Development of a pharmaceutical form of capsaicin with possible analgesic: evaluation of physical and chemical parameters

• Grant number: 13/04743-8
• Support Opportunities: Scholarships abroad - Research Internship - Doctorate
• Start date: September 01, 2013
• End date: September 30, 2013
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Guilherme Antonio Moreira de Barros
• Grantee: Valeria Romero Vieira da Motta
• Supervisor: Francisco J. Otero Espinar
• Host Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil
• Institution abroad: Universidade de Santiago de Compostela, Santiago (USC), Spain
• Associated to the scholarship: 12/22294-3 - Exposure of patients with myofascial pain syndrome to capsaicin: development of topical dosage form with possible analgesic, BP.DR

Abstract

The myofascial pain syndrome (MPS) is one of the most common causes of musculoskeletal pain. This pain may originate in a single muscle or may involve multiple muscles, creating complex patterns and variable pain. In this project, as an alternative for the treatment of SDM will use capsaicin. Capsaicin is a natural product obtained red pepper, and has been used for pain relief. The objective of this project is to evaluate the possible analgesic analgesic dosage form of a semi-solid (cream) of high concentration of capsaicin in patients with myofascial pain syndrome, and to investigate the possible in this population analgesic and adverse effects related to employment applied topical capsaicin in patients with SDM. In the initial stage of the project will be developed formulations Fc1 (cream based formula) and Fc2 (+ capsaicin cream formula). The products will be packaged in suitable packaging and tested for microbiological, physical and chemical quality evaluation of the product as recommended by ANVISA. The study will be developed in the Department of Pain Therapy and Palliative Care Program (TACP), located at the Hospital of the FMB-UNESP, reference to the treatment of pain syndromes. Always in the hospital, patients will be divided into two groups, a total of 40 patients, 20 patients identified by Group PLC will receive the cream base, and another 20 patients identified by CPS Group cream incorporated to receive 8% capsaicin. Be chosen by the patient PG him most causes discomfort and pain on palpation to be held topical application of the product. The creams (FC1 and FC2) are applied in the amount of 10g for 30 minutes. The administration of the creams will be held on topical or local, with full spreadability in the defined area. Located immediately above the skin surface, corresponding to PG higher pain (diameter approximately 2 cm), through trained and skilled professional. All personal protective equipment (PPE) will be offered for the security professional. After application, the product will be removed immediately, as well as parameters will be evaluated tolerability and toxicity to the skin. Prior to application of the creams the study, the patient will receive topical anesthetic ointment for a period of 50 minutes in the area corresponding to PGs. The pain is quantified immediately before and during application of the cream, and after its withdrawal. This will employee evaluation tool as the verbal numeric scale (0 to 10) where 0 means no pain and 10 the worst pain imaginable. After withdrawing the product, the application area is cleaned by a cleaning solution itself. At the end of the cleaning will be collected from the patients blood samples for quantification of plasma concentration of capsaicin in HPLC and forwarded to the Center for Toxicological Analysis (CEATOX - UNESP). As capsaicin is present in many foods eaten routinely be investigated in clinical protocol diet the last 6h of all patients, even those in Group PLC - which serve as a benchmark for analyzing the CPS group. After a two-month period, patients return to the TACP and will again be asked about their painful condition. The patient will not be notified of the assigned treatment until the study is completed. If there is recurrence of pain, a new clinical and diagnostic hypothesis should be conducted. (AU)