Impact of splitting clonazepam tablets: a comparative evaluation
Impact of splitting clonazepam tablets: a comparative evaluation
DOI:
https://doi.org/10.47456/hb.64.50803Keywords:
clonazepam, tablets, tablet splitting, quality controlAbstract
Clonazepam (CLO) is the most prescribed drug in the benzodiazepine class, used as an antiepileptic and anxiolytic agent. Tablets are the most commercialized pharmaceutical form in the world. Pill partitioning refers to the practice of dividing a pill into smaller parts to adjust the prescribed dose of a drug, and is a decision related, in most cases, to the flexibility of doses, reduction of the cost of therapy and to facilitate swallowing, presenting a high risk to public health and impacting the quality of the drug. The objective of this study was to evaluate quality aspects of whole and broken tablets containing CLO, according to the Brazilian Pharmacopoeia, to correlate losses after Quality Control tests such as Content, Unit Dose Uniformity, Weight Determination, Friability, Hardness, and to compare the impact of the use of different partitioning methods by the population: knife, hands, and tablet cutter. The tests proved to be adequate to evaluate the quality of the tablets after partitioning, demonstrating that the physical characteristics of the evaluated tablets influence the cut. The loss of quality in all drugs after partitioning was notorious, with increased Friability, reduced Hardness and problems of dose homogeneity (Unit Dose Uniformity Test). In addition, it is possible to determine that the best performing tablets after partitioning were R (reference drug) and G1 (generic drug). Thus, the best method of partitioning the pills according to the research was with the use of one's own hands, but it is not a recommended action.
References
1. AGÊNCIA NACIONAL DE VIGILÂNCIA SANITÁRIA (ANVISA). “Partição de comprimido: é a prática de dividir o comprimido ao meio...”, 2019. Disponível em: https://www.facebook.com/AnvisaOficial/posts/2219813498128325/. Acesso em 19 de fevereiro de 2025.
2. BRASIL. AGÊNCIA NACIONAL DE VIGILÂNCIA SANITÁRIA (ANVISA). Resolução RDC nº 298, de 12 de agosto de 2019. Aprova a 6ª edição da Farmacopeia Brasileira. Diário Oficial da União, Brasília, 13 ago. 2019.
3. BRASIL. AGÊNCIA NACIONAL DE VIGILÂNCIA SANITÁRIA (ANVISA). Resolução RDC nº 940, de 14 de novembro de 2024. Aprova a 7ª edição da Farmacopeia Brasileira. Diário Oficial da União, Brasília, 19 nov. 2024.
4. BRUNTON LL, CHABNER BA, KNOLLMANN BC. Goodman & Gilman: As bases farmacológicas da terapêutica, 12.ed., Rio de Janeiro: McGraw-Hill/AMGH, 2012, 2079p.
5. BUTTOW AA, PRIMO FT, ROCHA ASR, HERTZOG GI, FERREIRA M. Avaliação do processo de partição em comprimidos de hidroclorotiazida. J Basic Appl Pharm Sci 33(4): 555-560, 2012.
6. KAKDE RB, SATONE DD. Spectrophotometric method for simultaneous estimation of escitalopram oxalate and clonazepam in tablet dosage form. Indian J Pharm Sci 71(6): 702-705, 2009.
7. KARAJGI S, PATIL A, KOTNAL R. Area under curve UV spectrophotometric method for the determination of clonazepam in tablets. Int J Pharm Pharm Res 6(2): 1-6, 2016.
8. KATZUNG BG, TREVOR AJ. Farmacologia básica e clínica, 13.ed., Porto Alegre: McGraw-Hill, 2017, 1202p.
9. MAGALHÃES IMQS, TESSMANN L, MEDEIROS-SOUZA P, CORDOBA JCM, TAVARES NUL, ABÍLIO VM, MATOS DO. Partição de comprimidos antineoplásicos utilizados no tratamento de leucemias agudas em crianças e adolescentes. Rev Bras Cancerol 66(2): 1-10, 2020.
10. MOFFAT AC, OSSELTON MD, WIDDOP B, WATTS J. Clarke’s analysis of drugs and poisons, 4th. ed., London/Chicago: Pharmaceutical Press, 2011, 2736p.
11. RANG HP, DALE MM. Farmacologia clínica, 8.ed., Rio de Janeiro: Elsevier, 2016, 760p.
12. RASHED SSB, TUSHAR RR, AHMED F, VABNA NJ, JAHAN L, BILLAH MM. Comparative in vitro dissolution study of clonazepam tablets of Bangladesh by UV-visible spectrophotometry. Acta Pharm Sci 59(4): 641-653, 2021.
13. ROCHA RVS, JACINTO PMS, FONTES BA. Consumo de ansiolíticos benzodiazepínicos durante a pandemia de COVID-19: um estudo remoto com estudantes universitários. Sapienza Int J Interdiscip Stud 3(1): 1-10, 2022.
14. TEIXEIRA MT, SÁ-BARRETO LCL, SILVA DLM, CUNHA-FILHO MSS. Panorama dos aspectos regulatórios que norteiam a partição de comprimidos. Rev Panam Salud Publica 39(6): 372-377, 2016.
15. VASCONCELOS SB, LEITE LB, ADELINO CC, CONTI MA. Partição de comprimidos: considerações sobre o uso apropriado. Boletim Farmacoterapêutico – CEBRIM/CFF 12(4/5): 1-6, 2007.
16. VERRUE C, MEHUYS E, BOUSSERY K, REMON J, PETROVIC M. Tablet-splitting: a common yet not so innocent practice. J Adv Nurs 67(1): 26-32, 2011.
17. ZORZANELLI RT, GIORDANI F, GUARALDO L, MATOS GC, BRITO JUNIOR AG, OLIVEIRA MG, SOUZA RM, MOTA RQM, ROZENFELD S. Consumo do benzodiazepínico clonazepam (Rivotril®) no estado do Rio de Janeiro, Brasil, 2009-2013: estudo ecológico. Cienc Saude Colet 24(8): 3129-3140, 2019.
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