Polymorphism

Discover the right form

Improved Pharma uses 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.  This process can be carried out during the scale up of the synthesis.  Then the selected form is manufactured.  This form is fully characterized and used for both the preclinical studies and the clinical supplies. Forms of interest include crystalline forms, salts, liquid crystals, nanoparticles, and amorphous materials.  Improved Pharma assigns its inventions to the client.

Getting the solid state chemistry right is particularly important for poorly soluble compounds.  For these materials it is possible to gain substantial improvement in solubility by using the proper solid form- typically a salt, cocrystal, liquid crystal, nanoparticle, or amorphous form. Improved Pharma’s strategies are superior for poorly soluble compounds.
Stability

Improved Pharma uses its extensive experience with solid state stability to prepare stable clinical supplies. During the solid form screening, extensive stability studies under accelerated and forced degradation conditions 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 for the clinical study.  These stability studies are used to select the form for manufacture into clinical supplies

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.

Control-API

Improved Pharma will typically develop a method to insure control of the solid form in the API and drug product.  This method will be easy to use and typically involves comparison of the observed pattern with a reference pattern.

Particle size

Improved Pharma has extensive experience with particle size issues and analytical methods to determine methods.  It is critical to understand particle size in the manufactured lot(s).  Furthermore, in some cases milling with surfactants is sufficient to achieve the desired solubility. Improved Pharma has the experience and knowledge to understand particle size effects on bioavailability and stability.

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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....