Quality Control of Brand Name Aspirin drug and Generic Aspirin drug

Abstract

Brand name drug is developed and produced by the brand name drug company through a complicated process. A new drug has to pass the following steps to be brought to the public: discovery, delivery, and manufacturing. A new compound needs to be found to fit the chemistry and physical characteristics. The dosage form of a suitable compound is then developed. The routes of administration are tested and dosage duration is optimized. The drug needs to be delivered into the targeted area at a certain rate in the environment in the human body. The active ingredient needs to be combined with other inactive ingredients for the easier manufacturing process as well as better absorption, distribution, metabolism, excretion and lower toxicity. The last part is the manufacturing part, which involves the development of the manufacturing process on a larger scale as well as getting approval from the FDA and testing results for pre-clinical and clinical tests. The company holds on the patent for the drug and the manufacturing process for 10 years, usually about the same period as the developing process. After the original patent expires, other generic drug companies can produce generic drugs (1). FDA requires the generic drug producer to prove that the drug they produce could have the same or comparable clinic effect as the brand name drug (2). The generic drugs are produced based on the concept of bioequivalence, meaning that the product should meet the same or comparable effect when the same number of active ingredients in the same dosage form and under the same route of administration is used (3). The 1984 Drug Price Competition and Patent Term Restoration Act stopped the requirement for performing pre-clinical and clinical tests all the generic copied drugs because the bioequivalence allows the generic drug to have the same performance in the pre-clinical and clinical tests. There are certain differences between generic drugs and brand name drugs. The shape, inactive ingredient, packing methods, color, and flavoring may be different between the generic drug and brand name drugs to prevent violation against trademark laws (5).