PO Q1 2021 - 38

CONTRACT RESEARCH

achieve the right effect, it is important to use the device correctly and
ensure the entire dose is administered. The major challenge here is to
develop a device and a composition that limit the risk of an unskilled
patient not benefiting from the intended effect from their medication.

for patients to administer these drugs themselves at home, without
the need for professional help or supervision.
In addition, many technologies for modified release, such as coated
pellets, initially developed decades ago have evolved to enhance
useability creating drugs that minimize side effects, reduce dosage
frequency and can even combine multiple APIs into one dose. As a
result, they are fast becoming recognized as their own as a segment.

For parenteral dosage forms, useability means different things in
different contexts. When used by health care professionals, the user is
very skilled, so concerns around incorrect administration are less of an
issue. Still, valuable time can be saved by convenient products such
as prefilled syringes. However, with self-administered injectables on
the rise, it is becoming increasingly important to design autoinjector
devices that untrained patients can use on themselves.

The Search for Dosage Perfection
The drive to deliver ever better drugs is meaning increased
prominence is being placed on selecting the ideal dosage form early
on in development. Great strides have been made in this area, but
there is still a long way to go before we achieve this goal for one
key reason - there is no single " perfect " dosage form, it necessarily
depends on the needs of the API combined with what the patient
requires and why.

We can expect the need for useability to become ever more pressing in
the coming years, due to the significant impact that user-friendliness
has on patient adherence and, consequently on patient health.

Benefiting from Patients' Insights

The ideal dosage form should have broad applicability - one reason
why tablets and capsules are so common. With tablets you can
achieve so many different release profiles, including immediate
release, modified release, orally disintegrating tablets, fixed dose
combinations and many others. As a result, there is opportunity to
adapt the formulation to the product requirements.

The quest for user-friendly dosage forms has the potential to be
solved by engaging with patients and medical professionals, seeking
their insight into how drug products can be more easily used.
We are already seeing companies seeking out a better understanding
of the patients using their drugs, their behaviors, and their preferences.
For example, it has been a common practice to use taste panels for
selection of suitable taste-masking for a long time.

Changing Dosage Development Priorities

However, we can expect companies to begin digging much deeper
into the needs of patients as well as nurses and doctors. It is becoming
increasingly important to understand how the product as a whole
is perceived by the patient in a realistic dosing situation, and this
perception may change depending on the patient group.

There are some dosage form characteristics that will always be important - these include: bioavailability; stability; and dose homogeneity.
However, as we look into the future, it is likely that drug company
priorities for their dosage forms will change, or at least broaden. One
key characteristic that is moving up the agenda with good reason is
manufacturability. The cost of manufacturing and packaging make
up a considerable part of the total cost of a drug and this is highly
dependent on choices made in development. Failure to strike the
right balance could impact profits, and limit patient access to valuable
new treatments.

Focus groups with patients are becoming a widely used research tool,
enabling companies to use qualitative as well quantitative methods
to evaluate their preferences.

Other Trends Shaping the Dosage Future
In addition to changing manufacturing priorities and patient needs,
there are other key drivers of rapid transformation in dosage forms
that we can expect to affect the space in the coming years.

With this in mind, it is vital that drug companies begin to focus on the
impact of dosage form on scale-up and commercialization as early
as possible in their project. Both new and existing technologies can
help to bring unique benefits that optimise the value of the product
as well as its performance.

The rise of biopharmaceuticals will continue, leading to a
corresponding growth in parenteral products. That being said, small
molecules will continue to play an important role for a long time
to come, due to their cost-effectiveness, which makes them highly
attractive to healthcare providers with limited budgets.

The Rise of User-Friendliness
Another dosage characteristic that is fast becoming a top priority
is user-friendliness - how pleasant or easy the drug is for patients
to use. Each formulation comes with its own challenge in this area.
Oral formulations are in general user friendly in the sense that
swallowing things is natural to humans, but attention needs to be
paid to ensure that swallowing is not unpleasant due to the size,
taste, or odor of the product.

The growth of precision medicine designed for smaller patient
populations is likely to continue as well. This could have many
implications for drug products and dosage forms, and the technology
used to manufacture them.
For example, 3-D printing is a technology that may allow a very high
degree of individual adaption of the medicine. However, a number of
issues regarding quality assurance and cost may limit the use of 3-D
printing in the next 10 years. Adapting conventional manufacturing

Inhalation, on the other hand, is generally seen as less user-friendly
as it is less natural than oral administration to most patients and, to
Pharmaceutical Outsourcing |

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PO Q1 2021

Table of Contents for the Digital Edition of PO Q1 2021

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