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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
29%
Breakthrough designations
10%
Protecting the supply chain
43%
Expedited reviews of drug submissions
10%
More stakeholder involvement
10%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here