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Question

Posted on: March 6 2013

Questions about a omeprazole syrup 10mg/ml for paediatric use in Excipient pH 8.

In TMF A omeprazole syrup is described 0.2 mg/ml, of which I followed the method of preparation but I had some questions:
  1. does the use of 1g omeprazole in 100ml require a different amount of NaHCO3?
  2. in TMF is talk of making the preparation on Magn. stirrer but then apparently it has to be homogenised with & #039; Homogenizer & #039;, is that the & #039; rotor-stator mixer & #039; that all of us are obliged to purchase?
  3. The taste was extremely bitter. A colleague gave me the council to add nasaccharinate. Is this allowed?
  4. would there have been a problem with a stir-up and pH with the 1% suspension?

Answer

Question 1: no; Also the addition of Nasaccharinate will not have any noticeable influence on the pH.

question 2: yes; This is a very useful device!

Question 3: Yes

question 4: I suspect no problems; perhaps doubling the amount of polysorbate is useful.