Partnering for Sublingual Success

Oral drug delivery has maintained a position of strength within the bio/pharma industry for a number of years, yet challenges associated with oral delivery, such as the harsh conditions of the gastrointestinal tract and enzymatic breakdown, have given rise to the advancement of alternative approaches. One such approach to drug delivery that could help in overcoming the challenges associated with the more common solid dosage form used in oral drug delivery is to administer drugs via transmucosal routes. 

In a recent move to take advantage of the potential of this area of drug delivery, STA Pharmaceutical (a WuXi AppTec company) and Swiss biotech, BioLingus, formed an exclusive technology and marketing collaboration. To learn more about the reasons behind this collaboration and how sublingual delivery may advance in the industry, Pharmaceutical Technology spoke with Jinling Chen, PhD, VP of Pharmaceutical Development from STA.

PharmTech: Could you provide some details on the recent partnership between STA and BioLingus?

Chen (STA): STA and BioLingus worked together to develop some of BioLingus’s proprietary drugs for further development. During our collaboration, it became apparent that the distinct advantages the technology offers could provide distinct benefits to our other customers. This enabling delivery technology is an excellent fit and will help in a small way towards our overall mission that ‘every drug can be made, and every disease can be treated.’

PharmTech: Could you please elaborate on the significance of the deal in terms of expanding into macromolecules, such as peptides and proteins?

Chen (STA): There are many areas within STA’s platform where this unique delivery technology can be an advantage. In additional to some small molecules, we recently expanded modalities to include peptides, which can be challenging to administer in oral form due to enzymatic breakdown in the intestine or high acid environment in the stomach. The BioLingus technology stabilizes a peptide to enable the drug to enter the blood stream avoiding gastrointestinal processing. 

Another area where it can be an advantage is in specific patient populations, such as pediatrics or geriatrics, where swallowing any dosage form can be difficult. A further case use could be small-molecule drugs that are not stable in the gastrointestinal tract and therefore don’t reach the target at appreciable quantities-meaning a very high initial dose would have been required-potentially causing a good degree of variability (time of day, contents of stomach, and so on) lead to less reliable results.

The BioLingus technology has many advantages for both macro and small molecules, such as easier dose administration and lower dose when foregoing the GI tract. But the particular advantage for peptides-and other modalities-include easy administration for patients, lower cost of production, and longer shelf life compared to injectable or other non-invasive (nasal, dermal, etc.) dosage forms. 

PharmTech: What benefits can drug developers achieve through the use of a sublingual delivery technology over other forms of drug delivery?

Chen (STA): The BioLingus platform has been engineered over many years, with patented equipment, so that an optimized and stable formulation using a highly robust process is achieved. Stabilizing the molecules to allow the absorption from the mucosa, directly to the blood stream and lymphatic system without degradation, is a breakthrough in drug delivery.

PharmTech: Could you provide a bit more detail on the integrated CMC platform and how this will benefit customers and the industry?

Chen (STA): STA has built a wide range of drug substance and drug product capability and capacity at facilities, but crucially these are all in close geographic proximity, which enables scientists to efficiently exchange know-how on a per-project basis and reduces time lost to transfer materials or methods over distance that may involve shipment issues (temperature, delays, etc.). The knowledge retention and time saved will help bring therapies to patients faster, which is the hope and promise of new drug development.

PharmTech: In your opinion will the sublingual delivery technology, provided through the integrated CMC platform, afford a paradigm shift for the market in the coming years? 

Chen (STA): The breakthrough sublingual technology will create a new possibility for drugs that seemed undruggable or where the cost was overly prohibitive. Offering this technology through WuXi STA’s integrated CMC platform means that any company with any drug has a better chance to succeed.