Abstract
Supercritical assisted Liposome formation (SuperLip) is a lab-scale process for the production of liposomes. SuperLip was recognized as being a versatile supercritical assisted technique for the encapsulation of molecules for different industrial applications, such as pharmaceutic, cosmetic, textile, and nutraceutic purposes. The aim of this work was to perform an economic analysis to assess the profitability of the SuperLip process. The liposomes market was analyzed and the SuperLip process was compared to other techniques in terms of manufacturing advantages using the Canvas and Strengths, Weaknesses, Opportunities, and Treats (S.W.O.T.) models. SuperLip Plant Capital Expenditures (CAPEX) were estimated, and plant Operating Expenditures (OPEX) were also evaluated and integrated with personnel cost and other plant goods and services. A profit and loss statement was generated, together with a cash flow analysis. According to the market average selling price, liposome price is 1.8 €/mL; in order to join the market rapidly, the selling price of liposomes produced using SuperLip was set at 1.1 €/mL. A payback time has been identified at the fourth year of business. Economic indexes such as ROI and ROS were calculated on a 10-year business prospect, obtaining about a 230% return on investment and a 26.7% return on sales.
Highlights
Liposomes are spherical drug carriers characterized by an inner water nucleus surrounded by a lipidic barrier [1]
The liposome production methods proposed in the literature suffer from drawbacks such as low cellular uptake [9], difficult-to-control particle size distribution [10], low encapsulation efficiency [11], and discontinuous layout [12]
Low entrapment efficiencies and the difficult-to-control particle size distribution of liposomes [13] are responsible for the waste of huge percentages of the entrapped amount of molecules and, as a consequence, the production cost increases significantly [14]; the use of solvents negatively contributes to environmental impact [15]
Summary
Liposomes are spherical drug carriers characterized by an inner water nucleus surrounded by a lipidic barrier [1]. Processes 2020, 8, 1604 literature [17,18,19], their main problem was linked to the hydration step of the lipidic layer, which caused a low replicability of the produced vesicles [20]. Atomized water droplets are fast covered by phospholipids, thanks to the high diffusivity of supercritical carbon dioxide [26] According to this mechanism, the main advantage of this process is referred to the one-shot production of liposomes with a continuous and reproducible plant layout. According to the international scale (from 1 to 9) for Technology Readiness Level (TRL) reported in the literature [28,29], the SuperLip process achieved a TRL of 7, meaning that the system is under a prototyping working environment This process has been developed in continuous configuration, and its scalability to the industrial level could be achievable.
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