Validation of the Active Substance in Original and Generic NSAIDs via HPLC Analysis.

Introduction

A generic drug is identical - or bioequivalent - to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.

When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn't allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the public authorities must approve it.

Health professionals and consumers can be assured that approved generic drugs have met the same rigid standards as the innovator drug. To gain approval, a generic drug must:

•             contain the same active ingredients as the innovator drug(inactive ingredients may vary).

•             be identical in strength, dosage form, and route of administration.

•             have the same use indications.

•             be bioequivalent.

•             meet the same batch requirements for identity, strength, purity, and quality.

•             be manufactured under the same strict standards of regulations required for innovator products.

Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less; therefore, generic drugs are usually less expensive than brand-name drugs.

The circulation of those drugs is not free of problems. Consider the case of the antidepressant bupropion. In September 2012, the US Food and Drug Administration (FDA) announced  that it had asked Israel-based manufacturer Teva Pharmaceuticals to stop distributing the

generic Budeprion XL (bupropion) 300 mg after it conducted testing and found that significant differences existed between Budeprion and the original Welbutrin XL 300 mg.

In a 2012 review the FDA found that "Budeprion XL 300 mg fails to demonstrate therapeutic equivalence to Wellbutrin XL 300 mg(FDA, 2012).

 The FDA said the product was approved at the 300 mg dose based on studies conducted using the 150 mg dose. The agency noted the lower dose was used as the basis of approval due to concerns that the higher dosage could cause seizures in otherwise healthy adults, and this concern caused the FDA to grant Teva a waiver for the studies-a process it refers to as "waiving up."

The FDA would ultimately reissue bioequivalency standards for the drug at the 100, 200, 300, 450 and 522 mg dose levels.

Teva's drug was formally withdrawn by FDA in March 2013, and withdrawals of other manufacturers' drugs soon followed.

In spite of the problems of generic drugs, they are circulating in abundance in good quality.

The use of generic drugs is widely spread in the group of nonsteroidal anti-inflammatory drugs (NSAIDs). They are a class of drugs which have pain-killing and fever-reducing properties. This is due to blocking the enzyme cyclooxygenase which is responsible for the synthesis of prostaglandins. NSAIDs also reduce the function of platelets and the ability of blood to clot.

Ibuprofen is an NSAID  that has proven to be a safe and effective analgesic for treating many different types of pain (osteo-artritis, rheumatoid arthritis and moderate to severe post-operative pain). Approved oral formulations contain ibuprofen in doses from 200 mg up to 800 mg.