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Naproxen parenteral formulation studies.

K S Peswani1, J K Lalla

  • 1Department of Pharmaceutics, Principal K. M. Kundnani College of Pharmacy, Bombay, India.

Journal of Parenteral Science and Technology : a Publication of the Parenteral Drug Association
|November 1, 1990
PubMed
Summary

A new parenteral naproxen sodium formulation was developed and finalized. Accelerated stability studies indicate a projected shelf life of 4.2 years for this injectable drug product.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Formulation
  • Stability Studies

Background:

  • Naproxen sodium is a widely used nonsteroidal anti-inflammatory drug (NSAID).
  • Parenteral formulations offer advantages for rapid drug delivery and specific patient populations.
  • Development of stable, injectable naproxen sodium presents formulation challenges.

Purpose of the Study:

  • To develop and finalize a stable parenteral dosage form of naproxen sodium.
  • To evaluate key formulation parameters including solubility, pH, and excipient compatibility.
  • To project the shelf life of the developed parenteral naproxen sodium formulation.

Main Methods:

  • Utilized Plackett Burman experimental design to optimize formulation parameters.
  • Conducted solubility and pH studies to guide formulation development.
  • Performed excipient compatibility assessments to ensure drug-excipient stability.
  • Initiated accelerated stability studies under stressed conditions (high temperature).

Main Results:

  • Successfully finalized a parenteral naproxen sodium formulation.
  • Identified optimal conditions for solubility, pH, and excipient compatibility.
  • Accelerated stability data projected a shelf life of 4.2 years.
  • Further toxicological and efficacy studies are reported separately.

Conclusions:

  • A stable parenteral naproxen sodium formulation has been successfully developed.
  • The formulation demonstrates a promising projected shelf life suitable for pharmaceutical use.
  • This parenteral formulation holds potential for improved naproxen delivery.

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