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talian pharmaceutical company is looking for a partner to develop a new 3D printing system of personalized medicines.

Country of Origin: Italy
Reference Number: TRIT20210301001
Publication Date: 1 March 2021

Summary

The Italian company, specialized in pharmaceutical sector, is developing a novel system for 3D printing of customized medicines, based on extrusion technique.
The company is seeking for partners interested in a technical cooperation agreement, with the aim to study and develop the process about loading the machine.

Description

The company, established in the southern Italy in 2001, works in the pharmaceutical field and is authorized by Italian Drug Agency to import, repack, perform quality controls and release batches of active pharmaceutical ingredients. The enterprise has a GMP certification (good manufacturing practice) and a food additives/supplements division, authorized by the Authorities of Region Puglia to the “Production and packaging of products intended for particular nutritional uses (according to art. 6, paragraph 3 of the Directive EC 852/84 and Legislative Decree 111/92)”. In addition to this division, the company has also other three departments dedicated to raw materials, packaging and technologies/equipments.
Since a long time, they have adopted a sound strategy in supporting hospital as well as territorial pharmacists in formulating galenic preparations providing them with ready-to-use standardized, safe and stable bases to solubilize active pharmaceutical ingredients.
3D printed formulation is a step further along this strategy because, in addition to specific mixtures and APIs (active pharmaceutical ingredients), the company will implement a unique innovative platform for 3D printing of drugs.
Starting from a deep review of the scientific literature, they matched technologies used with the model drug used; the Italian company chose to focus on powder mixtures to be directly extruded and on the use of hydroxypropyl cellulose (HPC), which is one of the most widely used polymers due to its suitable mechanical properties and ease of extrusion.
A systematic study together with a design of experiment (DoE) of data confirmed that the HPC molecular weight affect the shape of the printed dosage forms.
Moreover, the addition to the mixture of small percentages of other excipients may help the printing process.
Currently there are different technologies and different polymers but it lacks a unique and integrated platform composed by hardware/software and APIs/ready-to-use mixtures of excipients.
Among classical methods, for example, there is the fused deposition modeling (FDM) printing; this system needs for the preparation of drug-loaded filaments using hot melt extrusion (HME) techniques.
The use of HME before the 3D printing process increases the likelihood of drug degradation by the thermal effect.
However, the most important disadvantage is the limitation in the use of excipients and drugs to obtain filaments with the appropriate mechanical and physical characteristics for 3D printing.
The Italian company, instead, wants to develop a game-changing project, avoiding the HME step in FDM 3D printing, giving immense value in pharmaceutical drug development for pharmacists.
The innovation is addressed to the development of an innovative integrated platform for pharmacists for the production of 3D printed formulations by a direct pharmaceutical powder – Active Pharmaceutical Ingredient (API) mixed with suitable excipients – extrusion.
The technology involves the extrusion of material through a nozzle of the printer in the form of powder (not filaments) which is directly printed using a single screw extruder; it does not require the preparation of filaments using HME and it could potentially allow the extrusion of mixtures that would not be possible to be printed by conventional FDM due to the inadequate mechanical characteristics of the filaments, such as being too brittle or too flexible.
The company is looking for a partner interested to sign a technical cooperation agreement. The ideal partner is a company or a research centre with expertise in material engineering in order to study the behavior of powders under the rheological, mechanical and physical aspects.

Expertise sought

The ideal partner should have expertise in material engineering and pharmaceutical fields, in order to study the behavior of Active Pharmaceutical Ingredient (API) mixed with suitable excipients under the rheological, mechanical and physical aspects.

Stage Of Development

Available for demonstration

Requested partner

Type: company or research centre.

Activity: material engineering and pharmaceutical fields.

Role: the ideal partner should study the behavior of active pharmaceutical ingredient (API) mixed with suitable excipients under the rheological, mechanical and physical aspects.

Cooperation offer ist closed for requests