Progress in spray-drying of protein pharmaceuticals: Literature analysis of trends in formulation and process attributes

Figures & data

Table 1. Commercially approved protein pharmaceuticals produced via spray-drying.

Product	Active pharmaceutical ingredient	Approval	Excipients	Formulation	Route of administration
Exubera^® (Pfizer)	Insulin	January 2006^a	Mannitol, glycine and sodium citrate	Ready to use powder	Inhalation
Trelstar® LA (Verity Pharmaceuticals)	Triptorelin pamoate	October 2010^a	PLGA, mannitol, carboxymethyl- cellulose, polysorbate 80	Microsphere suspension (powder for reconstitution)	IM injection
Somatuline® LA (Ipsen)	Lanreotide acetate	November 2013^b	PLGA, mannitol, carmellose sodium, polysorbate 80	Microsphere suspension (powder for reconstitution)	IM injection
Raplixa® (The Medicines Company)	Fibrin sealant (human)	April 2015^a	Trehalose, calcium chloride, albumin, sodium chloride, sodium citrate, L-arginine hydrochloride	Ready to use powder	Topic

^a By United States Food and Drug Administration.

^b Product specific waiver granted by the European Medicines Agency for the powder formulation (not approved in the U.S).

* Withdrawn from market subsequently.

Figure 1. Resume of the strategy for the literature research.

Figure 2. Classes of protein pharmaceuticals found in spray-drying literature.

Figure 3. Overview of the published studies by year: (a) total number and (b) used class of protein pharmaceuticals.

Figure 4. Classes of excipients used in the formulation of protein pharmaceuticals via spray-drying.

Figure 5. Sub-categorization of the saccharides used in the formulation of protein pharmaceuticals for spray-drying.

Figure 6. Amino acids used in the formulation of protein pharmaceuticals for spray-drying.

Figure 7. Surfactants used in the formulation of protein pharmaceuticals for spray-drying.

Figure 8. Salts used in the formulation of protein pharmaceuticals for spray-drying.

Figure 9. Proteins used as excipients in the formulation of protein pharmaceuticals for spray-drying.

Figure 10. Sub-categorization of other various excipients used in the formulation of protein pharmaceuticals for spray-drying.

Figure 11. Media used to spray-dry protein pharmaceuticals.

Figure 12. Nozzles used to spray-dry protein pharmaceuticals.

Figure 13. Overview of the DROPPO^® system (a) schematic design of the die-head and (b) droplet formation on an individual jet.

Figure 14. Equipment used to spray-dry protein pharmaceuticals across scales.

Figure 15. Overview of the complex relationship of parameters affecting the spray-drying of protein pharmaceuticals.

Figure 16. SWOT analysis associated with the spray-drying of protein pharmaceuticals.