Instability of Misoprostol Tablets Stored Outside the Blister: A Potential Serious Concern for Clinical Outcome in Medical AbortionReportar como inadecuado




Instability of Misoprostol Tablets Stored Outside the Blister: A Potential Serious Concern for Clinical Outcome in Medical Abortion - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Introduction

Misoprostol Cytotec is recognised to be effective for many gynaecological indications including termination of pregnancy, management of miscarriage and postpartum haemorrhage. Although not licensed for such indications, it has been used for these purposes by millions of women throughout the world. Misoprostol tablets are most often packaged as multiple tablets within an aluminium strip, each within an individual alveolus. When an alveolus is opened, tablets will be exposed to atmospheric conditions.

Objective

To compare the pharmaco technical characteristics weight, friability, water content, misoprostol content and decomposition product content type A misoprostol, type B misoprostol and 8-epi misoprostol of misoprostol tablets Cytotec Pfizer exposed to air for periods of 1 hour to 720 hours 30 days, to those of identical non exposed tablets.

Methods

Four hundred and twenty 420 tablets of Cytotec Pfizer were removed from their alveoli blister and stored at 25°C-60% relative humidity. Water content, and misoprostol degradation products were assayed in tablets exposed from 1 to 720 hours 30 days. Comparison was made with control tablets N = 60 from the same batch stored in non-damaged blisters. Statistical analyses were carried out using Fisher’s exact test for small sample sizes.

Results

By 48 hours, exposed tablets demonstrated increased weight +4.5%, friability +1 300%, and water content +80% compared to controls. Exposed tablets also exhibited a decrease in Cytotec active ingredient dosage −5.1% after 48 hours and an increase in the inactive degradation products +25% for type B, +50% for type A and +11% for 8-epi misoprostol after 48 hours compared to controls.

Conclusion

Exposure of Cytotec tablets to ‘typical’ European levels of air and humidity results in significant time-dependent changes in physical and biological composition that could impact adversely upon clinical efficacy. Health professionals should be made aware of the degradation of misoprostol with inappropriate storage of misoprostol tablets.



Autor: Veronique Berard , Christian Fiala, Sharon Cameron, Teresa Bombas, Mirella Parachini, Kristina Gemzell-Danielsson

Fuente: http://plos.srce.hr/



DESCARGAR PDF




Documentos relacionados