Multiple response optimization of processing and formulation parameters of Eudragit RL/RS-based matrix tablets for sustained delivery of diclofenac

References

• Shargel L, Wu-Pong S, Yu A, eds. Modified-release drug products. In: Applied biopharmaceutics and pharmacokinetics. 6th ed. NewYork (NY): McGraw-Hill Education; 2012:469–503.
   Google Scholar
• Sun Y, Peng Y, Chen Y, Shukla AJ. Application of artificial neural networks in the design of controlled release drug delivery systems. Adv Drug Deliv Rev 2003;55:1201–1215.
   PubMed Web of Science ®Google Scholar
• Hamed E, Sakr A. Application of multiple response optimization technique to extended release formulations design. J Control Release 2001;73:329–338.
   PubMed Web of Science ®Google Scholar
• Shivakumar HN, Desai BG, Deshmukh G. Design and optimization of diclofenac sodium controlled release solid dispersions by response surface methodology. Indian J Pharm Sci 2008;70:22–30.
   PubMed Web of Science ®Google Scholar
• Pal D, Nayak AK. Development, optimization, and anti-diabetic activity of gliclazide-loaded alginate–methyl cellulose mucoadhesive microcapsules. AAPS PharmSciTech 2011;12:1431–1441.
   PubMed Web of Science ®Google Scholar
• Wu XG, Li G, Gao YL. Optimization of the preparation of nalmefene-loaded sustained-release microspheres using central composite design. Chem Pharm Bull 2006;54:977–981.
   PubMed Web of Science ®Google Scholar
• Chaibva FA, Walker RB. The use of response surface methodology for the formulation and optimization of salbutamol sulfate hydrophilic matrix sustained release tablets. Pharm Dev Technol 2012;17:594–606.
   PubMed Web of Science ®Google Scholar
• Shivakumar HN, Desai BG, Subhash PG, et al. Design of ocular inserts of brimonidine tartrate by response surface methodology. J Drug Delivery Sci Technol 2007;17:421–430.
   Web of Science ®Google Scholar
• Fini A, Fazio G, Benetti L, Ghedini V. Thermal analysis of some diclofenac salts with alkyl and alkylhydroxy amines. Thermochim Acta 2007;464:65–74.
   Web of Science ®Google Scholar
• Kovala-Demertzi D. Recent advances on non-steroidal anti-inflammatory drugs, NSAIDs: organotin complexes of NSAIDs. J Organomet Chem 2006;691:1767–1774.
   Web of Science ®Google Scholar
• Gohel MC, Parikh RK, Nagori SA, Jethwa BA. Fabrication and evaluation of bi-layer tablet containing conventional paracetamol and modified release diclofenac sodium. Indian J Pharm Sci 2010;72:191–196.
   PubMed Web of Science ®Google Scholar
• Mourão SC, da Silva C, Bresolin TMB, et al. Dissolution parameters for sodium diclofenac-containing hypromellose matrix tablet. Int J Pharm 2010;386:201–207.
   PubMed Web of Science ®Google Scholar
• Liew CV, Chan LW, Ching AL, Heng PWS. Evaluation of sodium alginate as drug release modifier in matrix tablets. Int J Pharm 2006;309:25–37.
   PubMed Web of Science ®Google Scholar
• Fu J, Wang X, Xu L, et al. Preparation and in-vitro in-vivo evaluation of double layer coated and matrix sustained release pellet formulations of diclofenac potassium. Int J Pharm 2011;406:84–90.
   PubMed Web of Science ®Google Scholar
• Semdé R, Amighi K, Devleeschouwer MJ, Moës AJ. Studies of pectin HM/Eudragit RL/Eudragit NE film-coating formulations intended for colonic drug delivery. Int J Pharm 2000;197:181–192.
   PubMed Web of Science ®Google Scholar
• Apu AS, Pathan AH, Shrestha D, et al. Investigation of in-vitro release kinetics of carbamazepine from Eudragit® RS PO and RL PO matrix tablets. Trop J Pharm Res 2009;8:145–152.
   Web of Science ®Google Scholar
• Abdelkader H, Youssef AO, Salem H. Formulation of controlled-release baclofen matrix tablets. II. Influence of some hydrophobic excipients on the release rate and in-vitro evaluation. AAPS PharmSciTech 2008;9:675–683.
   PubMed Web of Science ®Google Scholar
• Pongjanyakul T, Khuathan N. Quaternary polymethacrylate–sodium alginate films: effect of alginate block structures and use for sustained release tablets. Pharm Dev Technol 2016;21:487–498.
   PubMed Web of Science ®Google Scholar
• Eudragit RS, Eudragit RL. Data sheets. Technical Information on Eudragit RL 100 and Eudragit RS 100. Röhm Pharma GmbH, Darmstadt1991. Available from: http://eudragit.evonik.com/sites/lists/HN/ProductSpecifications/evonik-specification-eudragit-rl-100-rl-po-rs-100-rs-po.pdf [last accessed May 2016].
   Google Scholar
• Ibrahim MA. Formulation and evaluation of mefenamic acid sustained release matrix pellets. Acta Pharm 2013;63:85–98.
   PubMed Web of Science ®Google Scholar
• USP-NF. United States Pharmacopeia and National Formulary, 26th Ed. Rockville, MD; 2003.
   Google Scholar
• Elzayat EM, Ibrahim MF, Abdel-Rahman AA, et al. A validated stability-indicating UPLC method for determination of diclofenac sodium in its pure form and matrix formulations. Arabian J Chem 2013. [Epub ahead of print]. doi: 10.1016/j.arabjc.2013.12.022.
   Google Scholar
• Khan KA. The concept of dissolution efficiency. J Pharm Pharmacol 1975;27:48–9.
   PubMed Web of Science ®Google Scholar
• Costa P, Sousa Lobo JM. Modeling and comparison of dissolution profiles. Eur J Pharm Sci 2001;13:123–33.
   PubMed Web of Science ®Google Scholar
• Moore JW, Flanner HH. Mathematical comparison of dissolution profiles. Pharm Technol 1996;20:64–74.
   Google Scholar
• ICH guideline. Stability testing of new drug substances and products Q1A(R2); 2003. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf [last accessed May 2016].
   Google Scholar
• Amaral MH, Lobo JM, Ferreira DC. Effect of hydroxypropyl methylcellulose and hydrogenated castor oil on naproxen release from sustained-release tablets. AAPS PharmSciTech 2001;2:14–21.
   Google Scholar
• Pignatello R, Ferro M, Puglisi G. Preparation of solid dispersions of nonsteroidal anti-inflammatory drugs with acrylic polymers and studies on mechanisms of drug-polymer interactions. AAPS PharmSciTech 2002;3:35–45.
   Google Scholar
• Manyikana M, Choonara YE, Tomar LK, et al. A review of formulation techniques that impact the disintegration and mechanical properties of oradispersible drug delivery technologies. Pharm Dev Technol 2016;21:354–66.
   PubMed Web of Science ®Google Scholar
• Capan Y. Influence of technological factors on formulation of sustained release tablets. Drug Dev Ind Pharm 1989;15:927–56.
   Web of Science ®Google Scholar
• Khan GM, Jiabi Z. Formulation and in vitro evaluation of ibuprofen-Carbopol 974P-NF controlled release matrix tablets. III: Influence of co-excipients on release rate of the drug. J Control Release 1998;54:185–90.
   PubMed Web of Science ®Google Scholar
• Majid Khan G, Zhu J-B. Studies on drug release kinetics from ibuprofen-carbomer hydrophilic matrix tablets: influence of co-excipients on release rate of the drug. J Control Release 1999;57:197–203.
   PubMed Web of Science ®Google Scholar
• Lotfipour F, Nokhodchi A, Saeedi M, et al. The effect of hydrophilic and lipophilic polymers and fillers on the release rate of atenolol from HPMC matrices. Farmaco 2004;59:819–25.
   PubMedGoogle Scholar
• Maderuelo C, Zarzuelo A, Lanao JM. Critical factors in the release of drugs from sustained release hydrophilic matrices. J Control Release 2011;154:2–19.
   PubMed Web of Science ®Google Scholar
• Gao P, Skoug JW, Nixon PR, et al. Swelling of hydroxypropyl methylcellulose matrix tablets. 2. Mechanistic study of the influence of formulation variables on matrix performance and drug release. J Pharm Sci 1996;85:732–40.
   PubMed Web of Science ®Google Scholar
• Yang L, Fassihi R. Examination of drug solubility, polymer types, hydrodynamics and loading dose on drug release behavior from a triple-layer asymmetric configuration delivery system. Int J Pharm 1997;155:219–29.
   Web of Science ®Google Scholar