Considerations for Parenteral Dosage Form Development of Natural Alpha Interferon

Sean Evans and Peter Grassam

Abstract

Parenteral dosage form development of novel pharmaceuticals with natural or recombinant proteins present specific challenges in order to obtain a stable, manufacturable, and marketable product. An understanding of the physical and chemical properties of the bulk active is essential for the efficient development of stable and efficacious dosage forms. Several parameters that must be considered and evaluated for such a development, are listed: (1) Screening and selection of compatible excipients, (2) container and closure selection, (3) method of sterilization (4) factors such as thermal and mechanical stress, and (5) other parameters will be reviewed.

  • Received April 6, 1986.
  • Accepted April 30, 1986.

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