Percentage of Excipients Used in Sterile Formulation

Pharmaceutical sterile products are sophisticated formulations, where include injection, infusion, and ophthalmic preparation. During development of sterile formulation excipinets selection should be more technical for product stability and patient safety.

A List of Excipients Used in Sterile Formulation

• Alpha Tocopherol – 0.001 to 0.05% (as an antioxidant)

• Ascorbic acid – 0.01 to 0.1% (as an antioxidant)

• Benzalkonium chloride – 0.01 to 0.02% w/v (as an antimicrobial preservative)

• Benzoic acid – 0.17% (as an antimicrobial preservative)

• Boric acid – amount may vary (as a buffering agent)

• Butylated Hydroxyanisole – 0.03% (as an antioxidant in IM injection)

• Butylated Hydroxyanisole – 0.0002 to 0.0005% (as an antioxidant in IV injection)

• Butylated hydroxytoluene – 0.03% (as an antioxidant in IM injection)

• Butylated hydroxytoluene – 0.0009 to 0.002% (as an antioxidant in IV injection)

• Chlorobutanol – up to 0.5% w/v (as an antimicrobial preservative)

• Chlorocresol – 0.05% (as an antimicrobial preservative in ophthalmic preparation)

• Chlorocresol – 0.1% (as an antimicrobial preservative in injections)

• Citric acid – 0.1 to 2% (as a buffering agent)

• Cresol – 0.15 to 0.3% (as an antimicrobial preservative)

• Cyclodextrins – amount may vary (as a solubilizing agent or stabilizing agent)

• Disodium edetate – 0.005 to 0.1% w/w (as a chelating agent)

• Docusate sodium – 0.015% (as an anionic surfactant in IM injections)

• Glycerin – 0.5 to 3% (as an antimicrobial preservative or tonicity agent)

• Hydrochloric acid – amount may vary (as an acidifying agent)

• Hypromellose – 0.45 to 1% (as a thickening agent)

• Lactic acid – 0.012 to 1.16% (as an acidifying agent)

• Lecithin – 0.3 to 2.3% (as a solubilizing agent in IM injections)

• Mannitol – 20 to 90% (as a carrier in lyophilized preparation)

• Polyvinyl alcohol – 0.25 to 3% (as a viscosity increasing agent in ophthalmic preparation)

• Povidone – 2 to 10% (as a solubilizer)

• Propylparaben – 0.005 to 0.2% (as a preservative)

• Sesame oil – amount may vary (as a solvent)

• Sodium hydroxide – amount may vary (as an alkalizing agent)

• Sodium Metabisulfite – 0.01 to 1% (as a preservative or antioxidant)

• Dibasic sodium phosphate – amount may vary (as a buffering agent)

• Sodium thiosulfate – amount may vary (as an antioxidant)

• Thimerosal – 0.01% (as an antioxidant)

Read also: Percentage of Excipients Used in Tablet Formulation