Inhalation | Combination therapy |  SAX | DISCUS | PRT

Controlling and actively manipulating nucleation and subsequent crystal growth behaviour is fundamental to the improvement of pharmaceutical crystallization and crystal engineering processes. Prosonix achieve this through the selective application of power ultrasound, via patented particle engineering and crystallization technologies, such as SAX, DISCUS and PRT, for manufacturing of Advanced Pharmaceutical Ingredients (APIs).

The control of the crystal particle size of APIs is necessary when the final product performance is reliant upon having well-defined and engineered mesoscopic particles, such as in inhaled medicines including asthma, COPD and antibiotics. The size of the particle and the crystal form of the API can influence behaviour in a biological system, such as rate of dissolution. This is of particular importance given that over 40% of new molecules being developed are poorly water soluble.

Prosonix Advanced Particle Engineering (APE) technologies span all aspects of the pharmaceutical development pipeline from discovery through to process optimisation / manufacture and formulation / drug delivery. Our aim is to make better medicines by embracing principles of crystal and particle engineering and by being cognisant of formulation and drug delivery.

Prosonix molecule to particle technologies can yield consistent crystallization leading to improved drug formulation and ultimately better structure pharmaceutical products. By employing our technology our customers benefit from the control of crystal habit, polymorphism and crystal size distribution.

There is need for developing technologies that can tailor particles for a variety of applications. For many new drugs, the need for improved and efficient drug delivery systems has become apparent, especially when administered in a particulate form. In respiratory drug delivery, effective deep lung deposition is achieved with particles of 1 to 5 microns in size.

Prosonix technologies that can deliver microcrystalline particles with narrow size distribution now show great promise in preparing particulate pharmaceuticals with defined physicochemical properties. For drug delivery these technologies take things to a different level in terms of crystallinity and morphology control. To achieve optimal drug delivery to the lung it is important to ensure that the drug is formulated into particles of the appropriate aerodynamic size, shape and density. Our technologies have been applied to many compounds for inhalation including steroidal asthma drugs Budesonide (shown left) and Fluticasone, long acting beta-agonists (LABAs) Salmeterol xinafoate and Formoterol fumarate, antibiotics such as Tobramycin, and many new chemical entities (NCEs) under development.

There is also a real drive to produce Combination particles whereby two or more APIs in an exact ratio can be converted to a particle containing the very same drug substances as separate crystalline entities. In combination therapies for asthma and COPD the APIs often have synergistic action at molecular and cellular level (such as inhaled steroids and long-acting beta agonists) and need to be delivered in an exact ratio to the site of action in the lung.

Prosonix technologies are also available for improving primary product manufacture whether they are drug substances for tablets or injection.

There are many instances where primary drug product cannot be micronized, or where better flow or compression characteristics are demanded. Prosonix Sonocrystallization, DISCUS and PRT can all be used creatively in API manufacture. At Prosonix we have used these techniques for a wide variety of pharmaceutical materials including our engineered alpha-lactose (LactoSonic - image left), oxcarbazepine and metformin. Prosonix technologies are set to revolutionize the primary and secondary manufacturing of drug particles for inhalation, oral and injection

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