I recently wrote to the major manufacturer of HCT tablet's here in New Zealand and sent them copy of a letter that I had with our Minister of Health.   Last night when I checked my e-mail, they had resonded back to me.  Here is what it say's.  

 

Dear Ms Jefferies:

Thank you very much for your letter.  We agree, this difficult situation
must not continue.  In this day and age, there is certainly no reason for
our children to receive inaccurate doses of life-saving medicines.

After receiving your letter, I immediately started investigating the
subject in order to come up with some possible solutions to this serious
problem

Suspension
Initially we thought about perhaps making a hydrocortisone suspension, but
soon realised that there are many uncertainties with this type of product,
in particular hydrocortisone absorption is highly dependent on the choice
of ingredients in the suspension (which is the reason for Pharmacia having
to recall their product when they changed the formulation).

A suspension would be a completely new product for our company, it would
therefore involve a great deal of development, validation, stability and
pharmacokinetic work.  These experiments alone would take us at least 2
years to complete.

Considering the potential formulation complexities and serious time delays,
we decided that developing a suspension formulation would not be a viable
option.


Tablet
We have considerable experience with the manufacture of hydrocortisone
tablets with our long history of supplying the 5mg and 20mg strengths for
New Zealand.  We have a dedicated facility for the manufacture of high
potency hormonal products, so we are fully equipped to supply this type of
specialised product.

We are grateful for your suggestion to develop a 1mg hydrocortisone tablet
and after discussing this subject with our in-house experts, we feel that
it might be quite straightforward to make a 1mg hydrocortisone tablet.

The tablet would be approximately the same weight as the current 5mg
tablet, but it would have a slightly smaller diameter (6.0 mm versus the
current 6.35mm) and consequently it would be a slightly thicker tablet.  A
major advantage of using this tablet format is that one side would have the
marking "HRT" (which would be taken to stand for HydrocoRTisone) and the
other side would have a double breakline like this "+".  This breakline may
be used as a cutting guide for a sharp knife, making it easy to break the
tablet into quarters if required.  This would enable dosing in increments
of 0.25mg, in order to accurately fine tune the dosing if required.

Clinical/Regulatory/Funding
I have contacted John Kristiansen who is the Paediatric Pharmacist at
Auckland Hospital.  John is very knowledgeable on this subject and he is a
strong advocate for your cause.  He fully agrees that we should develop the
1mg tablet as there is a definite clinical need for this product.  With
John's kind assistance, we are now in dialogue with both Medsafe and
Pharmac on this subject.  It is our hope that we will be able to work very
closely with Medsafe to achieve registration of a 1mg tablet as soon as
possible.  Pharmac are determining the size of the hydrocortisone
suspension market (i.e. that prepared in retail pharmacies), to provide us
with some idea of how many 1mg tablets we should be making to supply the
need for New Zealand.

I would like to thank you very much for bringing this important matter to
our attention.  We have a great deal of empathy for your situation, and I
am pleased to report that we are working diligently to provide you with a
solution.


Sincerely,


Andrew McLeod, Ph.D.

***********************

I just thought that I would post this here because when I wrote last week I was very despondant about the situation and to read this---well it kind of sounded like they are actually sitting up and taking note here of my plight as a parent.  Does anyone have any ideas how I can give these guys any more info about their project?  I mean it sounds like initially this will be for "kiwi kids" but I forsee other's needing the same everywhere else and I feel that there is a market for this. 

 

Hope your all as heartened by this letter as I was!

Merry Christmas All and special wishes for peaceful and prosperous New Year!   Things are getting quite busy here, as per usual.