Placing excipients at the heart of safe medicines

The humble excipients which go into the formulation of a medicinal product rarely capture the attention commanded by active pharmaceutical ingredients, but are critical and essential components of drugs (Julio/Agosto 2011).

Their functions are many. Some excipients help to transport the API to the site in the body where it is supposed to exert its activity, protecting it so it can exert the optimal therapeutic effect. Others make sure the API is released at the right time or place, thereby avoiding potential side effects. Some help to identify a product if its authenticity is in question, while others aid patient compliance by improving the taste or appearance of a medicine.
Despite being inactive, excipients generally make up the bulk of a medicine in terms of weight and generally have well-defined functions in a drug product. Clearly, that makes it important that they are of good and consistent quality, as even minor deviations in an excipient can have a significant impact on its pharmaceutical functionality and performance.
Patients rightly expect that any medicine they take has been manufactured to the highest standards and, while this is true most of the time, recent manufacturing problems affecting even the largest drugmakers are evidence that this is not necessarily assured. Moreover, there have been several cases in recent years where serious adverse reactions have been attributed to the excipients used in a drug product.
For example, in Nigeria in 2008, at least 84 children aged between 2 months and seven years died as a result of deliberate substitution of the widely-used excipient glycerine with diethylene glycol in a teething mixture. An incident in Panama the previous year led to the deaths of 21 people died after taking a cough syrup made with diethylene glycol that had again been mislabelled as glycerine. Another 38 people were affected by side effects including disorientation and kidney failure.

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Palabras clave:  gmp,   api,   placing excipients, 

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