Evolution of pediatric pharmaceutical forms for treatment of Hansen’s disease (leprosy)

ABSTRACT

Introduction

Leprosy is a neglected, infectious, granulomatous and chronic disease caused by the pathological agent Mycobacterium leprae. The course of the disease is more aggressive in patients under 15 years of age, but the current treatment offered worldwide consists of solid forms, by the combination of antibiotics such as rifampicin, clofazimine and dapsone. This represents results in lack of adherence in pediatric patients and drug therapy failure, although numerous formulations and technologies have already been developed.

Area covered

This study aims to analyze the technological evolution of the pharmaceutical treatment of leprosy, aimed at children. A review of patents around the world was conducted to look for technical and clinical aspects of formulations and devices.

Expert Opinion

Innovative formulations for pediatric patients were classified according to the routes of administration as oral, inhalable, injectable and transdermal. The formulations were organized as alternatives for pediatric therapy, taking into account the physicochemical aspects of drugs and the physiological aspects of pediatric patients. Among the difficulties for the patented formulations to reach the market, of special note is the low stability of the physicochemical characteristics of the drugs. Optimization of formulations would favor the pediatric treatment of leprosy, aiming at therapeutic success.

KEYWORDS:

• Pharmaceutical technology
• routes of drug administration
• dapsone
• clofazimine
• rifampicin

Article highlights

• Pharmacological therapy for leprosy consists of antibiotics and has low adherence by patients, especially pediatric patients.

• Pharmaceutical innovations aimed at the treatment of pediatric leprosy are related to the delivery of drugs by the oral, inhaled, transdermal or injectable routes.

• The technological readiness level reveals that pharmaceutical technologies for the treatment of leprosy are still in early stages.

• The oral administration route has the greatest advantages in the care of pediatric patients with leprosy.

• Dapsone, clofazimine and rifampicin are the main drugs that are being developed in drug delivery systems for the treatment of leprosy.

Acknowledgments

The authors thank the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES), the Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) and the Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco (FACEPE) for the support provided during the development of this study.

Declaration of interests

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.

Reviewer disclosures

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

Author contribution statement

JDS Santos: main author, responsible for structuring and general writing of the article. FDC Alves: organization of topics according to routes of administration. EJDS Junior: elaborated the images and related discussions. JLS Sobrinho: responsible for the final correctional and critical analysis of the paper. MFDLR Soares: guide and idealizer.

Additional information

Funding

This paper was not funded.