Formulation in Pharmacy Practice

SOTALOL

 

Sotalol hydrochloride is freely soluble in water and aqueous solutions are stable for at least 60 days when the pH is adjusted to 4 - 5.1 The injection can be given orally and most tablet formulations disperse easily. The stability of a sotalol hydrochloride oral liquid prepared from tablets has been investigated.1 A 5mg per mL mixture was prepared by levigating Sotacor® tablets with a suspending vehicle base.   The base consisted of simple syrup 30% and methylcellulose 1% gel 70%.  The gel was preserved with 0.2% sodium benzoate.  An expiry date of 8 weeks was recommended under refrigeration. The following formula has been adapted from a published study.1 Sotalol has also been shown to be stable in Ora-Plus. 2 [Ref] Formula Sotalol 5mg per mL   Sotalol hydrochloride tablets 80mg 5    *Syrup 25  mL Parabens 0.1  % Methylcellulose 1% to   80  mL   *Syrup can be replaced with glycerol. If necessary adjust the pH to 4 - 5 with citric acid.   Expiry:  30 days   Storage:  Refrigerate.  Use amber containers.   Shake well before use     NOTE As the drug is soluble the methylcellulose can be omitted.  Tablet excipients will be in suspension and may bind some of the drug.  Shaking is still necessary. REFERENCES Dupuis L.L., James G., Bacola G.  Stability of a sotalol hydrochloride oral liquid formulation. Can J Hosp Pharm 1988; 41 (3): 121-23. Nahata MC, Morosco RS. Stability of sotalol in two liquid formulations at two temperatures. Ann Pharmacother. 2003 Apr;37(4):506-9 [PubMed Link]

 

Formulation in Pharmacy Practice 2nd Edition