Roller Compaction of Anhydrous Lactose and Blends of Anydrous Lactose with MCC - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Roller Compaction of Anhydrous Lactose and Blends of Anydrous Lactose with MCC
The authors studied the behavior of anhydrous lactose and the combination of anhydrous lactose and the combination of anhydrous lactose with microcrystalline cellulose on a pilot-scale roller compactor.


Pharmaceutical Technology



Figure 7: Hausner ratio versus roll pressure.
The blends containing MCC displayed different behavior. The bulk density remained constant with increasing pressure, and tapped density increased slightly. The net result was a similar increase in Hausner ratio with increasing compactor pressure for all formulations (see Figure 7).


Figure 8: Tablet crushing strength of tablets compacted at 5, 10, 15 and 20 kN of the roller compacted granules.
Tablet testing. Figure 8 shows the tablet crushing strength of the tablets compacted from the granules. The tablet crushing strength is compared with that of tablets made from powder blend equivalents of the precompacted granules (i.e., blends that were not roller compacted).

The tablet crushing strength of the tablets increased with increasing compression forces. The granules prepared with 8.4 kN/cm roller compactor pressure capped at compression forces above 10 kN. The tablet crushing strength is, however, more than sufficiently high at this compaction force, as shown in the figure. It was not possible to produce tablets from the granules made at 10.5 kN/cm pressure because of the extremely poor flow of the granules. No attempt was made to improve this situation by adding, for example, a flow agent. The friability of all tablets was low (all below 0.1%). Tablets containing MCC were slightly more robust.

A decrease in tablet crushing strength occurred between powder blends containing MCC and the granules of the same blend. This decrease between non-roller compacted blend and roller compacted granules was not seen with only anhydrous lactose. The tablet crushing strengths of tablets with and without MCC were similar at equivalent compression forces.


Figure 9: Weight uniformity relative standard deviation (RSD) of tablets compacted at 5, 10, 15, and 20 kN of the roller compacted granules.
The weight uniformity of the tablets (see Figure 9) is best when the blend contains MCC and at the lower roller compaction pressures, which may be a result of granule-flow properties. Again, because tablets were not produced using the granules compacted at 10 kN/cm (because of poor flowability), no results for these tablests are portrayed in the figure.

Conclusion

Anhydrous lactose and blends of anhydrous lactose and MCC are highly suitable for roller compaction. There are beneficial and adverse effects of using blends of anhydrous lactose and MCC compared with anhydrous lactose alone. The addition of MCC decreased the throughput of the roller compactor and increased the temperature of the ribbon. However, roller compaction could be performed without the addition of a lubricant when a blend of anhydrous lactose and MCC was used. In addition, including MCC slightly improved the tablet properties with lower tablet friabilities and improved tablet-weight uniformity. On balance, the blend containing 35% MCC was optimal.

Increasing roller compactor pressure resulted in granules with wider particle-size distributions and worse flow. In these studies, where milling was not optimized, a pressure of 4.2 kN provided the best balance between particle-size distibution, flow, and tablet properties.

Sander van Gessel* is a product and business development manager, and Henk van Duinen is a research and development scientist, both at DMV-Fonterra Excipients, Nörten-Hardenberg, Germany,
. Ivan Bogaerts is a test facility manager at The Fitzpatrick Company Europe, Sint Niklaas, Belgium.

*To whom all correspondence should be addressed.

Reference

1. S. Hein, J. Langridge, and K. Picker-Freyer, "Evaluation of Various Lactose Types and MCC for Roller Compaction," poster presented at the 2007 AAPS Annual Meeting, San Diego, CA.


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
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
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