HCPC Study Reveals Degradation Risk

The Healthcare Compliance Packaging Council has released the results of a study investigating the potential degradation of three widely prescribed prescription drugs when packaged in conventional formats. The study results reveal the effect daily exposure to oxygen and moisture can have on non-coated Simvastatin, Lisinopril and Metformin tablets during in home use of multi-dose containers or through permeation of low barrier blister film typically used in Long Term Care settings.
 
The results indicate that undue moisture and oxygen exposure increases the risk of physical degradation during normal use. More specifically, polypropylene vials, HDPE bottles or PVC blisters found in retail and institutional settings may increase the risk of higher physical degradation than high barrier packages such as PVC/Aclar or PVC/PVdC blisters. However, the study also revealed that higher temperature conditions affected the physical properties of products studied, regardless of packaging format, calling into question the practice of mail-order delivery for some prescriptions.
 
The study focused on the physical degradation that occurs during the prescribed in-use period by assessing changes to the drug in moisture gain, tablet hardness, and disintegration time. It was found that degradation increased when the tablets were tested in higher humidity (25°C/90%RH), versus those tested in 25°C/75%RH. In addition, when subjected to higher temperature conditions (40°C/75%RH) temperature sensitivity was observed in all drugs. The degradation observed under these various conditions indicate that Simvastatin, Lisinopril and Metformin when dispensed in polypropylene amber vials, HDPE bottles or PVC blisters undergo physical changes through daily exposure to typical home environments. Whether these changes affect these drugs’ specific efficacy or their absorption rates needs further investigation.
 
Walt Berghahn, HCPC executive director, said, “The unique outcomes seen with these three products indicates how little we know about the impact of patient at-home storage conditions on the quality of the $320 billion of drugs we dispense today.  Regardless of the drug form, all medicines need to be protected through distribution and pharmacy until used by the patient. Packages need to protect drug products during their entire life cycle.  As shown in this study, unit dose packages using high barrier materials can accomplish that goal, if the temperature profile is maintained. Once we move closer to protecting these products appropriately, we ensure that patients will receive effective products to treat their conditions.”
 
Through this study the HCPC intends to bring awareness to potential impact on drug products’ efficacy due to the packaging format along with the environment in which they are kept. The study leads to the initial conclusion that U.S. patients taking their medications from non-barrier packaging may not get the designed clinical benefit of the drug due to potential product compromise as a result of daily exposure to the home environment. The HCPC believes the next step would be to broaden the scope of this study and include chemical assay tests on drugs exposed to these or similar study conditions in order to determine the potential impact on efficacy.