Clinical Supplies

·       Method development

·       Improved Pharma’s access to beamline 11-BM at Argonne National Laboratory allows perhaps the most sensitive powder diffraction analysis in the world.  This beamline has a 1-meter diameter diffractometer equipped with 12 analyzers offering the highest resolution in the Americas and among the highest resolution in the world.  This capability means it is possible to detect even very weak diffraction lines form a range of contaminating crystalline materials.  Through its collaboration with Excelsus, Improved Pharma is able to utilize sophisticated analytical algorithms to determine percentages of low concentrations of contaminants.Optimization of Spray Drying Methods

The levitated drop experiments outlined above are simulations of spray drying where the solvent evaporates from a droplet leaving a solid particle.  Thus the translation from the levitated drop experiments to spray drying is expected to be routine in typical cases.  Scale-up of manufacturing using spray drying is provided by Improved Pharma through its collaboration with the Purdue University Industrial Pharmacy Services Laboratory.  The formulation is then hand filled into capsules for further study.  If needed, GMP manufacturing can be provided in either the Purdue GMP Center or at the University of Minnesota GMP laboratory.  In this way, formulations can be scaled up to prepare clinical supplies in a rapid, efficient manner.

A range of parameters needs to be controlled to optimize formulations prepared by spray drying.  These parameters include solvent, polymer, polymer to drug ratio, salt formation, and the inclusion of surfactants.  Typically, a design of experiments matrix is utilized to guide these experiments.  Pair distribution function (PDF), stability, and/or dissolution profile are utilized to evaluate the various formulations.  Improved pharma can provide a complete optimization study following these general procedures.  The exact parameters optimized are determined on a case-by-case basis.  Of particular interest is the utilization of salt-forming polymers to prepare especially stable formulations.  Once the methods are optimized, they can be scaled up to prepare clinical supplies.

·       Conversion of Spray Drying Formulations to Melt Extrusion

The conversion of spray dried methods to melt extrusion is possible especially if the structure of the spray dried formulation is understood as described above.  Knowing the key structural parameters that need to be preserved in order to maintain optimum stability and optimum solubility/dissolution allows conversion of spray drying processes to melt extrusion processes. 

Stability

Improved Pharma can carry out a range of accelerated and forced degradation studies. These studies focus on both chemical and physical stability of the solid form. Improved Pharma has a strategy using a minimum of experiments to obtain information on the stability of clinical supplies. These stability studies are used for a wide range of applications including selecting the best formulation and troubleshooting formulations problems.

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Powerful methods of analysis including IVIVC

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Informatics system to insure quality documents

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Strong IP assigned to client

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Quality by Design for formulations

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Rapid assessment of the risk of stability problems

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Fast screening for the right solid form....