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Título

COMPOUNDING AND HANDLING OF ONCOLOGY DRUGS: DEVELOPMENT OF AN ORAL CAPECITABINE SOLUTION FOR “OFF-LABEL” USE

Resumo

Introduction Capecitabine can be used as second-line for the treatment of patients with metastatic breast cancer for which prior anthracycline‐based chemotherapy has failed, and and it does not exist as an oral solution. This drug has to be used with caution as it can cause serious adverse effects when used incorrectly. Objectives: In addition, the aim of this study was to evaluate off-label formulations available in the literature that could specifically be reproduced in patients for which, the Capecitabine could not be employed in tablets. This information is provided for professionals in oncology trained for the correct administration of oral solids solution. Methods: The review was performed on integrative literature search in the on the following database systems Stabilis Data Base and PubMed for all studies published in the English for the period from October 2019. Search term used were “extemporaneous formulations AND/OR, oral liquid NAD/OR, suspension AND/OR, compounding AND/OR, anticancer therapy AND/OR, antineoplastic agent” out. Results: Two were identified formulas for the preparation of Capecitabine oral solution. Formulation nº 1: dissolve 4 tablets of 500 mg in 50 mL purified water for at least 15 minutes at 55°C. Administration using an oral syringe. Formulation nº 2: dissolve 37 grinded up tablets of Capecitabine 500 mg, oral suspension solution q.s.to 185 mL. Stability is 14 days under at 4-8ºC. Oral suspension solution formula: xanthan gum (0.1 g), 70% sorbitol (50 mL), glycerin (20 mL), saccharin (0.2 g), methylparaben (0.2 g), citric acid (3 g), sodium citrate dihydrate (4.0 g), potassium sorbate (0.2 g), and purified water q.s.to 200 mL. Methods These formulas might be prepared from tablets or capsules. Liquid formulation provides maximal dosing flexibility and allows a single formulation over a wide age range. This strategy was effective in prevent medication errors and contributing to promote patient safety and pharmaceutical care.

Palavras Chave

Capecitabine, compounding, oral extemporaneous, oncology drugs

Área

Complicações do tratamento oncológico (infertilidade, impotência, cistite ...)

Instituições

Hospital Universitário Antonio Pedro - Rio de Janeiro - Brasil

Autores

GILBERTO BARCELOS SOUZA