E-DRUG: Paediatric drug formulations (cont'd)
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Dear Pierre,
I was very excited to read your message, indeed the interest in this area has finally been magnified.
I will quickly let you know what is happening at my end, in the area of
HIV/AIDS:
- In the developed world, Mother to Child Transmission of HIV is close to
0% - which means there is no market for paediatric ARV formulations. That
is the story we all know.
- What is being done by some UN agencies, UNICEF being the lead, is to
review experiences with and/or access to paediatric antiretroviral
formulations - a task that has been split into several prongs, and that
will provide vital information on populations of children reached and gaps
in treatment and access to treatment. It is also necessary to drastically
increase procurement of existing paediatric formulations to establish a
market which can justify further the need for adapted formulations.
- Industry has already responded to requests for dealing with this issue.
I believe one major innovator company is looking into improving paediatric
formulations of ARVs, and therefore a company I would like to work with if
the chance arises. Some generic companies are also making efforts in
making available paediatric FDCs - I understand one triple FDC ARV may go
on the market in India this year.
* What I am looking at for my studies is:
A- To the innovator company in its new formulation project. I do not know
at what stage they are, if indeed work has begun, but I would like to
follow it from the project concept, to the choice of excipients and
delivery system, and even though this will provide enough documentation to
complete an MSc write-up, I would carry on following their project right
to phase IV trials.
B- To work with drug delivery technology specialists, some of whom I have
already had the occasion of meeting during my course, on methods of
improving physico-chemical and organoleptic properties of paediatric ARV
medicines currently available eg. enveloping API as a matrix using
pharmaceutically acceptable excipients as a method for taste masking.
Preparation of pellets, for example by extrusion/spheronization, is indeed
another possibility as pellets can easily be encapsulated and then emptied
into food at the time of administration. Each capsule would contain a
defined dose.
I think there are several other patient groups that have similar problems
to children in terms of drug administration so technologies designed for
these groups can be adapted for our purposes; the difficulty is dealing
with the pharmacokinetics/dynamics as children are certainly not little
adults - but I will be satisfied knowing children have access to cheap,
palatable, easily administered and stored, efficacious and safe
medication. Altering ADME profiles is a different issue...
I would like to learn more about your progress and please feel free to
email me for further discussions. I wish you all the best.
Lombe
MSc Candidate
Danish School of Pharmaceutical Sciences
Copenhagen, Denmark
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