pjs
★    

India,
2015-05-13 05:45
(2651 d 03:43 ago)

(edited by Dr_Dan on 2015-05-13 08:30)
Posting: # 14798
Views: 9,863
 

 Promazine hydrochloride Pharmacokinetics [Design Issues]

Dear all,

Please suggest the innovator for Promazine hydrochloride in EMEA. We are developing two strengths 50mg and 25mg.

Also suggest about the pharmacokinetic linearity and intra subject variability of Promazine.

Regards,
PJS


Edit: Category changed. [Dr_Dan]
BTW, please do your homework first. This forum is no free of charge consultancy service.
pjs
★    

India,
2015-05-13 11:51
(2650 d 21:38 ago)

@ pjs
Posting: # 14800
Views: 8,801
 

 Promazine hydrochloride Pharmacokinetics

Dear all,

» Please suggest the innovator for Promazine hydrochloride in EMEA. We are developing two strengths 50mg and 25mg.

Wyeth pharma is the innovator for Promazine IN US (Approved in 1957 discontinued in 1997). IN EMEA couldnt find the active marketing status of innovator in any country. Yet generic tab were aprroved in 2015 (Is innovator tablet still available in the market or bibliographic application?).

» Also suggest about the pharmacokinetic linearity and intra subject variability of Promazine.

Have searched several times couldnt find a single BE study or linearity information. Promazine is reported to be highly variable after oral administration but no information regarding intrasubject CV.

One literature suggested dose proportional increase in urinary elimination after oral administration in the dose range. Promazine is highly permiable and soluble (BCS class 1). However no specific mention of pharmacokinetic linearity is there.

Regards,
PJS
nobody
nothing

2015-05-13 12:41
(2650 d 20:48 ago)

@ pjs
Posting: # 14801
Views: 8,678
 

 Promazine hydrochloride Pharmacokinetics

I found one formulation in the UK for sedating agitated elderlies, nothing else in the EU, nothing in US.

Totally dead and for good reason...

Kindest regards, nobody
pjs
★    

India,
2015-05-14 10:45
(2649 d 22:44 ago)

@ nobody
Posting: # 14812
Views: 8,682
 

 Promazine hydrochloride Pharmacokinetics

Dear nobody,

» I found one formulation in the UK for sedating agitated elderlies, nothing else in the EU, nothing in US.

Promazine is available as a tablet in Croatia, Finland, Greece and Poland but as generic no innovator. In UK as a Sol.
How can I find if any product is approved based on full dossier or is generic.

» Totally dead and for good reason...

Can u please elaborate.

Regards,
Pjs
The Outlaw Torn
★    

Europe,
2015-05-14 11:52
(2649 d 21:37 ago)

@ pjs
Posting: # 14814
Views: 8,663
 

 Promazine hydrochloride Pharmacokinetics

» Promazine is available as a tablet in Croatia, Finland, Greece and Poland but as generic no innovator. In UK as a Sol.
» How can I find if any product is approved based on full dossier or is generic.

Hi pjs,

I really doubt any company would develop promazine based on a full dossier (I mean, what are the sales like?), but I could be wrong.

We've encountered a similar situation with another API that didn't have an originator on the EU market, and it was suggested to us following Scientific Advice from a northern European agency, whose country brews great beer, that we should submit as well established use.

Since there is no originator, it's unlikely you could convince an authority to accept a BCS-based biowaiver (lacking the dissolution comparison), but I could be wrong about that too. Good luck.
nobody
nothing

2015-05-14 13:25
(2649 d 20:04 ago)

@ The Outlaw Torn
Posting: # 14816
Views: 8,660
 

 Promazine hydrochloride Pharmacokinetics

WEU might be an option, but how to prove significant use within the EU for the last 10 years?

Kindest regards, nobody
The Outlaw Torn
★    

Europe,
2015-05-14 13:52
(2649 d 19:37 ago)

@ nobody
Posting: # 14817
Views: 8,681
 

 Promazine hydrochloride Pharmacokinetics

» WEU might be an option, but how to prove significant use within the EU for the last 10 years?

I'm not sure you'd have to prove significant use, just use (and point out One Flew Over the Cuckoo's Nest for it's historical use :-P). We certainly didn't have to prove this, though this was not a problem with our API. We did encounter some push back based on the ERA as this product was not in all markets (and not in the RMS market!!!) and not everyone accepted the standard statement that a full ERA is not necessary, etc. And, get this, a bioequivalence study was requested for this well established use procedure! :surprised: We sort of provided one, but with caveats I don't care to get into at this point as they won't help pjs.
nobody
nothing

2015-05-14 14:33
(2649 d 18:56 ago)

@ The Outlaw Torn
Posting: # 14818
Views: 8,608
 

 Promazine hydrochloride Pharmacokinetics

...I'm sure you will have to prove significant use, especially if someone does not want your API to (re-)enter the market ;-)

BE for bibliographic is possible, but cool stuff anyways :-D


Edit: Please don’t shout[Helmut]

Kindest regards, nobody
pjs
★    

India,
2015-05-14 16:20
(2649 d 17:09 ago)

@ nobody
Posting: # 14819
Views: 8,661
 

 Promazine hydrochloride Pharmacokinetics

Dear all,

just one qurious question dnt knw about regulatory acceptance.

If the diff dosage form (like sol) than innovator product is approved based on hybrid submission and shown acceptable BE. then can that generic be used as reference product.

note the drug is BCS class 1 drug
the idea behind using innovator as ref is that not more than 20% difference is there for all generic but in this case dosage form is sol so no disso evaluation and diff. bcs class 1 molecule, no excipient diff. no deviation from approved ref product can be thought. also generic is available in RMS and is well tolerated for more than 10 years.

please share your views.

Regards,
Pjs
qualityassurance
☆    

Jordan,
2020-11-05 08:34
(647 d 23:55 ago)

@ pjs
Posting: # 22058
Views: 2,025
 

 Promazine hydrochloride Pharmacokinetics

Dear Pjs and all,

I know I am getting back to this post after almost more than 5 years!!

Did you/anyone conducted BE study for promazine oral solution?

Kindly let me know if you have any experience regarding PK parameters and intra subject CV for promazine.

Regards.
UA Flag
Activity
 Admin contact
22,301 posts in 4,667 threads, 1,585 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Monday 09:29 CEST (Europe/Vienna)

Science… never solves a problem
without creating ten more.    George Bernard Shaw

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5