The fight against chronic illnesses has gained a powerful ally in the form of biologic drugs. Biologics represent an innovative and rapidly expanding category of drugs – by 2022, it is estimated that sales from biologics will account for roughly 30% (or $326 billion) of prescription drug sales globally.1
Compared to conventional pharmaceutical drugs, biologics feature robust therapeutic efficacy, high selectivity, and limited side effects.2 As a result, doctors are increasingly prescribing them to improve the health of patients with chronic disease. While these drugs represent the state-of-the-art treatment in terms of outcomes there are marked limitations for the delivery of biologic drugs. The oral route of administration is the undisputed ultimate goal of any drug therapy. However, the chemical structure of biologics make them extremely susceptible to the harsh conditions of the gastrointestinal tract. In the absence of a proven, robust method to orally administer these drugs, invasive needle-based delivery of biologic drugs is the accepted standard of care. Most injectable drug formulations on the market are available for intravenous infusion and/or subcutaneous injection via pre-filled syringes and autoinjectors.
There are challenges with these delivery methods. A key consideration in the development of formulations for subcutaneous administration is the limited volume (1 to 2 mL) available in the subcutaneous space 3, 4 which calls for the development of highly concentrated, stable formulations of medications intended for subcutaneous delivery.3 This introduces a difficult drug delivery challenge – at high concentrations of drugs (>100 mg/ mL), the viscosity of formulation increases exponentially.5 In addition, biologic drugs need to be stored at temperatures between 2 to 8 °C and these low temperatures result in an additional increase in drug viscosity.5 This unique relationship between concentration, temperature and viscosity introduces a set of specific requirements for any drug delivery mechanism employed. Common problems reported with subcutaneous injectors include the high force requirements to eject highly viscous formulations and a prolonged injection time.
Portal Instruments is changing the present state of affairs, and is disrupting the injectable medication space with a revolutionary needle-free delivery solution. Portal’s platform delivers the drug into the body via a very fine, accelerated jet of medication, about the size of a strand of hair, without compromising the integrity of the pharmaceutical drug. It is the ideal delivery system for biologics as the delivery performance is agnostic to drug temperature, concentration and viscosity. What this means is that the device can administer 1 mL injections in less than half a second, irrespective of those conditions. This delivery platform is designed to promote a more comfortable patient experience and could potentially drive up adherence.
Pharmaceutical companies have an opportunity to capitalize on existing delivery limitations by leveraging Portal’s needle-free solution. Engineered for superior self-administration, the Portal platform is designed for use by patients with limited mobility and dexterity, like arthritic populations and could be adjusted for use among pediatric and elderly populations. For patients that choose to not self-administer because of an aversion to handling needles, the Portal solution provides an alternative home-based care delivery option that emphasizes a convenient and patient-preferred approach – patients avoid handling needles and no longer need to travel to the hospital every 4 to 6 weeks for 3 to 4 hours per visit for more expensive intravenous infusions.
Biologics represent cutting-edge medicine that deserves a delivery method as innovative as the medication itself. Portal’s needle-free technology provides a unique, one-of-a-kind delivery platform that radically changes the drug delivery status quo by forgoing the needle. Furthermore, the market trend is moving towards cost-effective, reliable home-based care compared to the more expensive clinic-based alternative – this puts the spotlight on the development of patient-centric and more ergonomic drug delivery options. Portal’s user-friendly design places the patient at the helm of their treatment, and gives them power to tackle their disease head-on through the coupling of leading drug therapies and the next-generation drug delivery technology. For pharmaceutical companies, Portal’s technology presents a means to differentiate a company’s biologic offering from competing biologic products, including biosimilars, to help rapidly gain and maintain market share. The bottom line is that the Portal device represents a win for the patient as well as the pharmaceutical manufacturer.
Learn more about partnering with Portal Instruments by visiting portalinstruments.com/partnering/ today.
1 World Preview 2017, Outlook to 2022. EvaluatePharma® Accessed 19 Oct. 2017
2 Škalko-Basnet, Nataša. “Biologics: The Role of Delivery Systems in Improved Therapy.” Biologics: Targets & Therapy 8 (2014): 107–114. PMC. Web. 23 Oct. 2017.
3 Tomar, Dheeraj S. et al. “Molecular Basis of High Viscosity in Concentrated Antibody Solutions: Strategies for High Concentration Drug Product Development.” mAbs 8.2 (2016): 216–228. PMC. Web. 23 Oct. 2017.
4 SBerteau, Cecile et al. “Evaluation of the Impact of Viscosity, Injection Volume, and Injection Flow Rate on Subcutaneous Injection Tolerance.” Medical Devices (Auckland, N.Z.) 8 (2015): 473–484. PMC. Web. 23 Oct. 2017.
5 Palm, Thomas et al. “The Importance of the Concentration-Temperature-Viscosity Relationship for the Development of Biologics.” BioProcess International. Web. 23 Oct. 2017.