Buccal delivery of small molecules and biologics: of mucoadhesive polymers, films, and nanoparticles

Current Opinion in Pharmacology

Volumn 36, Issue , 2017, Pages 22-28

  Morales, Javier O ^a,b,c   Brayden, David J ^d  

^a UNIVERSITY OF CHILE   (Chile)

^b Biofísica y Bioinformática   (Chile)

^c LULEÅ UNIVERSITY OF TECHNOLOGY   (Sweden)

^d UNIVERSITY COLLEGE DUBLIN   (Ireland)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCAGON LIKE PEPTIDE 1; GOLD NANOPARTICLE; INSULIN; MACROCYCLIC COMPOUND; NANOPARTICLE; PENETRATION ENHANCING AGENT; PEPTIDE; POLYMER; BIOLOGICAL PRODUCT;

BUCCAL DRUG ADMINISTRATION; CHEEK EPITHELIUM; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; FILM; HALF LIFE TIME; HUMAN; MACROMOLECULE; MOLECULAR WEIGHT; MUCOADHESION; ORAL SPRAY; PRIORITY JOURNAL; REVIEW; TABLET; ADHESION; ANIMAL; METABOLISM; MOUTH MUCOSA;

ADHESIVENESS; ADMINISTRATION, BUCCAL; ANIMALS; BIOLOGICAL PRODUCTS; DRUG DELIVERY SYSTEMS; HUMANS; MOUTH MUCOSA; NANOPARTICLES; POLYMERS;

EID: 85026830309     PISSN: 14714892     EISSN: 14714973     Source Type: Journal    
DOI: 10.1016/j.coph.2017.07.011     Document Type: Review

References (63)

1. Rathbone, M.J., Pather, I., Senel, S., Overview of oral mucosal delivery (Internet). Rathbone, M.J., Senel, S., Pather, I., (eds.) Oral Mucosal Drug Delivery and Therapy, 2015, Springer US, 17–29 Seminal recent textbook on buccal delivery.
2. Morales, J.O., Fathe, K.R., Brunaugh, A., Ferrati, S., Li, S., Montenegro-Nicolini, M., Mousavikhamene, Z., McConville, J.T., Prausnitz, M.R., Smyth, H.D.C., Challenges and future prospects for the delivery of biologics: oral mucosal, pulmonary, and transdermal routes. AAPS J, 2017, 10.1208/s12248-017-0054-z.
3. Squier, C.A., Wertz, P.W., Structure and function of the oral mucosa and implications for drug delivery. Rathbone, M.J., (eds.) Oral Mucosal Drug Delivery, 1996, Informa Health Care.
4. Gandhi, R.B., Robinson, J.R., Oral cavity as a site for bioadhesive drug delivery. Adv Drug Deliv Rev 13 (1994), 43–74.
5. Sattar, M., Sayed, O.M., Lane, M.E., Oral transmucosal drug delivery – current status and future prospects. Int J Pharm 471 (2014), 498–506.
6. Law, S., Wertz, P.W., Swartzendruber, D.C., Squier, C.A., Regional variation in content, composition and organization of porcine epithelial barrier lipids revealed by thin-layer chromatography and transmission electron microscopy. Arch Oral Biol 40 (1995), 1085–1091.
7. Hoogstraate, A.J., Senel, S., Cullander, C., Verhoef, J., Junginger, H.E., Boddé, H.E., Effects of bile salts on transport rates and routes of FITC-labelled compounds across porcine buccal epithelium in vitro. J Controlled Release 40 (1996), 211–221.
8. Patel, M.P., Churchman, S.T., Cruchley, A.T., Braden, M., Williams, D.M., Electrically induced transport of macromolecules through oral buccal mucosa. Dent Mater 29 (2013), 674–681.
9. Morales, J.O., McConville, J.T., Manufacture and characterization of mucoadhesive buccal films. Eur J Pharm Biopharm 77 (2011), 187–199.
10. Laffleur, F., Mucoadhesive polymers for buccal drug delivery. Drug Dev Ind Pharm 40 (2014), 591–598.
11. Laffleur, F., Wagner, J., Barthelmes, J., A potential tailor-made hyaluronic acid buccal delivery system comprising rotigotine for Parkinson's disease?. Future Med Chem 7 (2015), 1225–1232.
12. Laffleur, F., Leder, N., Barthelmes, J., In vitro evaluation of thio-poly acrylic acid for intraoral delivery. Drug Deliv 23 (2016), 2065–2073.
13. Laffleur, F., Bacher, L., Vanicek, S., Menzel, C., Muhammad, I., Next generation of buccadhesive excipient: preactivated carboxymethyl cellulose. Int J Pharm 500 (2016), 120–127.
14. Wasnik, M.N., Godse, R.D., Nair, H.A., Development and evaluation of buccoadhesive tablet for selegiline hydrochloride based on thiolated polycarbophil. Drug Dev Ind Pharm 40 (2014), 632–638.
15. Boateng, J.S., Ayensu, I., Preparation and characterization of laminated thiolated chitosan-based freeze-dried wafers for potential buccal delivery of macromolecules. Drug Dev Ind Pharm 40 (2014), 611–618.
16. Mortazavian, E., Dorkoosh, F.A., Rafiee-Tehrani, M., Design, characterization and ex vivo evaluation of chitosan film integrating of insulin nanoparticles composed of thiolated chitosan derivative for buccal delivery of insulin. Drug Dev Ind Pharm 40 (2014), 691–698.
17. Montenegro-Nicolini, M., Morales, J.O., Overview and future potential of buccal mucoadhesive films as drug delivery systems for biologics. AAPS PharmSciTech 18 (2016), 3–14.
18. Khan, S., Trivedi, V., Boateng, J., Functional physico-chemical, ex vivo permeation and cell viability characterization of omeprazole loaded buccal films for paediatric drug delivery. Int J Pharm 500 (2016), 217–226.
19. Montero-Padilla, S., Velaga, S., Morales, J.O., Buccal dosage forms: general considerations for pediatric patients. AAPS PharmSciTech 18 (2017), 273–282.
20. Trastullo, R., Abruzzo, A., Saladini, B., Gallucci, M.C., Cerchiara, T., Luppi, B., Bigucci, F., Design and evaluation of buccal films as paediatric dosage form for transmucosal delivery of ondansetron. Eur J Pharm Biopharm 105 (2016), 115–121.
21. Khan, S., Boateng, J.S., Mitchell, J., Trivedi, V., Formulation, characterisation and stabilisation of buccal films for paediatric drug delivery of omeprazole. AAPS PharmSciTech 16 (2015), 800–810.
22. Montenegro-Nicolini, M., Miranda, V., Morales, J.O., Inkjet printing of proteins: an experimental approach. AAPS J 19 (2017), 234–243 First description of the potential of inkjet printing of biologics for buccal delivery.
23. Genina, N., Fors, D., Palo, M., Peltonen, J., Sandler, N., Behavior of printable formulations of loperamide and caffeine on different substrates—effect of print density in inkjet printing. Int J Pharm 453 (2013), 488–497.
24. Palem, C.R., Dudhipala, N.R., Battu, S.K., Repka, M.A., Rao Yamsani, M., Development, optimization and in vivo characterization of domperidone-controlled release hot-melt-extruded films for buccal delivery. Drug Dev Ind Pharm 42 (2016), 473–484.
25. Buanz, A.B.M., Saunders, M.H., Basit, A.W., Gaisford, S., Preparation of personalized-dose salbutamol sulphate oral films with thermal ink-jet printing. Pharm Res 28 (2011), 2386–2392.
26. Genina, N., Janßen, E.M., Breitenbach, A., Breitkreutz, J., Sandler, N., Evaluation of different substrates for inkjet printing of rasagiline mesylate (Internet). Eur J Pharm Biopharm, 2013, 10.1016/j.ejpb.2013.03.017.
27. Alomari, M., Mohamed, F.H., Basit, A.W., Gaisford, S., Personalised dosing: printing a dose of one's own medicine. Int J Pharm 494 (2015), 568–577.
28. Sandler, N., Preis, M., Printed drug-delivery systems for improved patient treatment. Trends Pharmacol Sci 37 (2016), 1070–1080.
29. Palem, C.R., Dudhipala, N., Battu, S.K., Goda, S., Repka, M.A., Yamsani, M.R., Combined dosage form of pioglitazone and felodipine as mucoadhesive pellets via hot melt extrusion for improved buccal delivery with application of quality by design approach. J Drug Deliv Sci Technol 30 (2015), 209–219.
30. Alhijjaj, M., Bouman, J., Wellner, N., Belton, P., Qi, S., Creating drug solubilization compartments via phase separation in multicomponent buccal patches prepared by direct hot melt extrusion – injection molding. Mol Pharm 12 (2015), 4349–4362.
31. Dawson, P.L., Hirt, D.E., Rieck, J.R., Acton, J.C., Sotthibandhu, A., Nisin release from films is affected by both protein type and film-forming method. Food Res Int 36 (2003), 959–968.
32. Padgett, T., Han, I.Y., Dawson, P.L., Incorporation of food-grade antimicrobial compounds into biodegradable packaging films. J Food Prot 61 (1998), 1330–1335.
33. Cossé, A., König, C., Lamprecht, A., Wagner, K.G., Hot melt extrusion for sustained protein release: matrix erosion and in vitro release of PLGA-based implants. AAPS PharmSciTech 18 (2017), 15–26.
34. Morales, J.O., Ross, A.C., McConville, J.T., Protein-coated nanoparticles embedded in films as delivery platforms. J Pharm Pharmacol 65 (2013), 827–838.
35. Morales, J.O., Huang, S., Williams, R.O. III, McConville, J.T., Films loaded with insulin-coated nanoparticles (ICNP) as potential platforms for peptide buccal delivery. Colloids Surf B Biointerfaces 122 (2014), 38–45.
36. Rao, S., Song, Y., Peddie, F., Evans, A., Particle size reduction to the nanometer range: a promising approach to improve buccal absorption of poorly water-soluble drugs. Int J Nanomedicine, 2011, 10.2147/IJN.S19151.
37. Baumgartner, R., Teubl, B.J., Tetyczka, C., Roblegg, E., Rational design and characterization of a nanosuspension for intraoral administration considering physiological conditions. J Pharm Sci 105 (2016), 257–267.
38. Mouftah, S., Abdel-Mottaleb, M.M.A., Lamprecht, A., Buccal delivery of low molecular weight heparin by cationic polymethacrylate nanoparticles. Int J Pharm 515 (2016), 565–574 One of the largest molecular weight molecules considered for buccal delivery.
39. Al-Dhubiab, B.E., Nair, A.B., Kumria, R., Attimarad, M., Harsha, S., Formulation and evaluation of nano based drug delivery system for the buccal delivery of acyclovir. Colloids Surf B Biointerfaces 136 (2015), 878–884.
40. Mazzarino, L., Borsali, R., Lemos-Senna, E., Mucoadhesive films containing chitosan-coated nanoparticles: a new strategy for buccal curcumin release. J Pharm Sci 103 (2014), 3764–3771.
41. Abd El Azim, H., Nafee, N., Ramadan, A., Khalafallah, N., Liposomal buccal mucoadhesive film for improved delivery and permeation of water-soluble vitamins. Int J Pharm 488 (2015), 78–85.
42. Giovino, C., Ayensu, I., Tetteh, J., Boateng, J.S., An integrated buccal delivery system combining chitosan films impregnated with peptide loaded PEG-b-PLA nanoparticles. Colloids Surf B Biointerfaces 112 (2013), 9–15.
43. Lv, Q., Shen, C., Li, X., Shen, B., Yu, C., Xu, P., Xu, H., Han, J., Yuan, H., Mucoadhesive buccal films containing phospholipid-bile salts-mixed micelles as an effective carrier for Cucurbitacin B delivery. Drug Deliv 22 (2015), 351–358.
44. Mauro, M., Crosera, M., Bianco, C., Bellomo, F., Bovenzi, M., Adami, G., Larese Filon, F., In vitro permeability of silver nanoparticles through porcine oromucosal membrane. Colloids Surf B Biointerfaces 132 (2015), 10–16.
45. 2 nanoparticle uptake. Nanotoxicology 9 (2015), 253–261.
46. Roblegg, E., Fröhlich, E., Meindl, C., Teubl, B., Zaversky, M., Zimmer, A., Evaluation of a physiological in vitro system to study the transport of nanoparticles through the buccal mucosa. Nanotoxicology 6 (2012), 399–413.
47. Teubl, B.J., Meindl, C., Eitzlmayr, A., Zimmer, A., Fröhlich, E., Roblegg, E., In-vitro permeability of neutral polystyrene particles via buccal mucosa. Small 9 (2013), 457–466.
48. Kweon, M.-N., Sublingual mucosa: a new vaccination route for systemic and mucosal immunity. Cytokine 54 (2011), 1–5.
49. Upadhyay, J., Upadhyay, R.B., Agrawal, P., Jaitley, S., Shekhar, R., et al. Langerhans cells and their role in oral mucosal diseases. North Am J Med Sci, 5, 2013, 505.
50. Wang, N., Wang, T., Zhang, M., Chen, R., Niu, R., Deng, Y., Mannose derivative and lipid A dually decorated cationic liposomes as an effective cold chain free oral mucosal vaccine adjuvant-delivery system. Eur J Pharm Biopharm 88 (2014), 194–206.
51. Wang, N., Wang, T., Zhang, M., Chen, R., Deng, Y., Using procedure of emulsification–lyophilization to form lipid A-incorporating cochleates as an effective oral mucosal vaccine adjuvant-delivery system (VADS). Int J Pharm 468 (2014), 39–49.
52. Baudner, B.C., O'Hagan, D.T., Bioadhesive delivery systems for mucosal vaccine delivery. J Drug Target 18 (2010), 752–770 Realization that buccal delivery has potential for mucoadhesive vaccines.
53. Mašek, J., Lubasová, D., Lukáč, R., Turánek-Knotigová, P., Kulich, P., Plocková, J., Mašková, E., Procházka, L., Koudelka, Š., Sasithorn, N., et al. Multi-layered nanofibrous mucoadhesive films for buccal and sublingual administration of drug-delivery and vaccination nanoparticles – important step towards effective mucosal vaccines. J Controlled Release 249 (2017), 183–195.
54. Zhen, Y., Wang, N., Gao, Z., Ma, X., Wei, B., Deng, Y., Wang, T., Multifunctional liposomes constituting microneedles induced robust systemic and mucosal immunoresponses against the loaded antigens via oral mucosal vaccination. Vaccine 33 (2015), 4330–4340.
55. Wang, T., Zhen, Y., Ma, X., Wei, B., Li, S., Wang, N., Mannosylated and lipid A-incorporating cationic liposomes constituting microneedle arrays as an effective oral mucosal HBV vaccine applicable in the controlled temperature chain. Colloids Surf B Biointerfaces 126 (2015), 520–530.
56. Morales, J.O., McConville, J.T., Novel strategies for the buccal delivery of macromolecules. Drug Dev Ind Pharm 40 (2014), 579–590.
57. Caon, T., Jin, L., Simões, C.M.O., Norton, R.S., Nicolazzo, J.A., Enhancing the buccal mucosal delivery of peptide and protein therapeutics. Pharm Res, 2014, 10.1007/s11095-014-1485-1.
58. Iyire, A., Alaayedi, M., Mohammed, A.R., Pre-formulation and systematic evaluation of amino acid assisted permeability of insulin across in vitro buccal cell layers. Sci Rep, 6, 2016, 32498.
59. Patel, M.P., Churchman, S.T., Cruchley, A.T., Braden, M., Williams, D.M., Delivery of macromolecules across oral mucosa from polymeric hydrogels is enhanced by electrophoresis (iontophoresis). Dent Mater 29 (2013), e299–e307.
60. Oh, D.-H., Chun, K.-H., Jeon, S.-O., Kang, J.-W., Lee, S., Enhanced transbuccal salmon calcitonin (sCT) delivery: effect of chemical enhancers and electrical assistance on in vitro sCT buccal permeation. Eur J Pharm Biopharm 79 (2011), 357–363.
61. Telò, I., Tratta, E., Guasconi, B., Nicoli, S., Pescina, S., Govoni, P., Santi, P., Padula, C., In-vitro characterization of buccal iontophoresis: the case of sumatriptan succinate. Int J Pharm 506 (2016), 420–428.
62. Ren, W., Baig, A., White, D.J., Li, S.K., Characterization of cornified oral mucosa for iontophoretically enhanced delivery of chlorhexidine. Eur J Pharm Biopharm 99 (2016), 35–44.
63. Midatech Pharma – news release. http://www.midatechpharma.com/news/69/143/Midatech-Pharma-announces-clinical-pipeline-update.html (accessed: 26th April 2017). Update on Midatech and Monosol pipeline and description of the gold nanoparticle-in-film system for insulin.