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THE PHARMA REVIEW (JANUARY - FEBRUARY 2012)

Adverse Effects of Pharmaceutical Excipients

1 Rakesh Kumar Rishi, 2Rakesh K. Patel, and 3Anil Bhandari

Abstract: The excipients account for most of the weight or volume of a medicinal product. The term excipient is derived from the Latin word excipere, meaning ‘to except’, which can be simply explained as ‘other than’. They are most important components of the finished pharmaceutical formulation ensuring the accurate dosage, stability and bioavailability of the active drug. Before administration to humans, they must undergo all the toxicity tests designated for active ingredients. Ideally, excipients should be inert and safe. However, recent studies of adverse reactions have suggested otherwise. Some examples of known excipient-induced toxicities include renal failure and death from diethylene glycol, osmotic diarrhea caused by ingested mannitol, hypersensitivity reactions from lanolin, and cardiotoxicity induced by propylene glycol – to name a few.

 
Introduction: The most important part of a medicine as far as its weight is concerned, is constituted by its excipients, which have the important functions of guaranteeing the accurate dosage, stability and bioavailability of the Active Pharmaceutical Ingredient (API)1 Any ingredient added in preparing an official pharmaceutical dosage form shall be innocuous, shall have no adverse influence in the therapeutic efficacy of the active ingredients and shall not interfere with the tests and assays of the Pharmacopoeia. Care should be taken to ensure that such added substances are free from harmful organisms (source: I. P. 2010). The problem with this definition is that in recent years, it has been found that excipients can react with other ingredients in the formulation in order to cause adverse and hypersensitivity reactions in patients2. These adverse consequences due to pharmaceutical excipients range from a mild rash to a potentially life-threatening reaction. Different brands of the same finished drug formulation may contain different excipients, especially preservatives and colourants2. In past, the safety issues with pharmaceutical excipients were not given due importance and it was taken for granted that they are not hazardous for human health. However, recent research indicates that some of the ingredients of the pharmaceutical formulations are toxic. Present review of literature focuses mainly on the adverse effects of excipients that are widely used in the finished pharmaceutical dosage form.

 

 

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