MHRA publishes a report on levothyroxine tablet products: A review of the clinical and quality considerations

Source: MHRA Area: News In response to concerns expressed by patients and healthcare professionals regarding potential inconsistencies in the quality and effectiveness of levothyroxine products, the MHRA has conducted and published a review.  Recommendations from this review were endorsed in March 2012 by the Commission on Human Medicines, an independent panel of experts who advise the licensing authority.    The review stated that levothyroxine tablets are difficult to manufacture and may be prone to instability once formulated. However, tighter controls on the quality of the tablet in the form of a discriminating dissolution test and limit will be implemented to minimise potential for variability between products and batches. Similarly, additional regulatory expectations are proposed regarding the extent of data generated to support apparently minor and more major changes in manufacture and to support the introduction of new levothyroxine products.   Additionally, the ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news