Formulation development using different natural and semi synthetic polymers, in vitro evaluation of colon targeted Sulfasalazine tablets for ulcerative colitis
Paper Details
Formulation development using different natural and semi synthetic polymers, in vitro evaluation of colon targeted Sulfasalazine tablets for ulcerative colitis
Abstract
In this present research work, the aim was to develop colonic targeted matrix tablets of Sulfasalazine for colonitis treatment. Matrix tablets of Sulfasalazine were prepared using microsomal enzyme dependent polymers by wet granulation compression method.The colon targeted tablets were prepared using various polymers in combination. All pharmacopeia tests were performed to ensure its specifications. The colon-targeting tablets prepared via wet granulation method. Different polymers used in controlled release formulation for colon. The compatibility was assessed using FT-IR,XRD and DSC studies for pure drug, polymers and their physical mixtures. The physicochemical properties of all the prepared matrix tablets batches were found to be in limits. The drug content percentage in the optimized formulation H was found to be 99.24 ± 0.10%. Formulations H was containing 2.8% of pectin and 5.7% of HPMC K15M and 11.5% Guar gum and release of drug is about 4% in basic medium (6.8pH) for 3 hrs. This was acceptable range for colon targeting drugs in 3 hrs using medium of 6.8pH. The study concluded that that colon targeted tablets can target the colon and extend the release of sulfasalazine in colon for many hours and also ensure enhanced bioavailability.
Camma C, Giunta M, Rosselli M, Cottone M. 1997. Mesalamine in the maintenance treatment of Crohn’s disease: a meta-analysis adjusted for confounding variables. Gastroenterology 113, 1465-1473. https://doi.org/10.1053/gast.1997.v113.pm9352848
Commission BP, Council GM, Commission G. BM. 2001. British pharmacopoeia, Her Majesty’s Stationery Office.
Khan MZI, Prebeg Ž, Kurjaković N. 1999. A pH-dependent colon targeted oral drug delivery system using methacrylic acid copolymers: I. Manipulation of drug release using Eudragit® L100-55 and Eudragit® S100 combinations. Journal of Controlled Release 58, 215-222. https://doi.org/10.1016/S0168-3659(98)00151-5
Klotz U, Maier K, Fischer C, Heinkel K. 1980. Therapeutic efficacy of sulfasalazine and its metabolites in patients with ulcerative colitis and Crohn’s disease. New England Journal of Medicine 303, 1499-1502. https://doi.org/10.1056/NEJM198012253032602.
Kothawade P, Gangurde H, Surawase R, Wagh M, Tamizharasi S. 2015. Conventional and novel approaches for colon specific drug delivery.
Krishnaiah Y, Satyanarayana V, Kumar BD, Karthikeyan R. 2002. In vitro drug release studies on guar gum-based colon targeted oral drug delivery systems of 5-fluorouracil. European journal of pharmaceutical sciences 16, 185-192. https://doi.org/10.1016/S0928-0987(02)00081-7
Kumar DV, Sitharavamma Y, Nagalakshmi K, Prasanna T, Ravindra K. 2015. Formulation and Optimization of Nitrendipine Sustained Release Tablets Journal of Controlled Release, 1.
Lamprecht A, Ubrich N, Yamamoto H, Schäfer U, Takeuchi H, Maincent P, Kawashima Y, Lehr CM. 2001. Biodegradable nanoparticles for targeted drug delivery in treatment of inflammatory bowel disease. Journal of Pharmacology and Experimental Therapeutics 299, 775-781.
Loftus E, Silverstein M, Sandborn W, Tremaine W, Harmsen W, Zinsmeister A. 2000. Ulcerative colitis in Olmsted County, Minnesota, 1940–1993: incidence, prevalence, and survival. Gut, 46, 336-343. https://doi.org/10.1136/gut.46.3.336
Loftus JR, EV, Sandborn WJ. 2002. Epidemiology of inflammatory bowel disease. Gastroenterology Clinics of North America 31, 1-20. https://doi.org/10.1016/S0889-8553(01)00002-4
Mallick S, Sagiri S, Singh V, Pal K, Pradhan D. Bhattacharya M. 2014. Effect of Processed Starches on the Properties of Gelatin-based Physical Hydrogels: Characterization, in vitro Drug Release and Antimicrobial Studies. Polymer-Plastics Technology and Engineering 53, 700-715. https://doi.org/10.1080/03602559.2013.877927
PANT S, Sharma PK, Malviya R. 2015. Evaluation of Different Concentration of Binders on the Dissolution Profile of Paracetamol Tablets. Advances in Biological Research 9, 82-85.
Patel M, Shah T, Amin A. 2007. Therapeutic opportunities in colon-specific drug-delivery systems. Critical Reviews™ in Therapeutic Drug Carrier Systems 24, 147-202. https://doi.org/10.1615/CritRevTherDrugCarrierSyst.v24.i2.20
Patil H, Tiwari RV, Upadhye SB, Vladyka RS, Repka MA. 2015. Formulation and development of pH-independent/dependent sustained release matrix tablets of ondansetron HCl by a continuous twin-screw melt granulation process. International journal of pharmaceutics 496, 33-41 https://doi.org/10.1016/j.ijpharm.2015.04.009
Pharmacopoeia B. 2007. British Pharmacopoeia commission office. London, UK, 2, 1078-1080.
Pharmacopoeia U, National Formulary 21. USP Convention, Rockville. 2003.
Pravda J. 2014. Materials and methods for treatment of disorders associated with oxidative stress. Google Patents.
Rawas-Qalaji MM, Werdy S, Rachid O, Simons FER, Simons KJ. 2015. Sublingual Diffusion of Epinephrine Microcrystals from Rapidly Disintegrating Tablets for the Potential First-Aid Treatment of Anaphylaxis: In Vitro and Ex Vivo Study. AAPS PharmSciTech 16, 1203-1212 https://doi.org/10.1208/s12249-015-0306-0
Samanta A, Jena AK, Das M, De A, Mitra D. 2014. Determination of efficacy of a natural tablet binder: Characterization and in-vitro release study. Asian Journal of Pharmaceutical and Clinical Research 7.
Santomaso A, Lazzaro P, Canu P. 2003. Powder flowability and density ratios: the impact of granules packing. Chemical Engineering Science 58, 2857-2874. https://doi.org/10.1016/S0009-2509(03)00137-4
Sinha VR, Kumria R. 2003. Coating polymers for colon specific drug delivery: A comparative in vitro evaluation. ACTA Pharmaceutica-Zagreb- 53, 41-48.
Yasir Mehmood, Hammad Yousaf, Umer Farooq, Humayun Riaz, Noviara Saleem, Muhammad Billal Hassan, Rana Khalid Mahmood, Abdul RaheemMalik, Muhammad Sameer Ashaq, Abdulmannan Kashif, Tehseen Zahra, Syed Atif Raza, 2019. Formulation development using different natural and semi synthetic polymers, in vitro evaluation of colon targeted Sulfasalazine tablets for ulcerative colitis. Int. J. Biosci., 15(1), 42-55.
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