On any given week, you can pick up a newspaper and see an article about a prescription drug or an over the counter drug being recalled for one reason or another. Some people shrug it off and say that the company is doing the right thing by catching the error. Others wonder if any drug testing is actually happening because of the recalls.
Prescription drugs are tested for various criteria to ensure that they are manufactured properly before we take them. Once the FDA gives a drug approval, it doesn’t mean that the pharmaceutical companies can stop testing. It means: test everything and more.
Before you swallow that pill or squirt that nasal spray, every component leading to that moment has been rigorously tested to ensure that no harm will come to you or your loved ones. The raw materials are tested, the machinery is tested for cleanliness, the bottles are tested to make sure they meet specifications, the labels are tested and finally the final pill is tested before being placed in your hand. Think of how much testing Lance Armstrong does for cycling. The same is done for prescription drugs.
How Do You Test Packaging of Prescription Drugs?
Most people are surprised to find out that packaging is tested for prescription drugs. I mean, a bottle is just plastic, does it matter? Absolutely it matters. Consider this; there are over 100 different types of plastic bottles not even considering the different grades. If you spent a billion dollars developing a prescription drug, are you going to go with a cheap bottle? I really hope not.
The packaging is tested for what is called extractables and leechables. Simply put, you want to make sure no chemical can come from the packaging after filling it (extractable) and nothing can leak out over time (leechable) from sitting in the packaging. Any chemical that leaks from the packaging and ends up on the prescription drug can alter the drug and create additional side effects or even poison you. The label is also tested to make sure neither the adhesive seeps through the container nor that the label fades away over time. Most prescription drugs are packaged in the same type of containers so if all the labels fade, your pharmacist is in deep trouble.
How Are Prescription Drugs Tested?
All prescription drugs are tested prior to being released to the public. There are minimum standardized tests required by the pharmaceutical industry. The criteria for release are determined during drug development and either adjusted or approved by the FDA. All drug testing has acceptance criteria that must be met before being released.
The main test all drugs go through is called assay and impurities. Assay testing is to ensure that the correct amount of the active component is in the pill. Impurity testing is to ensure that the correct components that make up the pill are identified and ensure that nothing else snuck into the production process. The second main test is called content uniformity. Content uniformity ensures that random pills have a consistent blend and the exact amount of active ingredient. You don’t want one pill to have 90% of the active ingredient and another to have 110%. You want all the pills to be consistently close to 100%.The third test is called dissolution. Dissolution is like its name, it measures how long a pill takes to dissolve over time to get to its optimal concentration. This test is sensitive but important in the sense that we have no way of mimicking our entire digestive system accurately. Dissolution is the closest thing. Consider this, if you have a prescription drug that is an extended release formulation, you don’t want it completely dissolving in your stomach within the first 10 minutes. You want it to dissolve over time and dissolution will show you if it does just that.
The last two tests are codependent and have to do with prescription drugs degrading over time. One is called Karl Fischer which measures the amount of water in the pill. A high amount of water will degrade the prescription drug over time and make it less effective. The other test is Microbial testing which measures what kind of bacteria will grow on the prescription drug. The obvious answer is that you don’t want any bacterial growth. Again, too much water or if you store it in high moisture areas (bathroom medicine cabinet) will result in bacterial growth. All of these tests are designed to catch any errors or flaws before reaching the consumer. If there are ever any breakdowns, the pharmaceutical companies will try and catch it before distribution or face lawyers in a courtroom. Have you ever had a medication recalled?