Research
& Development

For the last 20 years, as a result of our scientific and financial efforts, we have occupied a privileged place on the list of Portuguese companies that invest the most in Research and Development.

Our Research and Development activities are focused on applied research and/or experimental development. They enable us to bring to market a range of pharmaceutical products aimed at treating the most relevant conditions affecting society, such as cardiovascular and metabolic diseases, nervous system disorders, and infectious diseases.

To this end, we rely on the areas of pharmaceutical chemistry, pharmaceutical development, cell culture, and clinical research to advance our Research and Development programmes and projects.

We have an experienced team with training in the areas of medicine, pharmacology, biology, biotechnology, microbiology, biochemistry, chemistry, and engineering for the design, implementation, and management of Research and Development activities.

+ 10
Projects developed
15%
Of the turnover of the Tecnimede Group is invested in R&D
+90
Staff members developing R&D activities
+440
Patents (patents granted an patent applications)

Our Pipeline

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Research projects
  • In development: 35
  • Bioavailability/ Bioequivalence: 2
  • Concluded: 81
Total
Pharmaceutical development projects of value added medicines
  • CNS: 4
  • Cardiovascular: 3
  • Dyslipidemia: 4
  • Diabetes: 2

In our Research & Development Unit, besides the more common technologies that we have in place to develop high-quality pharmaceutical products, we also have available a set of highly valuable technologies to overcome drug solubility and bioavailability problems and for the development of specific pharmaceutical dosage forms.

Spray Drying

A technology with multiple applications plays an important role in particle engineering to increase drug solubility and consequently its bioavailability, being used in the development of oral solid dosage forms and other complex formulations.

Hot Melt Extrusion

A technology also used for solubility and bioavailability enhancement of BCS class 2 and 4 drugs. This technology has multiple applications, being used in the development of IR and XR oral solid dosage forms and more complex formulations.

Featured projects

Research and development of own fixed combinations

Tecnimede Group researches and develops its own fixed combinations with the purpose of developing new drugs that contribute to improving the health and quality of life of people. The combination of active substances within a single pharmaceutical formulation may present several advantages, including, among others, the improvement of therapeutic compliance or the enhancement of the therapeutic effect resulting from the combination of the drugs.

Development and provision of generic medication

Generic drugs are drugs with the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form as the reference drug. The bioequivalence of generic drugs in relation to the reference drug has also been guaranteed through appropriate bioavailability studies. The Tecnimede Group develops about a dozen new generic drugs every year.

The development and availability of generic medicines enables national healthcare systems and the user to save very considerable amounts of money while ensuring the safety, efficacy, and quality of the medicine.

The billions of euros of savings that generic medicines produce every year boost the sustainability of healthcare systems, improve the accessibility of medicines to the population, free up capital for essential treatments and services for patients, and stimulate research into new therapeutic solutions.

Research into new chemical entities for new drugs

The Tecnimede Group, with the purpose of developing new drugs that contribute to improving people's health and quality of life, researches and develops new chemical entities that enable the treatment of the most relevant conditions affecting society, with particular emphasis on infectious diseases and nervous system diseases. The varied patented chemical entities available to our scientists and researchers ensure they work every day to find new and improved solutions to meet the population’s needs.

Co-financed projects

PROVIR

Development of a clinical experimental prototype to test the efficacy and safety of a drug in the treatment of moderate COVID-19.

PROPIRS

Patent right applications resulting from entering the national/regional phase of patent application PCT/PT2014/000029

PROPIRPRO

Patent right applications resulting from entering the national/regional phase of patent application PCT/PT2014/000027

PROPRIST

Patent right applications resulting from entering the national/regional phase of patent application PCT/PT2014/000026

Repositioning of drugs approved for the treatment of COVID-19

The CoVInov project is a research and technological development project that aims to identify drugs, which are already known and approved for use in humans, having a potential antiviral effect, specifically to combat SARS-CoV2.

There are numerous substances approved for use in humans and, at the same time, there is knowledge about their toxicological and safety profile. This prior knowledge facilitates the faster preclinical and clinical development of a treatment for COVID-19.

The project makes use of repositioning techniques, based on targets and therapeutic classes with proven action in the inhibition of SARSCoV and MERS-CoV. The repositioning study is based on the assessment of viral cytopathic effect in two in vitro screenings, an initial screening for alpha (HcoV-229E) and betacoronaviruses (HcoV-OC43), and another confirmatory screening for SARS-CoV-2.

Technological Development of Polymeric Implants for Sustained Drug Delivery

The IMPUCT 2 project, “Technological Development of Polymeric Implants for Sustained Drug Release”, is a project that aims to generate new knowledge and respond to a set of technical and scientific challenges, in order to develop a pharmaceutical product with potential for use in humans.

An active substance delivery technology, such as polymeric implants, which enables a constant release of the active substance over a prolonged period of time, has the potential to increase treatment efficacy by reducing fluctuation in the plasma profile of the drug, keeping it within the therapeutic range, with fewer side effects and enables a reduction in the number of injections throughout the treatment period, thus increasing patient compliance.

As such, the following objectives have been established:

- Investigate the optimal formulation of the prototype implant, ideally for monthly use;

- Investigate operations and variables of the implant production process for robust and scalable manufacturing;

- Develop analytical methods that enable the biological activity of the active substance to be validated in vitro;

- Investigate the in vivo efficacy of the prototype through study in animal models and characterisation of its pharmacokinetic properties.

Innovative project to assess the feasibility of dendritic cell vaccine production

The ImmunoDCs@CancerStemCells project, which is being jointly promoted by the Tecnimede Group, Associação UC Tecnimede, and the University of Coimbra, is an R&D project aimed at developing a clinical-grade cell vaccine to eliminate cancer stem cells, thus making it an innovative therapeutic approach with enormous potential and added value for cancer patients.

The project “Cellular immunotherapy targeted at eliminating cancer stem cells” aims to optimise the production of the vaccine at the pilot stage, an achievement that will provide the Tecnimede Group with technical and scientific knowledge, crucial to leverage the subsequent establishment of pilot clinical trials for the treatment of lung and pancreatic carcinomas.

As such, the following objectives have been established:

- To develop and optimise the production of a dendritic cell vaccine targeting cancer stem cells.

- Assess and demonstrate the functionality of the vaccine in vitro for specific cases of pancreatic tumours and non-small cell lung tumours. In the first instance, this will be done using commercially available cell lines and subsequently with patient samples to verify the proof of concept.

The project is co-financed by COMPETE 2020 within the Research and Technological Development Incentive System.

Patents and Publications

One of the objectives of the Tecnimede Group is the dissemination of scientific knowledge obtained during the course of R&D programmes and projects by periodically patenting and publishing the results obtained.

To date, the Tecnimede Group has over 750 patents (patents granted and patent applications) relating to new chemical entities, alternative synthesis processes, new salts, pharmaceutical compositions, and new therapeutic indications.

1 Terrasso AP, Pinto C, Serra M, Filipe A, Almeida S, Ferreira AL, et al. Novel scalable 3D cell based model for in vitro neurotoxicity testing: Combining human differentiated neurospheres with gene expression and functional endpoints. J Biotechnol 2015 Jul 10;205:82-92.
Disponível em: http://www.sciencedirect.com/science/article/pii/S0168165614010475

2 Filipe A, Almeida S, Pedroso PF, Neves R, Marques S, Sicard E, et al. Single-dose, randomized, open-Label, two-Way, crossover bioequivalence study of two formulations of pregabalin 300 mg hard capsules in healthy volunteers under fasting conditions. Drugs R D 2015 Jun;15(2):195-201.
Disponível em: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4488182/

3 Filipe A, Pedroso P, Almeida S, Neves R, Boudreault S. Bioequivalence study of two formulations of ibandronic acid 150-mg film-coated tablets in healthy volunteers under fasting conditions: a randomized, open-label, three-way, reference-replicated crossover study. Drugs R D 2014 Jun;14(2):105-12.
Disponível em: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4070455/

4 Morais M, Santos PA, Mateus-Pinheiro A, Patrício P, Pinto L, Sousa N, et al. The effects of chronic stress in hippocampal adult neurogenesis and dendritic plasticity are reversed by selective MAO-A inhibition. J Psychopharmacol 2014 Dec;28(12):1178-83.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/25315831

5 Pedroso P, Almeida S, Filipe A, Neves RI, Boudreault S, Jiménez C. Bioequivalence studies for two different strengths of montelukast in healthy volunteers: 10 mg film-coated tablets and 5 mg chewable tablets. Drug Res (Stuttg). 2013 Sep;63(9):477-483.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/23780502

6 Almeida S, Pedroso P, Filipe A, Neves RI, Tanguay M, Torns A. Bioequivalence of two formulations of escitalopram. Arzneimittelforschung 2012 Jul;62(7):307-12.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/22628062

7 Branco JC, Tomé AM, Cruz MR, Filipe A. Pirlindole in the treatment of depression and fibromyalgia syndrome. Clin Drug Investig 2011 Oct;31(10):675-89.
Disponível em: http://link.springer.com/article/10.2165%2F11595410-000000000-00000

8 Tomé AM, Filipe A. Quinolones: review of psychiatric and neurological adverse reactions. Drug Saf 2011 Jun 1;34(6):465-88.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/21585220

9 Almeida S, Pedroso P, Filipe A, Pinho C, Neves R, Jiménez C, et al. Study on the bioequivalence of two formulations of eplerenone in healthy volunteers under fasting conditions: data from a single-center, randomized, single-dose, open-label, 2-way crossover bioequivalence study. Arzneimittelforschung 2011;61(3):153-159.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/21528639

10 Almeida S, Filipe A, Neves R, Pinho C, Pedroso P, Castillo A, et al. Truncated areas under the curve in the assessment of pioglitazone bioequivalence: data from a single-center, single-dose, randomized, open-label, 2-way cross-over bioequivalence study of two formulations of pioglitazone 45 mg tablets under fasting conditions. Arzneimittelforschung 2011;61(1):32-9.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/21355444

11 Macedo A, Leiria E, Filipe A. Pirlindole in the treatment of depression - a meta-analysis. Clin Drug Investig 2011;31(1):61-71.
Disponível em: http://link.springer.com/article/10.2165/11586690-000000000-00000/fulltext.html

12 Neves R, Almeida S, Filipe A, Franco Spínola AC, Abolfathi Z, Lévesque A, et al. Bioequivalence studies of two different film-coated tablet formulations of valacyclovir of two different strengths in healthy volunteers. Arzneimittelforschung 2010;60(5):273-81.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/20533765

13 Almeida S, Filipe A, Neves R, Desjardins I, Shink E, Castillo A. Bioequivalence study of two different tablet formulations of donepezil using truncated areas under the curve: a single-center, single-dose, randomized, open-label, 2-way cross-over under fasting conditions. Arzneimittelforschung 2010;60(3):116-23.
Disponível em: http://www.ecv.de/download/download/Zeitschriften/ArzneimForsch/volltext/af_S00116-00123_33-Almeida.pdf

14 Almeida S, Filipe A, Neves R, Franco Spínola AC, Tanguay M, Ortuño J, et al. Mycophenolate mofetil 500-mg tablet under fasting conditions: single-dose, randomized sequence, open-label, four-way replicate crossover, bioequivalence study in healthy subjects. Clin Ther 2010 Mar;32(3):556-74.
Disponível em: http://www.sciencedirect.com/science/article/pii/S0149291810000998

15 Franco Spínola AC, Almeida S, Filipe A, Neves R, Abolfathi Z, Yritia M, et al. Comparative bioavailability of two formulations of sibutramine. Int J Clin Pharmacol Ther 2009 Oct;47(10):627-37.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/19825326

16 Franco Spínola AC, Almeida S, Filipe A, Neves R, Trabelsi F, Farré A. Results of a single-center, single-dose, randomized-sequence, open-label, two-way crossover bioequivalence study of two formulations of valsartan 160-mg tablets in healthy volunteers under fasting conditions. Clin Ther 2009 Sep;31(9):1991-2001.
Disponível em: http://www.sciencedirect.com/science/article/pii/S0149291809003142

17 Filipe A, Almeida S, Franco Spínola AC, Neves R, Tanguay M, Jiménez C, et al. Single-dose randomized, open-label, 2-way crossover bioequivalence study of clopidogrel 75 mg tablet in healthy volunteers under fasting conditions. Int J Clin Pharmacol Ther 2009 Mar;47(3):187-94.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/19281728

18 Franco Spínola AC, Almeida S, Filipe A, Neves R, Tanguay M, Yritia M. Bioequivalence of two formulations of levetiracetam. Int J Clin Pharmacol Ther 2008 Nov;46(11):591-96.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/19000558

19 Filipe A, Almeida S, Franco Spínola AC, Neves R, Trabelsi F, Torns A, et al. Bioequivalence study of two enteric-coated formulations of pantoprazole in healthy volunteers under fed conditions. Arzneimittelforschung 2008;58(9):451-6.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/18972875

20 Filipe A, Almeida S, Franco Spínola AC, Trabelsi F, Ortuño J. Bioequivalence study of two letrozole tablet formulations. Single dose, randomized, open-label, 2-way crossover bioequivalence study of letrozole 2.5 mg tablets in healthy volunteers under fasting conditions. Arzneimittelforschung 2008;58(8):419-22.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/18807583

21 Neves R, Almeida S, Filipe A, Franco Spínola AC, Abolfathi Z, Yritia M, et al. Bioequivalence study of two different film-coated tablet formulations of losartan-hydrochlorothiazide in healthy volunteers. Arzneimittelforschung 2008;58(8):369-75.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/18807576

22 Tomé A, Filipe A. Farmacovigilância. Boletim do HPV. 2008 Janeiro/Março;XXI(1):13-17.

23 Franco Spínola AC, Almeida S, Filipe A, Tanguay M, Yritia M. Bioequivalence study of two tablet formulations of sildenafil. Arzneimittelforschung 2008;58(3):122-5.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/18488808

24 Almeida S, Spínola AC, Filipe A, Trabelsi F, Farré A. Truncated AUCs in the assessment of the bioequivalence of topiramate, a long half-life drug. Arzneimittelforschung 2007;57(5):249-53.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/17598694

25 Almeida S, Almeida A, Filipe A, Penedo C, Rocha A, Lainesse A, et al. In vitro disintegration and dissolution and in vivo bioequivalence of two alendronate once-weekly formulations. Arzneimittelforschung 2006;56(2):84-9.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/16572922

26 Almeida S, Filipe A, Almeida A, Antonijoan R, Garcia-Gea C, Gich I, et al. Comparative study on the bioequivalence of two different gabapentin formulations. A randomised, two-period, two-sequence, crossover clinical trial in healthy volunteers. Arzneimittelforschung 2006;56(2):59-63.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/16572918

27 Almeida S, Filipe A, Almeida A, Gich I, Antonijoan R, Puntes M, et al. Comparative study on the bioequivalence of two formulations of pravastatin. Data from a crossover, randomised, open-label bioequivalence study in healthy volunteers. Arzneimittelforschung 2006;56(2):70-5.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/16572920

28 Almeida S, Filipe A, Almeida A, Wong H, Caparrós N, Tanguay M. Comparative bioavailability of two formulations of levofloxacin and effect of sex on bioequivalence analysis. Data from a randomised, 2 x 2 crossover trial in healthy volunteers. Arzneimittelforschung 2005;55(7):414-9.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/16080281

29 Abad-Santos F, Novalbos J, Gálvez-Múgica MA, Gallego-Sandín S, Almeida S, Vallée F, et al. Assessment of sex differences in pharmacokinetics and pharmacodynamics of amlodipine in a bioequivalence study. Pharmacol Res 2005 May;51(5):445-52.
Disponível em: http://www.sciencedirect.com/science/article/pii/S1043661804002890

30 Almeida S, Portolés A, Terleira A, Filipe A, Cea E, Cruz Caturla M. Comparative bioavailability/bioequivalence of two different sertraline formulations: a randomised, 2-period x 2-sequence, crossover, clinical trial in healthy volunteers. Arzneimittelforschung 2005;55(4):191-7.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/15901041

31 Almeida A, Almeida S, Filipe A, Gagnon S, Mirapeix A, Girard B, et al. Bioequivalence study of two different coated tablet formulations of finasteride in healthy volunteers. Arzneimittelforschung 2005;55(4):218-22.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/15901045

32 Portolés A, Filipe A, Almeida S, Terleira A, Vallée F, Vargas E. Bioequivalence study of two different tablet formulations of carvedilol in healthy volunteers. Arzneimittelforschung 2005;55(4):212-7.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/15901044

33 Almeida S, Filipe A, Vallée F, Tanguay M, Larouche R, Lainesse A. Comparative bioavailability of two formulations of terbinafine: data from a cross-over, randomised, open-label bioequivalence study in healthy volunteers. Arzneimittelforschung 2004;54(11):757-62.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/15612617

34 Portolés A, Almeida S, Terleira A, de Pablo I, Filipe A, Cruz Caturla M, et al. Truncated AUC in the evaluation of fluconazole bioequivalence. A cross-over, randomised, open-label study in healthy volunteers. Arzneimittelforschung 2004;54(11):752-6.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/15612616

35 Portolés A, Terleira A, Almeida S, García-Arenillas M, Cruz Caturla M, Filipe A, et al. Bioequivalence study of two formulations of enalapril, at a single oral dose of 20mg (tablets): a randomized, two-way, open-label, crossover study in healthy volunteers. Curr Ther Res Clin Exp 2004 Jan;65(1):34-46.
Disponível em: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4052970/

36 Maya M, Gonçalves N, Silva N, Filipe A, Morais J. Bioequivalence evaluation of three different oral formulations of ciprofloxacin in healthy volunteers. Eur J Drug Metab Pharmacokinet 2003 Apr-Jun;28(2):129-136.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/12877571

37 Maya M, Gonçalves N, Silva N, Filipe A, Morais J, Cruz Caturla M, et al. Comparative bioavailability of two immediate release tablets of enalapril/hydrochlorotiazide in healthy volunteers. Eur J Drug Metab Pharmacokinet 2002 Apr-Jun;27(2):91-9.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/12064377

38 Maya M, Domingos C, Guerreiro M, Filipe A, Morais J. Comparative bioavailability of two immediate release tablets of cisapride in healthy volunteers. Eur J Drug Metab Pharmacokinet 1998 Jul-Sep;23(3):377-381.
Disponível em (abstract): http://www.ncbi.nlm.nih.gov/pubmed/9842980

1 Terrasso AP, Serra M, Filipe AE, Ferreira AL, Pedroso P, Alves PM, et al. Novel human 3D cell models for neurotoxicity studies. Presented at: International Conference on Stem Cells for Drug Screening and Regenerative Medicine; 2013 Jul 19; Cantanhede, Portugal.

2 Franco Spínola AC, Almeida S, Filipe A, Neves R, Zohreh A, Farre A. Limitations of non-magic bullets compounds in bioequivalence assessment. How can this enhance knowledge towards the development of generic products? The Mycophenolate Mofetil Case. Ehrlich II. Presented at: 2nd World Conference on magic bullets; 2008 Oct 3-5; Nuremberg, Germany.

3 Almeida S, Spínola AC, Alves R, Filipe A, Trabelshi F. Body mass index in the assessment of the bioequivalence of pantoprazole formulations under fed conditions. Presented at: EUFEPS Conference on Bioavailability and Bioequivalence: Focus on Physiological Factors and Variability; 2007 Oct 1-2; Athens, Greece.

4 Almeida S, Portolés A, Terleira A, Filipe A, Cea E, Cruz Caturla M. Truncated AUCs in the assessment of sertraline bioequivalence in healthy volunteers. Presented at: 3rd World Conference on Drug Absorption, Transport and Delivery: clinical significance and regulatory impact. EUFEPS; 2005 Apr 18-20; Barcelona, Spain.

5 Gich I, Antonijoan RM, Puntes M, Mairal E, Almeida S, Barbanoj MJ. Bioequivalencia: los diseños normativos no siempre son suficientes. Presented at: Congreso Nacional de la Sociedad Española de Farmacología Clínica; 2002 Oct 17-19; Pamplona, Spain.

1 Terrasso AP, Simão D, Pinto C, Teixeira AP, Filipe AE, Pedroso P, et al. Functional human neuron-astrocyte 3D networks for neurotoxic studies. 3D Cell Culture 2016: How close to 'in vivo' can we get? Models, applications & translation; 2016 Apr 19-21; Konzerthaus Freiburg, Germany.

2 Franco Spínola AC, Almeida S, Filipe A, Neves R. Highly variable drugs and highly variable drug products. Briefing on regulatory and scientific Perspectives. Presented at: EUFEPS BABP Network Open discussion: Revised European Guidelines on Bioequivalence; 2009 Jan 14-15; Bonn, Germany.

3 Sampedro A, Terleira A, Almeida S, Cea E, Portolés A. Estudio de bioequivalencia de dos formulaciones de carvedilol en dosis única (25 mg), en voluntarios sanos. Libro de Resúmenes del XIX Congreso de la Sociedad Española de Farmacología Clínica, 2004.