Quality by Design Approach in the Formulation of Glibenclamide Mucoadhesive Buccal Films

References

• Miller, N.S., Chittchang, M., Johnston, T.P. (2005). The use of mucoadhesive polymers in buccal drug delivery. Adv. Drug Delivery Rev. 57(11): 1666-1691.
   PubMed Web of Science ®Google Scholar
• Sudhakar, Y., Kuotsu, K., Bandyopadhyay, A.K. (2006). Buccal bioadhesive drug delivery- A promising option for orally less efficient drugs. J. Control Release. 114(1): 15-40.
   PubMed Web of Science ®Google Scholar
• Wei, H., Dalton, C., Maso, M.D., Kanfer, I., Lobenberg, R. (2008). Physicochemical characterization of five glyburide powders: A BCS based approach to predict oral absorption. Eur. J. Pharma. Bio. Pharma. 69(3): 1046-1056.
   PubMed Web of Science ®Google Scholar
• Morales, O.J., McConville, T.M. (2010). Manufacture and characterization of mucoadhesive buccal films. Eur. J. Pharma and Biopharma. 77(2): 187-199.
   PubMed Web of Science ®Google Scholar
• Mahajan, A., Chhabra, N., Aggarwal, G. (2011). Formulation and Characterization of Fast Dissolving Buccal Films: A Review, Scholars Research Library Der Pharmacia Lettre. 3(1): 152-165
   Google Scholar
• Gorle, A., Patil, P., Bhaskar, R., Ola, M. (2015). Development and evaluation of buccal film containing antihypertensive agent. The Pharma Innov. J. 4(1): 53-60.
   Google Scholar
• Yehia, S.A., El-Gazayerly, O.N., Basalious, E.B., (2009). Fluconazole Mucoadhesive Buccal Films: In Vitro/In Vivo Performance. Current Drug Delivery. 6(1): 17-27.
   PubMedGoogle Scholar
• Kumar, A., Bali, V., Kumar, M., Pathak, K. (2013). Comparative Evaluation of Porous Versus Nonporous Mucoadhesive Films as Buccal Delivery System of Glibenclamide. AAPS Pharm. Sci. Tech. 14(4): 1321-1332.
   Google Scholar
• Philip, A.K., Srivastava, M., Pathak, K. (2009). Buccoadhesive gels of Glibenclamide: a means for achieving enhanced bioavailability. Drug Deliv. 16(7): 405-15.
   PubMed Web of Science ®Google Scholar
• Avdeef, A. (2007). Solubility of sparingly-soluble ionizable drugs. Adv. Drug Deliv. Rev. 59(7): 568-590.
   PubMed Web of Science ®Google Scholar
• United States Pharmacopeia and National Formulary. (2007). USP 30-NF- 25. 2: 1165
   Google Scholar
• Balsells, M., Garcia-Patterson, A., Sola, I., Roque, M., Gich, I., Corcoy, R. (2015). Glibenclamide, metformin, and insulin for the treatment of gestational diabetes: a systematic review and meta-analysis. British Med. J. 350: h102.
   PubMed Web of Science ®Google Scholar
• Gupta, J.R.D, Irchhiaya, R., Garud, N., Tripathi, P., Dubey, P., Patel, J.R., (2009). Formulation and evaluation of matrix type transdermal patches of Glibenclamide. International Journal of Pharmaceutical Sciences and Drug Research. 1(1): 46-50
   Google Scholar
• Ali, H.S.M., Hanafy, A.F. (2017). Glibenclamide Nanocrystals in a Biodegradable Chitosan Patch for Transdermal Delivery: Engineering, Formulation, and Evaluation. Journal of Pharmaceutical Sciences. 106(1): 402-410
   PubMed Web of Science ®Google Scholar
• Mutalik, S., Udupam, N. (2005). Formulation development in vitro and in vivo evaluation of membrane controlled transdermal system of Glibenclamide, Journal Pharm. Pharmaceutical Sci. 8(1): 26-38.
   PubMed Web of Science ®Google Scholar
• Nayak, A.K., Das, B., Maji, R. (2012). Calcium alginate/gum Arabic beads containing glibenclamide: Development and in vitro characterization. International Journal of Biological Macromolecules. 51(5): 1070-1078.
   PubMed Web of Science ®Google Scholar
• Gonçalves, L.M.D., Maestrelli, F., Mannelli, L.C., Ghelardini, C., Almeida, A.J., Mura, P. (2016). Development of solid lipid nanoparticles as carriers for improving oral bioavailability of Glibenclamide. Eur. J. Pharma Biopharma. 102: 41-50.
   PubMed Web of Science ®Google Scholar
• Dora, C.P., Singh, S.K., Kumar, S., Kumar, A.D., Deep, A. (2010). Development and Characterization of Nanoparticles of Glibenclamide by Solvent Displacement Method. Acta Poloniae Pharmaceutica Drug Research. 67(3): 283-290.
   PubMed Web of Science ®Google Scholar
• Shah, S.R., Parikh, R.H., Chavda, J.R., Sheth, N.R. (2013). Application of Plackett-Burman screening design for preparing Glibenclamide nanoparticles for dissolution enhancement. Powder Technology. 235: 405-411.
   Web of Science ®Google Scholar
• Dash, S.K., Khan, A.S., Das, S.R., Padhan, A., Rout, D. and Behera, B.C. (2012). Formulation and In-Vitro Evaluation of Sustained Released Glibenclamide Microspheres. IJPSR. 3(5): 1433-1443, ISSN: 0975-8232
   Google Scholar
• Venkateswarlu, K. (2017). Evaluation of Glibenclamide microspheres for sustained release. Journal of Pharmacy & Pharmacognosy Research. 5(2): 78-87.
   Web of Science ®Google Scholar
• Chellapan, D.K., Yee, N.J., Kaur, B.J., Singh, A.J., Panneerselvam, J., Madheshwaran, T., Chellian, J., Satija, S., Mehta, M., Gulati, M., Gupta, G., Dua, K. (2019). Formulation and characterization of glibenclamide and quercetin-loaded chitosan nanogels targeting skin permeation. Ther. Deliv. 10(5): 281-293.
   PubMed Web of Science ®Google Scholar
• Jadhav, K.R., Pawar, A.Y., Nile, A.S. (2014). Formulation and Evaluation of Buccal Film of Glimepiride, Pharma Science Monitor. An International Journal of Pharmaceutical Sciences. 5(3): 278-292.
   PubMedGoogle Scholar
• Al-Nemrawi, N.K., Alshrafi, S.S.M., Alzoubi, K.H., Alkhatib, R.Q. (2019). Preparation and characterization of insulin chitosan-nanoparticles loaded in buccal films. Pharmaceutical Development and Technology. 24(8): 967-974.
   PubMed Web of Science ®Google Scholar
• ICH Q8 International Conference of Harmonization. (2008). ICH Harmonized. Tripartite Guideline: Q8 (R1) Pharmaceutical Development. https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf
   Google Scholar
• Jadhav, J.B., Girawale, N.N., Chaudhari, R.A. (2014). Quality by Design (QbD) approach used in development of pharmaceuticals. Int. J. Pure Applied Biosci. 2(5): 214-223.
   Google Scholar
• Vasconcelos, T., Sarmento, B., Costa, P. (2007). Solid dispersion as strategy to improve oral bioavailability to of poor water soluble drugs. Drug Discovery Today. 12(23-24): 1068-1075.
   PubMed Web of Science ®Google Scholar
• Kan, S., Lu, J., Liu, J., Wang, J., Zhao, Y. (2014). A quality by design (QbD) case study on enteric coated pellets: Screening of critical variables and establishment of design space at laboratory scale. Asian J. Pharma. Sci. 9: 268-278.
   Google Scholar
• Visser, C.J., Dohmen, W.M.C., Hinrichs, W.L.J., Henderik, W.F., Breitkreutz, J., Herman. J.W. (2015). Quality by design approach for optimizing the formulation and physical properties of extemporaneously prepared Orodispersible films. Int. J. Pharma. 485: 70-76.
   PubMed Web of Science ®Google Scholar
• Dhillon, B., Goyal, N.K., Sharma, P.K. (2014) Formulation and evaluation of glibenclamide solid dispersion using different methods. Global J. Pharmco. 8(4): 551-556.
   Google Scholar
• Perioli, L., Ambrogi, V., Angelici, F., Ricci, M., Giovangoli, S., Cappucella, M., Rossi, C. (2004). Development of mucoadhesive films for buccal administration of ibuprofen. J. Control Release. 99: 73-82.
   PubMed Web of Science ®Google Scholar
• Goudanavar, P.S., Bagali, R.S., Patil, S.M., Chandashkhara, S. (2010). Formulation and in- vitro evaluation of mucoadhesive buccal films of Glibenclamide. Scholars Research Library Der Pharmacia Lettre. 2(1): 382-387.
   Google Scholar
• Karkhanis, V.V., Captain, A.D., Patel, P.H. (2013). Development and validation of UV spectrophotometric method for estimation of Glibenclamide in bulk and Pharmaceutical dosage forms. IJPSR. 4(5): 1865-67
   Google Scholar
• Prasanna, I.R., Sankari, U.K. (2012). Design evaluation and in vitro - in vivo correlation of Glibenclamide buccoadhesive films. Int J. Pharma Investig. 2(1): 26-33.
   PubMedGoogle Scholar
• Muzib, I.Y., Kumari, S.K. (2011). Mucoadhesive buccal films of Glibenclamide: development and evaluation. Int. J. Pharma Investig. 1(1): 42-47.
   PubMedGoogle Scholar
• Bahri-Najafi, R., Tavakoli, N., Senemar, M., Peikenpour, M. (2014). Preparation and Evaluation of Glibenclamide Slow Release Mucoadhesive Buccal Film. J. Res. Pharma. Sci. 9(3): 213-223
   PubMedGoogle Scholar
• ICH harmonized tripartite guideline Q1A (R2). (2003). Stability Testing of New Drug Substances and Products.; Current Step 4 version: 1-18.
   Google Scholar
• Mor, J., Batra, D., Ahlawat, S. (2016). Enhancement of drug dissolution of Glibenclamide using solid dispersion technique. The Pharma Innovation J. 5(7): 08-12.
   Google Scholar
• Das, S.K., Roy, S., Kalimuthu, Y., Khanam, J., Nanda, A. (2011). Solid Dispersions: An Approach to Enhance the Bioavailability of Poorly Water-Soluble Drugs. Int. J. Pharmco Pharma Tech. 1(1): 2277-3436.
   Google Scholar
• Nicolazzo, J.A., Reed, B.L., Finnin, B.C. (2005). Buccal penetration enhancers-how do they really work. J. Control Release. 105: 1-15.
   PubMed Web of Science ®Google Scholar
• Khanna, R., Agrawal, S.P., Ahuja, A. (1997). Preparation and evaluation of buccal films of clotrimazole for oral candida infections. Indian J. Pharm. Sci. 59: 299-305.
   Google Scholar