Influence of Superdisintegrants on the Rate of Drug Dissolution from Oral Solid Dosage Forms - Pharmaceutical Technology

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Influence of Superdisintegrants on the Rate of Drug Dissolution from Oral Solid Dosage Forms
The authors examine common superdisintegrants (i.e., crospovidone Type A, crospovidone Type B, croscarmellose sodium, and sodium starch glycolate) with a set of poorly soluble drug actives and evaluate in vitro drug dissolution.


Pharmaceutical Technology


Conclusion


Figure 11
At a time when formulators are faced with increasing numbers of poorly soluble drugs, it has become very important to select superdisintegrants to maximize drug dissolution. A comprehensive study conducted to evaluate the effect of crospovidone, croscarmellose sodium, and sodium starch glycolate on the dissolution rates of poorly soluble drugs with varying aqueous solubility showed crospovidone Type B to provide the fastest rate of dissolution for poorly soluble drugs. The fact that tablet strength and disintegration times for the tablets containing each drug and all the superdisintegrant studies were similar showed that tablet hardness and disintegration did not influence dissolution. Crospovidone Type B has unique chemistry, particle size, and particle morphology that result in high interfacial activity, which significantly aids dissolution.

Acknowledgments


Figure 12
The authors wish to acknowledge the support and contributions of ISP's pharmaceutical research and development and analytical scientists in Hyderabad, India, and Wayne, New Jersey.

Jagdish Balasubramaniam is a manager of pharmaceutical research and development at International Specialty Products India, and Tim Bee* is a senior director of pharmaceuticals at International Specialty Products, 1361 Alps Rd., Wayne, NJ 07470, tel. 973.628.4148,

*To whom all correspondence should be addressed.

References

1. J.R. Johnson et al., "Effect of Formulation Solubility and Hygroscopicity on Disintegrant Efficiency in Tablets Prepared by Wet Granulation, in Terms of Dissolution," J. Pharm. Sci. 80 (5), 469–471 (1991).

2. J.K. Pandit, M.K. Tripathi, and R.J. Babu, "Effect of Tablet Disintegrants on the Dissolution Stability of Nalidixic Acid Tablets," Pharmazie 52 (7), 538–540 (1997).

3. A. Sakr, M. Bose, and A. Menon, "Comparative Effectiveness of Superdisintegrants on the Characteristics of Directly Compressed Triamterene Hydrochlorothiazide Tablets," Pharm. Ind. 55 (10), 953–957 (1993).

4. J. Balasubramaniam et al., "Effect of Superdisintegrants on Dissolution of Cationic Drugs," Dissolution Technologies 15 (2), 18–25 (2008).

5. USP 31–NF 26 (US Pharmacopeial Convention, Rockville, MD, 2008).

6. S.A. Qureshi, "Developing Discriminatory Drug Dissolution Tests and Profiles: Some Thoughts for Consideration on the Concept and Its Interperatation," Dissolution Technologies 13 (4), 18–23 (2006).


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