Five minutes at DCAT with …

Based in the USA, SPI Pharma is a supplier of functional materials for pharmaceutical formulations, including antacid actives, excipients, taste-masking technology, drug delivery systems for tablets and fast-dissolve technologies. The company also offers a comprehensive drug development and testing service and promotes the concept of patient-friendly dosage forms.

PH: What do you mean by the term ‘patient-friendly dosage forms’?

Wilson: Being patient-friendly means considering the patient experience and making it so that the patient is happy to receive that treatment. Patient-friendly dosage forms come down to addressing the patient’s needs. There are a lot of different avenues. One is organoleptics. Some people have sensory issues, but many can’t swallow pills for a physical or mental reason. The industry is trending toward orally dispersible dosage forms, which disperse in the mouth, usually in 15-30 seconds, but sometimes take up to one minute. You have to avoid any negative interactions in terms of patient perception that could lead to the patient not taking the dosage form.

PH: Why does that matter?

Wilson: Non-compliance leads to industry losses of about $564 billion/year. Two things lead to that: the patient says “I don’t want that” or “I don’t like that” and/or the doctor cannot convince them to take it. With an antibiotic, you might feel better that day, but if you can’t see the effect, if you don’t know why you’re taking it, and if it doesn’t taste good, you may stop taking the pill. It can be worse still when a regimen involves up to ten pills per day like the earliest HIV drugs.  Different systems like multi-unit particulate tablet systems to condense many tablets into one and delayed or immediate release strategies are used instead of asking patients to take multiple pills per day. Some of the common terms are fixed dosage, orally dispersible powders and orally disintegrating tablets (ODTs). Those tablets can get to about 1,400 mg, which is big but they dissolve immediately and the patient swallows the slurry. The powders can get up to 2 gm – that’s a lot of powder but it disperses quickly and is easy to swallow. So, you can get to very high dosing levels in these types of systems and there are efficiencies in formulating the drug combinations.

PH: Is your focus mainly on oral dosage forms?

Wilson: We have the organoleptic and the high dosing sides but we also have products through our strategic partnership with Asahi Kasei that allow for formulation creativity in development and design. For instance, we also offer delivery systems geared to children, or situations where water is not available. The Asahi partnership only applies to the US and Canada for now

PH: What about excipients and other ingredients?

Wilson: Excipients are the puzzle pieces that go into making a finished formulation. We offer a number of excipients that go toward organoleptics and fast release in the mouth, like mannitol. Our Mannogem^® line is specifically geared toward chewable tablets and ODTs. We also offer pre-formulated systems, which reduce development time by already being in the functional realm that the formulator is looking for. So, instead of taking mannitol and trying to find the right excipients to create a functionality, we have pre-formulated excipients composed of co-processed materials that are already in that ball park, so the customer can get to market faster. These formulations are also used to extend product life-cycle.  For example, where a swallow tablet was on the market before, the patent owner can file for an ODT and get the extension.

PH: Are you presenting innovations here?

Wilson: We are experts mostly in polyols and compressible sugars, so we have a lot of experience in formulating those. We pride ourselves on being more customer-focused and we offer a lot of our experience for free in that regard. On the innovation side, we are always seeking to offer a new system, together with the customer. We are also looking to get into different strategies with co-processed excipients because that is another market trend: how to get different functionalities with the same accepted excipients that are already on the market.