Strength :- 3.3 g/30ml

TEMPLATES & PRESENTATIONS
1

dear all,
We are recently going to manufacture Amoxycillin and Potassium clavulanate oral suspension(Dry syrup) on p to p basis.For art work approval purpose I purchase market sample of a MNC group(which brand is declared as best selling brand in India for year of 2010).When I saw the strength and composition I on carton I become confused as I have no experience in dry syrup.The composition and strength are as follows:-

1.Generic Name-Amoxycillin and Potassium clavulanate oral suspension IP
2.Strength :- 3.3 g/30ml
3.Composition:
Each 5 ml of the reconstituted suspension contains:
Amoxycillin trihydrate IP 230mg equivalent to Amoxycillin ----200mg
Potassium clavulanate IP 34 mg(as potassium clavulanate diluted IP) equivalent to clavulanic acid------28.5mg

And the whole bottle should be diluted with 30 ml of water(As printed on carton)

So my question is as per composition each 5ml contain 228.5 mg of active so 30 ml will contain 228.5 x 6 = 1.371gm/30ml but how we can write the stength as 3.3g/30ml

Pls help me

also find the attachment
Regards
Kumar

Augmentin 1.pdf (267.3 KB)

2

Good day Kumar,

For me, you have to change your box label claim and it should be 200mg/28.5mg per 5 mL. you have to add also the reconstitution instruction.
If I were the customer or doctor, i will be confused on your claim of 3.3g/30mL.
Maybe this is your weight of the dry powder.

Hope it helps.
nida

3

It is weight (API + Execipients) per bottle [Target fiil weight of bottle], its not strength. No issue.

4

Dear Kumar Sir

It is not strength. it is the Target fill weight.

Gorav Singh