US Pharm. 2023;48(7):59-60.
Method of Preparation: Calculate the required quantity of each ingredient for the total amount to be prepared. After removing the trademark imprint with a paper towel dampened with Alcohol USP, allow the tablets to air-dry for a few minutes. Then, use a mortar and pestle to triturate the tablets to a fine powder. Weigh out the appropriate amount of ORA-Blend; then levigate the powder with a small quantity of the vehicle until a smooth paste is formed. Transfer the mixture to a calibrated bottle. Add a small amount of ORA-Blend to the mortar to rinse it of any drug residue, and add the contents to the calibrated bottle. Add sufficient vehicle to bring the final volume to 60 mL. Shake the bottle well until the powder is uniformly suspended. Package and label.
Use: Moxifloxacin oral suspension has been used to treat various types of bacterial infections, especially respiratory-tract infections, skin and soft-tissue infections, and intra-abdominal infections.
Packaging: Package in a tight, light-resistant container. Store at controlled room temperature.
Labeling: Keep out of reach of children. Shake well. Discard after ____ [time period].
Stability: USP <795> recommends a beyond-use date of 14 days for nonpreserved aqueous oral liquids and 35 days for preserved aqueous oral liquids.1
Quality Control: Weight/volume, pH, specific gravity, active drug assay, color, rheologic properties/pourability, physical observation, and physical stability (discoloration, foreign materials, gas formation, mold growth) are all examples of quality-control assessments.2
Discussion: Moxifloxacin is a fluoroquinolone antibiotic indicated for the treatment of bacterial infections in patients aged 18 years and older. Its mechanism of action involves inhibiting type II DNA topoisomerases, which are essential for the synthesis of bacterial messenger RNA and DNA replication. This agent is particularly effective against a range of bacterial infections, including community-acquired pneumonia, uncomplicated and complicated skin infections, complicated intra-abdominal infections, plaque, acute bacterial sinusitis, and acute bacterial exacerbation of chronic bronchitis. The treatment duration varies depending on the specific infection and may last from 5 to 21 days.
Moxifloxacin is available in both tablet and injection formulations. The tablet is supplied at a strength of 400 mg, and it contains microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and ferric oxide as inactive ingredients. Common adverse reactions that patients taking moxifloxacin may experience include nausea, diarrhea, headache, and dizziness. It is important to inform patients about the potential for developing QT prolongation, central nervous system reactions, or Clostridium difficile–associated diarrhea, among other adverse effects.3
Moxifloxacin hydrochloride (Avelox, C21H24FN3O4 × HCl, MW 437.9) is a crystalline, slightly yellow to yellow substance. Because of the presence of the hydrochloride salt, moxifloxacin hydrochloride has moderate acidity, which contributes to its water solubility. Moxifloxacin hydrochloride dissolves slowly in water, with a solubility of about 2.9 mg/mL at 25°C. The compound’s stability is influenced by a variety of factors, including pH and storage conditions. Moxifloxacin hydrochloride is stable in acidic (pH 1-2) and neutral (pH 7) media but is less stable in alkaline conditions. Higher pH values increase the rate of degradation, and prolonged exposure to alkaline pH may result in a reduction in potency over time.3
ORA-Blend, a sweetened vehicle that is commonly used in the compounding of oral products, is specifically formulated to improve the taste and stability of oral suspensions. This product consists of a synergistic blend of suspending agents with a high level of colloidal activity that form a gel-like matrix that effectively suspends particles while minimizing settling. The formulation is buffered to a slightly acidic pH, which helps reduce the oxidative degradation of medicinal agents. ORA-Blend also contains antifoaming agents, which permits for vigorous shaking with minimal formation of foam, thereby ensuring proper medication dispersion throughout the suspension.4
1. U.S. Pharmacopeia/National Formulary [current revision]. Rockville, MD: U.S. Pharmacopeial Convention, Inc; September 2022.
2. Allen LV Jr. Standard operating procedure for performing physical quality assessment of oral and topical liquids. IJPC. 1999;3:146-147.
3. Avelox (moxifloxacin hydrochloride) product information. Whippany, NJ: Bayer Healthcare Pharmaceuticals Inc; July 2016.
4. ORA-Blend product information. Minneapolis, MN: Padagis LLC; 2022.
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