On Wednesday, the Food and Drug Administration approved a new pill
called "Atripla" that combines three anti-retroviral medications used
for the treatment of AIDS. Doctors hope that the three-in-one drug
will make it easier for patients to keep up with their daily regimen.
Is it hard to put different medications in the same pill?
No. Anti-retroviral cocktail pills have been around for some time in
the developing world. Indian pharmaceutical companies and the
government of Thailand produce these single-dose medications using
older versions of the same kinds of drugs that go into Atripla. Even
in America, two of the three Atripla drugs already come in a single
pill called Truvada.
The process for making a combination can take longer in the United
States. The FDA must approve the new drug even if it has already
looked at each component. (In this case, FDA approval took only three
months under a special program to promote life-saving drugs.) Another
factor that might have delayed Atripla is the fact that its three
active ingredients—efavirenz, emtricitabine, and tenofovir disoproxil
fumarate—are sold commercially by two different companies,
Bristol-Myers Squibb and Gilead Sciences. The drug could hit the
market only after all the necessary business and legal agreements had
been reached. The ATRIPLA trademark belongs to a joint venture known
as "Bristol-Myers Squibb & Gilead Sciences, LLC."
Putting different drugs into the same pill can be as easy as blending
them into the same powder. But some ingredients may not mix
well—they'll tend to separate like oil and water—or they could have a
reaction when they come into contact with each other. Combining
chemicals might lower their melting point, for example. If the melting
point of a compound dips too low, your bottle of pills will turn into
medicinal soup.
Manufacturers can try to keep different drugs separate inside the same
pill. They can coat the powdery particles of one ingredient before
mixing it with another, to make sure that they don't actually touch.
They might also try to layer different ingredients within the same
pill.
Compounding pharmacies produce single-dose combinations of drugs on a
custom basis. One trick they use to keep drugs separate is to put a
pill into a large capsule and then fill the rest of the space in the
capsule by sprinkling in the powdered form of another drug.
(Compounding pharmacies don't need FDA approval for their concoctions.
They're regulated by the state boards of pharmacy.)
Once a pharmaceutical company has figured out a way to mix ingredients
into a single pill, they have to make sure the new combination drug
works. They have to test it in clinical trials to make sure that each
component is making its way into the bloodstream at an appropriate
rate. Since different ingredients may be most effective if taken at
certain times of day, the companies also have to figure out the best
way to prescribe the combination.
Labels: No Prescription, Online Pharmacy, Prescription Drugs
# posted by Network @ 6:43 AM
