Regulations, characteristics and feasibility of partitioning oral solid drugs according to current Brazilian legislation

Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02175| Published on: 03/10/2023

Abstract

Introduction: The difficulty in swallowing solid oral dosage forms is collectively reported by patients; however, this form of medication is still the most frequently prescribed. Objective: To investigate the format, dimension and viability of partitioning drugs in solid forms most frequently sold in Brazil and evaluate the regulations and the dissemination of this information to the population. Method: The shape and size of solid oral forms were obtained from the collection, analysis and measurement of 470 drugs. The feasibility of partitioning was verified by the presence or absence of grooves and by reading their respective package inserts. A bibliographic survey of current regulations was carried out and the format, size and partition data found were debated in terms of these regulations. Results: Pills with the same type and dose of the active pharmaceutical ingredient showed size differences related to the classification of the drug (reference, generic and similar) and pharmaceutical  laboratory. Generic drugs, in general, had larger dimensions than similar and reference drugs. The difference in volume (mm3) of tablets of the same classification and different pharmaceutical laboratories reached 66.00%. Considering the information on the package inserts, 90.00% of the drugs analyzed do not have partition permission. Several drugs do not present information about partition consistent with Anvisa RDC nº 47. Conclusions: Disclosure of the format and size of medications in package inserts and/or packaging can help patients with dysphagia. For greater security, partitioning
of medications should not be based on the groove present in them, and it is necessary to consult the package leaflet.