Bioequivalence and Bioavailability Forum • Strontium Ranelate: Dosing methodology

Srinetram
☆

India,
2013-07-02 08:30
(4741 d 10:06 ago)

Posting: # 10908
Views: 4,057

Strontium Ranelate: Dosing methodology [Design Issues]

Dear All

Good Morning (As per Indian Standard Time).

We are in process of conducting a fasting BE study for Strontium Ranelate Granules 2gm for EU submission.
As per the posology

The granules in the sachets must be taken as a suspension in a glass containing a minimum of 30 ml (approximately one third of a standard glass) of water.

My CRO has use the same words as mentioned in the SPC but while doing dispersion test we realized that after dispersing only 92-96% drug is getting transferred from the glass (some 4-8% drug/granules get stuck to the glass).

My worry is that if we will not hormonized the process (my plan was by rinsing the glass where the granules has been dispersed with some extra water ~150 ml and administring it to the volunteers) it may lead to inconculsive results.

How exactly such situation should be dealt with?

Shall we follow the exact posology by dispersing the drug in 30 ml and administring it without giving any water
or Shall we follow the follwoing process dispersive the drug in 30 ml water → Administer it to volunteer → rinse the glass with 150 ml of water → administer the rinsed water to the volunteer
My next question will be How does EMEA prefere to do BE study for Suspensions? With water or without water?

Regards
Srinetram

sarada06884 ☆ India, 2013-07-04 09:24 (4739 d 09:12 ago) @ Srinetram Posting: # 10934 Views: 3,261	Strontium Ranelate: Dosing methodology Post reply
	Dear Srinetram You can administer the dosage with 150 ml of water. As you said you can disperse the sachet in 30 to 40 ml of water administer the dosage to the subject and then rinse the dosing container with 40 ml of water again and administer this to the subject. This can be repeated till all the 150 ml of water is consumed. Regards P.S.Srinivas