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1. WO2022094685 - COMPOSITION, PHARMACEUTICAL COMPOSITION, USE OF A STABLE TOPICAL COMPOSITION COMPRISING A NANOEMULSION AND OF AT LEAST ONE ANTILEISHMANIAL COMPOUND, AND METHOD FOR THE TREATMENT OF CUTANEOUS LEISHMANIASIS

Publication Number WO/2022/094685
Publication Date 12.05.2022
International Application No. PCT/BR2021/050487
International Filing Date 08.11.2021
IPC
A61K 9/107 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
10Dispersions; Emulsions
107Emulsions
A61K 31/7036 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
70Carbohydrates; Sugars; Derivatives thereof
7028Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
7034attached to a carbocyclic compound, e.g. phloridzin
7036having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
A61K 31/7048 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
70Carbohydrates; Sugars; Derivatives thereof
7042Compounds having saccharide radicals and heterocyclic rings
7048having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin
A61K 31/138 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
13Amines, e.g. amantadine
135having aromatic rings, e.g. methadone
138Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
A61K 33/24 2019.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
33Medicinal preparations containing inorganic active ingredients
24Heavy metals; Compounds thereof
A61P 33/02 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
33Antiparasitic agents
02Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
Applicants
  • FUNDAÇÃO OSWALDO CRUZ [BR]/[BR]
Inventors
  • RABELLO, Ana, Lúcia, Teles
  • COSTA, Jorge, Carlos, Santos da
  • QUEIROZ, Dinalva, Brito de
  • TEIXEIRA, Eliane, de Morais
Agents
  • KASZNAR LEONARDOS PROPRIEDADE INTELECTUAL
Priority Data
BR102020022824-209.11.2020BR
Publication Language Portuguese (pt)
Filing Language Portuguese (PT)
Designated States
Title
(EN) COMPOSITION, PHARMACEUTICAL COMPOSITION, USE OF A STABLE TOPICAL COMPOSITION COMPRISING A NANOEMULSION AND OF AT LEAST ONE ANTILEISHMANIAL COMPOUND, AND METHOD FOR THE TREATMENT OF CUTANEOUS LEISHMANIASIS
(FR) COMPOSITION, COMPOSITION PHARMACEUTIQUE, UTILISATION D’UNE COMPOSITION TOPIQUE STABLE COMPRENANT UNE NANOÉMULSION, ET D’AU MOINS UN COMPOSÉ ANTI-LEISHMANIOSE, ET MÉTHODES POUR LE TRAITEMENT DE LA LEISHMANIOSE CUTANÉE
(PT) COMPOSIÇÃO, COMPOSIÇÃO FARMACÊUTICA, USO DE UMA COMPOSIÇÃO TÓPICA ESTÁVEL COMPREENDENDO UMA NANOEMULSÃO, E DE PELO MENOS UM COMPOSTO ANTILEISHMANIAL, E, MÉTODO PARA O TRATAMENTO DE LEISHMANIOSE CUTÂNEA
Abstract
(EN) The drugs available for treating cutaneous leishmaniasis have unsatisfactory effectiveness, frequent and serious side effects, and require long treatment plans. The search for novel treatment options for cutaneous leishmaniasis is therefore considered to be a priority by the World Health Organisation. The parenteral administration of pentavalent antimonials for treating all forms of leishmaniasis, including cutaneous leishmaniasis, has several limitations. Treatment takes a long time, requiring repeat doses, and side effects are frequent. Topical treatment is an attractive option for cutaneous leishmaniasis, offering significant advantages over systemic therapy: fewer side effects, easy administration, and lower costs. The aim of the present inventors was to provide a topical fixed-dose composition containing at least one antileishmanial compound and providing suitable absorption of the active principle. Another aim of the present invention is to provide a topical fixed-dose formulation that contains a combination of antileishmanial compounds and is sufficiently effective and safe for use in treating cutaneous leishmaniasis.
(FR) Les médicaments disponibles pour le traitement de la leishmaniose cutanée présentent une efficacité insuffisante, des effets secondaires fréquents et graves et requièrent de longs schémas thérapeutiques. Ainsi, la recherche de nouvelles alternatives de traitement pour la leishmaniose cutanée est considérée comme prioritaire par l’Organisation Mondiale de la Santé. L’administration parentérale d’antimoines pentavalents pour le traitement de toutes les formes de leishmaniose, y compris la leishmaniose cutanée, présente diverses limitations. La thérapie est longue, exigeant des doses répétées, et les réactions indésirables sont fréquentes. Le traitement topique est une alternative pour la leishmaniose cutanée, offrant des avantages significatifs par rapport à la thérapie systémique : moins d’effets secondaires, facilité d'administration et coûts plus faibles. Les présents inventeurs ont eu comme objectif d’obtenir une composition topique en dose fixe, contenant au moins un composé anti-leishmaniose, assurant une absorption adéquate du principe actif. Un autre objectif de la présente invention est d’obtenir une formulation topique, en dose fixe, contenant une combinaison de composés anti-leishmaniose possédant une efficacité et une sécurité suffisantes pour une utilisation dans le traitement de la leishmaniose cutanée.
(PT) Os medicamentos disponíveis para o tratamento da leishmaniose cutânea apresentam eficácia insatisfatória, efeitos adversos frequentes e graves e requerem longos esquemas terapêuticos. Assim, a busca por novas alternativas de tratamento para a leishmaniose cutânea é considerada prioritária pela Organização Mundial da Saúde. A administração parenteral de antimoniais pentavalentes para o tratamento de todas as formas de leishmaniose, incluindo a leishmaniose cutânea, apresenta várias limitações. A terapia é longa, exigindo doses repetidas e as reações adversas são frequentes. O tratamento tópico é uma alternativa atraente para a leishmaniose cutânea, oferecendo vantagens significativas sobre a terapia sistêmica: menos efeitos adversos, facilidade de administração e custos mais baixos Os presentes inventores tiveram como objetivo prover uma composição tópica em dose fixa, contendo pelo menos um composto antileishmanial, provendo a absorção adequada do princípio ativo. Um outro objetivo da presente invenção é prover uma formulação tópica, em dose fixa, contendo uma combinação de compostos antileishmaniais que possua eficácia e segurança suficientes para ser utilizada no tratamento da leishmaniose cutânea.
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