Stability evaluation of tablets containing  diclofenac sodium and papaverine hydrochloride and different auxiliary substances in equilibrium relative humidity condition

Authors

Keywords:

diclofenac sodium, papaverine hydrochloride, stability, moisture, equilibrium relative humidity

Abstract

Two formulas of tablets with diclofenac sodium and papaverine hydrochloride and addition different excipients were prepared and stored in the climatic chamber for stability testing. The studies showed that tablets containing potato starch, polyvinylpirrolidone and mannitol kept their shape and the quantity of active substances does not change after achievement of equilibrium relative humidity condition in tablets.

References

1. Al-Gohary O.M.N., Al-Kassas R.S.: Stability studies of aspirin-magaldrate double layer tablets. Pharm. Acta Helv., 74, 351, 2000.

2. Heidemann D.R., Jarosz P.J.: Preformulation studies involving moisture uptake in solid dosage forms. Pharm. Res., 8, 292, 1991.

3. International Conference of Harmonization, 2003. Stability testing of new drug substances and products, ICH Q1A (A). WHO working document QAS/06.179, 2006.

4. Kasperek R.: Determination of diclofenac sodium and papaverine hydrochloride in tablets by HPLC method. Acta Pol. Pharm – Drug Res., 65, 4, 403, 2008.

5. Kasperek R.: The tablets containing of diclofenac sodium with analgetic and spasmolytic effect and their preparation. Polish patent No P-380847, 2006.

6. Matsunaga Y., Ohta R., Bando N. et al.: Effects of water content on physical and chemical stability of tablets containing an anticancer drug TAT-59. Chem. Pharm. Bull., 41, 720, 1993.

7. Naveršnik K., Bohanec S.: Predicting drug hydrolysis based on moisture uptake in various packaging designs. Eur. J. Pharm. Sci., 35, 5, 18, 447, 2008.

8. Ohmori S., Kataoka M., Koyama H.: Stability of cyanocobalamin in sugar-coated tablets. Int. J. Pharm., 337, 161, 2007.

9. Polish Pharmacopoeia VIII, Warsaw, 2008.

10. Stulzer H.K., Silva M.A.: Stability studies of coated granules and tablets contained captopril. Acta Pharma. Bonaerense, 25, 497, 2006.

11. Yang Y., Gupta A., Carlin A.S. et al.: Comparative stability of repackaged metoprolol tartrate tablets. Int. J. Pharm., 385, 92, 2010.

12. Vromans H., Schalks E.J.M.: Comparative and predictive evaluation of the stability of different freeze-dried formulations containing an amorphous moisture-sensitive ingredient. Drug Dev. Ind. Pharm., 20, 757, 1994.

13. Waterman K.C., Adami R.C.: Accelerated aging: Prediction of chemical stability of pharmaceuticals. Int. J. Pharm., 293, 101, 2005.

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Published

2010-12-30

Issue

Vol. 23 No. 4 (2010): Annales UMCS, Pharmacia, Sectio DDD, Volume XXIII

Section

Artykuły

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