SyrSpend® SF - Stability data for 20 commonly used API’s now available

Thu, 03/03/2016

In order to address the particular needs of patients who require non-standard doses, experience swallowing difficulties or receive medication via enteral feeding tubes, compounding oral liquid dosage forms is common and important pharmacy practice.1

The challenge in compounding oral liquids is that often there is limited information available on the stability of these preparations.1-3 To overcome this challenge, Fagron has started to study the stability of more than 100 commonly used active pharmaceutical ingredients (APIs) in SyrSpend® SF and publish the results in peer-reviewed scientific journals. With SyrSpend® SF we are creating the world's largest compatibility library for a single oral liquid vehicle.

The API concentrations used in each of these studies has been selected to allow for easy dosing for children and/or adults, based on an extensive review of commonly prescribed concentrations, scientific literature and (inter)national formularies.

The results of two studies recently published in the International Journal of Pharmaceutical and Biomedical Analysis4 and  International Journal of Pharmaceutical Compounding5 include data for 20 commonly used API’s from different pharmaceutical classes:

  • Amiodarone
  • Amlodipine besylate
  • Chloro­quine phosphate
  • Dapsone
  • Furosemide
  • Hydrocortisone hemisuccinate
  • Hydrocortisone sodium phosphate
  • Nifedipine
  • Phenobarbital
  • Phenytoin
  • Prednisolone sodium
  • Pyridoxine hydrochlo­ride
  • Ranitidine
  • Simvas­tatin
  • Spironolactone
  • Sulfadiazine
  • Sulfa­salazine
  • Tetracycline hydrochloride
  • Trimethoprim
  • Zoni­samide

In both studies, oral suspensions with active pharmaceutical ingredients were compounded in plastic bottles at a specific concentration in SyrS­pend® SF PH4 or SyrSpend® SF Alka. All suspen­sions were stored both at refrigerator temperature (2–8 °C) and room tem­perature (20–25 °C).

Fifteen API’s were stable at least 90 days at refrigerator and controlled room tem­perature.

Prednisolone sodium, ranitidine, hydrocortisone hemisuccinate and sodium phosphate proved to be stable for 30-60 days in the refrigerator and at room temperature. Furosemide proved to be stable for 14 days at 2-8 °C.

An overview of all available formulations with SyrSpend® SF can be found in our free online formulations database, Compounding Matters.

 

[1] Glass BD, Haywood A. Stability considerations in liquid dosage forms extemporaneously prepared from commercially available products. J Pharm Pharmaceut Sci 2006; 9(3):398-426.

[2] Brion F, Nunn AJ, Rieutord A. Extemporaneous (magistral) preparation of oral medicines for children in European hospitals. Acta Paediatr 2003; 92:486-490.

[3] Conroy S. Extemporaneous (magistral) preparation of oral medicines for children in European hospitals. Acta Paediatr 2003; 92:408-410.

[4] Ferreira AO, Polonini HC, Silva SL, Patrício FB, Brandão MA, Raposo NR. Feasibility of amlodipine besylate, chloroquine phos­phate, dapsone, phenytoin, pyridoxine hydrochloride, sulfadiazine, sulfasalazine, tetracycline hydrochloride, trimethoprim and zonisamide in SyrSpend® SF PH4 oral suspensions. J Pharm Biomed Anal 2015; 118: 105-112.

[5] Geiger CM, Sorenson B, Whaley P. Stability Assessment of 10 Active Pharmaceutical In­gredients Compounded in SyrSpend. Int J Pharm Compound 2015; 19, 5 : 420-427.