Oral solid dosage forms are still the preferred method of delivery for the pharma industry but what challenges are encountered and how does the industry solve these potential problems?
problem solving
An overriding comment I have found when reading about oral solid dosage (OSD) forms is that they are the preferred method of delivery for the pharma industry. And, thinking about supermarket and pharmacy shelves, of course, in general what we buy is a tablet or capsule of some description. It’s easy to self-administer and widely accepted as an efficacious way to receive treatment.
However, as a sector there are certain challenges that pharma manufacturers need to overcome. One such challenge is the ever-shrinking drug discovery pipeline. In an effort to overcome this, we are seeing more combination therapies being considered and drugs that are already in existence being applied to different indications. Fixed-dose combinations, for example, are a popular way of managing the shrinking drug pipeline as they offer a useful way of protecting patents and enable quick development of a new chemical entity.
Specific patient groups, in particular paediatrics and geriatrics, also raise a set of challenges. Swallowability of an OSD form is a key consideration for both these groups so, in response the industry have developed orally disintegrating formulations, effectively taste-masked medicines and smaller tablet sizes to help these patients.
Linking with the above is the issue of patient compliance. Pharma manufacturers have therefore, spent a substantial amount of time looking at the patient experience when consuming an OSD form. Mouth-feel, swallowability, number of tablets required, tablet size and taste all factor into this and can potentially mean a patient adheres to the treatment regimen or doesn’t.
The last point I will touch on here is the rising tide of biologics. These macromolecules throw up their own set of challenges, size of molecule, protection of the biomolecule and bioavailability, for example. New formulation techniques and process, which are being developed, are set to help with these molecules and soon there should be biologics and biosimilars available in OSD forms.
Problem-solving, therefore, is a key aspect of OSD formulations — certain challenges must be overcome to ensure the safe and effective delivery of the medicine while also ensuring the patient experience is optimal. I think along these lines, Michael Dell, CEO and founder of Dell Technologies probably said it best: “Real entrepreneurs have a ‘passion’ for what they're doing, a ‘problem’ that needs to be solved, and a ‘purpose’ that drives them forward.” And, certainly when looking at the innovation, problem-solving and care for the patient considered in OSD forms, all three ‘Ps’ are there in abundance.