Problem Solving

Improved Pharma consultants have extensive experience with problem solving all along the path to proof of concept.

Solid State Chemistry - polymorphs, salts, cocrystals, and amorphous forms

Improved Pharma provides an expert assessment of the current status of your polymorph screening activities. Improved Pharma may suggest additional experiments or approaches to determine which form is most stable. Improved Pharma can also use its superior expertise in solid state chemistry to design a solid form screening and selection process based on the structure and known properties of the starting drug. Finally, Improved Pharma can suggest when it is most appropriate to search for salts, cocrystals, or amorphous forms. If desired, Improved Pharma can evaluate and recommend vendors for your particular screening problem.

Stability

During the solid form screening, extensive stability studies under accelerated and forced degradation studies are performed. 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 to select the form for manufacture into clinical supplies.

Formulation

Solving formulation problems is a particularly strong expertise of Improved Pharma. Whether your formulation is unstable, has low solubility, or exhibits dissolution rate problems, Improved Pharma has the experience and access to the technology to rapidly develop a solution. Improved Pharma consultants have also solved numerous scale-up and production scale problems. Contact Improved Pharma for an initial discussion and ask for a protocol.

Particle Size Reduction and Sub-Micron Sized Crystals

Particle size reduction and/or the production of crystals in the sub-micron range can often solve a bioavailability problem. Unfortunately, sub-micron crystals are physically unstable and ripen to larger agglomerates. Improved Pharma has extensive experience with milling, particle size analysis and coating particles to achieve improved stability.

Clinical Supplies

Through the years, Improved Pharma’s consultants have solved many problems with sameness of clinical supplies. That is, Improved Pharma has a vast amount of expertise in helping clients evaluate their clinical supplies and assess the sameness of these supplies to each other. This information is invaluable in speeding development and assisting in avoiding the use of “bad” lots of clinical supplies in clinical trials.

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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....