Unexpected drug failure is a lack of therapeutic effect, which is not expected based on the characteristics of the drug and patient. Essentially, it may occur either for interactions (with other drugs or foods) or for biopharmaceutical issues. The risk arising from interactions is generally well characterised and physicians are well aware of it, and the importance of reporting cases of failure due to interactions is obvious. Less is known about the mechanisms and potential risk deriving from biopharmaceutical problems, and we will therefore focus on this issue. Biopharmaceutics describes the influence of the physical/chemical properties of the drug and drug product on the rate and extent of systemic drug absorption. Because after oral administration of solid pharmaceutical forms drugs must dissolve in gastrointestinal fluids before being absorbed through the intestinal epithelium, biopharmaceutical problems essentially arise from an insufficient dissolution performance. A typical situation where an insufficient dissolution may cause unexpected drug failure is when a patient is switched from one drug product to a different product. Different drug products with the same active substance may differ in manufacture and excipient composition.

The importance of reporting unexpected drug failure / Romanelli, Luca; Mhillaj, Emanuela; Cuomo, Vincenzo. - In: JOURNAL OF PHARMACOVIGILANCE. - ISSN 2329-6887. - STAMPA. - 4:1(2016), pp. 1-2. [doi:10.4172/2329-6887.1000e148]

The importance of reporting unexpected drug failure

ROMANELLI, LUCA;MHILLAJ, EMANUELA;CUOMO, VINCENZO
2016

Abstract

Unexpected drug failure is a lack of therapeutic effect, which is not expected based on the characteristics of the drug and patient. Essentially, it may occur either for interactions (with other drugs or foods) or for biopharmaceutical issues. The risk arising from interactions is generally well characterised and physicians are well aware of it, and the importance of reporting cases of failure due to interactions is obvious. Less is known about the mechanisms and potential risk deriving from biopharmaceutical problems, and we will therefore focus on this issue. Biopharmaceutics describes the influence of the physical/chemical properties of the drug and drug product on the rate and extent of systemic drug absorption. Because after oral administration of solid pharmaceutical forms drugs must dissolve in gastrointestinal fluids before being absorbed through the intestinal epithelium, biopharmaceutical problems essentially arise from an insufficient dissolution performance. A typical situation where an insufficient dissolution may cause unexpected drug failure is when a patient is switched from one drug product to a different product. Different drug products with the same active substance may differ in manufacture and excipient composition.
2016
drug failure; drug effects; biopharmaceuticals problems
01 Pubblicazione su rivista::01a Articolo in rivista
The importance of reporting unexpected drug failure / Romanelli, Luca; Mhillaj, Emanuela; Cuomo, Vincenzo. - In: JOURNAL OF PHARMACOVIGILANCE. - ISSN 2329-6887. - STAMPA. - 4:1(2016), pp. 1-2. [doi:10.4172/2329-6887.1000e148]
File allegati a questo prodotto
File Dimensione Formato  
Romanelli_Importance_2016.pdf

accesso aperto

Tipologia: Versione editoriale (versione pubblicata con il layout dell'editore)
Licenza: Creative commons
Dimensione 248.26 kB
Formato Adobe PDF
248.26 kB Adobe PDF

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/866651
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus ND
  • ???jsp.display-item.citation.isi??? ND
social impact