Preparation and Evaluation of a Novel Buccal Adhesive System

Overview

Journal AAPS PharmSciTech

Publisher Springer

Specialty Pharmacology

Date 2005 Mar 12

PMID 15760069

Citations 26

Authors

K Gh Desai

T Mp Kumar

Affiliations

Soon will be listed here.

Abstract

The aim of the present study was to prepare and evaluate a novel buccal adhesive system (NBAS) containing propranolol hydrochloride (PH). A special punch was fabricated and used while preparing an NBAS. Solubility of PH in phosphate buffer solution (pH 6.6), partition coefficient between phosphate buffer (pH 6.6) and 1-octanol, and permeability coefficient through the porcine buccal mucosa were performed and found to be 74.66 mg/mL, 5.17, and 5.6, respectively. Stability of NBAS was determined in natural human saliva, and it was found that both PH and device are stable in human saliva. NBAS was evaluated by weight uniformity, thickness, hardness, friability, swelling, mucoadhesive strength, in vitro drug release, and in vivo human acceptability studies. Swelling index was higher (4.4) for formulations containing hydroxyl propyl methyl cellulose (HPMC) K4M alone, and it decreases with its decreasing concentration in the NBAS. Mucoadhesive strength (MS) was measured by using a modified apparatus. All NBASs showed higher MS with porcine buccal mucosa when compared with that of rabbit buccal mucosa. NBASs containing carbopol (CP) 934P and HPMC K4M at the ratio of 1:1 showed higher MS (44.76 g) with porcine buccal mucosa when compared with 1:2 (39.76 g), 0:1 (23.29 g), and 1:0 (22.22 g) ratios, respectively. The mechanism of PH release was found to be by non-Fickian diffusion (value of "n" between 0.5 and 1.0) and followed first order kinetics. In vivo human acceptability study showed that the newly prepared NBAS was comfortable in the human buccal cavity. It can be concluded that NBAS is a superior, novel system that overcomes the drawback associated with the conventional buccal adhesive tablet.

Citing Articles

Nanonization and Deformable Behavior of Fattigated Peptide Drug in Mucoadhesive Buccal Films.

Kim W, Ngo H, Nguyen H, Park J, Lee K, Park C Pharmaceutics. 2024; 16(4).

PMID: 38675128 PMC: 11054133. DOI: 10.3390/pharmaceutics16040468.

Improved Mucoadhesion, Permeation and In Vitro Anticancer Potential of Synthesized Thiolated Acacia and Karaya Gum Combination: A Systematic Study.

Munot N, Kandekar U, Rikame C, Patil A, Sengupta P, Urooj S Molecules. 2022; 27(20).

PMID: 36296425 PMC: 9609301. DOI: 10.3390/molecules27206829.

Glutaraldehyde-crosslinked chitosan-polyethylene oxide nanofibers as a potential gastroretentive delivery system of nizatidine for augmented gastroprotective activity.

Abd El Hady W, Soliman O, El Sabbagh H, Mohamed E Drug Deliv. 2021; 28(1):1795-1809.

PMID: 34470551 PMC: 8428272. DOI: 10.1080/10717544.2021.1971796.

Mucoadhesive Multiparticulate Drug Delivery Systems: An Extensive Review of Patents.

Komati S, Swain S, Rao M, Jena B, Dasi V Adv Pharm Bull. 2019; 9(4):521-538.

PMID: 31857957 PMC: 6912179. DOI: 10.15171/apb.2019.062.

Formulation and optimization of duloxetine hydrochloride buccal films: in vitro and in vivo evaluation.

El Sharawy A, Shukr M, Hassen Elshafeey A Drug Deliv. 2017; 24(1):1762-1769.

PMID: 29172829 PMC: 8241170. DOI: 10.1080/10717544.2017.1402216.

References

Choi H, Kim C . Development of omeprazole buccal adhesive tablets with stability enhancement in human saliva. J Control Release. 2000; 68(3):397-404. DOI: 10.1016/s0168-3659(00)00276-5. View

Giunchedi P, Juliano C, Gavini E, Cossu M, Sorrenti M . Formulation and in vivo evaluation of chlorhexidine buccal tablets prepared using drug-loaded chitosan microspheres. Eur J Pharm Biopharm. 2002; 53(2):233-9. DOI: 10.1016/s0939-6411(01)00237-5. View

Park C, Munday D . Development and evaluation of a biphasic buccal adhesive tablet for nicotine replacement therapy. Int J Pharm. 2002; 237(1-2):215-26. DOI: 10.1016/s0378-5173(02)00041-8. View

Kerec M, Bogataj M, Mugerle B, Gasperlin M, Mrhar A . Mucoadhesion on pig vesical mucosa: influence of polycarbophil/calcium interactions. Int J Pharm. 2002; 241(1):135-43. DOI: 10.1016/s0378-5173(02)00231-4. View

Martin L, Wilson C, Koosha F, Uchegbu I . Sustained buccal delivery of the hydrophobic drug denbufylline using physically cross-linked palmitoyl glycol chitosan hydrogels. Eur J Pharm Biopharm. 2003; 55(1):35-45. DOI: 10.1016/s0939-6411(02)00118-2. View

Gavini E, Sanna V, Juliano C, Bonferoni M, Giunchedi P . Mucoadhesive vaginal tablets as veterinary delivery system for the controlled release of an antimicrobial drug, acriflavine. AAPS PharmSciTech. 2003; 3(3):E20. PMC: 2784049. DOI: 10.1208/pt030320. View

Llabot J, Manzo R, Allemandi D . Double-layered mucoadhesive tablets containing nystatin. AAPS PharmSciTech. 2003; 3(3):E22. PMC: 2784051. DOI: 10.1208/pt030322. View

Capan Y, Jiang G, Giovagnoli S, Na K, DeLuca P . Preparation and characterization of poly(D,L-lactide-co-glycolide) microspheres for controlled release of human growth hormone. AAPS PharmSciTech. 2003; 4(2):E28. PMC: 2750591. DOI: 10.1208/pt040228. View

Mahaguna V, Talbert R, Peters J, Adams S, Reynolds T, Lam F . Influence of hydroxypropyl methylcellulose polymer on in vitro and in vivo performance of controlled release tablets containing alprazolam. Eur J Pharm Biopharm. 2003; 56(3):461-8. DOI: 10.1016/s0939-6411(03)00116-4. View

10.

Chowdary K, Srinivasa Rao Y . Design and in vitro and in vivo evaluation of mucoadhesive microcapsules of glipizide for oral controlled release: a technical note. AAPS PharmSciTech. 2003; 4(3):E39. PMC: 2750632. DOI: 10.1208/pt040339. View

11.

Walle T, Conradi E, Walle U, Fagan T, Gaffney T . The predictable relationship between plasma levels and dose during chronic propranolol therapy. Clin Pharmacol Ther. 1978; 24(6):668-77. DOI: 10.1002/cpt1978246668. View

12.

Tanaka M, Yanagibashi N, Fukuda H, Nagai T . Absorption of salicylic acid through the oral mucous membrane of hamster cheek pouch. Chem Pharm Bull (Tokyo). 1980; 28(4):1056-61. DOI: 10.1248/cpb.28.1056. View

13.

Schoenwald R, Huang H . Corneal penetration behavior of beta-blocking agents I: Physiochemical factors. J Pharm Sci. 1983; 72(11):1266-72. DOI: 10.1002/jps.2600721108. View

14.

Cid E, Mella F, Lucchini L, Carcamo M, Monasterio J . Plasma concentrations and bioavailability of propranolol by oral, rectal, and intravenous administration in man. Biopharm Drug Dispos. 1986; 7(6):559-66. DOI: 10.1002/bdd.2510070605. View

15.

Park H, Robinson J . Mechanisms of mucoadhesion of poly(acrylic acid) hydrogels. Pharm Res. 1987; 4(6):457-64. DOI: 10.1023/a:1016467219657. View

16.

Benes L, Claustrat B, Horriere F, Geoffriau M, Konsil J, Parrott K . Transmucosal, oral controlled-release, and transdermal drug administration in human subjects: a crossover study with melatonin. J Pharm Sci. 1997; 86(10):1115-9. DOI: 10.1021/js970011z. View

17.

Remunan-Lopez C, Portero A, Alonso M . Design and evaluation of chitosan/ethylcellulose mucoadhesive bilayered devices for buccal drug delivery. J Control Release. 1998; 55(2-3):143-52. DOI: 10.1016/s0168-3659(98)00044-3. View

18.

Agarwal V, Mishra B . Design, development, and biopharmaceutical properties of buccoadhesive compacts of pentazocine. Drug Dev Ind Pharm. 1999; 25(6):701-9. DOI: 10.1081/ddc-100102229. View

19.

Chen L, Chetty D, Chien Y . A mechanistic analysis to characterize oramucosal permeation properties. Int J Pharm. 1999; 184(1):63-72. DOI: 10.1016/s0378-5173(99)00091-5. View

20.

Alur H, Pather S, Mitra A, Johnston T . Evaluation of the gum from Hakea gibbosa as a sustained-release and mucoadhesive component in buccal tablets. Pharm Dev Technol. 1999; 4(3):347-58. DOI: 10.1081/pdt-100101370. View