Development of film coated Atrovastatin calcium tablet using Opadry-OY
Keywords:
Atorvastatin calcium, tablets, film coatin, aqueous dispersion system, opadryAbstract
Purpose: The aim of this study was to develop and evaluate the stability of film coated Atorvastatin Calcium (AtC) tablets using Opadry-OY-B-28920.Method:AtC uncoated tablets were developed and manufactured through the Wet Granulation process. Opadry-OY-B-28920 white aqueous coating dispersion was used as film coating material. Results: The film coated tablets were completely disintegrated within 10 minutes in water media, it was also completely dissolved (more than 85% of the drug was released) within 30 minutes in pH 6.8buffersolutions.The film coated tablets were studied under both long term and accelerated stability study and the results showed no significant variation in physical characteristics, color, hardness, no obvious defects or signs of peeling or chipping. These results reflect that the film coated system Opadry-OY-B-28920 can be successfully used in order to produce AtC film coated tablet that is protected from environmental conditions such as light and humidity. Conclusion: These findings suggest that aqueous film coating with OpadryOY-B-28920 system is an easy and economical approach for preparing stable film coated AtC tablet of immediate release.
References
Aulton ME. Pharmaceutics: The Science of Dosage Form Design New York: Churchill Livingstone, 2007;500-14.
Accessed on 4/2012
Akhter A, Kibria G. Effect of acrylic polymers on physical parameters of spheronized pellets using an aqueous coating systemAsian Journal of Pharmaceutics 2009;3(4):292-8.
Porter S. Remington:The science and practice of pharmacy. New York: Lippincott Williams & Wilkins, 2006;929-33.
Baudoux M, Dechesne J, Delattre L. Film coating with film polymers from aqueous dispersions. Pharm Technol Int 1990;12:18-26.
Wheatley T A, Steuernagel C. R. Latex emulsion for controlled drug delivery. In: delivery Lefcd, editor. Polymeric Coatings for Pharmaceutical Dosage Forms. New York: Marcel Dekker Inc, 1997.
Ogaji I, Nnoli O. Film coating potential of okra gum using paracetamol tablets as a model drug. Asian Journal of Pharmaceutics 2010;4(2 ):130-4.
Acceced on 4/2012. [cited; Available from:
Accessed on 4/2012.
Lam MW, Mabury SA. Photodegradation of the pharmaceuticals atorvastatin, carbamazepine, levofloxacin, and sulfamethoxazole in natural waters. Aquatic Sciences - Research Across Boundaries 2005;67(2):177-88.
Su-Gyeong A, Young-Taek S. Crystal forms of atorvastatin. Archives of Pharmacal Research 2009;32(6):933-6.
Parikh NH, Porter SC, Rohera BD. Aqueous Ethylcellulose Dispersion of Ethylcellulose. I. Evaluation of Coating Process Variables. Pharmaceutical Research 1993;10(4):525-34.
Sauer D, Zheng W, Coots LB, McGinity JW. Influence of processing parameters and formulation factors on the drug release from tablets powder-coated with Eudragit® L 100-55. European Journal of Pharmaceutics and Biopharmaceutics 2007;67(2):464-75.
Krogars K, Hein J, Vesalahti J, Marvola M, Antikainen O, Yliruusi J. Extrusion spheronization of pH-sensitive polymeric matrix pellets for possible colonic drug delivery. International Journal of Pharmaceutics 2000;199(2):187-94.
Rege PR, Garmise RJ, Block LH. Spray-dried chitinosans: Part II: in vitro drug release from tablets made from spray-dried chitinosans. International Journal of Pharmaceutics 2003;252(1-2):53-9.
McGinity JW, Mehta KA, Frisbee SE. Processing Factors That Influence the In Vitro and In Vivo Performance of Film-Coated Drug Delivery Systems Drug Development & Delivery 2002;2(1):72-6.
Atorvastatin calcium. United States Pharmacopoeia 2010.
Acceced on 4/2012.
Stability testing of new drug substances and products, ICH Guidelines, 6 February 2003, Available at: .
