R&D&i

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CONSTANT RESEARCH AND DEVELOPMENT

 

We innovate to better ourselves each day in order to offer safe and effective medicines that cover the needs of society.

 

Our R&D&I strategy is grounded on the development of new pharmaceutical formulations in all the phases and the manufacture of batches for clinical studies.

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All our activity is developed in the Esteve Pharmaceutical Innovation and Development Area (INFA). 

 

The facilities at the Martorelles (Barcelona) production plant cover 1,700 m2, where the Analytical Development Laboratories, the Preformulation Laboratories and the Pilot Plant are located.

 

The INFA team has 60 members divided into working groups: Analytical Development and Industrialisation, Pharmaceutical Development and Industrialisation, Stabilities and Pilot Plant.

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A PILOT PLANT WITH THE MOST ADVANCED TECHNOLOGY

 

Our Pilot Plant is authorised by the Spanish Agency of Medicines and Medical Devices (Spanish acronym AEMPS) and the Food and Drug Administration (FDA) for the development and manufacture of different pharmaceutical forms for medicines under research: hard capsules, tablets, coated tablets, extruded tablets and pellets.

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Our pharmaceutical development is carried out under the principles of Quality by Design (QbD), Experimental Design (ED) and Risk Analysis (RA).

The Pilot Plant is equipped to work under Principles of Good Manufacturing (EU and US) with new pharmaceutical technologies (Hot melt extrusion; Complexation – Cyclodextrins and PEGs-; SEDDS and SMEDDS), which broaden our extensive know-how on pelletisation.

We also have multifunction rooms where we can work with portable pilot machinery, facilitating experimentation with multiple technologies and devices, and allowing for an exponential increase in flexibility.

We manufacture medicines for clinical trials (Annex 13) and we have machinery that is specifically used for first-in-man administration, with dosage of active principle in capsules without excipients, in a highly precise and efficient manner.

 

We have the capacity to perform stability studies under ICH conditions and to generate all the necessary documents to file marketing authorisations.

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IN PHARMACEUTICAL INNOVATION AND DEVELOPMENT, WE HAVE EQUIPMENT FOR THE PREPARATION OF:

  • Granulated products

  • Tablets

  • Capsules

  • Pellets

  • Extruded products

  • Semisolid and liquids

  • Packaging and packing

  • Primary and secondary packages

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FROM THE MOST CLASSICAL TO THE MOST INNOVATIVE FORMULATIONS

 

We develop solid formulations in all the preformulation, scale-up, stability, validation and batch production phases for clinical studies, including their packing.

The most common solid formulas are tablets (direct compression and granulation) and capsules (powder and pellets).

 

Furthermore, the most innovative galenic technologies allow developing immediate-release and controlled-release formulations, based on coatings through pellets, mini-capsules, extrusion processes (Hotmelt), spheronisation and coating.

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