Excipients and Their Use in Injectable Products

Sandeep Nema; R. J. Washkuhn; R. J. Brendel

Abstract

Formulation of a new drug product with excipients, that have been previously added to an approved injectable product, may save pharmaceutical companies developmental time and cost. The Physicians' Desk Reference (PDR) and Handbook on Injectable Drugs were reviewed, extracting all information on excipients. The information was consolidated into eight tables, categorizing excipients as 1) Solvents and Co–solvents, 2) Solubilizing, Wetting, Suspending, Emulsifying or Thickening agents, 3) Chelating Agents, 4) Antioxidants and Reducing Agents, 5) Antimicrobial Preservatives, 6) Buffers and pH Adjusting Agents, 7) Bulking Agents, Protectants, and Tonicity Adjustors, and 8) Special Additives. Where applicable, tables list frequency of use, concentration, and an example of a commercial product containing the excipient. Excipients which are included in the 1996 FDA ‘Inactive Ingredient Guide,’ but do not appear in the PDR or Handbook on Injectable Drugs, were included as a separate list.

Received October 1, 1996.
Accepted May 16, 1997.

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