Excerpts from Article:
Therapeutic value and the importance of adherence
“It’s important to understand as early as possible which approaches will offer the most therapeutic value to patients, and that includes the proposed compound’s path to treatment and dosing regimens,” notes Kim Zubris, formulation director, Particle Sciences. “Obtaining desired or required bioavailability in pursuit of therapeutic targets begins in formulation and often involves addressing issues related to dose concentration, form, and administration routes including oral solids and liquids, inhalants, intravenous, long-acting injectables, and topically administered medications.”
…Zubris concurs that medication inconvenience being linked to poor adherence is well documented. “The therapeutic value and health benefits of a drug compound can only be realized if patients follow the course of treatment properly. Ease-of-administration and fewer negative side effects are just a few of the more critical aspects of formulation that drug developers need consider for good patient compliance,” she notes. “Minimizing or eliminating the pain involved in administering the effective dose, as well as minimizing the number of dosing events in the first place, ensure that a drug is easier for a patient to deal with.”
Delivering the goods
Poor aqueous solubility can severely limit the usefulness of an API and the ability to dose these molecules in traditional forms, explains Zubris. ”Without exploring alternative formulation techniques, these actives may not progress through the development pipeline,“ she confirms. Drug delivery devices can also help with effective disease treatment and management. “Drug-eluting devices, long-acting depots, and transdermal patches can combine anatomical specificity with API uptake considerations and are proving highly effective at treating disease effectively,” adds Zubris. “Divorcing the patient from actively administering dose after dose at precise intervals is inherently patient centric.”
New drug development was buoyant in 2018 with an increased level of new drug applications, many of which were in the orphan drug category, states Zubris. “At the same time, regulators are providing better drug development economies for therapies in certain preferred categories, assigning special regulatory considerations to speed up their approval process,” she says. Additionally, the focus on smaller patient groups is prompting drug innovators to integrate patient-centric principles and introduce them at the earliest stages of drug development, asserts Zubris. “This strategy will ensure pharma companies can develop new, more effective drugs faster while improving their therapeutic value with formulations and forms that treat disease more efficiently,” she explains.