Pharmaceutical Outsourcing Q2 2024 - 29

ROUNDTABLE
packaging, to ensure ease and accuracy of administration by the
parent or caregiver. If the dosage form is intended to be administered
by an oral syringe and feeding tubes, then appropriate delivered dose
and dose clearance studies should be performed to confirm dosing
accuracy. Some formats need to be co-administered with foodstuffs,
requiring sponsors to show diligence in performing representative
food compatibility studies to inform the product labelling.
The sponsor must consider the host of clinical and regulatory factors,
too. Typically, there will be a target PK profile to drive efficacy, and
this can be challenging when it comes to extrapolating adult-to-child
data for dose selection and the unique pediatric biopharmaceutics
features affecting in vivo drug delivery and bioavailability. The
intended posology should also be considered when justifying the
levels of excipients to be included within the formulation.
LaBella: This is primarily achieved through creating a palatable
product. With a good tasting product, children are less likely to
refuse to take or reject a dose of medicine. Color free liquids and
suspension may also be preferable if a child does reject a dose of
medicine rather than causing a purple or red stain on their clothing
or the carpet.
Could you share examples of innovative
solutions or technologies adopted to
meet the unique needs and preferences
of pediatric patients?
Shanmugam: Several innovative solutions and technologies have
been developed to address the unique needs and preferences of
pediatric patients.
Adare Pharma Solutions, a pediatric product development expert,
utilized taste-masking techniques to improve the acceptability of a
very bitter-tasting antiretroviral drug for HIV in pediatrics, Tenofovir.
This was accomplished using Microcaps®, one of Adare's proprietary
platform technologies. Additionally, these taste-masked Microcaps®
were efficiently transformed into a powder that could be sprinkled
on soft food and were packed into a multi-dose bulk HDPE bottle
with a calibrated dosing spoon/scoop.
This allowed for flexible
dosing options based on body weight or age of the patient and
offered convenience and ease of dosing.
In another example, Adare used MMTS minitabs to design and
develop pancreatic enzyme formulations treating pancreatic
insufficiency in pediatric patients who have difficulty swallowing
multiple tablets. These minitabs with enzymes were protected via
an enteric coating and converted into a formulation that can be
sprinkled on soft foods. This product, Zenpep®, provides flexible
dosing and an easy to swallow format for pediatric patients.
Additionally, Adare has taste masked bitter tasting drugs and
successfully converted them into effective dosage forms like ODTs,
chewable tablets, etc.
Kanji:
For
over
15
years, Quotient
Sciences'
Translational
Pharmaceutics® platform has been a turnkey solution we've leveraged
to accelerate GMP manufacturing and clinical testing for clients. Drug
products are made and dosed in a matter of days, with flexible CMC
submissions and adaptive clinical protocols allowing formulation
compositions to be optimized based on emerging clinical data.
We've applied Translational Pharmaceutics® to the assessment
of pediatric formulations, for example, in the selection of flavor/
sweetener systems to overcome aversive drug properties, and to
understand the PK performance of age-appropriate medicines and
use resulting data to inform dose selection. We've also addressed
traditional product manufacturing and supply logistics challenges
by using Translational Pharmaceutics® as a real-time manufacturing
and supply model. This enables drug products to be tuned to
individual patient needs and the design of the clinical trial.
Customized products can be manufactured, released, and shipped
for global patient studies within 1-3 weeks of subject eligibility and
formulation requirements being confirmed, to get the right product
to the right patient at the right time.
LaBella: Confectionary platforms like gummies are an innovation
area in which there is a lot of interest. These platforms must be
chewed by the patient and when broken down in the mount do not
create a lot of surface area to the tongue which helps hide the bad
drug taste. These types of platforms are not common in the Pharma
space and finding an FDA compliant confectionery shop will be very
challenging. Additionally, it is unclear how FDA will accept products
that are confectionary based as feasible drug platforms.
How crucial are partnerships
with contract development and
manufacturing organizations
(CDMOs) in expediting the
development and commercialization
of pediatric dosage forms?
Shanmugam: Sponsors with limited or no in-house pediatric
expertise benefit from collaboration with experienced CDMOs
in the development and manufacture pediatric dosage forms for
commercialization.
CDMOs like Adare who have an in-depth pediatric product
development and commercialization experience can offer sponsors
their deep understanding of the unique requirements associated
with pediatric products as well as their specialized expertise and
proprietary cutting-edge technologies.
CDMO partners can leverage the latest advancements in
technological and formulation science, enhancing the development
of novel and effective pediatric dosage forms.
Partners experienced with pediatric regulatory compliance can
help expedite the regulatory approval process and ensure that
developed formulations align with stringent guidelines.
pharmoutsourcing.com | 29 | April/May/June 2024
http://www.pharmoutsourcing.com
Pharmaceutical Outsourcing Q2 2024

Table of Contents for the Digital Edition of Pharmaceutical Outsourcing Q2 2024
