Mucoadhesive wafers for buccal delivery of probiotic bacteria: Mechanical properties and enumeration

The development of probiotic formulations has attracted great attention of researchers and industrial community. Their beneficial effects have been demonstrated in human health, and in buccal cavity including prevention of gingivitis, periodontitis, dental caries, oral candidiasis, and immunomodulation.

Highlights

Bifidobacterium bifidum BB12-mucoadhesive wafers were developed for oral cavity.

Wafers containing higher concentration of probiotics displayed lower enumeration.

The wafers containing less concentration of probiotics could be stored for 14 days.

These systems showed suitable mechanical properties for buccal application.

The development of mucoadhesive wafers as buccal systems is important to promote intimate contact between the probiotics and oral mucosa, as well as maintain the viability of anaerobic bacteria like Bifidobacterium bifidum BB12. The aim of this study was to develop wafers systems containing poloxamer 407, Carbopol 974 P®, probiotic microorganisms Bifidobacterium bifidum BB12 for oral cavity administration. Two concentrations of microorganisms were incorporated to the polymer blends and freeze-dried. The morphological, enumeration of bacteria and mechanical properties of the wafers with and without probiotic bacteria were examined. The most concentrated formulation demonstrated more difficulties in freeze-drying process and lower enumeration of B. bacterium BB12. The wafers containing probiotic microorganisms (1:10) could be stored during 14 days with probiotic benefits. Their mechanical properties were suitable, because of improved cohesiveness, adhesion properties and firmness in comparison to formulations without probiotics. The wafers were suitable to carry probiotic microorganisms for 14 days and suitable mechanical properties for buccal application. Continue on Mucoadhesive wafers for buccal delivery of probiotic bacteria

Keywords Bifidobacterium bifidum BB12, Mucoadhesion, Wafers, Poloxamer 407, Carbopol 974P

Excipient Information

Poloxamer 407 is a hydrophilic non-ionic surfactant of the more general class of copolymers known as poloxamers. Poloxamer 407 is a triblock copolymer consisting of a central hydrophobic block of polypropylene glycol flanked by two hydrophilic blocks of polyethylene glycol (PEG). The approximate lengths of the two PEG blocks is 101 repeat units, while the approximate length of the propylene glycol block is 56 repeat units. (Source: Wikipedia)
Kolliphor® P 407 is used primarily as thickening agent and gel former, as well as co-emulsifier and consistency enhancer in creams and liquid emulsions. For certain active substances such as nifedipine, naproxen and fenticonazole as well as for essential oils in pharmaceutical formulations Kolliphor® P 407 is also used as a polymeric solubilizer. In solid dispersions Kolliphor® P 407 can be used in physical mixing, melt granulation, spray drying and hot melt extrusion processes. Moreover, Kolliphor® P 407 is suitable for the formulation of active substances that show reduced solubility as well as chemical stability as a result of neutralization of gel formulations. Thanks to its ability to affect viscosity, it may also be used as stabilizer for topically administered suspensions and is used in tooth-pastes, gargles and mouthwashes. As dissolution enhancer, lubricant & wetting agent particularly Kolliphor® P 407 is specifically suitable for wet granulation processes. (Source: BASF)

Carbopol® 974P NF Polymer
Suitable applications for Carbopol® 974P NF: Oral and topical
Residual solvent for Carbopol® 974P NF: Ethyl acetate

Carbopol® 974P NF polymer was introduced for use in oral and mucosal contact applications such as oral liquids, bioadhesive formulations, oral care formulations and extended release tablets. Additionally, Carbopol 974P NF polymer can be used to formulate viscous gels, emulsions and suspensions.

It is a highly crosslinked polymer and produces highly viscous gels with rheology similar to mayonnaise. Drug release from extended release tablets is affected by differences in the rates of hydration and swelling of the polymer hydrogel, which are largely defined by the crosslinker levels. Lightly crosslinked polymers, such as Carbopol 971P NF polymer, tend to be more efficient in controlling drug release than highly crosslinked polymers such as Carbopol 974P NF polymer. (Source: Lubrizol)