This study evaluated the safety of a pain medication that was administered through a topical dermal patch and the effect of the compounds on the adhesive properties at different environmental temperatures. Recruiting this study was challenging. It required recruiting subjects in two different seasons.
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EMLA Cream (lidocaine 2.5% and prilocaine 2.5%) is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine. It is a numbing cream that can be placed on skin to provide pain relief. It is often used to numb an area before placing an IV, drawing blood, or giving injections.
Typical stability study is conducted by the assay of active pharmaceutical ingredient (API) in the drug product. However, the assay results may not indicate drug product’s penetration rate similarity between different products over a certain period of time frame because of the differences in its topical product qualities (such as rheology, particle size, excipients, penetration enhancers, etc.). Therefore, it is important to evaluate the penetration of compounds into human skin during drug product stability study.
In vitro human cadaver skin model using Franz diffusion cells (invented in 1975) is widely regarded as the most valid in vitro model for evaluating the penetration of compounds into human skin. It can be used to determine the product equivalence.
Chronic pain affects millions of Americans, with a prevalence higher than heart disease, cancer, and diabetes combined. Chronic pain resulting in osteoarthritis and cancer is often treated with opioid medications. Opioid medications can provide short-, intermediate-, or long-acting analgesia. Hydrocodone is one of the currently approved formulations available in IR and ER forms. Extended-release forms are formulated as both combination products with acetaminophen or non-steroidal anti-inflammatory drugs or single-entity drug. All currently approved oral opioids have limitations, including continued concern about abuse and misuse in the intended patient population. Like other opioids used in analgesia, hydrocodone can be abused and is subject to criminal diversion. A number of the abuse-deterrent formulations in development and available on the market utilize hard-to-crush tablet technologies. Frontage possesses wide experience in running studies with controlled substances. Frontage provided full support in developing the protocol, revising study methodology, developing full package for IRB submission, including Informed Consent Form.
In this Q&A, Nan Zhang MD PhD, Vice President of Global Central Lab and Biomarker Services at Frontage, speaks on the role of analytical and central laboratories in providing accurate laboratory data and seamless logistics services.