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Innovations in medication delivery

In this Q&A, Healthcare Packaging discusses next-generation drug-device delivery methods with Technology Catalysts International.

NuPathe
NuPathe

In March, Healthcare Packaging (HCP) posted a story online that focused on a new report called, “Next-Generation Self-Administered Drug-Device Combinations: New Technologies and Business Opportunities,” from Technology Catalysts International (TCI). In the following question-and-answer article, HCP goes into more detail on newer drug-device delivery vehicles with Ajay Rastogi (AR), vice president, Business Development and Marketing, Sandra Erb (SE), vice president, Research, and Amy Hicks (AH), research analyst, Drug Delivery. TCI is a Falls Church, VA-based multinational consulting firm specializing in technology licensing and assessment, small company acquisitions, and technical/business research in pharmaceuticals, drug delivery, consumer products, biomedical devices, chemicals, advanced materials, advanced processes, and biotechnology.

HCP: What is the focus of the report?

SE: We are looking at self-administrative devices, focusing on three broad drug-device areas. One is the parenteral group, which includes autoinjectors, needle-free injectors, pens, and evolving electronic devices. An example of this is Enbrel (etanercept), a biologic injection from Amgen/Pfizer used to treat moderate-to-severe rheumatoid arthritis. The original launch required the patient to mix the lyophilized vial with a diluent before injection. Now the product is in a prefilled syringe or autoinjector, making it much simpler for the patient to administer the dose.

The second is the broad transdermal area, including Insulet Corporation’s OmniPod (OmniPod system) diabetes insulin pump and transdermal patches with microneedles. The third is pulmonary, in which the use of inhalers has been very extensive and has been around for quite some time. These devices have had to be very patient-friendly. During an asthma attack, the patient needs to be able to quickly use the inhaler. Now, pharmaceutical companies are looking to use inhalers to treat other indications beyond respiratory.

HCP: Does patient responsibility factor into these delivery methods?

AR: There are a lot of people with a needle phobia who would prefer anything that is noninvasive. One of the drivers for this report is in its phrase “self-administered.” The future of medical care is likely to involve the transfer of more responsibility to the patient, both from the point of view of reducing medical expenditures, and also trying to enhance compliance/adherence, because if you can do something yourself, hopefully, the patient will do it as opposed to going to the hospital to have it done intravenously. Of course, efficacy will depend on how religiously the patient follows the prescribed drug regimen.

HCP: What developments do you see evolving in medical care and drug delivery?

AR: There seems to be powerful potential for future drug delivery of biologics. More and more of the future drugs and medications are going to be larger molecules, which are not amenable to traditional drug delivery systems. So today’s normal transdermal patch, for example, would not work to deliver a biologic. You need something to activate and enhance its capabilities.

The skin forms a natural barrier. You can send in small molecules through a traditional patch, say for a pain medication. But larger molecule biologics would not go through the skin via today’s patch, or they would take too much time to go through the skin. One new path that has recently been launched, for example, is to activate the medication through electrical energy.

There is a small battery that allows the skin pores to become a little larger and accept, say, a migraine drug. One example is the transdermal patch for the acute treatment of migraines from NuPathe (shown). It’s activated using a small battery. Microneedles, which can be around 250 microns in diameter, are going to be the transdermal method for the future because they can allow biologics to go through the skin.

There are several varieties of microneedles. There are hollow needles that would have the drug in the patch, where you would put it on your skin, and the needles would open up the skin and allow the drug to diffuse through the needle. There is a dissolving or coated type of needle where the active is in the needle and as it dissolves it is delivered through the skin. These needles are nanometers in size and are in the surface of the patch. So the patch is a way to get the needles to adhere to the skin without breaking them. The two companies that have the most advanced programs in microneedles are 3M and Zosano. Zosano has completed a Phase II study that shows effective transfer of an osteoporosis treatment transdermally and may be closest to the market.

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