First in Man Fast
Formulation Services
Pii understands the need to reduce development costs and enter the clinic quickly to establish efficacy. For fast in man enabling studies, Pii offers API in a capsule filling capabilities using Capsugel's Xcelodose®. The Xcelodose system is a precision powder micro-doser and automated encapsulator that allows the direct fill of API into capsules. By eliminating the need for excipients and drug product analytical methods development, Xcelodose can dramatically shorten time to clinic for first in man studies.
Poorly Soluble Compounds
As the number of NCE's with poor solubility continues to increase, Pii offers extensive expertise in finding formulation solutions for improving the bioavailability of poorly soluble compounds. Pii's formulation development capabilities include:
- Amorphous Solid Dispersions
- Lipid-based Systems
- Micro/Nano Emulsions
- Mixed Phase Co-crystals
- Cyclodextrins
- Co-solvent Systems
- Spray Drying
- Hot Melt Extrusion
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Pii is here to help you at every step of the development pathway, offering a range of services with the customer service and advice you need to move your project forward. Our scientists can screen different solid forms, characterize and select the best candidate for development, develop early phase formulations and manufacture cGMP clinical material. |
Solid-State Chemistry
Pii offers a comprehensive package of advanced solid-state screening, characterization and interpretation services to support the development of new and existing active drug substances and drug product formulations. Solid state screening services include:
- Polymorph Screening
- Salt Screening & Selection
- Co-Crystal Formation
- 'Developability' assessment
- Amorphous Content Quantification
At Pii we understand the value of your API. Using state-of-the-art technologies we provide the data you need with rapid turnaround using minimal drug substance. Our combination of experienced staff and high-throughput technologies, provide you with the insight you need to make an informed decision about your development strategy.
Characterization Tools Include:
- XRPD
- Thermal Analysis by DSC, TGA, hot-stage microscopy
- High-throughput TRANSMISSION X-ray diffractometer (96 well plate)
- High-throughput Raman spectroscopy (96 well plate)
- NMR
- Gravimetric Vapor Sorption
Our industry leading transmission X-ray powder diffraction provides a resource unparalleled in the contract service industry, especially when used in conjunction with our Raman capabilities. Multiple DSC, TGA GVS instruments, a wealth of supporting services and robotics ensure the capacity to take on your project and provide you with the best and most rapid service at great value.
