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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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