DESC:It has surprisingly been found that melt composite of the present invention, comprising one or more curcuminoids and carrier selected from rice bran extract, mannitol, maltodextrin and mixture thereof, exhibit rapid dissolution and enhanced bioavailability of the curcuminoid(s). The carriers as used herein may be obtained from natural source. The composites may further optionally be comprised of at least one excipient acceptable for pharmaceutical, nutraceutical, cosmetic or food industry.

The present invention uses curcuminoid extract of Curcuma species of the Zingiberaceae (ginger) family.

The term ‘curcuminoid extract’ is used herein to mean the extract of roots, tubers or rhizomes of the Curcuma species of the Zingiberaceae (ginger) family including but not limited to species like Curcuma longa, Curcuma amada, Curcuma angustifolia, Curcuma caesia, Curcuma zedoaria, Curcuma caulina, Curcuma aromatica, Curcuma wenyujin, Curcuma xanfhorrhiza, Curcuma phaeocaulis, Curcuma leucorrhiza and Curcuma kwangsiensis.

The term ‘curcuminoid’ is used herein to mean curcumin (diferuloylmethane), desmethoxycurcumin, or bisdesmethoxycurcumin, including their polymorphs, hydrates, solvates, derivatives, and mixtures thereof. The curcuminoid may be obtained by natural or synthetic means.

The term ‘melt composite’ as used herein refers to a composition which exists as a combination of two or more components that results in better or enhanced properties than those of the individual components used alone. These properties can be related to performance of the product like dissolution, stability, bioavailability and the like. Such composition in present context can be prepared by specific process, using conditions of controlled heat treatment and granulation. The components in present invention are one or more curcuminoids, carrier selected from rice bran extract, mannitol, maltodextrin and mixture thereof, along with one or more excipient, which may be optionally added during the process of preparation. The carrier used in the composite is obtained from natural source.

The one or more curcuminoids in the composition may be in their crystalline form or in the amorphous form or as mixtures of crystalline and amorphous forms.

As per one embodiment of the invention, the present composition uses a curcuminoid extract containing at least 30% by weight of one or more curcuminoids. The curcuminoid content in the extract is preferably in the range of 30% to 100%, more preferably in the range of 50% to 95%, and most preferably in the range of 70% to 95% by weight of the extract.

As per one more embodiment of the invention, the curcuminoid(s) may be present in concentrations from 5% to 90% by weight of the composition. More preferably curcuminoids may be present in concentrations from 10 to 85% by weight of the composition.

According to one embodiment of the invention, the ratio of the curcuminoid(s) to carrier, in the melt composite ranges from about 1:0.1 to about 1:20 preferably from about 1:0.15 to about 1:15 and more preferably from about 1:0.2 to about 1:10.

In one of the embodiments of the present invention, the melt composite is comprised of about 10% to about 95% carrier by weight of the composition.

As per one embodiment of the present invention, the melt composite may be comprised of one or more curcuminoids and carrier selected from rice bran extract, mannitol, maltodextrin and mixture thereof.
As per still one more embodiment, the composite may be comprised of one or more curcuminoids and a mixture of rice bran and mannitol as a carrier.
According to one embodiment, the composite may be comprised of one or more curcuminoids and a mixture of rice bran extract and maltodextrin as a carrier.
According to still one more embodiment, the melt composite may preferably be comprised of one or more curcuminoids and a mixture of rice bran extract, mannitol and maltodextrin.

In one of the embodiments, the melt composite comprises rice bran extract at a concentration of about 10% to about 95% by the weight of the melt composite.

The rice bran extract generally contains varied concentrations of proteins, fats, and carbohydrates.

For example, one type of rice bran extract has protein content of about 13% to about 18%, fat content of about 15% to about 25% and carbohydrate content of about 40% to about 52%, when considered by weight of the extract.

Another type of rice bran extract has protein content of about 14% to about 20%, fat content of about 18% to about 21% and carbohydrate content of about 33% to about 40%, when considered by weight of the extract.

The fat content of the extract may vary from about 14% to about 18% for a full fat rice bran, about 3% to about 14% for low fat rice bran or less than about 3% for de-fatted rice bran.
Another type of rice bran extract may have protein content of about 12% to about 14%, fat content of about 15% to about 19% and carbohydrate content of 40% to about 45%, when considered by weight of the extract.

Other types of rice bran extract may have protein content of about 9% to about 13%, fat content of about 12% to about 18% and carbohydrate content of 64% to about 71%, when considered by weight of the extract.

Yet another type of rice bran extract may have protein content of about 8% to about 10%, fat content of about 6% to about 9% and carbohydrate content of 77% to about 82%, when considered by weight of the extract.

Yet another type of rice bran extract may have protein content of about 11% to about 15%, fat content of about 1% to about 20% and carbohydrate content of 34% to about 65%, when considered by weight of the extract.

The curcuminoid melt composites may comprise mixtures of rice bran extract and mannitol, wherein the ratio of the curcuminoid(s) to the said mixture ranges from 1:0.1 to 1:20.

As per one embodiment of the invention, the curcuminoid melt composites may comprise one or more curcuminoids, rice bran extract and mannitol, in the ratio ranging from 1:0.05:0.1 to 1:10:10 and preferably ranging from 1:0.1:0.2 to 1:8:9.

According to one embodiment, curcuminoid melt composite may comprise mixtures of rice bran extract and maltodextrin, wherein the ratio of the curcuminoid(s) to the said mixture ranges from 1:0.1 to 1:20.

The curcuminoid melt composites may comprise one or more curcuminoids, rice bran extract and maltodextrin, in the ratio ranging from 1:0.05:0.1 to 1:10:10 and preferably ranging from 1:0.1:0.2 to 1:8:9.
The melt composite may optionally be comprised of at least one more excipient selected from diluents, carriers, binders, disintegrants, lubricants, glidants, solubilizers, carriers, vehicles, stabilizers, buffers, preservatives, acidifiers, alkalizers, sorbents, antioxidants, complexing agents, viscosity enhancers, plasticizers, coating materials, sweeteners, colors, and flavors. The optional excipient may be intragranularly or extragranularly added in the melt composite.

As per one embodiment, the optional excipient comprised in the melt composite may be selected from the group of polysaccharide and polysaccharide hydrocolloids, but not limited to mucilages, glucans and gums such as acacia, tragacanth, karaya, xanthan gum, gellan gum, karaya gum, gum ghatti, Hibiscus mucilage, alginates, chitosan, carrageenan, pullulan, fucoidan, hyaluronan and the mixtures thereof;
sugar alcohols selected from, but not limited to xylitol, sorbitol, arabitol, erythritol, glycerol, isomalt, lactitol, maltitol;
Starch and starch sugars selected from, but not limited to corn starch, tapioca, arrowroot, and wheat, rice, and potato starches. glucose, dextrose, fructose, and the mixtures thereof;
The excipients which may be optionally used as per the invention can aid the processing of the melt composite to final granular or powder form. These excipients can be also selected from the group of, but not limited to silicon dioxide, citric acid and the like.

The melt composites of the present invention do not necessarily use surfactants to achieve the desired objective.

The melt composites of the present invention can be manufactured using the techniques such as melt granulation, melt extrusion, melt solidification, melt spray congealing and the like, wherein the components of the composite can be subjected to controlled conditions of heating, followed by granulation.

The compositions of the melt composites of the present invention may be tablets, effervescent tablets, orally-disintegrating tablets, mouth dissolving tablets, sublingual tablets, buccal tablets, capsules, pills, chewing gums, films, powders, granules, beads, pellets, lozenges, pastilles, soft-gels, jellies, semi-solid, pastes, syrups, elixirs, solutions, suspensions, dispersions, and emulsions and the like.

The melt composites can be formulated in suitable compositions by using one or more excipients acceptable in pharmaceutical, nutraceutical, cosmetics or food industry. The compositions comprising the said melt composites may be manufactured by conventional processes known to a person skilled in the art. The compositions are useful for human and animal consumption in various applications such as joint health, brain health, skin and personal care, sports nutrition and liver health.

The melt composites and their compositions are analyzed for their dissolution in accordance with the recommendation of Dietary Supplements Compendium (DSC) 2015, United States pharmacopeia (USP) using the following conditions: 900 ml of purified water containing 1% sodium lauryl sulphate, USP apparatus II (paddle) at 100 revolutions per minute, 370C. The pharmacokinetics of curcuminoid melt composites of the present invention is studied in animal model and bioavailability study of curcuminoid composition filled in capsules is carried out in healthy volunteers in comparison to standard curcuminoid extract capsules, which is used as a reference formulation.

The invention is now illustrated with non – limiting examples.
,CLAIMS:1. A melt composite comprising one or more curcuminoids and carrier selected from rice bran extract, mannitol, maltodextrin and mixture thereof; wherein said composite exhibits rapid dissolution and enhanced bioavailability.
2. Melt composite as claimed in claim 1, wherein one or more curcuminoids comprise about 5 to 90% by weight of the composition.
3. Melt composite as claimed in claim 1, wherein the ratio of curcuminoid to carrier ranges from about 1:0.1 to 1:20.
4. Melt composite as claimed in claim 1, wherein ratio of one or more curcuminoids to rice bran extract ranges from about 1:0.1 to 1: 20.
5. Melt composite as claimed in claim 1, wherein ratio of one or more curcuminoids to maltodextrin ranges from about 1:0.1 to 1: 20.
6. Melt composite as claimed in claim 1, wherein ratio of one or more curcuminoids to mannitol ranges from about 1:0.1 to 1: 20.
7. Melt composite as claimed in claim 1, wherein the ratio of one or more curcuminoids to the mixture of rice bran extract and maltodextrin ranges from 1:0.1 to 1:20.
8. Melt composite as claimed in claim 1, wherein the ratio of one or more curcuminoids, rice bran extract and mannitol ranges from 1:0.05:0.1 to 1:10:10.
9. Melt composite as claimed in claim 1, wherein the ratio of one or more curcuminoids, rice bran extract and maltodextrin ranges from 1:0.05:0.1 to 1:10:10.
10. Melt composite as claimed in claim 1, which may be optionally comprised of at least one or more excipient selected from diluents, binders, disintegrants, lubricants, glidants, solubilizers, vehicles, stabilizers, buffers, sorbents, antioxidants, complexing agents, viscosity enhancers, plasticizers, coating materials, sweeteners, colours, flavors and the combination thereof.
11. A process for preparing curcuminoid composite comprising one or more curcuminoids and carrier selected from rice bran extract, mannitol, maltodextrin and mixture thereof, comprising steps of
a. mixing one or more curcuminoids and a carrier selected from rice bran extract, mannitol, maltodextrin and mixture thereof
b. subjecting the mixture to heat treatment to obtain a molten mass
c. extruding the molten mass to obtain the extrudates
d. optionally adding one more excipient to above mixture
e. cooling and milling the extrudates