The ProRelease™ amorphous microparticle technology can be applied to a wide range of compounds to enhance aqueous solubility, drug dispersion and dissolution and bioavailability
With an increasing number of poorly soluble or difficult to crystallise drugs entering development, new formulation strategies are continually required to achieve sufficient bioavailability. Amorphous solid dispersions (ASDs) are an interesting option receiving increased attention in recent years and offer the advantages of improved dissolution rates and higher apparent solubility characteristics compared to the crystalline state.
Therefore, if drug permeability is sufficient, the absorption rate and absolute bioavailability can be dramatically increased by enhancing solubility and dissolution kinetics.
How the ProRelease™ technology works
Through Solvent Mediated Activation (SMA), ProRelease™ creates New Physical Entities (NPEs) of a drug by erasing the crystal lattice to produce an amorphous state, which is then stabilised with biologically inert GRAS carriers. The carriers used in the ProRelease™ system are biocompatible and readily dissolve in the body's GI fluids, releasing the drug in a molecularly dispered form to afford increased kinetics of dissolution and apparent solubility.
Benefits of the ProRelease™ technology
Compared to current approaches to manufacture Amorphous Solid Dispersions (ASDs), the ProRelease™ technology requires only milligram quantities of material to effectively screen for suitable stabilising matrix systems. Once identified, our in-house designed process for manufacture allows for small scale production (typically < 200 mg) and subsequent analysis in vivo for preclinical testing.
Unlike many production methods, the final product is a free-flowing powder that can be incorporated into a variety of dosage forms to achieve the most effective delivery.
The ProRelease™ system offers additional advantages including:
- Produces a free flowing drug powder which can be incorporated into a variety of dosage forms, including tablets and capsules
- Produces molecularly dispersed and physically stable drug / excipient microparticulates
- Manufacturing process allows for quick and cost effective feasibility evaluation
- Ability to precisely control the particle size distrubition of amorphous microparticles
- Careful selection of excipients allows production of immediate or modified release products
For more information about the ProRelease™ amorphous microparticle technology, please contact us at enquiries@synectix-pharma.com
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