Abstract

Preparation and Characterization of a New Alternative Formulation of Sodium p-aminosalicylate

Author(s): Hergert Lisandro Y, Sperandeo Norma R, Allemandi Daniel A, Mazzieri Maria R

Issue: Jul/Aug 2011 - Volume 15, Number 4

Page(s): 344-349

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  • Preparation and Characterization of a New Alternative Formulation of Sodium p-aminosalicylate Page 1
  • Preparation and Characterization of a New Alternative Formulation of Sodium p-aminosalicylate Page 2
  • Preparation and Characterization of a New Alternative Formulation of Sodium p-aminosalicylate Page 3
  • Preparation and Characterization of a New Alternative Formulation of Sodium p-aminosalicylate Page 4
  • Preparation and Characterization of a New Alternative Formulation of Sodium p-aminosalicylate Page 5
  • Preparation and Characterization of a New Alternative Formulation of Sodium p-aminosalicylate Page 6

Abstract

Sodium p-aminosalicylate is an orphan drug used in patients affected with multidrug-resistant tuberculosis. In this article, the preparation and characterization of a new alternative formulation of p-aminosalicylate is described. It consists of a powder for extemporaneous reconstitution, p-aminosaliyilate–extemporaneous, to be orally administered in solution. It is finally packaged in a tightly closed, light-resistant glass container as a unitary dose. In order to promote accessibility to multidrug-resistant tuberculosis treatment, the formulation is low cost and simple to manufacture, being compounded with only four ingredients. To improve patient compliance and treatment adherence, the unpleasant taste of p-aminosalicylate was masked as p-aminosalicylate–extemporaneous, which is easier to drink. The p-aminosalicylate–extemporaneous was characterized in relation to its content uniformity, time of blending, powder bulk properties (flowability), and stability. The proposed alternative formulation remained stable in its final containers for 3 months, as demonstrated by analytical assays and flowability properties.

Related Keywords

  • sodium p-aminosalicylate
  • multidrug-resistant tuberculosis
  • formulation
  • drug resistance
  • patient compliance
  • extemporaneous reconstitution
  • bulk powder
  • stability
  • packaging
  • Argentina

Related Categories

  • FORMULATIONS
  • PACKAGING
  • PEER-REVIEWED
  • STABILITIES, COMPATIBILITIES
  • INFECTIOUS DISEASE

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