Carbamazepine multisource products: A comparative study of dissolution profiles and polymorphism.

ECV-EDITIO CANTOR VERLAG MEDIZIN NATURWISSENSCHAFTEN

Año: 2009 vol. 72 p. 1176 - 1176

The establishment of the quality of pharmaceutical productsat marketing stages remains an important issue. Thus, theaims of this study were to evaluate the dissolution characteristicsof 200 mg carbamazepine (CBZ) (CAS 298-46-4) multisourceproducts obtained from the Argentinian market and todetermine the polymorphic form of the active pharmaceuticalingredient in comparison with the reference product (Tegretol"). Dissolution behaviour was evaluated with USP apparatus2 in 1% sodium lauryl sulphate (SLS) and in buffers ofpH 1.2, 4.5 and 6.8. The polymorphic state of CBZ in tabletswas investigated using X-ray powder diffraction (XRPD) anddifferential scanning calorimetry (DSC). In SLS all formulationspassed the Argentinian compendial specification at60 min, one failed at 15 min and two matched the innovatorprofile; whereas, in the three media commonly used to establishsimilarity among multisource pro