Avaliação físico-química da dispersão de micofenolato de mofetila: estabilidade e administração em sondas

Avaliação físico-química da dispersão de micofenolato de mofetila: estabilidade e administração em sondas

Authors

DOI:

https://doi.org/10.20435/vol30iss76.4763

Keywords:

micofenolato de mofetil, imunossupressores, nutrição enteral, tecnologia farmacêutica, suspensões

Abstract

The aim of this study was to evaluate the stability of a liquid formulation of MMF 10 mg/mL at temperature of 20ºC-25ºC and 2ºC-8ºC. The vehicle was developed in the Pharmacotechnical Laboratory at the Federal University of Ceará, and the formulations were monitored for changes in pH, density, viscosity and sedimentation. The formulation showed good stability across all parameters at both temperatures, with a decrease in the active ingredient nearly to 90% after 15 days at 20ºC-25ºC, and after 47 days at 2ºC-8ºC. When administered via simulated nasoenteral tube, 95.75% of the drug was recovered as identified by High Performance Liquid Chromatography (HPLC). The formulation appears stable and represents a suitable option for patients who require enteral administration, simplifying the operations for nursing staff.

Author Biographies

Flavio Rodrigues Lopes Filho, Universidade Federal do Ceará (UFC)

PhD candidate in Pharmaceutical Sciences with an emphasis on Clinical Pharmacy and Health Surveillance at the Federal University of Ceará (UFC). Holds a Master’s degree in Pharmaceutical Sciences with an emphasis on Clinical Pharmacy and Health Surveillance from UFC. Specialist in Clinical Pharmacy and Pharmaceutical Prescribing from the Faculdade de Quixeramobim. Coordinator of the Pharmacy undergraduate program at the educational group Aqui Você Pode.

Maria Aparecida Alexandre Josino, Universidade Federal do Ceará (UFC)

PhD in Medical Microbiology from the Federal University of Ceará (UFC). Bachelor’s degree in Pharmacy from UFC. Conducts research in the field of antimicrobial drug synergism, with an emphasis on studying the antimicrobial potential of drugs originally indicated for other therapeutic uses, development of formulations with antimicrobial activity and pediatric formulations, physicochemical quality control, analytical validation, and evaluation of pharmacokinetic parameters of formulations administered to transplant patients.

Said Gonçalves da Cruz Fonseca, Universidade Federal do Ceará (UFC)

PhD in Pharmaceutical Development and Technological Innovation from the Federal University of Rio Grande do Norte (UFRN). Master’s degree in Pharmaceutical Sciences from the Federal University of Pernambuco (UFPE). Bachelor’s degrees in Pharmacy and Industrial Pharmacy from the Federal University of Ceará (UFC). Associate Professor at UFC. Has experience in the field of Pharmacy, with an emphasis on pharmaceutical development (galenic development), mainly working on quality control, pharmaceutics, and herbal medicines.

Marta Maria de França Fonteles, Universidade Federal do Ceará (UFC)

Marta Maria de Franca Fonteles has a degree in Pharmacy from the Federal University of Ceará (UFC), a master's and doctorate in Pharmacology from UFC, and a post-doctorate in Clinical Pharmacy from the University of Auckland, New Zealand. She is a full professor at UFC, ad hoc consultant at the Federal Pharmacy Council (2014 - current) and full member of the Cearense Academy of Sciences (ACECI). In addition to being a CNPq researcher (PQ 1D scholarship holder), she also works as general didactic-pedagogical coordinator of the Multiprofessional Residency in Hospital Health Care at UFC, in the hospital complex (Hospital Universitário Walter Cantídio/Maternidade Escola Assis Chateaubriand). She is currently vice-coordinator of the Postgraduate Program in Development and Technological Innovation in Medicines (PPGDITM/UFC, doctorate in association); is co-tutor of PET- Farmácia/UFC and is also participating as a member of the Pharmacy and Therapeutics Commission (CFT) and the Clinical Pharmacy Management Committee of the Ceará State Health Department (SESA). She has experience in the area of ​​Neuropharmacology, studying drugs and medicinal plants that act on the CNS, through behavioral, neurochemical, neuroprotection studies, and seizure models. It also investigates the mechanism of action of adverse reactions caused by medicines, in the field of post-marketing surveillance of medicines/safety studies - Phase IV. Develops projects in the area of ​​Pharmaceutical Assistance, especially involving topics related to Clinical Pharmacy/Pharmaceutical Care, Hospital Pharmacy, Pharmacovigilance, as well as teaching methods for the practice of assistance and clinical functions in the area of ​​Pharmacy. It is part of the National Institute of S&T in Pharmaceutical Innovation (INCT_if). Belongs to the Brazilian Association of Pharmaceutical Sciences (ABCF), Brazilian Association of Pharmaceutical Education (ABEF), Brazilian Society of Clinical Pharmacy (SBFC; president, since 11/2019, of SBFC- regional Ceará), Brazilian Society of Hospital Pharmacy (SBRAFH) , and the Brazilian Society of Pharmacology and Experimental Therapeutics (SBFTE). She is leader of the Pharmaceutical Care Research Group (GRUPATF) at CNPq, coordinator of the Center for Studies in Pharmaceutical Care (CEATENF), the Laboratory of Clinical and Communication Skills of the Pharmacy course (Lab. HabClinCom), and the Laboratory of Research in Clinical and Translational Pharmacy (Lab. FarmaClin T), belonging to UFC. He also participates in the research groups Prevention of Misuse of Medicines (GPUIM) and Best Medicines for Children (MeMeCri).

References

ATTEBÄCK, M.; HEDIN, B.; MATTSSON, S. Formulation optimization of extemporaneous oral liquids containing naloxone and propranolol for pediatric use. Scientia Pharmaceutica, Umea, v. 90, n. 1, p. 15, march, 2022.

BATISTA, L. A. A. Monitorização do uso clínico de formulação extemporânea de captopril preparada com o veículo “Gute”. 2014. 133f. Dissertação (Mestrado em Ciências Farmacêuticas) - Faculdade de Farmácia, Odontologia e Enfermagem, Universidade Federal do Ceará (UFC), Fortaleza, 2014.

BRASIL. Farmacopeia Brasileira. v. 2. 6. ed. Brasília, DF: Agência Nacional de Vigilância Sanitária; Ministério Nacional da Saúde, 2019.

BRASIL. Ministério da Saúde. Resolução-RDC n. 67, de 8 de outubro de 2007. Dispõe sobre boas práticas de manipulação de preparações magistrais e oficinais para uso humano em farmácias. Brasília, DF: Presidência da República, 9 oct. 2007.

BOULLATA, J. I. Enteral Medication for the Tube‐Fed Patient: Making This Route Safe and Effective. Nutrition in Clinical Practice, [S. l.], v. 36, n. 1, p. 111-132, dec. 2020.

COSTA, A. L. O. Éster 2-morfolinoetil e sal sódico do ácido micofenólico: desenvolvimento e validação de métodos analíticos para o controle de qualidade de matéria-prima e comprimidos. 2009. 210p. Dissertação (Mestrado em Ciências Farmacêuticas) - Faculdade de Farmácia, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, 2009.

FAHIMI, F.; BANIASADI, S.; MORTAZAVI, A.; DEHGHAN, H.; ZARGHI, A. Physical and chemical stability of mycophenolate mofetil (mmf) suspension prepared at the hospital. Iranian Journal of Pharmaceutical Research, [S. l.], v. 11, n. 1, 2012.

FOLEY, L.; TONEY, J.; BARLOW, J. W.; O’CONNOR, M.; FITZGERALD-HUGHES, D.; RAMTOOLA, Z. Investigation of the physical, chemical and microbiological stability of losartan potassium 5 mg/ml extemporaneous oral liquid suspension. Molecules, [S. l.], v. 26, n. 2, 2021.

INTERNATIONAL CONFERENCE ON HARMONIZATION. ICH. Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for Industry. Geneva: International Conference on Harmonization, 2005.

MEDEIROS M. S. G. Avaliação sensorial de formulações extemporâneas de medicamentos cardiovasculares preparados com o veículo “GUTE” e utilizadas em pacientes pediátricos. 2014. 141f. Dissertação (Mestrado em Ciências Farmacêuticas) - Universidade Federal do Ceará (UFC), Fortaleza, 2014.

MOTTA, A. P. G.; RIGOBELLO, M. C. G.; SILVEIRA, R. C. C. P.; GIMENES, F. R. E. Nasogastric/nasoenteric tube-related adverse events: an integrative review. Revista Latino-Americana de Enfermagem, Ribeirão Preto, v. 29, jan. 8 2021.

PEREIRA, R. A.; SOUZA, F. B.; RIGOBELLO, M. C. G.; PEREIRA, J. R.; COSTA, L. R. M.; GIMENES, F. R. E. Quality improvement programme reduces errors in oral medication preparation and administration through feeding tubes. BMJ open quality, [S. l.], v. 9, n. 1, 2020.

SOUSA, A.; SOUSA, E.; JOSINO, M.; CRUZ, S. Desenvolvimento de suspensão oral contendo hidroclorotiazida para uso em pediatria. Boletim Informativo Geum, [S. l.], v. 5, n. 2, 2014.

SOUSA, E.; JOSINO, M.; SOUSA, A.; CRUZ, S. Desenvolvimento de uma forma farmacêutica líquida de cloridrato de valganciclovir e seu estudo de estabilidade. Informative Geum Bulletin, [S. l.], v. 5, n. 2, 2014.

SWENSON, C. F.; DENTINGER, P. J.; ANAIZI, N. H. Stability of mycophenolate mofetil in an extemporaneously compounded sugar-free oral liquid. American Journal of Health-System Pharmacy, [S. l.], v. 56, n. 21, 1999.

USP-NF. The United States Pharmacopeia. 38. ed. Rockville: The United States Pharmacopoeial Convention, 2015.

VENKATARAMANAN, R.; MCCOMBS, J. R.; ZUCKERMAN, S.; MCGHEE, B.; PISUPATI, J.; DICE, J. E. Stability of mycophenolate mofetil as an extemporaneous suspension. Annals of Pharmacotherapy, [S. l.], v. 32, n. 7-8, jul. 1998.

WAITZBERG, D. L. Nutrição oral, enteral e parenteral na prática clínica. 5. ed. São Paulo: Atheneu, 2017.

WANDEN-BERGHE, C.; PATINO-ALONSO, M. C.; GALINDO-VILLARDÓN, P.; SANZ-VALERO, J. Complications Associated with Enteral Nutrition: CAFANE Study. Nutrients, [S. l.], v. 11, n. 9, 2019.

YELLEPEDDI, V.; SAYRE, C.; BURROWS, A.; WATT, K.; DAVIES, S.; STRAUSS, J.; BATTAGLIA, M. Stability of extemporaneously compounded amiloride nasal spray. PLOS ONE, [S. l.], v. 15, n. 7, jul. 2020.

ZAJICEK, A. et al. A report from the pediatric formulations task force: perspectives on the state of child-friendly oral dosage forms. The AAPS Journal, [S. l.], v. 15, n. 4, oct. 2013.

Downloads

Published

2026-02-13

How to Cite

Lopes Filho, F. R., Josino, M. A. A., Fonseca, S. G. da C., & Fonteles, M. M. de F. (2026). Avaliação físico-química da dispersão de micofenolato de mofetila: estabilidade e administração em sondas: Avaliação físico-química da dispersão de micofenolato de mofetila: estabilidade e administração em sondas. Multitemas, 30(76). https://doi.org/10.20435/vol30iss76.4763

Issue

Vol. 30 No. 76 (2025): MULTITEMAS set./dez.

Section

Artigos

License

Copyright (c) 2025 FLAVIO RODRIGUES LOPES FILHO, Maria Aparecida Alexandre Josino, Said Gonçalves da Cruz Fonseca, Marta Maria de França Fonteles

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Os artigos publicados na Revista Multitemas têm acesso aberto (Open Access) sob a licença Creative Commons Attribution, que permite uso, distribuição e reprodução em qualquer meio, sem restrições desde que o trabalho original seja corretamente citado.

Direitos Autorais para artigos publicados nesta revista são do autor, com direitos de primeira publicação para a revista. Em virtude de aparecerem nesta revista de acesso público, os artigos são de uso gratuito, com atribuições próprias, em aplicações educacionais e não-comerciais.