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. From highly potent compounds to biologics, We Deliver®.

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, we specialize in BCS II/III/IV molecules and 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 FDA registered and DEA licensed for all controlled substances. In concert with our clients, we design the optimum program to achieve the desired output.

Preformulation studies are the foundation of any efficient drug product development effort. Particle Sciences (PSI) has developed a proprietary 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

PSI utilizes DOSE as one of a variety of tools for evaluation and formulation of novel materials or novel approaches to known materials. The characterization of APIs in this way allows for the classification of materials into functional categories, predictive of physicochemical behavior and providing reality checks for experimental results obtained and vice versa. In the formulation development stage, the parameters are used to find compatible ingredients, maximize API solubility and for the replacements undesirable ingredients. Formulation goals are quickly optimized using this in combination with DoE (Design of Experiments).

This powerful approach of combining hands-on measurements with predictive software provides PSI's clients with a competitive advantage by decreasing the time and money necessary to make informed decisions early on in the formulation development process. PSI continues to work with Professor Abbott to understand and better leverage this tool for specific drug development issues relevant to PSI client projects

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.