What studies have been done on excipients?

Question

Are they for the manufacturers benefit or the consumers.

Answer 1

They are for the manufacturers benefit and up until a few years ago, consisted mostly of LACTOSE which is rediculus as a large percentage of people, especially those taking medication, are lactose intolerant, meaning that they don't have the conjugated enzyme responsible for cleaving the milk sugar into its galactose and glucose. This is just one example. Manufacturers will use the most cost effective ingredient that will provide the best binding agent necessary for the capsule or tablet to conform to standards. Recent changes by manufacturers, mostly competing with rival generic manufacturers have required them to rethink this once, trivial consideration and very few tablets or capsules are made from 'sensitive' ingredients. However, it is ultimately up to the consumer to identify what he or she is allergic to including dyes and binding agents.

Answer 2

There have been numerous studies done on various excipients... in fact, I just did a search on Yahoo, and almost a quarter million hits came up for "excipient studies". The first hit was from the FDA (at http://www.fda.gov/cber/gdlns/dvpexcp.pd... ) and the second was http://www.ipecamericas.org/public/guide... (both of which look very comprehensive).

Ultimately to address what's behind your question, no company with any good quality assurance (and one that doesn't want to get sued by customers) will use approved excipients. Most of them are primarily for the manufacturer's benefit, but some also benefit the consumer. For example, the most common excipients include flow agents like Magnesium Stearate or Microcrystalline Cellulose... those two have no positive (or negative) benefit to the body, but they help the powders to flow more efficiently into the capsules.

There are a few excipients that can also add a benefit to the body, such as Silica (which is good for hair, skin, and nail health) or Calcium Carbonate (it can help bone health and help reduce stomach acidity).

Overall, though, they are mainly to help the manufacturer keep costs down, which helps decrease prices.