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
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