Mucosite project (mucoaderent oral gel with crajiru - Arrabidaea chica)

• Grant number: 20/12768-4
• Support type: Research Grants - Innovative Research in Small Business - PIPE
• Duration: December 01, 2021 - August 31, 2022
• Field of knowledge: Health Sciences - Pharmacy - Pharmaceutical Technology
• Principal researcher: Elaine Cristina de Moraes
• Grantee: Elaine Cristina de Moraes
• Company: Wecare Desenvolvimento e Comércio de Medicamentos e Cosméticos Ltda
• CNAE: Comércio varejista de produtos farmacêuticos para uso humano e veterinário ; Pesquisa e desenvolvimento experimental em ciências físicas e naturais ; Atividades de atenção à saúde humana não especificadas anteriormente
• City: São Paulo
• Assoc. researchers: Emiro Khury ; Tamara Rezende de Azevedo

Abstract

Cancer is the main public health problem in the world. For Brazil according to the INCA (National Cancer Institute) (Brazil 2020), the estimate for each year of the triennium 2020-2022 indicates that there will be 625,000 new cases of cancer (450,000, excluding cases of non-melanoma skin cancer). According to estimates by the World Health Organization (WHO) in 2015, cancer is the first or second leading cause of death before the age of 70 in 91 of the 172 countries, and ranks third or fourth in 22 additional countries (Bray et al. 2018).. Still, according to INCA, about 632,000 cancer patients are diagnosed per year. Most of these patients will have to go through some phase, chemotherapy or radiotherapy. According to the Supplementary Health Care Map, in 2016, beneficiaries of health plans performed more than one million consultations, almost 2.4 million chemotherapy sessions, and radiotherapy and 314,748 hospitalizations due to neoplasms. Mucositis, caused by chemotherapy and radiotherapy, has a considerable economic impact due to nutritional support, infection control and hospitalization. The economic consequences are significant with an incremental cost of more than US$ 17,000 per patient with head or neck cancer (Keefe, DM. et al.2007; Elting and Chang 2019) Due to this impact, the Mucositis project consists of the development of mucoadherel product formulated with the standardized extract of Arrabidaea chica popularly known as Crajiru. The development of this formulation should allow the use of this product with scarring and protective properties in order to reduce negative effects on the mucosal areas of patients undergoing cancer treatment. The Crajiru project will enable the future launch of products for healing and analgesia (according to studies ongoing) of the oral mucosa of cancer patients. It is important to note that the project arose from the partnership between Unicamp and Wecare through the collaboration agreement signed between the parties so that Unicamp can pass on a. chica's knowledge to Wecare. Unicamp holds the knowledge and already works with the standardized extract A. chica. There is a clinical study that proves the safety and efficacy of A. chica in mucosal healing. However, a formulation has not yet been developed that stabilizes A. chica at room temperature that makes it unfeasible to commercialize the product. The development of the product will take place by researching a formulation that can stabilize the standardized extract of Crajiru in a semi-solid pharmaceutical form, mucoadherent gel, at room temperature and photostable. Two or more formulations with different components and variations of concentrations for the formation of mucoader gel and that help in the stabilization of the drug will be tested. In addition to the formulations, three different types of packaging materials will be tested. The formulations will be placed at different temperatures: refrigerator, room temperature and at 40ºC for 3 months with analysis protocol. Wecare is a Brazilian startup that operates in the oncology area and develops products to mitigate the side effects of chemotherapy and radiotherapy. It develops anesthetic, analgesic, healing and antiseptic products derived from natural ingredients and biotechnological processes. (AU)