Pharmaceutical spray drying

Proven track record of developing and manufacturing spray-dried dispersions to overcome poor drug solubility and delivery challenges.

Poor solubility compounds are highly prevalent in the industry pipeline presenting a major challenge for dosage-form selection. Pharmaceutical spray drying is an established formulation technique at Quotient Clinical, tailored towards the physical and chemical properties of each molecule.  Providing GMP manufacturing capabilities at the 100mg to 3kg scale, we have advanced more than 20 spray dried dispersion (SDD) formulations into clinical studies in the last 2 years.

In a typical program of work we will:

  • Review molecule properties and identify strategies for SDD formulation development
  • Rapidly characterise prototypes using chemical, physical and biorelevant tools
  • Develop oral dosage forms including suspensions, capsules and tablets
  • Manufacture SDDs and SDD-dosage forms under GMP conditions

Capabilities and applications include:

  • Aqueous and solvent-based processing
  • Oral and inhaled drug delivery
  • GMP manufacture for testing in our on-site clinical pharmacology unit
  • GMP manufacture for flexible supply into global Phase I/II studies

Quotient Clinical recently expanded its GMP processing capabilities with a larger scale Niro Mobile Minor™ Spray Dryer (read more), and a partnership with spray-drying specialists Upperton Ltd (read more).

 

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Picture courtesy of GEA Niro