According to a recent Tufts Centre report, the cost of developing a new drug has increased even further. Despite all of the spending on research and development, does the pharmaceutical industry really develop products and dosage forms that are fit for purpose for the patient or carer?
Richard Fazackerley, Technical Director, Finished Dose, Aesica Pharmaceuticals, comments: I have spent a large part of my career working on the interface between manufacturing and development, bringing new products to market. But, I can honestly say, I learn more about product needs and design from patients.
Ultimately, the industry designs products for patients. And although being involved and committed, we need to ensure that products are designed to suit the patients’ needs, not the industry needs. It is also important to recognize another simple fact: by their very nature, patients are not well.
A real-life example was my late father’s medication for the treatment of Parkinson’s disease and Alzheimer’s, both chronic conditions requiring a strict regime of medication. My father’s fine motor skills were poor and yet a number of the tablets prescribed were typically small and most often blister packed. The act of simply removing the tablet from the pack and taking it was a daily challenge and, judging by the number of escapee’s found under the kitchen toaster, not always successful.
Oral solid dosage forms such as tablets or capsules are the most popular dosage form; however, in cases like the one above, perhaps a different dosage form would be more appropriate such as a larger oral dispersible tablet.
Another example is from a colleague who reported getting frustrated with a development team member who kept asking at every development meeting if the product was compatible with pureed apple. When challenged as to why, the reason was simple in that for many of the target patients this was the most common administration route. In such cases a granule or powder formulation will be far more appropriate than a tablet.
Patients can be very inventive at overcoming some of the design shortcomings in pharmaceutical products and I never cease to be amazed. Examples include grinding tablets to obtain easy to administer powders, opening capsules and a whole host of other strategies that may inadvertently undo all of the good work in development and, in some cases, are even dangerous.
A classic example was an elderly patient who asked visitors to open a child-resistant bottle for her; a simple request but then asked people not to close the bottle as it was too difficult for her to open. It became apparent that her strategy was to leave the bottle, a month’s supply, open until empty – bang goes the in-user stability study. If the food industry can supply artificial sweeteners in simple push dispensers, why is the technology not adopted more widely for pharmaceutical products?
The challenge the industry face is that what is convenient for pharmaceutical manufacturers is not necessarily what meet the patient’s needs. Using the previous example a standard round bottle is great for production as issues with controlling the orientation are not an issue; but, perhaps a square bottle is better for the patient to handle … however much more of a challenge for production.
Good product design can truly enhance the patient experience, compliance as well as significant benefits for the developer. The right combination of drug, dosage form, device and packaging can be life changing for patients and carers. There are many examples but you know when you get thank you letters from patients and doctors that you’ve got it right.
Don’t second guess. If in doubt, ask the patient!