Upscaling Synthesis of Ordered mesoporous silica material for Drug delivery Applications

Información del proyecto

USODA

Identificador del acuerdo de subvención: 672723

DOI

10.3030/672723

Proyecto cerrado

Fecha de la firma de la CE 1 Mayo 2015

Fecha de inicio 1 Junio 2015

Fecha de finalización 30 Noviembre 2015

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

FORMAC PHARMACEUTICALS NV
Belgium

Periodic Reporting for period 1 - USODA (Upscaling Synthesis of Ordered mesoporous silica material for Drug delivery Applications)

Período documentado: 2015-06-01 hasta 2015-11-30

Resumen del contexto y de los objetivos generales del proyecto

FORMAC Pharmaceuticals NV, pioneer in Silica based drug delivery, is developing and positioning Ordered Mesoporous Silica (OMS) carriers for the formulation of complex small molecules that suffer from solubility issues. FORMAC's OMS formulation platform enables solid oral dosage forms with excellent physical and chemical stability and unprecedented loading capacity and enhanced bioavailability. Despite numerous promising early successes and results based on a “fit for purpose” scale approach, further commercialisation has been hampered by perceived uncertainties related to the feasibility of scale-up, cost effectiveness of OMS at larger scale and the scale-up timeline.

The USODA project (Upscaling Synthesis of Ordered mesoporous silica material for Drug delivery Applications) aimed at further improving the cost of goods profile linked to the OMS synthesis and assess scale up opportunities.
This project conducted with academic and industrials partners focused on yield increase, decrease in raw materials consumption and optimization of process steps.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

As a result of the USODA project, a 76% reduction in the manufacturing cost of OMS at a 1 kilogramme scale was achieved. The material resulting from this new synthesis process was tested for pharmaceutical performances and proved to be similar to the pre USODA material.

In parallel, market assessment through a survey with key stakeholders (pharma and generic companies) has been conducted to position OMS in terms of pricing strategy. Based on the new cost of goods calculation and potential selling price, a clear way forward towards scale up strategy and timing has been defined.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

The USODA project provided essential information on the viability of Ordered Mesoporous Silica Drug Delivery. With a process leading to an increase in yield of 168%, better processing steps and potential routes for further improvements, the OMS scale up trajectory at commercial scale is validated. The company also capitalizes on research agreements that could unlock the decision to invest in large scale production.

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