Spray Drying as a One-Step Formulation Process

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Micro Spray Drying as a One Step Formulation ProcessThe manufacture of tailored drugs for small numbers of patients (where n could be =1) is challenging both technically and economically. The large-scale manufacture of solid dispersions is multi-stage and inefficient. Additive manufacturing offers one solution to the manufacture of single tailored dosage form but can suffer from often requiring specialized inks that maybe specific to each therapeutic. Such can limit its ability to rapidly prototype and explore formulation-space, and moreover creates significant issues and barriers to regulatory approval.The spray drying process is a long-established, approved continuous manufacturing process that is routinely used for the production of amorphous solid dispersions, used to enhance the oral bioavailability of poorly soluble drugs. The concept here is to scale down the spray drying process to the point of being able to produce amorphous solid dispersions for a single dosage unit at a time, together with the any other constituents necessary for the dosage form.This could be run at a manufacturing scale, producing many dosage forms individually in a single step, where 7 or more steps are currently required. Or, this could be run at a small scale, producing personalised tablets of poorly soluble drugs on demand.Spray-drying is favoured here as it is known to be a highly controllable and repeatable process, hence it is ideally suited to:- SCALE UP for rapid single step manufacture of complex tablets.- SCALE DOWN to enable personalised tablet manufacture.The project will develop a flexible miniaturised spray drying manufacturing process platform for small quantities of patients offering the capability to manufacture tailored micro-encapsulated powder, for use in oral dosage forms such as capsules, incorporation into micro needle arrays, blending with proteins, etc.We will study the engineering and physical principles behind the spray-drying process, in particular using physicochemical characterization of properties such as surface tension and viscosity to reveal how these can inform the design and engineering of the fluidic (micro and macro) flow, nozzle geometry, gas flow, temperature, flow geometry, etc. We will design and develop a working miniaturized spray-drying prototype and use this and the knowledge gained from the characterization of the materials and their behaviour in the device to generate design rules that can be used to formulate personalized dosage forms of a variety of APIs. Micro-spray dried material will be compared to that produced using a traditional small-scale manufacture system.One potential application for our flexible micro-spray drying platform would be for personalised combination chemotherapy. Combination therapy, a treatment modality that combines two or more therapeutic agents, is a cornerstone of cancer therapy. The amalgamation of anti-cancer drugs enhances efficacy compared to the mono-therapy approach because it targets key pathways in a characteristically synergistic or an additive manner. The ability to potentially formulate, on site and on demand, personalized combination therapies offers saving in cost and time, and stands to make a significant impact in the delivery of therapies.Rapid small-scale manufacture would also quicken the development of new formulations, either for new actives or for new indications.Project aligned to Pharmaceutical Process Engineering and Advanced Product Design