We have developed a series of transformational particle engineering technologies to facilitate the development of novel mono- and combination therapies for respiratory diseases.
Although constructive processes for the production of drug particles with an optimum particle size range for pulmonary delivery are available, there still remains a need to implement robust particle engineering technologies which can achieve a greater control over the particle physico-chemical properties post-micronisation whilst maintaining throughput and industrial scalability.
At Kuecept, we have developed 2 particle engineering solutions to produce micronised drug particles that precisely meet the specific requirements for mono and combination therapy and are suitable for use in both dry-powder and suspension based pressurized metered dose inhalers.
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Micron-Ease™ is a top-down particle size reduction technology that is used to manufacture micronised drug particles whilst giving a very precise control on particle size distribution and morphology.
Additional benefits include:
- Less aggressive method of particle size reduction compared to covnentional approaches such as air jet milling
- Excellent control of particle size distribution with tight spans and in-process sampling
- Process independent from quality on input feed material (size, shape, brittle/ductile nature)
- Maintains crystalline state (little or no amorphous content) providing good physical stability that is vital for a stable inhalation product
- Ability to process hydrates/solvates with no loss of bound moisture / solvent
- Process is directly scalable from mg evaluation to Kg batch manufacture for cGMP clinical supplies.
Micron-Ease™ is now available for access on a fee-for-service basis. In addition, Kuecept has specific technical knowledge and Intellecutal Property (IP) around processing certain high value actives for inhaled therapy, including Tiotropium Bromide (hydrates, solvates and anhydrous forms), Fluticasone Propionate and many more. Please contact us for more information.
Combination inhalation therapy (e.g. a LABA and an ICS) provides convenience to the patient along with synergistic pharmacological actions, leading to better compliance and therapeutic outcomes. Conventional blending of the active pharmaceutical ingredients (APIs) with lactose carrier particles is commonly used in formulating combination inhalation products. However, the blend performance is highly variable, depending on the amount of amount of fines, surface roughness, API polymorphic form, production batch and grade of the carrier lactose. Furthermore, unpredictable or preferential adhesion of one API over the other on the lactose, along with self-agglomeration of one or both drugs, will cause content segregation and dose non-uniformity. Any difference in the particle properties between the APIs, as manifested in different interactions between the drugs, carrier and container surface, may lead to changes in the fine particle fraction (FPF), device retention and dose variability.
To address these issues, Kuecept Ltd has developed a robust and scaleable particle engineering technology (CombiSphere™) which enables the rapid manufacture of crystalline drug combination particles suitable for delivery by both carried-based DPIs and suspension based pMDIs.
Each particle produced by the CombiSphere™ technology contains two or more actives in an exact ratio and which consistently demonstrate improved Fine Particle Dose (FPD) and co-deposition delivery compared to using individual micronized powders.
- Particle production independent of the chemistry of the actives, allowing a wide range of formulations to be manufactured
- Ability to rapidly manufacture batches from mg to multi-kilo scale using robust and scalable processes
- Particles demonstrate ideal physico-chemical properties for secondary processing, i.e. flow, surface charge, cohesion / adhesion forces
- Particles are highly crystalline in nature, ensuring physical stability of material during processing and storage (quarantine)
- Particles remain stable during high-shear blending (i.e. no particle fracture) ensuring consistent dose content uniformity
- Ability to formulate particles into drug only pMDIs and carrier based DPIs
CombiSphere™ is now available for evaluation for specific drug product manufacture and testing.