[nanoPost] Nanotechnologies based on supercritical fluids

COMPANY SPAIN

The combination of the following three factors pushed pharmaceutical companies and their suppliers at every stage, in every therapeutic class, in every country to redefine and strengthen their Product Life Cycle Management:

* Dramatic reduction of the number of new drug approvals in the last years. It is hard to find real NCE (New Chemical Entities) in Pharmaceutical Pipelines.

* Increasing share of generic drugs through expiration of 'blockbuster' drug patents. Generics are pushing pharmaceutical companies to define new approaches to regulatory and IP protection.

* Polymorphism (crystaline polymorphs and amorphous forms) used to engineer Active Pharmaceuticals Ingredients (API) with unique and differentiated properties (better bio- availability, stronger patent protection, specific performance...)

In this battle for a competitive market, the company is working together with pharmaceutical and biotechnological companies, to enhance and enable a new life for existing drugs or new actives.

Enhancing Solubility and Bioavailability

Sales of poorly soluble drugs and poor bioavailability accounted for approximately $57 billion in 2000, offering a strong opportunity for nanoparticles and nanostructure based drugs. In addition, 40% of new pharmaceuticals in development are based on poorly water soluble actives. Therefore, improving bioavailability by increasing solubility or permeability is a permanent challenge for pharmaceutical companies which should ensure sufficient absorption or simply prove acceptable efficacy of new compounds. Our technology platform provides extensive possibilities for drug/excipient co-precipitation obtaining stabilized amorphous states.

As discussed in many pharmaceutical textbooks, in many cases amorphous drug solubility is enhanced in comparison to crystalline states. Co-precipitation with SCF generates a solid solution of the drug(s) and the excipient(s) in which the constituents are molecularly dispersed providing optimum dissolution properties and enhanced physical stability in contrast to conventional methods.

Stability, purity and product consistency

Increasing chemical purity or enhancing physical and chemical stability of active pharmaceutical ingredients has proved to be a promising way to enforce and extend the life cycle of medicinal products. Equally, the simplification or avoidance of certain steps in the production process reduces variability thus increasing the chances to obtain the desired therapeutic response. The company provides SCF produced powders with excellent physical stability allowing the use of metastable polymorphs or amorphous forms in pharmaceutical formulations. Our technology uses single step production processes without the need for further, drying, milling etc. giving our clients the opportunity to save costs.

Enabling New routes of administration

Alternatives to injected macromolecules are seen as the solution to invasive therapies for better patient compliance and as a way to create new therapeutic categories at global level.

New functional crystal forms

Monitoring and controlling the change of the crystal structures of active ingredients with supercritical fluid processing may lead to a permanent change in the permeability and bioavailability characteristics of the final product and hence to the creation of better performing products. The company provides expert knowledge in the field of polymorphic separation. Our technology provides our clients with the means to produce purer and more stable polymorphic forms. Further, the discovery of new solid state forms (e.g. polymorphs, co-crystals) by means of highly developed screening methods is possible.

Precise targeting

The ability to produce nanostructured particles or to suspend particles ranging from 100 to 1000 nm may allow selective targeting of tumor microvasculature with greater pores than healthy tissues. A similar process may be envisioned to pass natural barriers like the blood-brain barrier. Our technology platform can generate powders with average particle sizes as low as 100 nm. Together with our expertise in drug/excipient co-precipitation this allows us to create structured micro- and nano-particles for improved and targeted drug delivery.

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