Designing Drugs

Making medicine for pediatric malaria victims is one of my projects. Our team must design the medicine in order to save lives.

Some problem background. Malaria sickens about 250,000,000 people and outright kills close to 1,000,000 every year. Most deaths are pregnant women or children under the age of five. For every child killed, the disease cripples or mentally impairs perhaps another ten kids. There's no immunity -- victims may suffer malaria multiple times yearly -- and vaccines have been "five years away" for the last fifty years.

We in the U.S. have forgotten malaria was once a scourge here too. We eradicated malaria in the 1950s and 1960s. We killed it with fire, poured oil on swamps, and sprayed entire cities with DDT. Mosquito-borne infections were such a big problem that my home town's mosquito control district existed until 1998.

Bed nets, insecticides, quarantines, abatement programs all work. But when infected, people need treatment to kill the Plasmodium sp. parasites swimming through their veins and laying eggs in their livers and blood cells. Let me restate: there is no immunity to malaria. Victims get it again and again and again every year. Exhausted victims just ... die.

Part of the problem is availability of treatment. Distribution and logistics in malaria-infested regions that are typically remote and rural are sketchy at best, and suppliers contend with black markets, thuggery, and graft.

For young children who can get medicine, its poor usability often bars effective treatment. The medications are giant pills meant for adults. They're meant to be taken in sequence over three days. The come with complex instructions, often in tiny print and in English. Parents and caregivers must break up pills and hope the dosing works for their kids. Too little, and the children remain sick while the parasites start becoming resistant.

The Real Problem

Packaging and package design are critical. We've one answer, depicted on the BioSUNATE™ site and below. Here are some of the design constraints:

• Packaged drugs must survive the tropics. Heat and humidity degrade the product. In the pharma business, this is known as stability. A minimum two year shelf life is desirable.
• The patient must take the full three-day course or it won't kill the parasites. This one's hard. In countries where it's possible to buy a single Tylenol™ from a pharmacist, multi-course treatments get broken apart and sold as individual doses, or patients keep some medicine "for later" instead of taking the full required course.
• Illiterates must be able to use it. The package must convey the dose-to-patient match. Overdoses are as harmful as underdoses. Children, especially young children, are most often mis-dosed.
• Ethnic and tribal divisions are rife. One people will refuse to take medicine which depicts another people on the box or label. It's not prejudice, it's identification: "Oh, this medicine is for Yorubas, not Igbos."
• The consumer price must be low. Therapies run US$3-8 in countries where this represents between two days and two weeks wages. This forces the manufacturing price under a dollar.
• It tastes bad. Really bad. Bitter as poison. Infants and toddlers will spit it out and hence fail to get the full dose.

These problems omit the rest of the issues with setting up a business, finding buyers and suppliers. Fun.

Fixing the Design

We're looking for other solutions, too. The packet design has some flaws: it's easy to split up for resale (three packets are required to complete the course). The taste mask for the active ingredients is bulky. The medicine must be mixed with food or drink and some patients are too sick to eat.

We are also considering development of a melt-in-the mouth medicated strip. Children may take it more readily than having to swallow something.

There's more about what we're doing at CURE Pharmaceutical's BioSUNATE™ site. Ideas are welcome; funding for the project is even more welcome. If you can help with either, contact us at info@curepharmaceutical.com.

"Good design" doesn't mean texting your BFF faster or getting the latest game from the app store. "Good design" in this problem means gravely sick kids get the right drug course comprising the right doses of active compound. "Good design" here means a child lives.


References

WHO Malaria Home Page

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