Banca de DEFESA: ANGELO ELIAS MERI JUNIOR

Uma banca de DEFESA de MESTRADO foi cadastrada pelo programa.
STUDENT : ANGELO ELIAS MERI JUNIOR
DATE: 15/12/2022
TIME: 08:00
LOCAL: Plataforma online
TITLE:

RELATIONSHIP BETWEEN THE USE OF DIFFERENT PHARMACEUTICAL PRESENTATIONS OF METFORMIN

HYDROCHLORIDE AND THE OCCURRENCE OF GASTROINTESTINAL ADVERSE EVENTS: A BIOPHARMACEUTICAL

AND USER PERCEPTION STUDY

KEY WORDS:

type II diabetes mellitus, diarrhea, nausea, biguanides, gastrointestinal disturbances.

PAGES: 102
BIG AREA: Ciências da Saúde
AREA: Farmácia
SUBÁREA: Análise e Controle de Medicamentos
SUMMARY:

Introduction: Metformin hydrochloride (MET) is a hypoglycemic agent of oral administration, considered the drug of choice for the treatment of type 2 diabetes mellitus (DM2). The main adverse effects (AEs) related to the use of MET are gastrointestinal disorders. A hypothesis associated with the occurrence of these AEs due to the use of MET is related to the speed of drug release from its pharmaceutical form, since the higher the release rate, the higher its concentration in the intestine. It is relevant to investigate whether there is a difference in the perception of gastrointestinal AEs, as well as the correlation with the quality and the rate of drug release among the different commercial products containing MET. Methods: This is a prospective observational cohort study, in which diarrhea was related by patients with DM2 who started treatment with extended-release (XR) formulations of MET at doses of 500 mg. Additionally, at this stage of the study, the assay of MET and the test of uniformity of dosage units of different formulations of MET were conducted as described in the monographs of the American Pharmacopoeia. The dissolution profiles of the different MET brands were also performed in order to verify the percentage of the drug dissolved as a function of time. Results: Considering the patients eligible for study participation (n= 27) nineteen (66.7%) used the reference drug (R) and eight (33.3%) used the generic drug (G) of MET 500 mg XR. A lower frequency of gastrointestinal AEs was observed in patients who used the reference formulation when compared to those who used the generic. In both groups (R and G) the AEs did not affect the social and family life, as well as the quality of life of the patients. In the G4 sample, the assay test revealed that the content of MET was below the limit specified by the America Pharmacopoeia, being therefore considered an unsatisfactory result. The G2 sample presented the maximum amount of MET dissolved in the time of 10 minutes (97.69%), remaining constant subsequently. In G3, the amount of dissolved MET was gradual, reaching a maximum concentration in 25 minutes (92.07%), remaining constant afterward. The results obtained so far suggest that the AEs and the rate of drug release may be associated with the type of formulation, however, additional studies involving the evaluation of quality, dissolution profile, and the perception of AEs are still being performed in order to better support the hypothesis raised. It is expected that this work can contribute to the optimization of the pharmacotherapy of patients intolerant to gastrointestinal AEs resulting from the use of MET.

BANKING MEMBERS:
Interno - 1300132 - WHOCELY VICTOR DE CASTRO
Interno - 1039964 - ANDRE DE OLIVEIRA BALDONI
Externa ao Programa - 1757957 - ANA JULIA PEREIRA SANTINHO GOMES
Externa à Instituição - MARIA JULIANA FERREIRA PASSOS
Externo à Instituição - MAIRON CESAR COIMBRA - UFSJ
Externo à Instituição - JOSÉ EDUARDO GONÇALVES - UFMG