Current technologies for preparing micron sized particles for respiratory drug delivery focus on high energy milling (fluid energy milling, micronisation) and involve a number of different stages. It is widely recognised that such processing operations can cause uncontrolled levels of crystallographic, chemical and/or surface damage to the fractured drug particles for many materials. Such changes can cause both downstream secondary processing problems as well as batch to batch variability issues. It also means that the yield for the process is notably lower as product is lost at each step.
In contrast, SCF processing is a single step operation resulting in a high yield of micron / sub-micron sized particles, which do not exhibit such damage. Yields that are typically acheived in optimised processes are more than 90%. The processes are highly reproducible, and deliver strong levels of intra- and inter-batch consistency along with a high level of particle size control. SCF technology is particularly effective when creating products for inhaled delivery as it enables particles to be engineered that have tight size distribution and low surface energetics. This allows for a much simplified formulation (often eliminating the need for lubricants or suspending agents in dry powder systems), which when combined with strong intrinsic particle aerodynamics leads to superior lung deposition and the potential for enhanced bioavailability at equivalent or lower doses.
The first SCF based medicine (Levadex) has filed an NDA and is expected to launch in 2013. It is an inhaled, dry powder therapeutic for migraine, a reformulation of an injectable drug. The inhaled formulation is able to deliver comparable performance to an intravenous injection.
CrystecPharma's intellectual property strategy is to protect products, maintaining its technology platform and scale-up expertise as trade secret.
We are keen to work with companies developing large and small molecule therapeutics for nasal/pulmonary delivery, as well as companies looking to enhance performance of inhaled therapeutics as part of a life cycle management (LCM) strategy.
Miss Catherine Hunter
Business Development Manager
CrystecPharma applies the latest supercritical fluid (SCF) technologies to improve the design and performance of medicinesView profile
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