Spray-drying is an inherently continuous and well-established industrial drying process. It can accelerate manufacturing of biopharmaceuticals and vaccine products, resulting in both an economic and health benefit. In this review, we cover a systematic assessment and discuss the spray-drying of diverse protein pharmaceuticals and excipients included therein, solvent systems applicable to these formulations, equipment used and, respective process parameters. Further, key quality aspects of spray-dried protein solids are discussed. Based on the overall trends, we present a concise perspective into the future of protein pharmaceuticals spray-drying.

Purpose The performance of carrier-based dry powder inhaler (DPI) formulations can be critically impacted by interfacial interactions driven by tribo-electrification. Therefore, the aim of the present work was to understand how distinct API particle characteristics affect the charging behaviour of blends intended for DPI delivery. Methods Salbutamol sulphate (SBS) particles engineered via spray-drying and jet milling were used as model APIs. D-mannitol was selected as a model carrier. The materials were characterized concerning their different particle properties and their charge was analysed alone and in blends before and after flow over a stainless-steel pipe. Results The spray-dried SBS (amorphous and spherical) charged positively and to a higher extent than jet milled SBS (crystalline and acicular) that charged negatively and to a lower extent. D-mannitol charged positively and to a higher extent than the APIs. All drug-excipient blends charged negatively and differences were found between the spray-dried and jet milled SBS blends at 2% and 5% drug loads. Conclusions It was demonstrated how distinct solid-states, particle shape, size and morphology as well as different water contents of the different materials can affect tribo-charging. For their binary blends, the amount and nature of fines seem to govern inter-particle contacts critically impacting charge evolution. Electronic supplementary material The online version of this article (10.1007/s11095-019-2612-9) contains supplementary material, which is available to authorized users.

The work aims at evaluating the usefulness of powdered milk as a drug matrix for the production of minitablets specifically designed for children. Mixtures made of powdered milk, paracetamol, mannitol, sodium croscarmellose and magnesium stearate (evaluated for flow properties, cohesiveness and caking tendency) were compacted into beams (evaluated for deformation, elasticity and stiffness) and minitablets (evaluated for uniformity of mass, thickness, tensile strength and paracetamol mean dissolution time) and a 2 3 factorial design performed. The increase on milk fraction in the formulation improved the compressibility of paracetamol and hardness of compacts, reducing weight variation and paracetamol release. A marked decrease on the dissolution time was observed as sodium croscarmellose was added to the milk rich formulations. The increase of the compression force resulted in the production of thinner compacts but had little effect on dissolution time. The production of beams has shown that deformation, bending strength and stiffness increased with both milk and compaction pressure, and decreased with sodium croscarmellose, whereas elasticity decreased when all variables increased. Tensile strength and mean dissolution time described minitablets well, unlike compaction force. The study has proved that powdered milk is suitable for the production of minitablets by direct compression of poor compressible drugs. Highlights-Powdered milk can be used as a matrix to deliver poorly compressible drugs.-Minitablets can be produced by direct compression of drug and powdered milk.-Materials' behaviour is different as powders, compacts or tablets.-The complexity of milk materials justifies unexpected outcomes for compacts and tablets.-Mean drug dissolution time was the most sensitive parameter to assess tablets' performance.

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