If you want to understand the swallowing challenges faced by people with Parkinson’s disease, ask is a speech therapist at a nursing home. That’s one way a company with a device to convert pills and capsules into custom-flavored liquids approached the issue of how to make medicine more palatable.
Patients’ & Consumers’ Pharma’s approach harkens back to the days of using a mortar and pestle to get the desired drug compound. Compounding pharmacists still use this technique. One of the biggest challenges in grinding pills and capsules is getting uniform particles. The company’s Insta device uses a wet milling technique to solve this problem. A single use plastic container in a “single pot operation” avoids contamination with other drugs.
“We have taken a manual process that has a tremendous amount of variability and standardized it,” said Joe D’Silva, the CEO and founder.
D’Silva formed the company in 2000 rather than relocate to New Jersey when Aventis was formed through the acquisition of Rhone-Poulenc, now Sanofi-Aventis. He also recruited former colleague Anne Moore to work alongside him as the COO at the company’s location at the Pennsylvania Biotechnology Center of Bucks County in Doylestown, Pennsylvania.
“The genesis for us came from visiting relatives at nursing homes, and I was amazed how nurses and healthcare providers would run into the problem of people not being able to swallow tablets, so they would crush the medicine in different ways like using garlic presses and blending it into applesauce,” said D’Silva.
The company has been self-funded with help from a couple of D’Silva’s former colleagues and friends from Pfizer.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
D’Silva said one issue for many people with Parkinson’s is that it’s not enough to have a liquid medication — it needs a pudding-like consistency. Another is Parkinson’s patients tend to salivate but, ironically, many of the medications are lemon-flavored, which can make the problem worse.
The medications would be restricted to immediate release drugs to avoid complications. Pharmacists will be given access to a website with information about chemical stability, storage, and the most highly compounded drugs. They will also be able to select the disposable container size.
The product does not need approval from the U.S. Food and Drug Administration because it is not being sold to consumers, D’Silva said. It will only be sold to veterinarians, pharmacists and hospitals. It will be monetized through sales of its disposable containers.
Pharmacists could use vanilla flavors for Parkinson’s patients and cherry or orange flavors for pediatric patients. D’Silva said the company is researching an option for companion animals with flavors like bacon or salmon.
Combining multiple medications
It is also developing a computerized variable dosing combination system to combine several medications for a dosing interval into one or a few capsules, called Maestra formulation technology.
In contrast to its Insta platform technology, this will be a manufacturing process so it would have to go through regulatory approval. This product would be licensed out to manufacturers. “This is going from mass manufacturing to smart manufacturing,” D’Silva said.
Expanding to a public/private project
The company is also exploring a personalized medication products development center in Ohio or Belgium. The center would be a collaboration between the local government, business, local industries and universities.
The Belgian government was the first to court the company when a representative from government agency Biologistics in the University City Science Center approached D’Silva a couple of years ago. The government has since carried out a market research project to determine the level of interest for the Insta device in Europe. This led D’Silav to add the veterinary market to its platform technology.
Ohio came into the picture after D’Silva was invited to give a talk to the College of Pharmacy at Ohio State University where he got his degree.
Both Ohio and Belgium are looking to use public-private partnership structures to fund and develop the company’s products globally. Sustainable job creation was a noticeable selling point for the Belgians, D’Silva noted, although he has since observed it’s has become a point of interest with venture investors as well. It has also become part of the national dialogue, culminating with the recently approved JOBS Act.
“This evolved over time. When we were first speaking with venture capital groups it didn’t come up, but since then there is a sensitivity that wasn’t there before.”
D’Silva and Moore envision the development center housing a think tank for creating additional personalized medicine processes or products for the pharmaceutical industry.
