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The following message was posted to: PharmPK
Dear Members
I would like to know what is the dosing procedure a Oral suspension
and dispersible table in a BE study, is there any reference from any
regulatory guidance for the same?
Manoj K
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Dear Manoj,
Dosing procedure for oral suspension:
Prepare suspension as per instruction before half an hour of dosing.
At the time of dosing ask the subject to drink the suspension.
Subject is supposed to drink a fixed volume of water after dosing,
suppose 240 ml. After the subject drinks the suspension, pour some
water from glass containing 240 ml water into suspension container
and wash the remaining quantity of suspension attached to suspension
container and let the subject drink that. Ask the subject to drink
remaining quantity of water so that suspension attached to oral
cavity get dissolved and go to git.
Dosing procedure for dispersible tablet:
Before dosing instruct the subject not to chew or shallow the tablet
immediately after dosing. At the time of dosing, place the
dispersible tablet on the tongue of subject and instruct him / her to
keep it over the tongue for one minute. Let the subject close his /
her mouth. By next one minute, the tablet(s) would have been
dissolved. Now ask the subject to shallow it. Ask the subject to
drink a fixed quantity of water so that any amount of tablet attached
to oral cavity get dissolved and go to git.
Hope I have a clear idea.
I feel sorry that I can not provide any reference at this point of
time for the above mentioned procedure.
Regards,
Sumanta.
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Dear Manoj
I am totally agree with sumanta. This one is the exact procedure
that other CRO's are following. I would like to add in suspension
procedure.
Use such a container having a minimum surface area to avoid
unnecessary adherence of drug particle like sterile disposible syringe.
If you are using syringe for dispensing of suspension than cover the
nozzle of syringe with needle to make it sterile.
If you are using glassware than make it sterile by autoclaving.
If your original suspension is in dry condition than used freshly
boiled and cooled water for making it wet suspension.
Rest of the porcedure is same as sumanta given to you.
Regards
Virendra Patel
Team Leader - Clinical Division
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For Dosing of dispersible tablet (For USFDA study)
Before dosing, for example dosing time is 9:00:00 hrs, disperse the
tablet in 100 mL of water at 9:00:30 hrs and allow tablet to disperse
in water for 30 second. Ask the subject to drink the drug-water
solution and ask to drink remaining water of 140 mL. Check mouth for
the remaining particle with the help of torch.
A total amount of 240 ml will be administered to the subject. (This
includes the water which is used to disperse to tablet). You can
divide 240 mL water in to two equal parts also.
For dosing of Suspension (For USFDA study)
If suspension is dispensed in the syringe, transfer the content
(Suspension) in subject's mouth. Approximately 10 ml of water will be
used for rinsing the contents of syringe which will be administered
to the subject. If the particles of the suspension are still present
then the syringe will be rinsed with additional quantity of water
until the syringe is completely free of particles and this will be
administered to the subject. The remaining quantity of water will be
administered to the subject.
A total amount of 240 ml will be administered to the subject. (This
includes the water which is used for rinsing the syringe)
Thanks with regards,
Chintan Mehta
Ranbaxy Clinical Pharmacology Unit
B-22, Sector 62
Noida 201 301
Tel: +91 120 2404096
Email: Chintan.Mehta.aaa.ranbaxy.com
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The following message was posted to: PharmPK
Dear All,
Do you really think this is the procedure for dispersible tablets. I
understand that they are supposed to be dispersed (hence the
nomenclature 'dispersible') in water and drunk as such. The procedure
given by sumanta seems to be for the orally disintegrating tablets.
Any comments shall be appreciated.
with best regards,
Dr. Kshitij Soni
Ranbaxy CPU, Noida
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Dear Manoj,
for the suspension as per my experience we are doing dispensing on
the day of dosing just before the start of dosing. i.e 1 hrs before
the dosing to make sure that suspension will be made freshly.
consitute as per recommended dose of you study take in syringe and
also weigh emply and full syringe to set the claim of dose in gm or
in ml as per your requirement.
during dosing subject will be administered the suspension directly
administer in the mouth of subject, fill the syringe again with the
water (which will be given during dosing) and again administered in
the mouth of the subject.
for dispersible tablet put in subject mouth for a claimed time and
instruct to subject not swall and chew the tablet after complete
dispersion of tablet i.e claim for a 1 min mouth check and
administered water as per requirement.
or disperse the tablet in spoon and administered directly to the
subject.
above said procedure only in conformance with sponsor requirement and
agreement only hw he wants to do the study for dispersible tablet.
as such guideline for that is not clear as far as my knowldge might
be other member have an idea.
generally the adminstration method is written as you know in the
literature of reference and also reconsitute method also you can set
the method according to that.
regards,
p
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Dear all,
Comments by Dr. Kshitij Soni regarding dosing of dispersible tablet
seems to be more correct than the procedure explained by me earlier.
Regards,
Sumanta.
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The following message was posted to: PharmPK
Dear Dr Soni,Chintan and Sumanta,
Thanks for your answers in regards to the dosing of suspension and
dispersible tablets . I do agree with the response given by Dr Soni
and Chintan which is very much practical.
Manoj K
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Dear All,
I have some different views on the dosing of dispersible tablets/
disintegrating tablets.
When it comes to such tablet formulations , it is also better to have
a look at the SPC claims. let us see two cases
A] Dispersible Tablet: consider a case for an dispersible tablet
wherein the SPC claims that " This tablet may either taken after
dispersing in water in form of a suspension" OR swallowed whole with
water", then one should choose the worst case i.e. allow the patient
to swallow the tablet with water.
B] Orally Disintegrating Tablet: Let us see another case say an
orally disintegrating tablet i.e. the one which is allowed to
disperse in mouth before swallowing the contents. In such cases many
a times the SPC claims that " Allow the tablet to stay on the tongue
for a minute (to allow contents of tablet to disperse) and then
swallow the dispersed contents with or without water". Here, the
worst case becomes " allowing teh subject to disperse the tablet in
mouth and then asking him to swallow the contents [WITHOUT
ADMINISTRATION OF WATER]. So, in this case the study should be done
accordingly.
I know that many of the things may not exactly be written in the
guidelines. Also, there are chances that in case B the time taken by
the subject to disperse and swallow the entire content may show some
variation and needs to be controlled. there are also chances that
some of the drug if not swallowed may adhere in the oral cavity.
these all may add to the minor variations in the observed levels.
But many regulators expect demonstration of bio-equivalence in such
worst case situations.
Regards
Kaushal Prajapati
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