Why do few drug delivery systems to combat neglected tropical diseases reach the market? An analysis from the technology’s stages

ABSTRACT

Introduction

Many drugs used to combat schistosomiasis, Chagas disease, and leishmaniasis (SCL) have clinical limitations such as: high toxicity to the liver, kidneys and spleen; reproductive, gastrointestinal, and heart disorders; teratogenicity. In this sense, drug delivery systems (DDSs) have been described in the literature as a viable option for overcoming the limitations of these drugs. An analysis of the level of development (TRL) of patents can help in determine the steps that must be taken for promising technologies to reach the market.

Areas covered

This study aimed to analyze the stage of development of DDSs for the treatment of SCL described in patents. In addition, we try to understand the main reasons why many DDSs do not reach the market. In this study, we examined DDSs for drugs indicated by WHO and treatment of SCL, by performing a search for patents.

Expert opinion

In this present work we provide arguments that support the hypothesis that there is a lack of integration between academia and industry to finance and continue research, especially the development of clinical studies. We cite the translational research consortia as the potential alternative for developing DDSs to combat NTDs.

KEYWORDS:

• Drug delivery system
• neglected tropical disease
• nanotechnology
• technology readiness levels

Supplemental data

Supplemental data for this article can be accessed here.

Acknowledgments

Authors are grateful to the Coordination for the Improvement of Higher Education Personnel (CAPES) and Brazilian National Council for Scientific and Technological Development (CNPq), agencies of the federal Brazilian government. During the development of this work, Oliveira, J.H.P. was a recipient of a doctoral fellowship CAPES. Prof. Soares-Sobrinho, JL, and Prof. Soares, MFR received a grant from CNPq. The authors thank Mattias Maranhão (designer) for working with infographics. Oliveira JHP thanks first Reserve Lieutenant (Brazilian Army) and Professor Liliane Bezerra de Lima for discussions involving pre-clinical tests. The authors thank Joandra Maísa for reviewing the writing of the manuscript.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Article highlights

• Drug delivery systems (DDSs) are technological alternatives for overcoming the limitations of drugs used to combat NTDs, such as low solubility, low bioavailability, and high toxicity.

• The patent literature presents some DDSs alternatives in different TRL (Technology Readiness Levels), with emphasis on the treatment of Schistosomiasis, Chagas disease, and Leishmaniasis.

• The development of new pharmaceutical forms of drugs is an alternative for improving drug characteristics, among them: low absorption in the gastrointestinal tract, low water solubility and mainly problems with high toxicity and the existence of adverse effects.

• Lack of standardization in the execution of in vitro/in vivo studies is a limiting factor in relation to the performance of technologies and the scarcity of details about the tests developed also compromises the quality of the information.

• The development of DDSs in the range of TRL6 to TRL9 depends on the financial assistance of the pharmaceutical industry.

• Guided efforts in DDSs research and development are necessary to promote technologies at advanced TRLs.

• Translational research consortia are real alternative to develop DDSs with advanced TRL. The BERENICE project (BEnznidazole and triazole REsearch group for Nanomedicine and Innovation in Chagas Disease) is an example.

This box summarizes key points contained in the article.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.