Titre du document / Document title

Dissolution properties of piroxicam powders and capsules as a function of particle size and the agglomeration of powders

Auteur(s) / Author(s)

SWANEPOEL Erna ⁽¹⁾ ; LIEBENBERG Wilna ⁽¹⁾ ; DE VILLIERS Melgardt M. ⁽¹⁾ ; DEKKER Theo G. ⁽¹⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Research Institute for Industrial Pharmacy, Potchefstroom University for CHE, Potchefstroom, 2520, AFRIQUE DU SUD

Résumé / Abstract

The poor dissolution characteristics of relatively insoluble drugs have long been a problem to the pharmaceutical industry. An example is piroxicam, a highly potent anti-inflammatory agent. In many countries, a large number of generic piroxicam products are available to the prescriber. The aim of this study was to investigate the cause of the dissolution problems experienced by manufacturers of generic piroxicam capsules. Two raw material batches and the dissolution properties of several piroxicam capsules were studied. Differential scanning calorimetry (DSC) and X-ray powder diffraction (XRPD) results showed that the two raw material samples were identical with respect to polymorphic modification. The particles of powder I were smaller than those of powder 2, but the dissolution of powder I was much slower than that of powder 2. The dissolution results for the capsules showed a marked difference among different brands, with capsule C not meeting the USP tolerance. Adding surfactant to the dissolution medium increased the dissolution of both powder 1 and capsule C. Failure of powder 1 or capsule C to meet USP dissolution criteria could result in differences in product efficacy, as well as in potential side effects. Such observations should be taken into account along with other relevant considerations when decisions regarding the generic substitution of oral piroxicam products are made.

Revue / Journal Title

Drug development and industrial pharmacy   ISSN 0363-9045 

Source / Source

2000, vol. 26, n^o10, pp. 1067-1076 (19 ref.)

Langue / Language

Anglais

Editeur / Publisher

Taylor & Francis, Colchester, ROYAUME-UNI  (1977) (Revue)

Mots-clés anglais / English Keywords

Pharmaceutical technology ; Dosage form ; Piroxicam ; Non steroidal antiinflammatory agent ; Hard capsule ; Dissolution ; Physicochemical properties ; Active ingredient ; In vitro ; Powder ; Particle size ; Agglomeration ; Wettability ; Surfactant ; Generic drug ; Oral form ; Oxicam derivatives ; Comparative study ;

Mots-clés français / French Keywords

Technologie pharmaceutique ; Forme pharmaceutique ; Piroxicam ; Antiinflammatoire non stéroïde ; Gélule ; Dissolution ; Propriété physicochimique ; Principe actif ; In vitro ; Poudre ; Dimension particule ; Agglomération ; Mouillabilité ; Agent surface ; Médicament générique ; Forme orale ; Oxicam dérivé ; Etude comparative ;

Mots-clés espagnols / Spanish Keywords

Tecnología farmacéutica ; Forma farmacéutica ; Piroxicam ; Antiinflamatorio no esteroide ; Cápsula dura ; Disolución ; Propiedad fisicoquímica ; Principio activo ; In vitro ; Polvo ; Dimensión partícula ; Aglomeración ; Remojabilidad ; Agente superficie ; Medicamento genérico ; Forma oral ; Oxicam derivado ; Estudio comparativo ;

Localisation / Location

INIST-CNRS, Cote INIST : 17132, 35400009166985.0050