Useful information

90% of medicine is additives

2019/11/01

When you hear “additives”, many people have the image of “something bad for the body,” such
as preservatives and colorings used in processed foods.
In fact, pharmaceuticals also contain additives .
In fact, many pharmaceuticals contain more additives than active ingredients.
This month, we will inform you about these pharmaceutical additives.

What are medicine additives?

What are pharmaceutical additives?
Additives are those other than active pharmaceutical ingredients.
By the way, an active ingredient is an ingredient contained in the medicine that conveys the
effect that is the purpose of the medicine. For example, one of the commonly used painkillers is
“Loxonin”, but this active ingredient is “Loxoprofen sodium hydrate”.
There are “brand names” and “generic names” for drugs. This generic name is the name of the
active ingredient.
For instance, regarding loxonin, “Loxonin Tablets” is the trade name and “Loxoprofen Sodium
Hydrate” is the generic name.

Aside from these active ingredients, anything that composes pharmaceutical products is a
pharmaceutical additive.

Ratio of active ingredients to additives

If you hear “things other than active ingredients,” you might think that some of them are active
ingredients, and the rest are additives.
But that is not the case.
Take, for example, loxonin again.
Looking at the package insert of “Loxonin Tablets 60㎎”, it is written that 68.1㎎ (60㎎ as
anhydrous) of the active ingredient “Loxoprofen Sodium Hydrate” is contained in one tablet.
So, the weight of one tablet is specified as 250mg.
One tablet is 250㎎, the active ingredient is 60㎎, and the rest is additive.

The proportion of active ingredients and additives varies depending on the drug, but in fact,
there are many drugs whose additives are 90% or more.

Purpose of pharmaceutical additives

So why are pharmaceutical additives added?

The “Japanese Pharmacopoeia”, the standard document for pharmaceutical products, defines
the following as regards pharmaceutical additives.
“Additives are substances other than the active ingredients contained in the formulation which
are used to increase the usefulness of active ingredients and formulations,
Facilitate formulation,
Stabilize quality,
Improve usability”

However, the main premise is that the additive does not exhibit pharmacological action, is
harmless, and does not interfere with the therapeutic effect of the active ingredient.

Generic has the same active ingredients, and additives can be changed

By the way, generic drugs contain the same amount of the same active ingredient as the brand
name drug, and are basically the same in terms of efficacy, effect, usage, and dosage.
However, generic drugs may contain additives that are different from the brand name drugs.
In some cases, the brand name drug has a formulation patent, and the same product
composition cannot be used. In other cases, the additive may be changed to solve problems
with the original drug, such as “difficult to take” and “stability”. . In other words, it may be
improved, such as “easier to take” and “more stable.”
However, it is not approved as a generic drug unless the efficacy and safety are found to be the
same as per the result of various tests.

In this way, the additive itself has no pharmacological action, but it is an important component
of the drug.