gagandeep
●    

2007-03-30 17:28
(6208 d 18:12 ago)

Posting: # 605
Views: 8,838
 

 Azithromycin suspension dosing [Study Per­for­mance]

Dear all:

We have a situation here: We have a 40 mg/ml pediatric suspension (200 mg/5 ml) of Azithromycin to be tested for bioequivalence. I am of the opinion that if we are taking the study on adults we should dose in usual adult dose i.e. 250 mg or 500 mg. Now as per our analytical team, a dose of 300 mg or above should be considered since they have to be comfortable enough to detect the same in plasma. Again, to reduce the AE and to make the dose = 10ml, we are thinking of dosing 400 mg instead of 500 mg. My questions:

1. can we go ahead with 400 mg dosing of test and reference in each period of study?
2. are the kinetics linear for the drug?

I would be grateful if someone could guide me.

Regards,

Dr. Gagandeep Singh
Dr.Tarak Parikh
☆    

India,
2007-04-05 08:38
(6203 d 03:01 ago)

@ gagandeep
Posting: # 629
Views: 7,406
 

 Azithromycin suspension dosing

Dear,

you are very true about your decision, so here is the answer for your quiries.

1. You can go ahead with 400mg dosing of test and reference in each period but for this you have to perform both the studies, fasting as well as fed,
as in suspension, there is 56% increased absorption in fed condition in children,and in adult it is 28%.
if you want then i can send this data to you.
you can go as per guideline of suspension too....

2. Azithromycin is come in a group of non linear kinetic, that increase in dose will not impact on Cmax.

if any more quiry, we can discuss.

regards.
Dr.Tarak Parikh
MD,Physician
Sun Pharma industries ltd.
drshiv
★    

India,
2007-04-07 20:32
(6200 d 15:08 ago)

@ Dr.Tarak Parikh
Posting: # 646
Views: 7,298
 

 Azithromycin suspension dosing

Dear Sir,

Regarding your answer No.2 if Azithromycin follows non-linear kinetics, a small increase in dose will impact PK largely. Please check your answer.

Dr. Shiv

❝ 2. Azithromycin is come in a group of non linear kinetic, that increase in

❝ dose will not impact on Cmax.


❝ if any more quiry, we can discuss.


Edit: Full quote removed. [HS]
Dr.Tarak Parikh
☆    

India,
2007-04-09 15:08
(6198 d 20:31 ago)

@ drshiv
Posting: # 651
Views: 7,261
 

 Azithromycin suspension dosing

Dear,

its not like that Dr.shiv, as most of the antibiotics follow the non linear kinetic so all depends on carrier mediating process.

any way about which PK Parameters you want to know, i will send the literature. send me ur email...id ...please

thankyou.
regards
Dr.Tarak
drshiv
★    

India,
2007-04-12 16:46
(6195 d 18:54 ago)

@ Dr.Tarak Parikh
Posting: # 668
Views: 7,417
 

 Azithromycin suspension dosing

Dr. Tarak,

Its a myth to assume that most of the antibiotics follow non-linear pharmacokinetics.

In this process it is understood that by whatever the mechanism saturation occurs, a small increment in dose will cause a large increase in blood concentration hence pk parameters like Cmax and AUC are bound to increase.

Please provide the literture citations for me to know that Azithromycin follow non-linear pharmacokinetics and by increasing the dose after saturation (or beyond linear range) there is no impact on AUC and Cmax.

Dr. Shiv

Edit: Full quote removed. [HS]
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