Dr. Amolkumar
☆    

India,
2017-04-13 15:27
(2562 d 17:14 ago)

Posting: # 17235
Views: 2,738
 

 Calculation of Loading and Maintenance dose for Sustained release tablet [PK / PD]

Dear sir,

I am working on a project for development of Sustained release tablet (once or twice daily) against immediate release tablets (Conventional: 3 times a day, tau 8 h).
I have calculate Loading dose (Css X Vd), Rate for maintenance dose (Css X CL), Dose to be maintain (Total daily dose of Immediate release tablets - Loading dose), No. of hours required for maintenance dose (Maintenance dose / Rate for maintenance) and Total no. of hours for complete drug release (Tmax + No. of hours required for maintenance dose).

My questions are-
1. For the above calculation, I have consider the values of AUC last, Vd, CL, Tmax from the literature of drug of multiple oral doses. Am I right?
2. Is the obtained loading dose concentration (mg/h) for first hour or Tmax or anything else?
3. Should I have to multiply by Tmax to Loading dose for claiming that this Loading dose concentration is at Tmax ? or obtained Loading dose conc. itself is conc. at Tmax ?
4. Is that I am right or wrong for calculating Total no. of hours for complete drug release as mentioned above ?
5. By the above mentioned formula of Total no. of hours for complete drug release, the obtained answer is less than 24 hours. Then how should I claim that my SR tablet is sustainable for 24 hours ?
6. How can I calculate the no. of hours for maintenance dose till 24 hours considering the Rate for maintenance dose? and their release concentration required for every one/two hours till 100 % release at 24 hours ?
7. Can I plan for two sustained release tablets against three Immediate release tablets having same daily dose ?

Your reply will be benchmark to me for thinking here onward on such projects.:confused:
Thanks in advance.

Regards,
Dr. Amolkumar
UA Flag
Activity
 Admin contact
22,987 posts in 4,824 threads, 1,664 registered users;
81 visitors (0 registered, 81 guests [including 4 identified bots]).
Forum time: 08:41 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

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