The study carried out here was focused on developing conventional monolithic controlled release matrix tablet of Atorvastatin calcium using carbomer as release controlling polymer. This system ensures the drug release at the alkaline pH region where the drug has got maximum solubility. Further the study was concentrated on comparing the impact of gelling agent polyvinyl pyrrolidone on drug release. Quality by design tools were considered during formulation development and the polymer concentrations were optimized adopting the statistical tool, design of experiments (DoE). The optimized formulation of present study exhibited desired controlled drug release characteristics in the alkaline pH conditions and at acidic environment the drug dissolution was minimal as intended.
Lee, V.H.L. (1987) Controlled Drug Delivery Fundamentals and Applications. In: Robinson, J.R. and Lee, V., Eds., Influence of Drug Proporties on Design, 2nd Edition, Mercel Dekker, New York, 16-25.
Brahmankar, D.M. and Jaiswal, S.B. (2009) Biopharmaceutics and Pharmacokinetics. 2nd Edition, Vallabh Prakashan, Delhi, 399-401.
John, C. and Mortan, C. (2002) The Science of Dosage form Design, Aulton. In: John, C. and Morten, C., Eds., Modified Release Peroral Dosage Forms, 2nd Edition, Churchil Livingston, London, 290-300.
Wani, M.S., et al. (2008) Controlled Release System: A Review.
Lee, M.H., et al. (2008) Preparation of Carbopol-Chitosan Interpolymer Complex as a Controlled Release Tablet Matrix. Effect of Complex Formation Medium on Drug Release Characteristics. Archives of Pharmacal Research, 31, 932-937. https://doi.org/10.1007/s12272-001-1249-7
Durrani, M.J., Andrews, A., Whitaker, R. and Benner, S.C. (1994) Studies on Drug Release Kinetics from Carbomer Matrices. Drug development and Industrial Pharmacy, 20, 2439-2447. https://doi.org/10.3109/03639049409042648
Khan, G.M. and Zhu, J.B. (1999) Studies on Drug Release Kinetics from Ibuprofen-Carbomer Hydrophilic Matrix Tablets: Influence of Co-Excipients on Release Rate of the Drug. Journal of Controlled Release, 57, 197-203. https://doi.org/10.1016/S0168-3659(98)00122-9
Parojcic, J., Duric, Z., Jovanovic, M. and Ibric, S. (2004) An Investigation into the Factors Influencing Drug Release from Hydrophilic Matrix Tablets Based on Novel Carbomer Polymers. Drug Delivery, 11, 59-65. https://doi.org/10.1080/10717540490265379
Perez-Marcos, B., Ford, J.L., Armstrong, D.J., Elliott, P.N.C., Rostron, C. and Hogan, J.E. (1996) Influence of pH on the Release of Propranolol Hydrochloride from Matrixes Containing Hydroxypropyl Methyl Cellulose K4M and Carbopol 974. Journal of Pharmaceutical Sciences, 85, 330-334. https://doi.org/10.1021/js950359z
Khamanga, S.M. and Walker, R.B. (2005) Comparison of Method of Manufacture on the in Vitro Performance of Verapamil Matrix Tablets.
Dakkuri, A., David Butler, L. and DeLuca, P.P. (1978) Sustained Release from Inert Wax Matrixes III: Effect of Povidone on Tripelennamine Hydrochloride Release. Journal of Pharmaceutical Sciences, 67, 357-360. https://doi.org/10.1002/jps.2600670322
Dave, B.S., Amin, A.F. and Patel, M.M. (2004) Gastroretentive Drug Delivery System of Ranitidine Hydrochloride: Formulation and in Vitro Evaluation. AAPSPharmSciTech, 5, 77-82. https://doi.org/10.1208/pt050234
Arza, R., Gonugunta, C. and Veerareddy, P. (2009) Formulation and Evaluation of Swellable and Floating Gastroretentive Ciprofloxacin Hydrochloride Tablets. AAPSPharmSciTech, 10, 220-226. https://doi.org/10.1208/s12249-009-9200-y
Hintz, R.J. and Johnson, K.C. (1989) Modeling and Data Treatment in the Pharmaceutical Sciences. International Journal of Pharmaceutics, 51, 9. https://doi.org/10.1016/0378-5173(89)90069-0
Peppas, N.A. (1985) Analysis of Fickian and Non-Fickian Drug Release from Polymers. Pharmaceutica Acta Helvetiae, 60, 110-111.
Mylonaki, I., et al. (2016) Perivascular Sustained Release of Atorvastatin from a Hydrogel-Microparticle Delivery System Decreases Intimal Hyperplasia. Journal of Controlled Release, 232, 93-102. https://doi.org/10.1016/j.jconrel.2016.04.023
Kumar, S., et al. (2010) Development and Validation of Reverse Phase HPLC Method for Simultaneous Estimation of Atorvastatin Calcium and Telmisartan Tablet Dosage Form. International Journal of Pharm Tech Research, 2, 463-470.
Shete, G., Puri, V., Kumar, L. and Bansal, A. (2010) Solid State Characterization of Commercial Crystalline and Amorphous Atorvastatin Calcium Samples. AAPS Pharm SciTech, 11, 598-609. https://doi.org/10.1208/s12249-010-9419-7
Guidance for Industry (2009) Q8(R2)Pharmaceutical Development. Center for Drug Evaluation and Research, USFDA.
Balestrieri, F., et al. (1996) Application of Differential Scanning Calorimetry to the Study of Drug-Excipient Compatibility. Thermochimica Acta, 285, 337-345. https://doi.org/10.1016/0040-6031(96)02904-8
Bohanec, S. et al. (2010) Using Different Experimental Designs in Drug-Excipient Compatibility Studies during the Pre-Formulation Development of a Stable Solid Dosage Formulation. Acta Chimica Slovenica, 57, 895-903.
Yu, L. (2008) Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control. Pharmaceutical Research, 25, 781-791. https://doi.org/10.1007/s11095-007-9511-1
Hwang, R. and Kowalski, D.L. (2005) Design of Experiments for Formulation Development Pharmaceutical Technology.
Shivhare, M. and Mc Creath, G. (2010) Practical Considerations for DoE Implementation in Quality by Design.
Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms. Center for Drug Evaluation and Research. USFDA.
Gaura, P., Mishrab, S. and Bajpaia, M. (2014) Formulation and Evaluation of Controlled-Release of Telmisartan Microspheres: In Vitro/in Vivo Study. Journal of Food and Drug Analysis, 22, 542-548. https://doi.org/10.1016/j.jfda.2014.05.001
Rao, Y., et al. (2012) Atorvastatin Loaded Solid Lipid Nanoparticles: Formulation, Optimization, and in-Vitro Characterization. IOSR Journal of Pharmacy, 2, 23-32. https://doi.org/10.9790/3013-25102332
Khan, F.N., et al. (2011) Enhanced Bioavailability of Atorvastatin Calcium from Stabilized Gastric Resident Formulation. AAPS PharmSciTech, 12, 1077-1086. https://doi.org/10.1208/s12249-011-9673-3