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PP-020 Assessment of oral extemporaneous cardiology preparations as a rationale for development of liquid formulations in paediatrics
  1. J Stastna,
  2. V Krajcova,
  3. S Klovrzova,
  4. P Horak
  1. University Hospital in Motol, Hospital Pharmacy, Prague, Czech Republic

Abstract

Background The lack of registered medicines is a long-term issue in paediatrics. In the Czech Republic, pharmacists generally provide the desired doses by dispensing drugs into capsules. However, this can lead to preparation of high numbers of capsules with differing amounts of active substance.

Purpose To evaluate the extent of extemporaneous preparations for cardiology indications in the pharmacy of University Hospital in Motol and to consider developing liquid formulations for medicines frequently prepared in capsule form.

Materials and methods A retrospective study was performed for 2011 and 2012. The Pharmacy database (Apotheke) was reviewed for cardiology medicines not commercially available in the required doses and prepared in capsule form in our pharmacy. The number of capsules and dose per capsule were recorded. For outpatients, the age of patient at the time of preparation was extracted based on the patient’s personal number. Arbitrarily, a limit of 12,000 capsules per analysed period was chosen to consider development of new formulation and dosages were taken into account as well.

Results Capsules containing captopril, digoxin, furosemide, hydrochlorothiazide, propafenone, propranolol, sotalol, spironolactone and warfarin were the most frequently requested by physicians. In total 47.412, 28,921, 13,993 and 13,842 capsules of propranolol, sotalol, digoxin and furosemide respectively were prepared during the period analysed and thus were eligible for reformulation. For propranolol, 23 different doses ranging from 0.5 mg to 40 mg/capsule, for sotalol, 27 different doses ranging from 1 mg to 50 mg/capsule, for digoxin, 9 different doses ranging from 5 mg to 60 mg/capsule, for furosemide 12 different doses ranging from 0.5 mg to 15 mg/capsule were prepared. Outpatient records showed that most propranolol capsules were administered to patients under 23 months of age, while warfarin patients were mostly 2 to 11 years old.

Conclusions The enormous numbers and dose variations of prepared propranolol, sotalol, digoxin and furosemide capsules make these substances candidates for the development of stock liquid formulations with defined properties. The advantages will be: safer for patients, enable flexible dosing and less time consuming for pharmacists to prepare.

No conflict of interest.

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