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Preservative and Its Impact on Pharmaceutical Products

Preservatives are commonly added to various pharmaceutical products in order to prolong their shelf life. The addition of preservatives to pharmaceutical products, especially to those that have higher water content, is essential for avoiding alteration and degradation by microorganisms during storage. And it should be with proper justification.

According to European Medicines Agency (EMA) ophthalmic preparations without preservatives are strongly recommended for use in pediatric patients, especially neonates. When preservatives are required, the concentration should be at the minimum level consistent with satisfactory antimicrobial function in each individual preparation and a thorough justification for the choice of the preservative should be provided.

So it’s clear that, the use of these substances should be avoided or minimizes their use in general, especially when considering the suitability of related formulations to the pediatric population.

A List of Preservatives Commonly Used in Pharmaceutical Preparation

  • BENZOIC ACID (0.1 to 0.2%)
  • BENZYL ALCOHOL (0.5 to 10%)
  • BUTYLPARABEN (0.015%)
  • CHLORO BUTANOL (0.25 to 0.5%)
  • METHYLPARABEN (0.1 to 0.25%)
  • PROPYLPARABEN (0.05 to 0.25%)
  • SODIUM BENZOATE (0.1 to 0.2%)
  • THIOMERSAL (0.01-0.1%)

This concentration can varies depending on IIG (Inactive Ingredients Database) limit.

Commonly used Preservative acting pH

  • Methyl Paraben: 4.0 to 8.0
  • Propyl Paraben: 4.0 to 8.0
  • Benzalkonium chloride: 4.0 to 10.0
  • Sodium Benzoate: < 5.0
  • Benzoic Acid: < 5.0
  • Chlorobutanol: < 5.50

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