Excipients and their use in injectable products

Area of Science:

• Pharmaceutical Sciences
• Drug Formulation
• Excipient Science

Background:

• Developing new drug products often involves significant time and cost.
• Utilizing pre-approved excipients from existing injectable products can streamline this process.
• Excipients are crucial inactive ingredients that affect drug stability, delivery, and efficacy.

Purpose of the Study:

• To compile and categorize excipients used in approved injectable drug products.
• To provide a comprehensive reference for pharmaceutical formulators.
• To identify excipients that may accelerate drug development by reducing the need for extensive safety testing.

Main Methods:

• Systematic review of the Physicians' Desk Reference (PDR) and the Handbook on Injectable Drugs.
• Extraction and consolidation of data on pharmaceutical excipients.
• Categorization of excipients into eight functional groups.
• Inclusion of excipients from the FDA 'Inactive Ingredient Guide' not found in the reviewed handbooks.

Main Results:

• Excipients were categorized into eight functional groups: Solvents/Co-solvents, Solubilizing/Wetting/Suspending/Emulsifying/Thickening agents, Chelating Agents, Antioxidants/Reducing Agents, Antimicrobial Preservatives, Buffers/pH Adjusting Agents, Bulking Agents/Protectants/Tonicity Adjustors, and Special Additives.
• Tables detail the frequency of use, concentration ranges, and examples of commercial products for each excipient.
• A separate list was created for excipients in the FDA 'Inactive Ingredient Guide' but not found in the PDR or Handbook on Injectable Drugs.

Conclusions:

• A comprehensive database of injectable drug excipients has been established.
• This resource can aid formulators in selecting appropriate excipients, potentially reducing development timelines and costs.
• The categorization facilitates efficient identification of suitable excipients for new injectable formulations.