Cystic fibrosis (“CF”) is a life-limiting disease characterised by the build-up of thick mucus in a number of organs including the linings of the lungs; creating an ideal environment for bacterial infection and colonization. CF patients generally undergo intensive, long-term antibiotic therapy, resulting in unavoidable resistance to many anti-infective drugs. Lynovex® is a novel, highly differentiated single therapy for the treatment of various CF-associated lung disease symptomology using cysteamine bitartrate as the active ingredient. The treatment has a unique multi-action, breaking down the excessive mucus produced by the lining of the airways, having antimicrobial activity against bacteria responsible for the recurrent respiratory infections (anti-virulence, anti-biofilm and antibiotic potentiating) associated with CF. Lynovex® is intended for use alongside future standard of care therapy (including CFTR modulators) as a new treatment paradigm for CF. The delivery of maintenance treatments locally to the site of action allows lower ongoing doses to be used, and in the case of CF, local delivery is achieved via an inhaled dry powder delivered to the lung. In this work we demonstrate using the combination of spray drying and micronisation as a manufacturing process to produce particles uniform in size and composition, whilst maintaining an efficient process. The Lynovex® formulation produced shows excellent aerosolization properties, stability and in vitro efficacy. Patient benefits of this approach include improved compliance and acceptance, and a reduced systemic drug loading during treatment.
The use of a combinatorial manufacturing process using spray drying and milling has facilitated development of a novel inhaled multi-active treatment for maintenance of ventilatory function in cystic fibrosis, offering patients an effective and simple treatment administered by local delivery to the lung.