Effect of Binder Type and Binder Level on the Properties of Agglomerates Containing Lactose and Dibasic Calcium Phosphate Dihydrate - Pharmaceutical Technology

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Effect of Binder Type and Binder Level on the Properties of Agglomerates Containing Lactose and Dibasic Calcium Phosphate Dihydrate
The authors studied the effect of the combination of binders on the flow and compressibility characteristics of the agglomerates of binary combination of lactose and dibasic calcium phosphate dihydrate.


Pharmaceutical Technology
Volume 32, Issue 10, pp. 54-64


Figure 5, (All figures are courtesy of the authors.)
Figure 5 shows the overlay plot. Superimposing the contour of individual responses to achieve a region that satisfies the constraints for all the attributes generated the overlay plot. All combinations falling in the yellow region satisfy the selected constraints. Batch F3 falls is this region and therefore was selected as the best of the batches prepared according to the 23 factorial design. Tablets containing 30% acetaminophen and 70% agglomerates of batch F3 had friability values <1% and disintegration time <15 min. The in vitro dissolution study indicated that more than 90% of the drug released in 30 min, indicating the noninterference of the filler–binder with drug release.


Table VI: Validation of the evolved mathematical models.
Validation of the evolved mathematical models. To validate the evolved mathematical models, two check points were selected. Two batches CH1 and CH2 were prepared and evaluated (see Table VI). To further validate the model an optimum batch OPT was located using grid analysis where angle of repose was 23, Carr's index was 12, crushing strength of blank tablet was 110 N, and crushing strength of acetaminophen containing tablets was 51 N. Close agreement was found between observed and predicted values, thus strengthening the predictability of the mathematical model.

Conclusion

Various binders were screened for their effect on agglomerates of lactose and dibasic calcium phosphate diydrate. Each binder shows marked effect on various aspects of the agglomerate. If HPMC, starch, and silicon dioxide enhance the flow properties, acacia has a negative effect on these properties. PEG increases the crushing strength of blank tablets. Guar gum increased the hardness of tablets containing acetaminophen. Combination of binders for agglomeration of lactose and DCP to yield a directly compressible product with desirable attributes could be isolated using the 23 factorial design.

Anita Lalwani* is an assistant professor in the Department of Pharmaceutics at the K.B. Institute of Pharmaceutical Education and Research, Sector-23, Gh-6 Road, Gandhinagar-382023, Gujarat, India, tel. 91 98983 20018,
Jolly Parikh is an assistant professor in the Department of Pharmaceutics at A.R. College of Pharmacy and G.H. Patel Institute of Pharmacy, Vallabh Vidyanagar-388 120, Gujarat, India.

*To whom all correspondence should be addressed.

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References

1. G.K. Bolhuis and N.A. Armstrong, "Excipients for Direct Compaction: An Update," Pharm. Dev. Technol. 11 (1), 111?124 (2006).

2. M.C. Gohel and P.D. Jogani,"A Review of Coprocessed Directly Compressible Excipients," J. Pharm. Pharma. Sci. 8 (1), 76–93 (2005).

3. R. Linden et al., "Response Surface Analysis Applied to the Preparation of Tablets Containing a High Concentration of Vegetable Spray-Dried Extract," Drug Dev. Ind. Pharm. 26 (4), 441–446 (2000).

4. Y.K. Agrawal and K. Prakasam, "Effect of Binders on Sulfamethoxazole Tablets," J. Pharm. Sci. 77 (10), 885–888 (1988).

5. H.M. Elsabbagh, A.M. Sakr, and S.E. Abd-Elhadi, "Effect of Guar Gum on the Dissolution Rate of Ephedrine Hydrochloride and Sulphadimidine Tablets," Pharmazie 33 (11), 730–731 (1978).

6. N. Yaksel, A. Karataay, and T. Baykara, "Comparative Evaluation of Granules Made with Different Binders by a Fluidized Bed Method," Drug Dev. Ind. Pharm. 29 (4), 387-395 (2003).


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