Oral formulation of polyglucosamine derivatives in combination with a non-fermentable sugar
Inventors
Townsend, Stacy M. • Baker, Shenda M. • Wiesmann, William P.
Assignees
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Publication Number
US-10765616-B2
Publication Date
2020-09-08
Expiration Date
Abstract
Described herein are methods and compositions that contain a soluble polyglucosamine or polyglucosamine derivative for use in oral health. The compositions are useful for, e.g., reducing bacteria (e.g., by clumping and removing) or disrupting a biofilm in the mouth of a subject, reducing dry mouth, and reducing oral inflammation.
Core Innovation
The invention is directed to an oral care aqueous composition for treating dry mouth by administering to a subject a composition containing sorbitol, xylitol, and a soluble poly (acetyl, arginyl) glucosamine (PAAG) biopolymer. PAAG is defined by formula (I), with an integer n between 20 and 6000 and R1 substituents selected from hydrogen and acetyl, with at least 25% of R1 substituents being hydrogen and at least 1% being acetyl. The PAAG has a molecular weight from 20 to 200 kDa and is present at about 0.003% to about 0.05% w/v.
The composition is described as soluble across an oral-relevant pH range and includes aqueous excipients with optional additional agents such as glycerin, nonionic surfactants, flavoring, preservatives, and an optional fluoride anti-caries agent. The disclosure also includes embodiments with sorbitol and xylitol as non-fermentable sugars and PAAG-containing aqueous oral care compositions with defined formulation components.
The disclosure states that PAAG reduces oral biofilm/plaque via rapid bacterial aggregation through polycation–negatively charged EPS/phospholipid interactions. These effects are presented as potentially reducing oral inflammation associated with gingivitis, periodontitis, mucositis, stomatitis, and halitosis.
Claims Coverage
The independent claim is directed to treating dry mouth using an oral care aqueous composition with three principal inventive features: sorbitol, xylitol, and a structurally defined PAAG with specified molecular-weight and concentration ranges. Dependent claims further specify additional formulation components, PAAG functionalization constraints, and a pH range.
Treating dry mouth with sorbitol, xylitol, and PAAG
A method of treating dry mouth by administering an oral care aqueous composition comprising sorbitol, xylitol, and poly (acetyl, arginyl) glucosamine (PAAG).
Structurally defined PAAG
PAAG is defined by formula (I) where n is between 20 and 6000 and each R1 is independently selected from hydrogen and acetyl, with at least 25% of R1 substituents being hydrogen and at least 1% being acetyl.
PAAG molecular-weight range and concentration
The PAAG has a molecular weight from 20 to 200 kDa and is present in the composition at about 0.003% to about 0.05% w/v.
Additional formulation components for the aqueous composition
The composition further comprises glycerin and a flavoring agent, with additional optional agents including nonionic surfactants, preservatives, and an optional fluoride anti-caries agent.
Quantitative PAAG functionalization percentage
The PAAG is functionalized at about 5% to about 50%.
Narrow pH operating range
The method is carried out with a pH ranging from about 6 to about 8.
Claim coverage centers on treating dry mouth with an oral care aqueous composition containing sorbitol, xylitol, and PAAG defined by formula (I), constrained by a 20 to 200 kDa molecular-weight range and a presence level of about 0.003% to about 0.05% w/v, with dependent features adding formulation components, functionalization, and pH limits.
Stated Advantages
Reduction of oral biofilm/plaque via PAAG-mediated bacterial aggregation/clumping.
Potential reduction of oral inflammation, including gingivitis, periodontitis, mucositis, stomatitis, and halitosis.
Solubility across an oral-relevant pH range, with preferred pH ranges around pH 6 to 8.
Documented Applications
Treating dry mouth (xerostomia) by administering an oral care aqueous composition comprising sorbitol, xylitol, and PAAG.
Use of PAAG oral compositions to reduce oral biofilm/plaque and address oral inflammation associated with gingivitis, periodontitis, mucositis, stomatitis, and halitosis.
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