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Publication Number
US-9492547-B2
Publication Date
2016-11-15
Expiration Date
Abstract
The present invention relates to a new polymorphic form of inulin, designated delta inulin (dIN), to methods for the preparation of dIN, compositions comprising dIN and uses thereof. The present invention also relates to the use of dIN and compositions comprising dIN in the preparation of gamma inulin (gIN), compositions comprising gIN and uses thereof.
Core Innovation
The invention concerns inulin in a delta polymorphic form (delta inulin, dIN) that is distinguished by a 50% optical density at 700 nanometers (OD700) thermal transition point in dilute suspension within a temperature range of from 53°C to 58°C. This delta polymorphic form is distinct from other polymorphic forms of inulin, including alpha, beta, and gamma inulin.
The document describes that delta inulin is associated with thermal behavior in dilute suspension and that formation can occur near complete dissolution temperatures. It further describes that delta inulin can generate ghost fragments upon heating of gamma inulin (gIN), and that these ghost fragments act as micronuclei for recrystallisation to produce fine or ultrafine particulate gIN or dIN.
The particulate nature of the resulting inulin formulations is characterized by particle diameters described as below 1 μm and in the range of about 50 to 600 nm. The document links smaller particle formulations with enhanced immunological performance, including higher activity in the alternative pathway of complement (APC), enhanced seroconversion and antibody profiles, and reduced local reactogenicity.
Claims Coverage
The partial claim set contains two independent claims. Across the independent claims, there are four main inventive feature themes: delta polymorphic inulin defined by an OD700 thermal transition point, a preparation method that converts gamma inulin into delta inulin via heating conditions, particle size-constrained delta polymorphic inulin, and immune-response outcomes associated with APC activation.
Delta polymorphic inulin defined by OD700 thermal transition point
Inulin in a delta polymorphic form, wherein the inulin has a 50% OD700 thermal transition point in dilute suspension in a temperature range of from 53°C to 58°C.
Preparation of delta inulin by heating concentrated gamma inulin aqueous suspension
A method for the preparation of delta inulin, wherein the delta inulin has a 50% OD700 thermal transition point in dilute suspensions of from 53°C to 58°C, comprising heating a concentrated aqueous suspension comprising 10 mg/ml or greater gamma inulin, wherein the gamma inulin has a 50% OD700 thermal transition point in dilute aqueous suspensions less than 53°C, at a temperature of 50°C to 70°C for a time of from 30 minutes to 10 hours.
Particle size constrained delta polymorphic inulin
The inulin of claim 1 has particles whose majority have a diameter within about 50 nm to 600 nm.
Immune response including activation of alternative pathway of complement
The immune response includes activation of the alternative pathway of complement.
Overall, the claim coverage defines delta inulin by an OD700 thermal transition point in dilute suspension, provides a heating-based preparation route from gamma inulin with a lower transition point, characterizes particulate forms with a defined particle diameter majority range, and ties immune-response outcomes to activation of the alternative pathway of complement.
Stated Advantages
Smaller particles correlate with higher alternative pathway of complement (APC) activity.
Enhanced seroconversion and antibody profiles.
Reduced local reactogenicity in mice.
Documented Applications
Immunological compositions using delta inulin (dIN) and/or gamma inulin (gIN), including antigen-binding carrier materials and immune response stimulation with activation of the alternative pathway of complement (APC) for immune enhancement.
Anti-cancer treatment using immunological compositions involving delta inulin (dIN) and/or gamma inulin (gIN).
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