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Combination Products
Particle Sciences is the leading drug/device combination product CRO. Whether it's a new chemical entity, a line extension or generic Particle Sciences is equipped to handle the complete design, formulation and production of our client's drug eluting devices. This includes both controlled and highly potent compound based products.

In-house capabilities include extensive physical characterization equipment, injection molding, high shear mixing, extruding and compounding. With our in-house analytic services, drug release methods can be both developed and validated. The process starts with our highly refined preformulation approach we call DOSE™. Dose is based on a combination of empirically collected data and propriety computational tools Particle Sciences has built. The first module is used for calculating and predicting solubilization systems for API's and modeling the solubility of a given API in candidate polymers for drug-eluting polymeric devices. The software calculates the degree of physical compatibility - solubility or miscibility - of active pharmaceutical ingredients (APIs) with any other ingredient PSI is using. Each API, solvent, polymer or excipient can be characterized by the 3 HSPs (Hansen Solubility Parameters - dispersion, polar and hydrogen bonding) and their mutual compatibility, based on "like dissolves like", is calculated by the "distance" between the two sets of HSPs. By using a proprietary panel of solvents and an extensive database of known HSP values vetted against performance, Particle Sciences is able to quickly characterize a given API. The result of utilizing this tool is increased efficiency and a more scientifically rational approach to product development. This reduces the amount of time and resources used in developing formulations by providing insight into the physicochemical behavior of the APIs and narrowing the region of excipient space that needs to be evaluated during product development. The second module introduced in mid-2011 calculates inter-particle forces in dispersed systems, and leads to the design of stable nano or micro particle suspensions. The third and latest addition accurately models the elution of a given API from a non-degrading polymeric device, such as an implant or an intravaginal ring. Based on well-established mathematics and a set of base measurements, this latest addition allows Particle Sciences to significantly reduce the time needed for prototyping drug-device combination products. Particle Sciences works closely with experts like Dr. Steven Abbott, one of the Authors of HSPiP, to refine our programs for Particle Sciences' specific needs. Using this approach, physical properties such as solubilities, logP, permeation rates, and surface characteristics can be calculated and actionable predictions can be made that guide the development process.

With combination products, polymer control and supply are especially important. Particle Sciences has established preferred relationships with the world's leading polymer suppliers thus ensuring a seamless commercialization path for out clients.

Of course, combination product development is supported by Particle Sciences suite of cleanrooms built to handle anything from sterile products to highly potent compounds. Our Analytic group takes the project from API characterization through method development and validation, ICH stability programs and into the clinic. Particle Sciences is the only source for concept to clinic combination product development.

Partial Equipment List
  • Class 100 through 10,000 Cleanrooms
  • Sterile laminar flow hoods
  • Four twin screw extruders ranging from bench top to 18 mm
  • Strand, film, tube and coextrusion lines
  • 22-ton injection molder
  • 3-ton bench scale injection molder
  • Wet granulator and high shear mixer
  • Singles screw extruder
  • Induction welders
  • Silverson L4RT-A laboratory homogenizer with M-line capability
  • Ad-mix Benchmix OPLB-300 Rotosolver
  • Three Ultrasonic 500W dispersers/homogenizers with in-line capability
  • Netzsch Labstar LS1 media mill
  • Two Premier PLM-1.5 liter jacketed double planetary mixer with vacuum
  • Two Bucchi -290 Mini-spray dryers with solvent capability
  • Multiple Sturtevant Qualification Micronizers with sanitary collector capability
  • Roller mills
  • Gaulin 15MR laboratory homogenizer
  • Lyophilizer
  • Millipore bench-scale tangential flow filtration unit
  • Glass-lined jacketed and pressurized reactor
  • Cooling tower with 2 heat exchangers
  • Haake 9000 twin screw compounding extruder
  • USP water treatment system
  • Multiple Stability Chambers
  • Autoclave
  • M-110EH-30 Basic BioPharma Microfluidizer
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