Formulation in Pharmacy Practice

DOMPERIDONE

 

An oral liquid, Motilium® Suspension, is available in some countries.  It contains sorbitol, microcrystalline cellulose, sodium carboxymethylcellulose, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, sodium saccharin, polysorbate 20 , sodium hydroxide, and purified water.   Domperidone suspensions of both 1 and 10 mg/mL in a 1:1 mixture of Ora-Sweet and Ora-Plus were reported to be physically and chemically stable for a period of up to 91 days, both at room temperature and under refrigeration. An expiration date of 91 days was suggested. The pH of the suspensions ranged from about 4.3 - 4.6. Reference Ensom, Mary H.H., Decarie, Diane., Hamilton, Don P. Stability of Domperidone in Extemporaneously Compounded Suspensions. Journal of Informed Pharmacotherapy 2002;8 (Jan-Mar) NB Ora-Sweet and Ora-Plus are not available in most countries outside USA and Canada. The formula suggested below is a possible alternative as the ingredients are similar to the components of Ora-Plus. Add citric acid to ensure the pH is in the range quoted above and assign a more conservative expiration date (30 days suggested). Formula Domperidone Suspension 1mg per mL   Domperidone tablets 10mg 10    Glycerol 20  mL Methylcellulose 1% 50  mL Parabens 0.1  % Water to   100  mL   Expiry:  30 days.   Storage:  Refrigerate.  Protect from light.   Shake well before use

 

Formulation in Pharmacy Practice 2nd Edition