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Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/67105
Cyclophosphamide Sugar-coated Tablets
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[eng] Cyclophosphamide is a cytotoxic anti-tumor pro-drug belonging to the alkylating agents which is indicated for the treatment of many cancers as well as some immune-related disorders. In Spain, it is marketed as powder for injection and as sugar-coated tablets by Baxter Oncology. Cyclophosphamide is well absorbed from the gastrointestinal wall, with an oral bioavailability of 85-100%. This justifies the existence of an oral medication comprising the drug, like sugar-coated tablets. Cyclophosphamide structure is prone to undergo hydrolysis and other degradation reactions in aqueous solution, and is labile to high temperatures, changes in moisture levels, and light. Instability to the latter conditions might accelerate the degradation of the active ingredient during the manufacture of the drug product, and is one of the reasons for tablet coating. Accordingly, drug sensitivity to water and temperature are especially critical, since most manufacturing processes are carried out in aqueous medium and involve heating systems like hot air drying. Indeed, commercially available cyclophosphamide coated tablets are produced by means of a wet granulation process followed by coverage with the sugar-coating technique. Both of these methods are subjected to the use of water and to several drying stages, thus compromising the stability of the active ingredient. Hence, the main objective of this project has been to develop a novel formulation of cyclophosphamide coated tablets that minimized drug exposure to water and heat during the manufacturing process. As a result, sorbitol film-coated tablets have been proposed. These consist of a tablet core obtained by direct compression without the need of water, and a film-coating containing glycerol instead of water as the main coating solvent together with sorbitol as a plasticizer.
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Treballs Finals de Grau de Farmàcia, Facultat de Farmàcia, Universitat de Barcelona, 2015. Tutor: Joaquín Tejero Martínez.
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SANPERE AMAT, Emma. Cyclophosphamide Sugar-coated Tablets. [consulta: 8 de desembre de 2025]. [Disponible a: https://hdl.handle.net/2445/67105]