Physicochemical characterization of meloxicam-mannitol binary systems

J Pharm Biomed Anal. 2006 Jun 16;41(4):1191-7. doi: 10.1016/j.jpba.2006.02.055. Epub 2006 Apr 18.

Abstract

The dissolution behaviour of drugs remains one of the most challenging aspects in formulation development. The anti-inflammatory drug, meloxicam (ME) has poor water solubility. The object of this experiment was to improve the rate of dissolution of meloxicam in capsule form. In order to achieve this, mannitol was used as a carrier in different ratios, in physical mixtures and melted forms. Mannitol, a sugar alcohol, is a cheap and readily available excipient. Differential scanning calorimetry (DSC) and X-ray diffractometry were used to investigate the characteristics of meloxicam-mannitol binary systems. Multivariate curve resolution (MCR) as a chemometric method was applied to interpret the X-ray diffractograms. This is believed to be the first published use of this reasoning for this interpretation. According to the results, the amount of mannitol and the particle size of ME were important factors in the rate of dissolution. To the perfect dissolution of ME, the melt technology was used which resulted in mixed crystals. This technology was made by 10 parts of mannitol and 1 part of ME2 with about 6 microm in average particle size. The interaction (adhesion) between mannitol and ME for physical mixtures was not enough to the perfect dissolution.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-Inflammatory Agents, Non-Steroidal / chemistry*
  • Calorimetry, Differential Scanning
  • Capsules
  • Mannitol / chemistry*
  • Meloxicam
  • Particle Size
  • Thiazines / chemistry*
  • Thiazoles / chemistry*
  • X-Ray Diffraction / methods

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Capsules
  • Thiazines
  • Thiazoles
  • Mannitol
  • Meloxicam