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Question

Posted on: March 6 2013

Both Nilstat and Nystatin suspension Labaz are lacking. Is there a possibility to prepare this suspension magijet?

Answer

On the Internet we find the following information:

 

The Oral suspension contains 100.000 units of nystatin per ml. The inactive ingredients include artificial flavoring, FD & C Yellow #10, alcohol, sucrose, purified water, glycerin, sodium citrate, magnesium aluminum silicate, saccharin sodium, xanthan gum, benzaldehyde, edetate calcium disodium, Polysorbate 80, All and Propylparaben.

As a composition we can propose:

nystatin 5 million IU NaH2PO4 2aq 150mg Na2HPO4 2aq 650mg Avicel RC 581   1, 0g   (or cellulose dispersion 4% FN 25, 0g) Glycerin 5, 0g Polysorbate 80 100mg Sorbitol Syrup not krist. 10g Ethanol 96 ° 2, 5g Mint oil 2dr After saccharin 125mg Geconcentr. Solution of Hydroxybenzoate FN 500mg Water Q.S. AD 50ml

Other aromas are possible such as banana, cherry and raspberry.

The cooking method: In a small mortar, apply the amount of nystatin, which corresponds to 5 Milj. IU, and add 1g Avicel RC 581. Mix and rub this mixture with 5g glycerin. Weigh in a beaker 100mg Polysorbate 80, 500mg Contrac. Hydroxybenzoate solution and 2, 5g ethanol 96 °. Add 2dr Mint oil and 10g sorbitol syrup NK and mix to homogenous. Pour the contents of the beaker under stirring at the mixture into the mortar. In this beaker, apply 30ml of freshly boiled water and dissolve the phosphate salts and the after saccharinate; Pour this solution slowly and stirring well in the mortar. Homogenize with a small homogeniser. Transfer the contents of the mortar into a 100ml measuring cylinder. Rinse the mortar and the homogenizer with 15ml of freshly boiled water and pour the rinse water at the content of the measuring cylinder. Apply to Volume (50 ml) with freshly boiled water and mix.

Stability: The shelf life of the preparation is not clear. Vermerie, N. Malbrunot, C. Azar, M. Arnaud, P. Mention in Pharmacy World & Science. 19 (Aug): P 197-201, 1997, that Nystatin suspended at neutral pH remains stable (90% of the original titer) for 7 days when stored in the refrigerator. The speciality bears a shelf life of 3 years and is kept at room temperature. So do not deliver too large volumes and recommend storing the vial in the refrigerator.