409
Views
4
CrossRef citations to date
0
Altmetric
Research Articles

Formulation, development and in vitro characterization of modified release tablets of capecitabine

ORCID Icon, &
Pages 20-30 | Received 31 May 2019, Accepted 20 Nov 2019, Published online: 06 Dec 2019

References

  • Dong R, Wang M, Dong F. The new progress and outlook of oral colon-specific drug delivery systems for treating cancer. Int J Adv Med Sci. 2015;3:25–32.
  • Ferlay J, Soerjomataram I, Ervik M. GLOBOCAN 2012 V1.0, cancer incidence and mortality worldwide: IARC cancer base No. 11. Lyon (France): International agency for research on cancer; 2013.
  • World health organization [homepage on the Internet]. [Updated 2018 February]. Available from: http://www.who.int/en/news-room/fact-sheets/detail/cancer.
  • Alange VV, Birjdar RP, Kulkarni RV. Novel spray dried pH-sensitive polyacrylamide-grafted-carboxymethylcellulose sodium copolymer microspheres for colon targeted delivery of an anti-cancer drug. J Bio Sci polym Ed. 2016;28:1–44.
  • Brayfield A. Martindale the complete drug reference. 38th ed. London: Pharmaceutical Press; 2014. p. 757–759.
  • O’Neil MJ, Budavari S, Smith A, et al. The Merck index: an encyclopedia of chemicals, drugs, and biologicals. 13th ed. Whitehouse Station (NJ): Merck Research Laboratories Division of Merck and Co.; 2001.
  • Wei K, Peng X, Zou F. Folate-decorated PEG-PLGA nanoparticles with silica shells for capecitabine controlled and targeted delivery. Int J Pharm. 2014;464:225–233.
  • Moffat AC, Osselton MD, Widdop B. Clarke’s analysis of drugs and poisons. London: Pharmaceutical Press; 2004. p. 744.
  • Allen LV, Lawson LA, Adejare A, et al. Remington the science and practice of pharmacy. 22nd ed. London: Pharmaceutical Press; 2013. p. 966–969, 989, 993. University of the sciences Philadelphia College of pharmacy.
  • Khar RK, Vyas SP, Ahmad FJ, et al. Lachman/Lieberman’s the theory and practice of industrial pharmacy. 4th ed. New Delhi: CBS Publishers and Distributors; 2013. p. 244–245, 483–486, 597–598.
  • Brahmankar DM, Jaiswal SB. Biopharmaceutics and pharmacokinetics. 1st ed. Delhi: Vallabh Prakashan; 1995. p. 52, 337.
  • Allen LV, Popovich NG, Ansel HC. Ansel’s pharmaceutical dosage form and drug delivery systems. 9th ed. New Delhi: Wolters Kluwer Lippincott Williams and Wilkims; 2005. p. 100, 225, 256–257.
  • Rowe RC, Shesky PJ, Weller PT. Handbook of pharmaceutical excipients. 4th ed. London: Pharmaceutical Press; 2003. p. 289, 543–45. K.M. Varghese Company.
  • Gaikwad SS, Thombre SK, Kale YK, et al. Design and in vitro characterization of buccoadhesive tablets of timolol maleate. Drug Dev Ind Pharm. 2014;40:680–690.
  • Ortega FR. pH-responsive polymers: properties, synthesis and applications. In: Aguilar MR, Román JS, editors. Smart polymers and their applications. Cambridge (UK): Woodhead Publishing; 2014. p. 45–92.
  • Li L, Li J, Si S, et al. Effect of formulation variables on in vitro release of a water-soluble drug from chitosan-sodium alginate matrix tablets. Asian J Pharm Sci. 2015;10:314–321.
  • Vogel A. Elementary practical organic chemistry part I: small scale preparation. 2nd ed. New Delhi: CBS Publishers and Distributors; 1966. p. 76–81.
  • Furniss BS, Hannaford AJ, Smith PWG, et al. Vogel’s textbook of practical organic chemistry. 5th ed. India: Pearson Education; 2012. p. 236–238.
  • Jain KS, Miniyar PB, Chitre TS. Experimental pharmaceutical organic chemistry. 2nd ed. Nashik: Career publication. 2009. p. 16.
  • United States Pharmacopoeia NF. The official compendia of standards, Asian ed. United States Pharmacopoeial Convention 2009: 290, 386, 725–726.
  • Khandelwal KR. Practical pharmacognosy technique and experiment. 18th ed. Pune: Nirali Prakashan; 2013. p. 159.
  • Harini U, Pawar AK. Validated UV and visible spectrophotometric method for the estimation of capecitabine-a anticancer drug. Scholar Research Library. 2016;8:11–16.
  • Ramesh G, Subbarao M. Development and validation of a simple and specific UV spectrophotometric method for capecitabine assay in active pharmaceutical ingredients (API) and in its dosage forms. Int J Pharm Pharm Res. 2015;2:152–160.
  • ICH Q2B. ICH Harmonised Tripartite Guideline, “validation of analytical procedures: methodology”, Recommended for adoption at step 4 of the ICH process on 1966 November 6, by the ICH steering committee. 1966.
  • Kumbhar SC, Salunkhe VR. UV Spectrophotometric method development for capecitabine in eudragit and chitosan based microspheres and its validation. Indian J Pharm Bio Res. 2013;1:32–38.
  • Shao Y, Li L, Gu X, et al. Evaluation of chitosan-anionic polymers based tablets for extended release of highly water-soluble drugs. Asian J Pharm Sci. 2015;10:24–30.
  • Indian Pharmacopoeia. Controller of Publication. Govt. of India. Ministry of Health and Family Welfare, New Delhi. 2010;281:973.
  • Meulennar J, Beijnen JS, Schellens JMN, et al. Slow dissolution behaviour of amorphous capecitabine. Int J Pharm. 2013;441:213–217.
  • Li L, Wang L, Li J, et al. Insights into the mechanisms of chitosan-anionic polymers-based matrix tablets for extended drug release. Int J Pharm. 2014;476:253–262.
  • Patel N, Desai J, Kumar P, et al. Development and in-vitro characterization of capecitabine loaded alginate-pectinate-chitosan beads for colon targeting. J Macromolecular Sci Part B. 2016;55:33–54.
  • Carstensen JT, Rhodes CT. Drug stability principles and practices. 3rd ed. New York (NY): Marcel Dekker, Inc; 2000. p. 254–255.
  • Gaikwad SS, Jadhav AA, Chavan MK, et al. Design and in vitro evaluations of sublingual tablets of timolol maleate. Appl Clin Res Clin Trials Regul Aff. 2016;3:56–63.
  • Liebermann AA, Lachman L, Schwartz JB. Pharmaceutical dosage form: tablets. Vol. 1. 2nd ed. New York (NY): Marcel Dekker, Inc; 2008. p. 47–48.
  • Madgulkar A, Kadam S, Pokharkar V. Studies on formulation development of mucoadhesive sustained release itraconazole tablet using response surface morphology. AAPS Pharm SciTech. 2008;9:998–1005.
  • Sriamornsak P, Thirawong N, Korkerd K. Swelling, erosion and release behaviour of alginate-based matrix tablets. Eur J Pharm Biopharm. 2007;66:435–450.
  • Joshi NC, Ahmad Z, Mishra SK, et al. Formulation and evaluation of matrix tablet of tramadol hydrochloride. Indian J Pharm Education Res. 2011;45:360.
  • Sonawane MP, Gaikwad SS, Derle DV. Formulation, optimization and evaluation of pH dependent colon targeted drug delivery system of tizanidine hydrochloride. Invent Rapid Pharm Tech. 2013;1:1–7.
  • Jagtap J, Patil M, Patil V. Development and in-vitro evaluation of colon specific satranidazole tablet for the treatment of amoebiasis. Asian J Pharm. 2013;7:55–60.
  • Aulton ME. Pharmaceutics-the science of dosage form design. 2nd ed. Spain: Churchill living stone: 2002. p. 168–169.
  • Borgaonkar PA, Virsen TG, Hariprasanna RC, et al. Formulation and in vitro evaluation of buccal tablets of loratadine for effective treatment of allergy. Int J Pharm Chem. 2011;1:551–559.
  • Thombre SK, Gaikwad SS. Design and development of mucoadhesive buccal delivery of pantoprazole with stability enhancement in human saliva. Int J Pharm Pharm Sci. 2013;5:122–127.
  • Mistry AK, Nagda DC, Nagda CD, et al. Formulation and in vitro evaluation of ofloxacin tablets using natural gums as binders. Sci Pharm. 2014;82:441–448.
  • Balgani PK, Pallepati K, Katamreddy JD. Formulation design and evaluation of mucoadhesive buccal tablets of nitroglycerin. Int J Pharm Pharm Sci. 2014;6:251–259.
  • Mobarak H, Das B, Chakraborty J. Formulation, optimization and evaluation of capecitabine tablet for colon specific drug delivery system. Int J Pharm Clin Res. 2017;9:539–549.
  • Ishwariya VT, Soujanya GL, Santhoshi S, et al. Formulation development and optimization of extended release matrix tablets of azilsartan using natural and synthetic polymers. Eur J Pharm Med Res. 2016;3:294–304.
  • Shah UH, Patel B. Formulation and evaluation of controlled release matrix tablet of diltiazem hydrochloride by using HPMC and guar gum as polymeric matrix material. Ars Pharmaceutica. 2012;53:16–20.
  • Telasang A, Kumar A, Kulkarni SV. Formulation and in vitro evaluation of sustained release matrix tablets of roxatidine hydrochloride by using natural and synthetic polymers. Scholars Research Library. 2014;6:103–111.
  • Nayak K, Sharma S, Mishra M. Formulation and evaluation of sustained release matrix tablets of glibenclamide. World J Pharm Res. 2016;5:974–988.
  • Mahalaxmi D, Senthill A, Prasad V, et al. Formulation and evaluation of mucoadhesive buccal tablets of glipizide. Int J Biopharm. 2010;1:100–107.
  • Agarwal T, Narayana SNGH, Pal K, et al. Calcium alginate-carboxymethyl cellulose beads for colon targeted drug delivery. Int J Biol Macromol. 2015;75:409–417.
  • Sharma P, Chawla A, Pawar P. Design, development, and optimization of polymeric based- colonic drug delivery system of naproxen. The Scientific World Journal. 2013;2013:1–12.
  • Kumar S, Bhargava A. Formulation and evaluation of matrix tablets of naproxen for colon targeting. Asian J Biomed Pharm Sci. 2012;2:28–31.
  • Pawar PK, Gautam C. Design, optimization and evaluation of mesalamine matrix tablet for colon drug delivery system. J Pharm Investig. 2016;46:67–78.
  • Karim S, Uddin J, Bhuiyan MA, et al. Formulation and in vitro evaluation of aspirin sustained release tablets using hydrophilic polymer. World J Sci Eng. 2016;3:39–45.
  • Gauda R, Baishya H, Qing Z. Application of mathematical models in drug release kinetics of carbidopa and levodopa ER tablets. J Dev Drugs. 2017;6:2–8.
  • Pujeri SS, Khader AMA, Seetharamappa J. Stability study of capecitabine active pharmaceutical ingredient in bulk drug and pharmaceutical formulation. J Liq Chromatogr Relat Technol. 2012;35:40–49.
  • Katakam P, Phalguna Y, Harinarayana D. Formulation, characterization and in vitro evaluation of capecitabine loaded polycaprolactone-chitosan nanospheres. Bangla Pharma J. 2015;17:18–24.
  • Agnihotri SA, Aminabhavi TM. Novel interpenetrating network chitosan-poly (ethyleneoxide-g-acrylamide) hydrogel microspheres for the controlled release of capecitabine. Int J Pharm. 2006;324:103–115.
  • Tekade BW, Jadhao UT, Patil P. Formulation and in-vitro evaluation of capecitabine floating tablet. Pharma Innov J. 2017;6:171–175.
  • Raghavendra Rao NG, Richard Prasanna Raj K, Sanjeev Nayak B. Review on matrix tablet as sustained release. Int J Pharm Res Allied Sci. 2013;2:1–17.
  • Segale L, Mannina P, Giovannelli L, et al. Formulation and coating of alginate and alginate-hydroxypropylcellulose pellets containing ranolazine. J Pharm Sci. 2016;105:3351–3358.
  • European Medicines Agency. Guideline on quality of oral modified release products. London (UK): An agency of the European Union; 2014. p. 1–16.
  • Efentakis M, Buckton G. The effect of erosion and swelling on the dissolution of theophylline from los and high viscosity sodium alginate matrices. Pharm Dev Technol. 2002;7:69–77.
  • Liew CV, Chan LW, Ching AL, et al. Evaluation of sodium alginate as drug release modifier in matrix tablets. Int J Pharm. 2006;309:25–37.
  • Karvekar M, Khan AB. A brief review on sustained release matrix type drug delivery system. J Pharm Res. 2017;16:282–289.
  • Tonnesen HH, Karlsen J. Alginate in drug delivery systems. Drug Dev Ind Pharm. 2002;28:621–630.
  • Shaikh R, Thakur RR, Garland MJ, et al. Mucoadhesive drug delivery systems. J Pharm Bioall Sci. 2011;1:89–100.
  • Chavan S, Anantwar S, Derle D. Design and evaluation of once-daily sustained release matrix tablets of nicorandil. Int J Pharm Pharm Sci. 2011;3:13–18.
  • Costa P, Lobo J. Modeling and comparison of dissolution profiles. Eur J Pharm Sci. 2001;13:123–133.
  • Dash S, Murthy PN, Nath L, et al. Kinetic modeling on drug release from controlled drug delivery system. Acta Pol Pharm. 2010;67:217–223.
  • Holowka EP, Bhatia SK. Controlled release systems. In: Holowka E, Bhatia SK, editors. Drug Delivery, Material Design and Clinical Perspective. New York: Springer; 2014. p.1–62.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.