New NRF Regulation for Bisoprolol Fumarate Solution

Bisoprolol fumarate is increasingly recognized as a therapeutic option for pediatric patients suffering from heart failure, hypertension, or hypoplastic left heart syndrome. This medication has undergone extensive development and testing within hospital pharmacies, demonstrating its efficacy in treating various cardiac conditions.

One of the primary advantages of bisoprolol fumarate over other beta-blockers is its prolonged duration of action, allowing for a once-daily dosing regimen. This feature is particularly beneficial for adherence to treatment in young patients.

Currently, bisoprolol fumarate is available in small quantities as a compounding substance, enabling its preparation for outpatient care. However, challenges exist regarding the initial substance testing of the active ingredient. The European Pharmacopoeia mandates the use of infrared spectroscopy for identity verification, a method not universally accessible in all pharmacies. In response, the German Pharmaceutical Codex (DAC) is actively exploring the feasibility of alternative testing methods and reference substances.

An additional benefit of bisoprolol fumarate is its non-bitter taste, which enhances acceptance among younger patients. Consequently, there is no need to add sweeteners or flavors, although they may be included if necessary. For instance, a solution may be enhanced with 25.0 grams of sucrose per 100 milliliters, resulting in a density of ? = 1.097 g/ml. This means that 100 ml of sucrose-containing solution weighs 109.7 g, a factor that must be carefully considered when diluting with purified water. Optionally, a fruit flavoring can be added at a concentration of 0.01 percent. This modified formula is also detailed in the compounding guidelines for bisoprolol fumarate.

The new NRF regulation titled 'Bisoprolol Fumarate Solution 0.5 mg/mL (NRF 10.9)' outlines these developments and adjustments, reflecting the ongoing efforts to optimize pediatric cardiac care.