Scientific Study Reports That On Average Rapid-Release Acetaminophen Gelcaps Dissolve Slower Than Standard-Release Tablets
Valisure, America's first online Analytical Pharmacy, conducted the study on 1,200 samples of acetaminophen products from five major U.S. companies
Nov 15, 2018, 08:00 ET
NEW HAVEN, Conn., Nov. 15, 2018 /PRNewswire/ -- A study conducted by the research team at Valisure, America's first online Analytical Pharmacy, revealed strong evidence that, on average, rapid- or fast-release acetaminophen gelcaps dissolve slower than standard release tablets from the same companies.
A report of the findings was published November 12th in the journal Advances in Investigational Pharmacology and Therapeutic Medicine. Acetaminophen is the most commonly purchased over-the-counter, fever-reducing medication used by an estimated 50 million Americans each week. Rapid- or fast-release acetaminophen gelcaps are generally sold at higher prices than standard tablets.
"We were surprised to observe that most of the products labeled rapid- or fast-release actually dissolved slower," stated Kaury Kucera, PhD, Chief Scientific Officer of Valisure. "We believe that the results of this study warrant additional investigations into acetaminophen products and, more generally, into the marketing claims of over-the-counter drugs."
Testing was conducted on 1,200 acetaminophen products that were analyzed every two minutes throughout 30-minute intervals. Comparing 600 standard tablets and 600 rapid- or fast-release gelcaps across five companies revealed that, on average, rapid- or fast-release gelcaps take longer to dissolve compared to standard tablets. The authors investigated further by testing another 100 rapid- or fast-release gelcaps by removing the blue and red coatings.
"For most of the gelcap products, the gelcap is easily removed and reveals a gray-colored tablet inside. We also found this unusual since gelcaps or capsules are commonly used for containing medication in powder or pellet forms. The data strongly suggested that this coating is actually slowing down the dissolution of the drug," Dr. Kucera added. The study was conducted in Valisure's labs at Yale Science Park in New Haven, Connecticut.
"As we were developing Valisure's lab systems, we often used over-the-counter products for testing as they are inexpensive and readily available," explained David Light, Founder and CEO of Valisure and an author on the study. "The surprising results for the acetaminophen products were something that we stumbled upon and at first thought might be an issue with our instrumentation. The consistency of the data prompted us to do further testing on several top brands which confirmed the results, in fact, appear to be correct."
"Consumers have demanded quality and transparency for most retail products. When you buy packaged food you expect to see nutritional information on it, but yet all you know about your meds is they come in an orange bottle and say "100mg." With roughly 80% of medication ingredients being manufactured in India or China and there being about three drug recalls a day in the U.S., we at Valisure feel the same demand for quality and transparency should apply to medications," Light further commented. "Valisure is the first pharmacy that tests every batch of medication we dispense, which is likely why, after over a decade of these products being on the market, we're the first to uncover these findings."
Authors on this study include Kaury Kucera, Amber Jessop, Niuska Alvarez, David Gortler and David Light.
Valisure is the first online Analytical Pharmacy to chemically batch-validate medications and is committed to helping ensure the safety, quality and consistency of the medications it delivers to consumers. In response to rising concerns about counterfeit medications, generics and overseas manufacturing, Valisure has developed novel analytical technology that is used to screen out poor-quality batches. Every prescription Valisure ships comes with a certificate of analysis listing important chemical properties of each drug analyzed at Valisure's lab. Founded by a team of Harvard- and Yale-trained scientists, Valisure strives to bring consumers the utmost quality and only dispenses medications that have passed its rigorous screening process. Valisure has ISO 17025 accreditation and is DEA and FDA registered. For more information, please visit www.valisure.com or follow @Valisure on Twitter.
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