U10. Drug Formulation

U10-S01. Design & Development of pharmaceutical forms

Design & Development of pharmaceutical forms

Classic parenteral dosage forms: solutions, suspensions, emulsions,…
Parenteral dosage forms for sustained release.
Topical dossage: creams, gels,…
Classic oral dosage forms: capsules, tablets, coated tablets, microgranules,…
Oral dossages forms for suistanable release: hidrophylic matrixes, lipid matrixes, pellets,…

The techniques we use to make the pharmaceutical dosage forms are:

• binder jet printing,
• fused deposition modeling (FDM),
• semi-solid extrusion (SSE),
• stereolithography

Customer benefits

• Design of custom and specific formulations with molecules in development phases for preclinical evaluation.
• 3D printing offers on-demand manufacturing at the point of care with low-cost equipment and one-step processes.
• Printed personalised medicine

Target customer

• Pharmaceutical industry (e.g. nutraceuticals, cosmetics, …).
• Research groups aimed at the development of new drugs and pharmaceutics forms.
• Printlets: Hospitals, Pharmaceutical Companies and Universities.

Additional information

The following is an example of our bioprinted materials, which were used in the first study on 3D screen printing in the fabrication of drug delivery systems:

Reference: D. Moldenhauer, et al. 3D screen printing – An innovative technology for large-scale manufacturing of pharmaceutical dosage forms. International Journal of Pharmaceutics, Vol. 592, 2021, 120096, ISSN 0378-5173, DOI: 10.1016/j.ijpharm.2020.120096.

U10-S02. Design & Development of micro- & nanocapsules

Design & Development of micro- & nanocapsules

Design & Development of micro- & nanocapsules for conventional drugs, peptides and proteins.

Customer benefits

Use of micro- and nanotechnologies for the design of specific formulations and capsules with conventional drugs, peptides and proteins for preclinical evaluation.

Target customer

• Pharmaceutical industry (e.g. nutraceuticals, cosmetics, …).
• Research groups aimed at the development of new drugs and pharmaceutics forms.

U10-S03. Design & Development of lipid nanoparticles

Design & Development of lipid nanoparticles

Design & Development of lipid nanoparticles to encapsulate therapeutic actives for drug delivery or gene delivery purposes: SLNs (solid lipid nanoparticles), NLCs (nanostructured lipid carriers), LNPs (self-assembled lipid nanoparticles by microfluidic technology) and niosomes.

Customer benefits

Customized elaboration of nanovehicles to deliver the therapeutic material of interest (mRNA, plasmid DNA, drugs, growth factors, peptides, antibodies…). We are specialists in designing and developing formulations for several therapeutic purposes. Among them, we develop self-assembled lipid nanoparticles, which are formed by fast microfluidic mixing in a NanoAssemblr® platform. These kinds of nanoparticles have emerged as an ideal nanotechnology approach for drug delivery and non-viral gene therapy by the high efficient encapsulation and protection of the therapeutic material from degradation. This microfluidic technology, that has been employed for COVID-19 vaccine, works under GMP conditions and enables reproducibility and scalability, which enhances its clinical translation.

Physicochemical characterization of nanovehicles, following SOPs, regarding mean particle size, polydispersity index and zeta potential. Additional parameters can be determined, such as, pH of nanoparticle suspension, microscopic morphology of the nanoparticles, encapsulation efficiency of the active principle and in vitro release profile. Optionally, biological evaluation can be performed, such as transfection efficiency analysis of non-viral nanovehicles and/or cytotoxicity assays following SOPs that include the ISO 10993-5-2019 Biological evaluation of medical devices.

Target customer

• Customers with a specific target for therapeutic purposes.
• Preclinical use for validation in in vitro and in vivo models.

References

• Gallego I, Villate-Beitia I, Soto-Sánchez C, Menéndez M, Grijalvo S, Eritja R, Martínez-Navarrete G, Humphreys L, López-Méndez T, Puras G, Fernández E, Pedraz JL. Brain Angiogenesis Induced by Nonviral Gene Therapy with Potential Therapeutic Benefits for Central Nervous System Diseases. Mol Pharm. 2020 Jun 1;17(6):1848-1858. doi: 10.1021/acs.molpharmaceut.9b01213.
• Pastor M, Moreno-Sastre M, Esquisabel A, Sans E, Viñas M, Bachiller D, Asensio VJ, Pozo AD, Gainza E, Pedraz JL. Sodium colistimethate loaded lipid nanocarriers for the treatment of Pseudomonas aeruginosa infections associated with cystic fibrosis. Int J Pharm. 2014 Dec 30;477(1-2):485-94. doi: 10.1016/j.ijpharm.2014.10.048.
• Moreno-Sastre M, Pastor M, Esquisabel A, Sans E, Viñas M, Fleischer A, Palomino E, Bachiller D, Pedraz JL. Pulmonary delivery of tobramycin-loaded nanostructured lipid carriers for Pseudomonas aeruginosa infections associated with cystic fibrosis. Int J Pharm. 2016 Feb 10;498(1-2):263-73. doi: 10.1016/j.ijpharm.2015.12.028.

Additional information

U10-S04. Design & Development of living cells containing microparticules

Design & Development of living cells containing microparticules

Cell encapsulation in alginate based microcapsules.
Optionally, cell viability assays, metabolic activity and other phenotypic / biological studies can be carried out.

Customer benefits

Microencapsulation of cells allows their transplantation in absence of immunosuppression along a wide variety of diseases, with long retention in the engrafted tissue. This strategy improves the engraftment rate and survival of transplanted cells following implantation.

Target customer

Preclinical use for in vivo models

References

• Ziani K, Espona-Noguera A, Crisóstomo V, Casado JG, Sanchez-Margallo FM, Saenz-Del-Burgo L, Ciriza J, Pedraz JL. Characterization of encapsulated porcine cardiosphere-derived cells embedded in 3D alginate matrices. Int J Pharm. 2021 Apr 15;599:120454. doi: 10.1016/j.ijpharm.2021.120454.
• Espona-Noguera A, Etxebarria-Elezgarai J, Saenz Del Burgo L, Cañibano-Hernández A, Gurruchaga H, Blanco FJ, Orive G, Hernández RM, Benito-Lopez F, Ciriza J, Basabe-Desmonts L, Pedraz JL. Type 1 Diabetes Mellitus reversal via implantation of magnetically purified microencapsulated pseudoislets. Int J Pharm. 2019 Apr 5;560:65-77. doi: 10.1016/j.ijpharm.2019.01.058.
• Cañibano-Hernández A, Saenz Del Burgo L, Espona-Noguera A, Orive G, Hernández RM, Ciriza J, Pedraz JL. Hyaluronic acid enhances cell survival of encapsulated insulin-producing cells in alginate-based microcapsules. Int J Pharm. 2019 Feb 25;557:192-198. doi: 10.1016/j.ijpharm.2018.12.062.

Additional information