicity analysis
  • Moisture analysis
  • Excipient compatibility studies
  • Salt formation characteristics determination
  • Accelerated stability studies
  • Viscosity analysis
  • Disintegration studies
  • Dissolution studies