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Challenges in drug delivery 

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:

In this battle for a competitive market, Activery® 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.

Activery® 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.

Activery® 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.

Maximizing Product Returns Through Reformulation: Old Molecules, New Opportunities

Introduction

Pharmaceutical profit margins are being squeezed by rising costs, high promotional investment and a pipeline crisis. Alongside restoring productivity companies must implement strategies that fully exploit the commercial potential of existing molecules. Whether seeking to expand a market or protect sales following patent expiry, reformulation is one strategy available for maximizing ROI. Scope Benchmarks the performance of reformulations against competitive differentiation, promotional support, pricing and launch timing in the US market Review of reformulations in cardiovascular, CNS, dermatology, gastrointestinal, infectious disease, oncology, urology and women's health therapy areas

Case studies, analysis and interactive Datapack based on a basket of more than 30 reformulations launched in the US market between Q1 1999 and Q4 2003 Examines the role of reformulations in growing sales, expanding the scope of molecules, countering generics and seizing untapped market opportunities Highlights While only 41% of reformulations are deemed to be therapeutically superior to other formulations within their brand franchises, even when poorly differentiated, manufacturers can still achieve market success through effectively managing relative pricing, promotional support and launch timing.

Companies are effectively employing reformulations to boost franchise growth. 87% of 'switch and grow' franchises exhibited an increase in the rate of sales growth following reformulation launch. Competitive differentiation and promotional activity are key factors influencing the success of 'switch and grow' reformulations. 'Generic defense' reformulations do not receive the same degree of promotional support as 'switch and grow' reformulations and are not sufficiently differentiated from their predecessors to prevent rapid generic erosion. Manufacturers must review their use of reformulations in anti-generic strategies with a focus on promotional support and timing.