Novel melt-in-the-mouth solutions for pill fatigue

The ‘rapid oral disintegrating tablets’ melt in anything from 10-20 seconds to about a minute depending on the ingredients and the dose.

While this might seem like a niche market, there is a clear opportunity to target consumers that don’t like swallowing pills, the elderly, bariatric patients and children, said Dr Jose Rocca, founder of Miami-based Solara Inc and now its executive vice president of R&D.

However, meltable tablets are also appealing to people looking for nutrition on the go, as you don’t need to take them with water, added Rocca, who is adjunct professor of pharmaceutics at Nova Southeastern University and the former boss of the solid dose R&D department for Kos Pharmaceuticals/Abbott Laboratories.

"The EZ MELTS ​technology allows the nutrients to quickly go into solution in the oral cavity, facilitates administration, and makes nutrients immediately available for absorption."​

B vitamins, resveratrol and CoQ10… but not high-doses of green tea polyphenols​

Dr Rocca, who has been involved in the development of novel pharmaceutical delivery forms since the mid-1980s and has six patents to his name, was speaking to NutraIngredients-USA at Expo West in Anaheim over the weekend.

However, the technology behind Solara’s Ezmelts line is not patented, but rather a trade secret, said Rocca, who created Solara in 2007.

 “There are a few companies out there that say they are doing this, but it is actually far more difficult than it appears and involves expertise on formulation and ingredients and processing, especially when you are dealing with ingredients that are incompatible.​

"Many of the competing products are formulated by diluting the active components with a large amount of excipients. This creates tablets that are typically larger and more fragile, and do not hold up well over time. In most cases, we are able to produce smaller tablets that have improved stability, fast melting properties at a lower cost than our competitors."​

Technical challenges​

While Solara has achieved success with a wide range of ingredients from B vitamins to glucosamine, chondroitin, resveratrol and CoQ10, melt-in-the-mouth technology was not suitable for all nutraceuticals, he added: “It is not great if you want to deliver a lot of polyphenols, or something very bitter like high doses of green tea extracts, for example.​

"The nutrients that are challenging to work with in this dosage form are formulas with a large amount of active components, and with a poor taste profile. In some cases the taste can be improved by microencapsulation of the material prior to formulation.  Omega-3s and other oils can be formulated in this dosage form, but it is difficult to provide a large dose.  We have also worked with many probiotic materials, and these formulas are feasible, however they require careful processing conditions to not damage the live probiotic strains."​

As for dosages, he said: "The EZ MELTS ​delivery system is not ideal for large doses, so if the finished product requires a large dose to be efficacious, this delivery system may not be feasible, unless you divide the dose over multiple tablets.  There are many ingredients that provide efficacy at smaller doses, and these are more ideal for this delivery system."​

Custom formulations​

While Solara was building the Ezmelts brand, which is sold via Amazon and other online retailers as well as directly from ezmelts.com in blister packs, it also creates products for other more established players in the supplements space, he said.

“People will approach us and say can you get this into a meltable form and we’ll do the work and let them know what’s possible – we’ll do a custom formulation.”​

Solara, which has an integrated R&D and manufacturing facility in Miami, Florida, can take a project from concept to launch, looking at feasibility, prototype formulation, through to product scale-up manufacturing and finished product packaging, he said.

"We are having significant success formulating and manufacturing products under private label for many companies. We believe this is due to the fact that we have strong expertise in formulation development, and we can create unique delivery systems for our clients, not only limited to fast melting tablets but other oral delivery formulas such as sublingual tablets, lozenges, chewables, controlled and time release preparations, along with traditional tablets, capsules and powders.​

"Our company has grown significantly each year we have been in business. So far, 2011 was our best year to date, and our sales in 2012 are projected to grow by 100%."​

Click here​ to look at our picture gallery of novel delivery formats in the supplements space.

Click here​ to see our picture gallery from Engredea and Natural Products Expo West, 2012.