Limited release lingual thioctic acid delivery systems
AssigneeMolecular Product Management, LLC
InventorsJeffery Lee Benjamin, JR., William Carlton Zolentroff
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Abstract
A diffusion rate limiting matrix is utilized to buccally, lingually and/or sublingually deliver thioctic acid. This limited release matrix is intended for general nutritional supplementation and/or the treatment of various physiological disorders. Due to its lingual nature, this rate limiting matrix can deliver approximately IV-equivalent plasma levels of thioctic acid and is not meant to be swallowed.
Claims21
1-33. (canceled)
34) A method of minimizing a thioctic acid burn effect by preventing high concentrations of thioctic acid in a mouth when administering thioctic acid to the mouth, including lingual and sublingual administration, comprising:
- (A) a thioctic acid burn effect;
- (B) providing a formulation comprising:
- (i) a slow release matrix;
- (ii) a composition and method of manufacture of said matrix;
- (iii) wherein a dissolution rate of said matrix being dependent on said matrix composition and method of manufacture;
- (iv) a concentration of thioctic acid ranging from 1% to 25% by mass;
- (v) a first particular 36 gram lozenge having a first density equal to typical sucrose-based hard candies;
- (vi) a formulation surface area;
- (vii) wherein a size of said formulation surface area being less than a minimum surface area of said first lozenge;
- (viii) a thioctic acid release rate;
- (ix) wherein said thioctic acid release rate determining the degree of said thioctic acid burn effect,
- (x) wherein determining said thioctic acid release rate as being acceptably slow, when said thioctic acid burn effect being minimized to acceptable levels, while said formulation dissolving in a user's mouth and said formulation remaining intact, to the degree that said formulation surface area not exceeding said formulation's original surface area;
- (xi) wherein selecting said matrix method of manufacture and matrix composition, selecting said thioctic acid concentration, and selecting said formulation surface area, for providing said acceptably slow thioctic acid release rate;
- (C) administering said formulation to said user's mouth;
- (D) wherein said formulation remaining in said user's mouth while dissolving;
- and
- (E) said formulation remaining intact while dissolving, to a degree that said formulation surface area remaining less than said formulation's original surface area.
42) A method of minimizing a thioctic acid burn effect by preventing high concentrations of thioctic acid in a mouth when administering thioctic acid to the mouth, including lingual and sublingual administration, comprising:
- (A) a thioctic acid burn effect;
- (B) providing a formulation comprising:
- (i) a limited release matrix;
- (ii) a composition and method of manufacture of said matrix;
- (iii) wherein a dissolution rate of said matrix being dependent on said matrix composition and method of manufacture;
- (iv) a concentration of thioctic acid ranging from 1% to 25% by mass;
- (v) a first particular 36 gram lozenge having a first density equal to typical sucrose-based hard candies;
- (vi) a formulation surface area;
- (vii) wherein a size of said formulation surface area being less than a minimum surface area of said first lozenge;
- (viii) a thioctic acid release rate;
- (ix) wherein said thioctic acid release rate determining the degree of said thioctic acid burn effect,
- (x) wherein determining said thioctic acid release rate as being acceptably slow, when said thioctic acid burn effect being minimized to acceptable levels, while said formulation dissolving in a user's mouth and said formulation remaining intact, to the degree that said formulation surface area not exceeding said formulation's original surface area;
- (xi) wherein selecting said matrix method of manufacture and matrix composition, selecting said thioctic acid concentration, and selecting said formulation surface area, for providing said acceptably slow thioctic acid release rate;
- (C) administering said formulation to said user's mouth;
- (D) wherein said formulation remaining in said user's mouth while dissolving;
- and
- (E) said formulation remaining intact while dissolving, to a degree that said formulation surface area remaining less than said formulation's original surface area.
Dependencies are inferred from the claim text.