Providing solutions for special populations – CPHI North America Interview

In Philadelphia in May on site at CPHI North America we were able to meet with some of our speakers regarding their presentations. In the following interview Srinivasan Shanmugam, Executive Director, Pharmaceutical Sciences, Business Support, and New Technologies at Adare Pharma Solutions discusses his breakfast session. 

Please could you introduce yourself and the work you do at Adare? 

I’m Srini Shanmugam and I'm the Executive Director of Pharmaceutical Sciences, Business Support, and New Technologies at Adare Pharma Solutions. In my current role, I'm involved in expanding Adare’s dosage form technology platform, as well as supporting and facilitating in-house product development, co-development with customers, and tech transfer opportunities. Essentially, I'm a subject matter expert, helping in both technical and commercial activities.

Could you please give a brief overview of your breakfast session at CPHI North America? 

The title of my presentation is “Enhancing Acceptance and Adherence in Special Patient Populations.” The term ‘special populations’ in this case refers to paediatric and geriatric populations. In the presentation I detail a strategy for enhancing medication acceptance and adherence in these populations.

So, to set the scene at first, we ask what exactly is acceptance and adherence? And what is the relationship between the two? What are the variables or the factors that could impact the adherence, or that are responsible for non-adherence? Without understanding that, we can’t really address the issue, as these factors are part of the equation.

And my presentation highlights one of the main solutions to improving the acceptance and adherence of a drug: patient-centricity. Effective drugs must be based on the needs of the patient, especially in this case across special populations. 

I talk about how to really improve patient-centric product development. I've laid out the different technology solutions that can be leveraged to improve the acceptance via patient centricity, such as taste masking, easy to swallow formats, and flexible dosing solutions. 

Why do special populations need to have different measures when it comes to encouraging adherence to medication compared to the general population?

Special populations such as paediatrics and geriatrics have unique needs that necessitate special measures to improve medication adherence and cater to their specific physiological challenges.
Paediatrics often face challenges due to immaturity or incomplete development of their anatomy and physiology. In contrast, geriatrics may experience impairments or dysfunctions in their bodily functions due to aging or secondary outcomes of diseases.

One primary issue that needs to be addressed is the swallowing mechanism, known as swallowability, which is underdeveloped in paediatrics and can become dysfunctional in geriatrics. Medications need to be provided in easy-to-swallow formats. However, this introduces the problem of bitterness, requiring solutions for palatability, such as taste masking.

Additionally, the dosing requirements vary significantly within these groups. For paediatrics, there's a nearly 100-fold difference in dosing needs from birth to 18 years. Geriatrics, on the other hand, often require dose adjustments due to reduced liver and kidney functions as they age.

What are some of the challenges that treating these populations present, and how can they be overcome? 

There are two main aspects to consider here. First, you need to develop a product that meets all the needs of the patient. This includes creating an easy-to-swallow tablet or dosage form that is palatable and offers flexible dosing options. Additionally, you must adhere to stringent regulatory requirements to ensure the product's safety, efficacy, and suitability for different age groups. Developing a patient-centric product is a significant challenge because it requires substantial investment of money, resources, and time.

On the other side of the spectrum, there is the market challenge. For paediatrics, the market is very limited, making economic viability difficult. Investing heavily in creating a paediatric product to serve a small market can be a tough decision. The real challenge lies in finding a balance between economic viability and patient centricity.

Any company looking to develop a product must strike a good balance between these two factors.

How can Adare’s platform technologies be used to create patient-centric dosage forms and increase patient adherence to medication, and importantly, ensure persistent adherence? 

Adare’s platform technologies, whether used individually or in combination, are designed to create patient-centric dosage forms that address key needs such as palatability, swallowability, pill burden, and dosing frequency.
Firstly, many of Adare’s platform technologies are multiparticulate-based, offering dose convenience, flexibility, and accuracy, which are essential components of patient-centric formulations. The key areas of expertise include:

1.    Taste Masking Solutions: Technologies like Microcaps, Optimum, and Diffucaps provide efficient taste masking for highly bitter drugs, making them palatable and easy to swallow.
2.    Modified Release Solutions: Platforms such as Diffucaps and Minitab offer modified release solutions that reduce dosing frequency, thereby decreasing pill burden and enhancing dose convenience.
3.    Fixed Dose Combinations: The Adaptdose platform can combine two or more drugs into a single pill or capsule, reducing pill burden. This is particularly beneficial for paediatric and geriatric patients.
4.    Easy to Swallow Formats: Several of our technologies help improve dose convenience, including: Advatab, an advanced ODT platform; Parvulet, an oral solid dosage form that achieves a texture similar to applesauce in the presence of water; and Liquitard, a powder for reconstitution or direct-to-mouth application. These formats are compatible with multiparticulate-based technologies, allowing for the presentation of taste-masked, modified release drugs in easy-to-swallow formats or dose-dispensing systems. This ensures flexible dosing and convenience without compromising accuracy.

These patient-centric dosing solutions are what set us apart from many others in the field.

Do you find that your clients can hesitate to work with these special populations because of the costs of producing such highly specialised drugs for such a small population? 

As I mentioned earlier, there's always a cost-benefit analysis involved. Clients must differentiate themselves in the market, considering both the patient benefits and the business aspect. In a competitive market, creating a niche can justify a premium price. When product manufacturers approach us, they understand that our solutions might come at a premium cost. However, they also see the value in differentiation, which can grant them additional exclusivity and significantly improve the lives of paediatric or geriatric patients.

Moreover, there's an often-overlooked aspect of healthcare costs: if patients don't accept the medication, it can lead to greater long-term societal burdens. Our clients understand this, so they generally don't hesitate once they recognise the broader impact.

Of course, they seek efficiency in operations and cost. At Adare, as paediatric experts, we avoid much of the trial and error because we already know what works best. This knowledge enhances our efficiency, facilitating fast-tracked product development and significantly reducing costs and time. While clients might initially be hesitant, we ensure they understand the value behind our process, and they typically follow our recommendations once they see the rationale.

What other content tracks/sessions are you looking forward to at CPHI North America this year? 

I’m particularly excited about the gummy session because it aligns with one of our focus areas—creating easy-to-swallow formats. I'm interested in learning about similar technologies and solutions that can be leveraged for paediatrics and other special patient populations. I think exploring these innovations will be very interesting!

Watch the full session on demand below.