services		formulation / drug delivery		micro / nano technology		combination products
		analytic		bioanalytic		physical characterization
		clinical manufacturing		ICH stability		in-vitro release testing

Particle Sciences offers a broad array of integrated services and solutions to streamline development and minimize risk.

Proper pharmaceutical formulation is critical to an APIs performance. At Particle Sciences, we design delivery systems and excipients to work as a unit. From dry powders to multiphase emulsions to encapsulation systems, they are all means to the same end: getting the right amount of API to the right place at the right time.

Particle Sciences' staff are experts in the formulation of suspensions and unique solubilized systems. With a wide range of approaches at our disposal, we have an excellent track record of successfully incorporating even the most difficult APIs into the desired delivery format.

The formulation process starts by clearly defining the client's goals regarding API performance. Next, API characteristics are documented through a thorough preformulation effort and mapped against the desired performance. From this, a clear picture emerges as to what the entire delivery system needs to accomplish, enabling Particle Sciences to design a clear program incorporating timelines, milestones and performance testing.

Particle Sciences has a great deal of experience in the development of successful delivery systems for many types of APIs and sites of action. We have been designing solution, suspension, powder and semisolid formulations since 1991. From dry nanoparticles to multiphase emulsions PS has, on behalf of its clients, created many new commercialized products. Utilizing a number of approaches, PS can work with the most difficult APIs to maximize their bioavailablity and stability. Our formulation development labs are extremely well equipped and are supported by in-house GMP/GLP analytic facilities and ICH stability programs. Particle Sciences has worked with small molecules, oligos, peptides, proteins and sugars. We are registered with the DEA and can work with controlled substances. In concert with our clients, we design the optimum program to achieve the desired output.

Partial equipment list

• Class 10,000 Cleanroom
• Sterile laminar flow hoods
• 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
• 22-ton injection molder
• 3-ton bench scale injection molder
• Haake 9000 twin screw compounding extruder
• USP water treatment system
• Multiple Stability Chambers
• Autoclave
• M-110EH-30 Basic BioPharma Microfluidizer

To support formulation development and the establishment of release specifications, Particle Sciences offers an IVRT program using Franz cells. The choice of collection medium, conditions, membrane and interpretation of data all takes experience. At Particle Sciences, our staff has that experience. We regularly work with synthetic, biomimetic and tissue membranes. We routinely design and validate IVRT protocols for both product development and regulatory purposes.