Formulation development and Stability Studies of Meropenem Extended-Release matrix Tablets
Abstract
The aim of this research was to develop a new hydrophilic matrix system containing meropenem (MEX). Extended-release tablets are usually intended for once-a-day administration with benefits to the patient and lower discontinuation of the therapy. Formulations were developed with hydroxyl propyl methyl cellulose or poly (ethylene oxide) as hydrophilic polymers, with different molecular weights (MWs) and concentrations (20 and 30%). The tablets were found to be stable (6 months at 40 ± 2°C and 75± 5% relative humidity), and the film-coating process is recommended to avoid MEX photo-degradation. The dissolution profiles demonstrated an extended-release of MEX for all developed formulations. Dissolution curves analyzed using the Korsmeyer exponential equation showed that drug release was controlled by both drug diffusion and polymer relaxation or erosion mechanisms. A more erosion controlled system was obtained for the formulations containing lower MW and amount of polymer. With the increase in both MW and amount of polymer in the formulation, the gel layer became stronger, and the dissolution was more drug-diffusion dependent. Formulations containing intermediate MW polymers or high concentration (30%) of low MW polymers demonstrated a combination of extended and complete in vitro drug release. This way, these formulations could provide an increased bioavailability in vivo.
Keywords:
Extend Release Tablet, HPMC, Dissolution Profiles, Formulation
References
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45. H. Khan, J. T. Fell, andG. S.Macleod, “The influence of additives on the spreading coefficient and adhesion of a film coating formulation to a model tablet surface,” International Journal of Pharmaceutics, vol. 227, no. 1-2, pp. 113–119, 2001.
46. A. Kalbag, C. Wassgren, S. Sumana Penumetcha, and J. D. P´erez-Ramos, “Inter-tablet coating variability: residence times in a horizontal pan coater,” Chemical Engineering Science, vol. 63, no. 11, pp. 2881–2894, 2008.
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49. P. L. Ritger and N. A. Peppas, “A simple equation for description of solute release II. Fickian and anomalous release from swellable devices,” Journal of Controlled Release, vol. 5, no. 1, pp. 37–42, 1987.
50. P. R. Oliveira, L. S. Bernardi, O. L. Strusi et al., “Assembled modules technology for site-specific prolonged delivery of norfloxacin,” International Journal of Pharmaceutics, vol. 405, no. 1-2, pp. 90–96, 2011.
51. X. Zhao and K. Drlica, “Restricting the selection of antibioticresistant mutants: a general strategy derived from fluoroquinolone studies,” Clinical Infectious Diseases, vol. 33, no. 3, pp. S147–S156, 2001.
52. D. A. Talan, K. G. Naber, J. Palou, and D. Elkharrat, “Extendedrelease ciprofloxacin (Cipro XR) for treatment of urinary tract infections,” International Journal of Antimicrobial Agents, vol. 23, no. 1, pp. S54–S66, 2004.
53. P. Verze, F. Fusco, C. Imbimbo et al., “Efficacy and safety of ciprofloxacin XR 1000 mg once daily versus ciprofloxacin 500mg twice daily in the treatment of complicated urinary tract infections,” European Urology Supplements, vol. 10, p. 163, 2011.
54. F. M. E.Wagenlehner and K. G. Naber, “Treatment of bacterial urinary tract infections: presence and future,” European Urology, vol. 49, no. 2, pp. 235–244, 2006.
2. C. Ferrero and M. R. Jim´enez-Castellanos, “The influence of carbohydrate nature and drying methods on the compaction properties and pore structure of new methyl methacrylate copolymers,” International Journal of Pharmaceutics, vol. 248, no. 1-2, pp. 157–171, 2002.
3. F. Fichtner, G. Frenning, and G. Alderborn, “Drug release from compacted single inert matrix agglomerates,” Journal of Drug Delivery Science and Technology, vol. 17, no. 4, pp. 273–277, 2007.
4. P. Colombo, F. Sonvico, G. Colombo, and R. Bettini, “Novel platforms for oral drug delivery,” Pharmaceutical Research, vol. 26, no. 3, pp. 601–611, 2009.
5. I. Fuertes, I. Caraballo, A. Miranda, and M. Mill´an, “Study of critical points of drugs with different solubilities in hydrophilic matrices,” International Journal of Pharmaceutics, vol. 383, no. 1-2, pp. 138–146, 2010.
6. J. S. Park, J. Y. Shim, N. K. V. Truong et al., “A pharma-robust design method to investigate the effect of PEG and PEO on matrix tablets,” International Journal of Pharmaceutics, vol. 393, no. 1-2, pp. 79–87, 2010.
7. S. Conti, L. Maggi, L. Segale et al., “Matrices containing NaCMC and HPMC. 2. Swelling and releasemechanism study,” International Journal of Pharmaceutics, vol. 333, no. 1-2, pp. 143–151, 2007.
8. H. Omidian and K. Park, “Swelling agents and devices in oral drug delivery,” Journal of Drug Delivery Science and Technology, vol. 18, no. 2, pp. 83–93, 2008.
9. S. Chirico, A.Dalmoro, G. Lamberti,G. Russo, and G. Titomanlio, “Analysis and modeling of swelling and erosion behavior for pure HPMC tablet,” Journal of Controlled Release, vol. 122, no. 2, pp. 181–188, 2007.
10. P. Colombo, R. Bettini, P. Santi, and N. A. Peppas, “Swellable matrices for controlled drug delivery: gel-layer behaviour, mechanisms and optimal performance,” Pharmaceutical Science and Technology Today, vol. 3, no. 6, pp. 198–204, 2000.
11. P. Colombo, R. Bettini, P. Santi, A. De Ascentiis, and N. A. Peppas, “Analysis of the swelling and release mechanisms from drug delivery systems with emphasis on drug solubility and water transport,” Journal of Controlled Release, vol. 39, no. 2-3, pp. 231–237, 1996.
12. R. Bettini, P. L. Catellani, P. Santi, G.Massimo,N. A. Peppas, and P. Colombo, “Translocation of drug particles in HPMC matrix gel layer: effect of drug solubility and influence on release rate,” Journal of Controlled Release, vol. 70, no. 3, pp. 383–391, 2001.
13. S.Conti, L.Maggi, L. Segale et al., “Matrices containingNaCMC andHPMC. 1. Dissolution performance characterization,” International Journal of Pharmaceutics, vol. 333, no. 1-2, pp. 136–142, 2007.
14. C. L. Li, L. G. Martini, J. L. Ford, and M. Roberts, “The use of hypromellose in oral drug delivery,” Journal of Pharmacy and Pharmacology, vol. 57, no. 5, pp. 533–546, 2005.
15. K. C. Sung, P. R. Nixon, J.W. Skoug et al., “Effect of formulation variables on drug and polymer release from HPMC-based matrix tablets,” International Journal of Pharmaceutics, vol. 142, no. 1, pp. 53–60, 1996.
16. M. Ghimire, L. A. Hodges, J. Band et al., “In-vitro and invivo erosion profiles of hydroxypropylmethylcellulose (HPMC) matrix tablets,” Journal of Controlled Release, vol. 147, no. 1, pp. 70–75, 2010.
17. L. Maggi, R. Bruni, and U. Conte, “High molecular weight polyethylene oxides (PEOs) as an alternative to HPMC in controlled release dosage forms,” International Journal of Pharmaceutics, vol. 195, no. 1-2, pp. 229–238, 2000.
18. N. Wu, L.-S. Wang, D. C.-W. Tan, S. M. Moochhala, and Y.-Y. Yang, “Mathematical modeling and in vitro study of controlled drug release via a highly swellable and dissoluble polymer matrix: polyethylene oxide with high molecular weights,” Journal of Controlled Release, vol. 102, no. 3, pp. 569–581, 2005.
19. J. F. Pinto, K. F.Wunder, and A. Okoloekwe, “Evaluation of the potential use of poly (ethylene oxide) as tablet- and extrudateforming material,” AAPS Journal, vol. 6, no. 2, pp. 1–10, 2004.
20. M. Dimitrov and N. Lambov, “Study of Verapamil hydrochloride release from compressed hydrophilic Polyox-Wsr tablets,” International Journal of Pharmaceutics, vol. 189, no. 1, pp. 105– 111, 1999.
21. J. Petrovic, S. Ibric, G. Betz, J. Parojcic, and Z. Duric, “Application of dynamic neural networks in the modeling of drug release from polyethylene oxide matrix tablets,” Search Results European Journal of Pharmaceutical Sciences, vol. 38, pp. 172– 180, 2009.
22. J. Heller, J. Barr, S. Y. Ng, K. S. Abdellauoi, and R. Gurny, “Poly(ortho esters): synthesis, characterization, properties and ses,” Advanced Drug Delivery Reviews, vol. 54, no. 7, pp. 1015–1039, 2002.
23. A. M. Emmerson and A.M. Jones, “The quinolones: decades of development and use,” Journal of Antimicrobial Chemotherapy, vol. 51, no. 1, pp. 13–20, 2003.
24. F. Van Bambeke, J.-M.Michot, J. Van Eldere, and P. M. Tulkens, “Quinolones in 2005: an update,” Clinical Microbiology and Infection, vol. 11, no. 4, pp. 256–280, 2005.
25. L.Mandell, M. Bergeron, T.Marrie, L. Nicolle, D. Scheifele, and S. Shafran, “Norfloxacin: a new quinolone,” Canadian Medical Association Journal, vol. 139, no. 4, pp. 305–307, 1988.
26. Noroxin tablets package insert, 2009, http://www.merck.com/ product/usa/pi circulars/n/noroxin/noroxin pi.pdf.
27. W.-H. Sheng, Y.-C. Chen, J.-T. Wang, S.-C. Chang, K.-T. Luh, and W.-C. Hsieh, “Emerging fluoroquinolone-resistance for common clinically important gram-negative bacteria in Taiwan,” DiagnosticMicrobiology and Infectious Disease, vol. 43, no. 2, pp. 141–147, 2002.
28. Z. Alexiou, M. Mouktaroudi, G. Koratzanis et al., “The significance of compliance for the success of antimicrobial prophylaxis in recurrent lower urinary tract infections: the Greek experience,” International Journal of Antimicrobial Agents, vol. 30, no. 1, pp. 40–43, 2007.
29. R. Isturiz, “Global resistance trends and the potential impact on empirical therapy,” International Journal of Antimicrobial Agents, vol. 32, no. 4, pp. S201–S206, 2008.
30. J. L. Martinez, A. Fajardo, L. Garmendia et al., “A global view of antibiotic resistance,” FEMS Microbiology Reviews, vol. 33, pp. 44–65, 2009.
31. G. Taubes, “The bacteria fight back,” Science, vol. 321, no. 5887, pp. 356–361, 2008.
32. UNITED STATES PHARMACOPEIA, The (USP), Convention, Rockville,Md, USA, 34 edition, 2011.
33. Farmacop´eia Brasileira, Atheneu, S˜ao Paulo, Brazil, 4 edition, 1988.
34. P. R. Oliveira, L. S. Bernardi, C. Mendes, S. G. Cardoso, M. S. Sangoi, and M. A. S. Silva, “Liquid chromatographic determination of norfloxacin in extended-release tablets,” Journal of Chromatographic Science, vol. 47, no. 9, pp. 739–744, 2009.
35. World Health Organization, Annex 2: Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products, vol. 953 of WHO Technical Report Series, 2009.
36. BRAZIL, Agˆencia Nacional de Vigilˆancia Sanit´aria (ANVISA), Resoluc¸˜ao- RE 1, de 29 de julho de 2005,Guia para a realizac¸˜aode estudos de estabilidade, Bras´ılia, Brazil, 2005.
37. ICH-International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use, Stability testing: photostability testing of new drug substances and products, Q1B, 1996.
38. P. Costa and J. M. S. Lobo, “Modeling and comparison of dissolution profiles,” European Journal of Pharmaceutical Sciences, vol. 13, pp. 123–133, 2001.
39. T. Higuchi, “Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices,” Journal of Pharmaceutical Sciences, vol. 52, pp. 1145–1149, 1963.
40. R. W. Korsmeyer, R. Gurny, E. M. Doelker, P. Buri, and N. A. Peppas, “Mechanism of solute release from porous hydrophilic polymers,” International Journal of Pharmaceutics, vol. 15, pp.25–35, 1983.
41. J. W. Moore and H. H. Flanner, “Mathematical comparison of dissolution profiles,” Pharmaceutical Technology, vol. 20, pp. 64–74, 1996.
42. FDA Guidance for industry, “Dissolution testing of immediate release solid oral dosage forms,” US Department of Health and Human Services, CDER, 1997.
43. M. Ruotsalainen, J. Hein¨am¨aki, H. Guo, N. Laitinen, and J. Yliruusi, “A novel technique for imaging film coating defects in the film-core interface and surface of coated tablets,” European Journal of Pharmaceutics and Biopharmaceutics, vol. 56, no. 3, pp. 381–388, 2003.
44. S. Garc´ıa-Mu˜noz and D. S. Gierer, “Coating uniformity assessment for colored immediate release tablets using multivariate image analysis,” International Journal of Pharmaceutics, vol. 395, no. 1-2, pp. 104–113, 2010.
45. H. Khan, J. T. Fell, andG. S.Macleod, “The influence of additives on the spreading coefficient and adhesion of a film coating formulation to a model tablet surface,” International Journal of Pharmaceutics, vol. 227, no. 1-2, pp. 113–119, 2001.
46. A. Kalbag, C. Wassgren, S. Sumana Penumetcha, and J. D. P´erez-Ramos, “Inter-tablet coating variability: residence times in a horizontal pan coater,” Chemical Engineering Science, vol. 63, no. 11, pp. 2881–2894, 2008.
47. M. C´ordoba-Borrego,M. C´ordoba-D´ıaz, andD. C´ordoba-Diaz, “Validation of a high-performance liquid chromatographic method for the determination of norfloxacin and its application to stability studies (photo-stability study of norfloxacin),” Journal of Pharmaceutical and Biomedical Analysis, vol. 18, pp. 919–926, 1999.
48. K. A. K. Musa and L. A. Eriksson, “Theoretical assessment of norfloxacin redox and photochemistry,” Journal of Physical Chemistry A, vol. 113, no. 40, pp. 10803–10810, 2009.
49. P. L. Ritger and N. A. Peppas, “A simple equation for description of solute release II. Fickian and anomalous release from swellable devices,” Journal of Controlled Release, vol. 5, no. 1, pp. 37–42, 1987.
50. P. R. Oliveira, L. S. Bernardi, O. L. Strusi et al., “Assembled modules technology for site-specific prolonged delivery of norfloxacin,” International Journal of Pharmaceutics, vol. 405, no. 1-2, pp. 90–96, 2011.
51. X. Zhao and K. Drlica, “Restricting the selection of antibioticresistant mutants: a general strategy derived from fluoroquinolone studies,” Clinical Infectious Diseases, vol. 33, no. 3, pp. S147–S156, 2001.
52. D. A. Talan, K. G. Naber, J. Palou, and D. Elkharrat, “Extendedrelease ciprofloxacin (Cipro XR) for treatment of urinary tract infections,” International Journal of Antimicrobial Agents, vol. 23, no. 1, pp. S54–S66, 2004.
53. P. Verze, F. Fusco, C. Imbimbo et al., “Efficacy and safety of ciprofloxacin XR 1000 mg once daily versus ciprofloxacin 500mg twice daily in the treatment of complicated urinary tract infections,” European Urology Supplements, vol. 10, p. 163, 2011.
54. F. M. E.Wagenlehner and K. G. Naber, “Treatment of bacterial urinary tract infections: presence and future,” European Urology, vol. 49, no. 2, pp. 235–244, 2006.
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Sihare, M., and R. Chouksey. “Formulation Development and Stability Studies of Meropenem Extended-Release Matrix Tablets”. Himalayan Journal of Health Sciences, Vol. 3, no. 4, Dec. 2018, pp. 1-12, doi:10.22270/ijist.v3i4.18.
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