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Formulation, Characterisation and Stabilisation of Buccal Films for Paediatric Drug Delivery of Omeprazole

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Abstract

This study aimed to develop films for potential delivery of omeprazole (OME) via the buccal mucosa of paediatric patients. Films were prepared using hydroxypropylmethylcellulose (HPMC), methylcellulose (MC), sodium alginate (SA), carrageenan (CA) and metolose (MET) with polyethylene glycol (PEG 400) as plasticiser, OME (model drug) and L-arg (stabiliser). Gels (1% w/w) were prepared at 40°C using water and ethanol with PEG 400 (0–1% w/w) and dried in an oven (40°C). Optimised formulations containing OME and L-arg (1:1, 1:2 and 1:3) were prepared to investigate the stabilisation of the drug. Tensile properties (Texture analysis, TA), physical form (differential scanning calorimetry, DSC; X-ray diffraction, XRD; thermogravimetric analysis, TGA) and surface topography (scanning electron microscopy, SEM) were investigated. Based on the TA results, SA and MET films were chosen for OME loading and stabilisation studies as they showed a good balance between flexibility and toughness. Plasticised MET films were uniform and smooth whilst unplasticised films demonstrated rough lumpy surfaces. SA films prepared from aqueous gels showed some lumps on the surface, whereas SA films prepared from ethanolic gels were smooth and uniform. Drug-loaded gels showed that OME was unstable and therefore required addition of L-arg. The DSC and XRD suggested molecular dispersion of drug within the polymeric matrix. Plasticised (0.5% w/w PEG 400) MET films prepared from ethanolic (20% v/v) gels and containing OME: L-arg 1:2 showed the most ideal characteristics (transparency, ease of peeling and flexibility) and was selected for further investigation.

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References

  1. Garg SK, Danodia A, Dangi V, Dhakar RC. Buccal adhesive drug delivery system: safer delivery of biotherapeutics. Drug Del Ther. 2011;1(2):35–45.

    CAS  Google Scholar 

  2. Sudhakar Y, Kuotsu K, Bandyopadhyay A. Buccal bioadhesive drug delivery—A promising option for orally less efficient drugs. J Contr Rel. 2006;114:15–40.

    Article  CAS  Google Scholar 

  3. Boateng JS, Okeke O. Chitosan-based films for sustained release of peptides: a new era in buccal delivery? Ther Del. 2014;5(5):497–500.

    Article  CAS  Google Scholar 

  4. Sohi H, Ahuja A, Ahmad FJ, Khar RK. Critical evaluation of permeation enhancers for oral mucosal drug delivery. Drug Dev Ind Pharm. 2010;36(3):254–82.

    Article  CAS  PubMed  Google Scholar 

  5. Dixit RP, Puthli SP. Oral strip technology: overview and future potential. J Contr Rel. 2009;139(2):94–107.

    Article  CAS  Google Scholar 

  6. Siddhiqui N, Garg G, Sharma P. A short review on “A Novel Approach in Oral Fast-Dissolving Drug Delivery System and Their Patents”. Adv Biol Res. 2011;5(6):291–303.

    Google Scholar 

  7. Yehia SA, El-Gazayerly ON, Basalious EB. Design and in vitro/in vivo evaluation of novel mucoadhesive buccal discs of an antifungal drug: relationship between swelling, erosion, and drug release. AAPS PharmSciTech. 2008;9(4):1207–17.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  8. Birudaraj R, Mahalingam R, Li X, Jasti B. Advances in buccal drug delivery. Crit Rev Ther Drug Carrier Syst. 2005;22(3):295–330.

    Article  CAS  PubMed  Google Scholar 

  9. Salamat-Miller N, Chittchang M, Johnston TP. The use of mucoadhesive polymers in buccal drug delivery. Adv Drug Deliv Rev. 2005;57(11):1666–91.

    Article  CAS  PubMed  Google Scholar 

  10. Kianfar F, Chowdhry B, Antonijevic M, Boateng J. Formulation development of a carrageenan based delivery system for buccal drug delivery using ibuprofen as a model drug. J Biomater Nano Biotech. 2011;2(5A):582–95.

    CAS  Google Scholar 

  11. Pawar H, Tetteh J, Boateng J. Preparation and characterization of novel wound healing film dressings loaded with streptomycin and diclofenac. Coll Surf B: Biointerf. 2013;102:102–10.

    Article  CAS  Google Scholar 

  12. Rai D, Maniruzzaman M, Boateng J. Development and characterisation of sodium alginate and HPMC films for mucosal drug delivery. Int J Biotech. 2010;11(3–4):169–81.

    Article  Google Scholar 

  13. Boateng J, Mani J, Kianfar F. Improving drug loading of mucosal solvent cast films using combination of hydrophilic polymers with amoxicillin and paracetamol as model drugs. BioMed Res Int. 2013;2013:8. doi:10.1155/2013/198137. Article ID 198137.

    Article  Google Scholar 

  14. Kianfar F, Antonijevic M, Chowdhry B, Boateng J. Lyophilized wafers comprising carrageenan and pluronic acid for buccal drug delivery using model soluble and insoluble drugs. Coll Surf B: Biointerf. 2013;103:99–106.

    Article  CAS  Google Scholar 

  15. Morales J, McConville J. Manufacture and characterization of mucoadhesive buccal films. Eur J Pharm Biopharm. 2011;77(2):187–99.

    Article  CAS  PubMed  Google Scholar 

  16. Choi H-G, Jung J-H, Yong CS, Rhee C-D, Lee M-K, Han J-H, et al. Formulation and in vivo evaluation of omeprazole buccal adhesive tablet. J Contr Rel. 2000;68(3):405–12.

    Article  CAS  Google Scholar 

  17. Boateng J, Stevens H, Eccleston G, Auffret A, Humphrey J, Matthews K. Development and mechanical characterization of solvent-cast polymeric films as potential drug delivery systems to mucosal surfaces. Drug Dev Ind Pharm. 2009;35(8):986–96.

    Article  CAS  PubMed  Google Scholar 

  18. Lim K, Kim D, Paik U, Kim S. Effect of the molecular weight of poly(ethylene glycol) on the plasticization of green sheets composed of ultrafine BaTiO3 particles and poly(vinyl butyral). Mater Res Bull. 2003;38(1):1021–32.

    Article  CAS  Google Scholar 

  19. Lehrsch G, Sojka R, Koehn A. Surfactant effects on soil aggregate tensile strength. Geoderma. 2012;189–190:199–206.

    Article  Google Scholar 

  20. Alexander A, Ajazuddin M, Swarna M, Sharma M, Tripathi D. Polymers and permeation enhancers: specialized components of mucoadhesives. Stamford J Pharm Sci. 2011;4(1):91–5.

    CAS  Google Scholar 

  21. Wang Y, Dave R, Pfeffer R. Polymer coating/encapsulation of nanoparticles using a supercritical anti-solvent process. J Supercrit Fluids. 2004;28(1):85–99.

    Article  CAS  Google Scholar 

  22. Abruzzo A, Bigucci F, Cerchiara T, Cruciani F, Vitali B, Luppi B. Mucoadhesive chitosan/gelatin films for buccal delivery of propranolol hydrochloride. Carbo Polym. 2012;87(1):581–8.

    Article  CAS  Google Scholar 

  23. Figueiras A, Sarraguça J, Pais A, Carvalho R, Veiga F. The role of L-arginine in inclusion complexes of omeprazole with cyclodextrins. AAPS PharmSciTech. 2010;11(1):233–40.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  24. Kumar A, Negi Y, Bhardwaj N, Choudhary V. Synthesis and characterization of methylcellulose/PVA based porous composite. Carbo Polym. 2012;88(4):1364–72.

    Article  CAS  Google Scholar 

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Authors and Affiliations

  1. Department of Pharmaceutical, Chemical and Environmental Sciences, Faculty of Engineering and Science, University of Greenwich at Medway, Central Avenue, Chatham Maritime, ME4 4TB, Kent, UK

    Sajjad Khan, Joshua S. Boateng, John Mitchell & Vivek Trivedi

Authors
  1. Sajjad Khan
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  2. Joshua S. Boateng
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  3. John Mitchell
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  4. Vivek Trivedi
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Corresponding author

Correspondence to Joshua S. Boateng.

Additional information

Sajjad Khan and Joshua S. Boateng are joint first authors.

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Khan, S., Boateng, J.S., Mitchell, J. et al. Formulation, Characterisation and Stabilisation of Buccal Films for Paediatric Drug Delivery of Omeprazole. AAPS PharmSciTech 16, 800–810 (2015). https://doi.org/10.1208/s12249-014-0268-7

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  • DOI: https://doi.org/10.1208/s12249-014-0268-7

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