SAN FRANCISCO (KPIX 5) — The FDA has recently approved a new method to manufacture drugs that can help struggling patients split their dosages, with the help of high-technology.
Fred and Jackie Mayer of Marin County know how difficult it can be to accurately split pills in half.
“She takes 11 pills and I take 8 pills each day – at different times – and it’s very complicated,” explained Fred.
It’s very complicated, and not just when it comes to when you take the drug or how many pills you need to swallow. Complications also arise when it comes to the how the pills are made.
Drug makers currently mass produce their medications in factories, using standard doses: A kind of “one size fits all.”
But that’s not optimal for everyone. Most medication doses are tested on adult men.
“Sometimes we end up getting to much drug and that can lead to side effects. Other times we’re underdoing and you don’t see the effects of the drug,” said professor Tejal Desai, Chair of the Department of Bio-engineering and Therapeutic Sciences at UCSF.
To get the right dose of potassium for his wife, Fred needs to split her pills in half.
Fred, a pharmacist, warns it’s not an exact science.
“When you cut them in half you see the stuff coming out,” said Fred, pointing to the irregular edges, and the light powder that splattered from the tablets and over the table.
The old way of making pills is now facing a shakeup.
The FDA has given approval to a new kind of pill – the first medicine made with a 3-D printer.
The drug is an anti-epileptic drug called Spritam. It’s the same drug as the widely prescribed Levetiracetam or Keppra.
“The pill that they’re printing is a highly used seizure medication,” explained Doctor Andrea Synowiec, a doctor of osteopathic medicine. Dr. Synowiec is a specialist in epileptic seizures.
The 3-D technology allows for layers of the medication that can be packaged more tightly and in more precise doses.
With Spritam, a special kind of 3-D printing technology allows for a high dose product, that rapidly dissolves with just a sip of water. This is critical in treating seizures where patients cannot swallow the pill.
“I think it really opens up a lot of doors,” said Professor Desai. She believes the technology holds a lot of promise in the developing era of precision medicine.
“We have the ability to say we want a lower dose, or a higher dose and really customize the dose because we can 3-D print individual pills for the patient.” said Desai.
She predicted how one day, 3-D printing will allow for multiple drugs, each with a different dose to be layered on a single pill.
“So instead of taking five different pills, you really create your own customized tablet that has medicines that don’t interfere with each other, but medicine that is complimentary that can really tackle a host of different problems.” explained the scientist.
That would please the Mayers.
“I think it’s fantastic. Absolutely revolutionary whoever started this thing, my hats off to them,” said Fred.
Spritam should be available by prescription early next year.