Features of CritiTech's Spray Drying Technology

  • Widely accepted platform technology for bioavailability enhancement
  • Spray dried dispersions (amorphous API + polymer)
  • Spray dry precipitates (crystalline or amorphous API alone)
  • Non-potent API
  • Non-cytotoxic API
  • Potent API
  • Cytotoxic API (dedicated room, equipment and air handling system)
  • Cytotoxic and non-cytotoxic cGMP materials produced in separate facilities
  • Continuous processing
  • Proof of Concept (POC) through Phase II cGMP clinical production
  • Spray from aqueous or multiple organic solvents
  • Develop multiple formulations with grams of API
  • Milligrams to hundreds of kilograms

CritiTech's Spray Drying Equipment

  • Büchi Proof of Concept Unit
  • Custom manufactured by Cotter Brothers, 316 stainless steel, with proven capability of producing Development through cGMP Phase II clinical trial materials
  • Development Unit (SD30-analogous to Buchi 290)
    • Nominal drying gas rate : 40 – 100 kg/h
    • Mgs to tens of kilograms – DCM throughput up to 10 kg/hr
    • Scaled to SD300
  • cGMP Phase II (SD100-analogous to GEA Niro PSD-1 Mobile Minor™)
    • Nominal drying gas rate : 40 – 100+ kg/h
    • Two separate units at CritiTech
  • cGMP Manufacturing (SD300-analogous to GEA Niro PSD-3)
    • Nominal drying gas rate : up to 600 kg/h

A variety of spray drying nozzles can be utilized in our spray drying units.

 

Improving the likelihood of Development Success for New Compounds and Novel Agents

Water Solubility Problem

It is estimated that 70% – 90% of all new chemical entities have water-solubility problems that make these compounds unusable as drugs. To address this problem, companies often employ complex strategies to increase water solubility, such as using excipients, co-solvents (alcohol or detergents), prodrug formulations, or combining drugs with a carrier molecule. However, in many cases a reduction in particle size may be the appropriate means. The appeal of improving aqueous solubility via reduction of the size of the drug particle lies in its simplicity. Particle size reduction results in increasing the effective surface area of the compound, thus enhancing its dissolution rate. However, most micronization technologies are unable to reduce particle size to less than 1 micron and include a number of other issues as well. CritiTech’s Supercritical Precipitation Technology overcomes many of the limitations of other drug micronization techniques.

Opportunities to Enhance the Value of Currently Marketed Drugs

A growing number of pharmaceutical companies are now applying the technologies of drug-development/delivery companies to enhance the convenience, safety, and efficacy of currently marketed products. When successful, the approach of adding value to established products can yield substantial commercial success.

Spray Drying Technology is an Effective Life Cycle Management Strategy for Existing Drugs

There are hundreds of case studies showing that revenues from a drug can decrease by 70% upon patent expiration. Application of CritiTech’s Spray Drying Technology to existing compounds can potentially create a reformulated and improved 2nd generation drug that would be eligible for an extended period of exclusivity. CritiTech can help enable pharmaceutical companies to cost-effectively introduce a 2nd generation product with improved patient benefits due to the following:

  • Improved pharmacokinetics
    • Increased efficacy
    • Reduced adverse effects
  • Improved dosing regimen
  • New routes of administration

CritiTech’s Spray Drying Technology should be in your “toolbox” of options to improve pharmacokinetics of challenging drugs that you are working with.

Benefits of CritiTech's Spray Drying Technology

  • Bioavailability enhancement of poorly soluble drugs (BCS II and IV)
  • Applicable for peptides and biologics
  • CritiTech’s single pass nitrogen systems ideally suited for drugs
    • Vulnerable to abrasion or shearing
    • With high crystal lattice energy
    • Oxygen sensitive
  • Potential to improve pharmacokinetics
  • Can be utilized as a Life Cycle Management tool for a reformulated and improved 2nd generation product
  • Particles engineered for multiple routes of delivery
  • Readily accepted by regulatory authorities (FDA, EMA, etc.)
  • Scalable and reproducible

Customers may reserve production suites now.