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Article Excerpt
Combining drugs with synergistic mechanisms of action yields some indisputable-benefits; improved efficacy, reduced dosing, enhanced patient compliance, to name just a few. But is there a downside to combining active pharmaceuticals with distinctly different characteristics and behaviours? Specifically, will the combined product be chemically stable? Moreover, is there any commercial potential in combining off patent therapeutics? We sought the opinions of experts on both sides of the fence.
Incompatibility problems can be overcome
Rajesh Dubey, Avvaru Seshasayana,
Satti Phanikumar Reddy & Suryakumar Jayanthi
Dr Reddy's Laboratories Ltd
With declining numbers of new chemical entities (NCEs), there is a new-found aggression for developing differentiated products using currently approved drugs. Fixed drug combination products have emerged as a differentiation strategy, as is evident by the increasing number of such product approvals (1) and recent launches. The strategy involves identifying molecules that, when combined, will lead to an improved therapeutic outcome compared with other treatment options. The rationale for such products are the associated advantages, such as improved patient compliance, complementary pharmacodynamic effect and improved bioavailability. Product stability, however, is a common and significant factor affecting the outcome of the product development project.
What are the stability issues?
Stability problems in combination products can be attributed to three types of interaction:
* Drug-drug chemical interaction: two or more drugs interact directly, resulting in drug degradation and a number of impurities; for example, lisinopril combined with aspirin undergoes acetylation to generate acetyl lisinopril, (2) which could lead to a number of possible adverse events.
* Drug-excipient interaction: a drug in a combination product has an excipient that is incompatible with other...
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