Acta Pharm. 64 (2014) 463-474

 

full paper

Original research paper

 

Use of compounded dispersing media for extemporaneous pediatric syrups with candesartan cilexetil and valsartan

MONIKA MUSKO and MALGORZATA SZNITOWSKA

monikam@umb.edu.pl

1 Department of Pharmaceutical Technology, Medical University of Bialystok, Faculty of Pharmacy, Bialystok, Poland

2 Department of Clinical Pharmacy, Medical University of Bialystok, Faculty of Pharmacy, Bialystok, Poland

3 Department of Pharmaceutical Technology,Medical University of Gdansk, Faculty of Pharmacy, Gdansk, Poland

Accepted July 8, 2014

 

Available tablets or capsules for adults are often used to prepare extemporaneously formulated medicines appropriate for children. The most acceptable drug forms in pediatric population are oral liquids and pharmacists use commercial dispersing media to compound syrups from an active substance or from tablets available on the market. In many countries ready-to-use dispersing media are not available or refunded, but pharmacists can use other compounded media, providing their compatibility and stability are proven. The aim of this study was to formulate and evaluate the stability of syrups with candesartan cilexetil (1 mg mL–1) and valsartan (4 mg mL–1) extemporaneously prepared using commercial tablets (Diovan® and Atacand®). The following three different suspending media, which could be easily made in a pharmacy, were investigated: V1 – with xanthan gum (0.5 %), V2 – the USP/NF vehicle for oral solution and V3 – the medium based on a simple sucrose syrup. The stability of preparations was studied during 35 days of storage in a dark place at controlled temperature of 25 and 4 ºC. During the study, microscopic observation was carried out and pH, viscosity, and concentration of candesartan cilexetil and valsartan were analyzed. Syrups with valsartan prepared with V2 and V3 media were stable for 3 or 4 weeks when stored at 25 °C, while syrups with candesartan were stable for as long as 35 days. For syrups prepared using V1 medium, the14-day expiry date was not achieved because of microbial deterioration.

 

Keywords: extemporaneous formulation, pediatric syrups; candesartan cilexetil, valsartan, stability