Preparation and Characterization of Meloxicam–Myrj-52 Granules Obtained by Melt Granulation - Pharmaceutical Technology

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Preparation and Characterization of Meloxicam–Myrj-52 Granules Obtained by Melt Granulation
Various manufacturing techniques can improve a drug's solubility, thus increasing its bioavailability. The authors examined whether melt granulation can enhance drug solubility using meloxicam as the drug substance and myrj-52 as the binder.


Pharmaceutical Technology



Figure 11: Dissolution profile of tablets containing meloxicam: MCAM (Unichem Laboratories, Mumbai, India) marketed 15 mg, tablet containing myrj-52 granules.
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).

Conclusion

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.

Acknowledgment

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,
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.

References

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).


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