The mathematical models representing the response parameters were validated by preparing a new formulation with a combination
of factors within the experimental domain. The formulation was evaluated for the disintegration wetting and in vitro dissolution.
Table VI lists the value of the observed responses and those predicted by mathematical models. The prediction error for the
response parameters ranged from 3.39 to –2.44%. The low values of error prove the abilities of the generated mathematical
models and reveal the capabilities of multiple linear regression analysis and analysis of variance in predicting the performance
of the new formulation.
Table VI: Composition of the optimized formulations and comparison of the experimental values of the response parameters with
the predicted values. All figures are courtesy of the authors.
In this study, the enhancement of nabumetone solubility was possible by complexation with β-CD. Various solid-state characterization
techniques confirmed the formation of the drug β-CD inclusion complexes. A 23 factorial study performed indicated that complexation, amounts of ammonium bicarbonate, and crospovidone played a vital
role in the production of dispersible tablets with desirable wetting, disintegration, and dissolution. The results obtained
indicate that factorial studies can be successfully used to quantify the effect of several formulation and processing variables
on tablet properties, thereby minimizing the number of experimental trials and reducing formulation development cost.
The authors are grateful to Sri Prabhakar Kore, Chancellor, KLE Academy of Higher Education and Research, Deemed University,
Belgium for providing facilities to carry out the research work. The authors also thank Microlabs (Bangalore) for the gift
samples of nabumetone and Signet Chemical Corp. (Mumbai) for the gift samples of β-cyclodextrin.
H.N. Shivakumar, PhD,* is a professor at the department of pharmaceutical technology, K.L.E.S's College of Pharmacy, Bangalore, India, email@example.com
B.G. Desai is a professor and head of the department of pharmaceutical technology, K.L.E.S's college of pharmacy. S. Narasimha Murthy, PhD, is an assistant professor at the department of pharmaceutics, The University of Mississippi (University, MS). Ashish Sharma is a clinical research associate at Pharmanet Clinical Service, Bangalore, India.
*To whom all correspondence should be addressed.
Submitted: Jan. 19, 2007. Accepted:Mar. 7, 2007
1. A. Burke, E. Smyth, and G.A. Fritzgerald "Analgesic–Antipyretic Agents; Pharmacotherapy of Gout," in The Pharmacological Basis of Therapeutics, L.L. Burton, J.S. Laso, and K.L. Parker Eds. (McGraw-Hill Medical Publishing Division, New York, 11th ed. 2006), pp. 671–715.
2. S.C. Sweetman "Analgesics and Anti-Inflammatory Drugs and Antipyretics," in The Complete Drug Reference (Pharmaceutical Press, London, 34th ed. 2005), pp. 1–115.
3. L. Chelakara et al., "Spherical Agglomeration of Mefenamic acid and Nabumetone to Improve Micromeritics and Solubility:
A Technical Note," AAPSPharm SciTech. 7, Article 48 (2006).
4. N. Goyenechea et al., "Interaction of Nabumetone with Cyclodextrin in Solution and Solid State," J. Inclusion Phenomena Macrocyclic Chem. 44 (4), 283–288 (2002).
5. B.I. James, M.D. Roy, and C.P. Laurence, US Patent No. 5962022, (1994).
6. H. Jane et al., US Patent No. 6863901, (2005).