It is important to maintain strict checks and balances in order to properly follow policies and procedures. When it comes to manufacturing controlled substances, there are significant challenges to consider, including regulatory hurdles, supply chain issues, and safety and security concerns. In some cases, the API and adhesive cannot be mixed together, because their material components are simply not compatible, thus requiring an alternative layering structure within the patch. What is the release rate of the drug? Does it need to be administered over the course of a few hours, a day, or a week? When the API and adhesive are mixed together, it can speed up the rate at which the drug passes through the skin (because the drug is closer in proximity to the skin), but it can lessen the effectiveness of the adhesive itself. When it comes to pairing a drug with a patch, there are many things to consider. Finally, FDA has strict standards on elemental impurities in drug substances and delivery methods that must be considered. The therapeutic dose of the drug should also be less than about 10 mg per day. The molecular weight should be under 500 Dalton, as larger molecules cannot pass through the stratum corneum. In order to achieve proper skin absorption and penetration, the API should be non-ionic and be relatively lipophilic to enable partitioning into the lipophilic skin barrier. Transdermal patches also allow for removal of a drug in the event of an adverse reaction. Patches offer the ability to maintain a constant therapeutic effect for up to seven days. Because the drug is delivered through the skin, it avoids the gastrointestinal tract, so there are potentially fewer side-effects. McNamara(3M): Transdermal patches are a non-invasive way of self-administering medication. PharmTech: What are some of the primary considerations for developing and manufacturing patches? Pharmaceutical Technology spoke with Gene McNamara, Research Specialist at 3M Drug Delivery Systems, about some of the considerations for developing and manufacturing transdermal patches. Transdermal patches deliver drug through the skin and can be designed for extended release from hours to several days.
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