Pharmaceutical Product Analysis: ZipDose Senior

As the world becomes increasingly developed, population ageing has become a phenomenon in many countries as fertility rates decline and life expectancy increases. By 2050, it is expected that 17% of the world’s population will be over 65. In Hong Kong, this figure is already 16% as of 2017. As the older population continues to grow, multi-morbidity in these patient groups is also becoming increasingly relevant. Hence, patients over 65 years of age are some of the largest consumers of prescription medications. In fact, in the US 40% of all prescription drugs are prescribed to individuals over 65 years of age. In Canada, a study on a group of elderly (mean age of 81) patients showed that the average number of medications taken was 15. All these prescriptions, coupled with symptoms of old age such as forgetfulness and decreased mobility, have given rise to notable healthcare issues with medical adherence. Patients may lose track of the medications they are supposed to take, and for some, swallowing pills can also be difficult, making them even less willing to follow prescription instructions. While it may not seem like a big problem, in diseases such as diabetes mellitus where glycemic control is extremely important, medical adherence is absolutely fundamental in treatment success.

ZipDose Senior is a 3D printed tablet that combines multiple medications into one single pill that solubilises almost instantaneously upon contact with water. It directly meets the needs of the older patient population by providing a convenient way to customise prescribed drugs and its respective dosages on demand into one single tablet that is also extremely easy to swallow, making it easier for these patients to keep track and adhere to prescription instructions.

Scientific Nature of ZipDose Senior

ZipDose is a powder-liquid 3D printing (3DP) technology that allows the printing of high dosage tablets without compromising its solubility. It does this by selectively stitching layers of powdered drug together with an aqueous binding fluid. This results in a porous tablet that can be rapidly dissolved upon contact with liquid as there is no compression of the powdered drug. ZipDose 3DP technology can also allow the taste of the tablets to be masked with a wide range of options, making the swallowing of tablets much more pleasant than conventionally compressed pills.

ZipDose Senior uses this ZipDose printing technology and additionally, allows physicians to manipulate the powdered drug layer to include multiple active ingredients in the desired dosages to be prescribed to the patient. This results in a single ZipDose tablet containing a combination of drugs tailored to the patient’s prescription. Instead of taking (for example) 3 pills of drug A and 2 pills of drug B each time, this can all be combined into one pill that can be easily swallowed.

Innovation and novelty

There is currently one ZipDose 3DP drug that is approved by the FDA (Spritam), and it is also currently the only 3DP drug approved by the FDA. Although there are several academic institutions currently researching the possibility of combining multiple drugs into one single tablet using 3D printing, ZipDose Senior differs from these technologies as it combines the rapid solubility from ZipDose with the customisation multiple drugs into one tablet for each patient.

Target population and duration of needs

ZipDose Senior is generally targeted towards patients over 65 years of age. Since it is common for these patients to take multiple prescription medications over a long period of time to manage multi-morbidity and other health conditions, the duration of needs is assumed to be from 65 years of age until the rest of their lives. Impact on elderly patientsIt is anticipated that ZipDose senior can drastically improve medical adherence in elderly patients, not only by making it easier for them to keep track of their medications but also by making medications a more pleasant experience to take in general. By simplifying the treatment-taking process, patients are less likely to mix up and forget to take prescribed medications. Reducing the number of pills patients need to take can also help prevent the possibility of accidentally taking two different drugs at the same time that shouldn’t be taken together, hence preventing any adverse effects associated with drug interactions and medication misuse. Since ZipDose Senior tablets are also easy to swallow with taste masking properties, this improved experience of taking tablets can also increase the willingness of patients to take their medication according to prescription instructions. In many chronic diseases, increased medical compliance can be extremely beneficial to patients. In diabetes mellitus, for example, studies have shown that non-adherent patients are more likely to have worse clinical outcomes than adherent patients. By increasing medical adherence, ZipDose Senior hopes to improve the health and wellbeing of older patients who are taking multiple drugs at the same time to treat multiple health complications that come with old age. Product feasibilityAs mentioned previously, 40% of prescription drugs in the US are prescribed to individuals over 65, giving ZipDose Senior a huge potential market in countries where ageing population is a concern. Just like the FDA approved ZipDose drug Spritam, ZipDose Senior also plans to meet the market price of other commonly prescribed medications for older patients, such that switching to ZipDose Senior will not lead to a higher medical cost. However, ZipDose Senior does have its challenges. Since the contents of the powdered drug layer in the tablet will be changed, new formulas would also need to be developed to match the powdered drugs with suitable excipients and aqueous binding fluid. While research can first start with commonly prescribed medications for patients over the age of 65, in the future this can also then be expanded to other common multi-drug therapies.

Although the current ZipDose machine is 6 by 12 feet, making it hard to fit in local pharmacies and clinics, smaller machines will need to be developed such that local clinics and pharmacies can print the needed tablets on demand. Applying for approval could also be a potential issue, as ZipDose senior is not just one drug, but a combination of drugs in one tablet that is meant to be changed, swapped out and dose adjusted.

Competitors

The biggest competitors that ZipDose senior will face are other parties that are also researching ways to combine multiple active ingredients into one single pill. Prof. Soh Siow Ling from the National University of Singapore, for example, is developing a 3D-printed multi-drug with a different release profile of each drug in the pill. ZipDose Senior hopes to distinguish itself from competitors by putting a larger emphasis on user experience, by combining this customisable “poly-pill” design with ZipDose’s easy to swallow and taste masking characteristics.

Other concerns and future developments

Patenting

Aprecia Pharmaceuticals, the company responsible for Spritam, the first approved 3D printed drug, currently has over 50 patents protecting its ZipDose 3D printing technology lasting until 2033. Collaboration with Aprecia Pharmaceuticals can be proposed in order to use their ZipDose 3D printing technology before 2033.

Safety

However, since ZipDose Senior deals with multiple active ingredients in one single tablet which would all be immediately released in the body and metabolised at the same time, one of the major safety concerns is the possibility of drug-drug interactions. It is important to emphasise that ZipDose Senior is meant for combining drugs that are already supposed to be taken together, and therefore, it is crucial that it is the physician who customises and orders the tablet for the patient.

R&D and Post-Market Monitoring

Opportunities for further research and development include expanding the range of drugs that can be incorporated into ZipDose Senior, as well as the appropriate excipients to be used for different active ingredients. Developments can also be made to expand ZipDose Senior to suit patients from other age groups, as well as patients suffering from diseases that require multi-drug treatments. One example is the use of concomitant nonbismuth quadruple therapy to treat Helicobacter Pylori infections. In the future, research can also be conducted to explore the possibility of incorporating multiple release technologies into ZipDose senior such that different drugs can be released into the body at different times.

Post-Market monitoring will also need to be conducted to ensure the long-term safety of patients, as well as to look for potential areas that may need improvement.

Conclusion

ZipDose Senior is a patient-friendly product that could hopefully increase medical adherence in older patients by simplifying prescriptions and improving user experience. Undoubtedly, ZipDose Senior can potentially be a huge benefit to the wellbeing of our planet’s rapidly ageing population.