Characterization of tablets.
Tests for parameters such as hardness, friability, uniformity of content, disintegration time, weight variation, and dissolution
were carried out for marketed tablets and tablets containing myrj-52 granules. Tablets containing myrj-52 granules exhibited
better release than preparations available on the market (see Figure 11).
Figure 11: Dissolution profile of tablets containing meloxicam: MCAM (Unichem Laboratories, Mumbai, India) marketed 15 mg,
tablet containing myrj-52 granules.
This study suggests that myrj-52 can be used as a binder in melt granulation. Solid dispersion achieves greater solubility
enhancement, but because of its complex preparation method and cost ineffectiveness at the industrial level, melt granulation
would be an easier and faster method to improve meloxicam's dissolution rate. The granules show an increased dissolution rate
of meloxicam compared with those of pure drug and physical mixture. Characterization of the samples by differential scanning
calorimetry and powder X-ray diffraction indicates that this effect could be correlated to the improved wettability and dispersibility
of drug granules, which results from the solubilizing effects of the binder.
The authors would like to thank Glenmark Pharmaceuticals, Signet Chemicals, and Merck Ltd. for providing drugs and excipients.
Pramodkumar Sharma is a professor and department head at the Institute of Pharmacy, Bundelkhand University Jhansi, U.P., India. Praveen Chaudhari* is an assistant professor, and Hiren Bhagat is a student at the Padm. Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, Pune University, India, tel.
+91 9850179873, fax +91 22 27421097, email@example.com
Nishant Varia is a trainee research associate at Sun Pharmaceuticals Industries, Vadodara, India.
*To whom all correspondence should be addressed.
Submitted: Apr. 17, 2007. Accepted: May 29, 2007.
1. G.V. Betageri and K.R. Makarla, "Enhancement of Dissolution of Glyburide by Solid Dispersion and Lyophilization Techniques,"
Int. J. Pharm.
126 (1–2), 155–160 (1995).
2. B.R. Hajratwala, "Dissolution of Solid Dispersion Systems," Aust. J. Pharm. Sci.
NS (3), 101–110 (1974).
3. G.H. Kristensen and T. Schaefer, "Granulations," in Encyclopedia of Pharmaceutical Technology, Vol. 7 , J. Swarbrick and J.C. Boylan, Eds. (Marcel Dekker, New York, 1993), pp. 121–160.
4. R. Thies and P. Kleinebudde, "Melt Pelletization of a Hygroscopic Drug in a High Shear Mixture—Part I: Influence of Process
Variables," Int. J. Pharm.
188 (2), 131–143 (1999).
5. D. Voinourich et al., "Preparation in High Shear Mixer of Sustained Release Pellets by Melt Pelletization," Int. J. Pharm.
203 (1–2), 235–244 (2000).
6. D. Voinovich et al., "Screening of High Shear Mixer Melt Granulation Process Variables Using an Asymmetrical Factor Design,"
Int. J. Pharm.
190 (1), 73–81 (1999).