The present invention provides a composition and method for preventing or healing injured nipples or areolas in mammalian females utilizing components of water, peppermint oil and poloxamer in a synergistic ratio.

The invention relates to an extract of Ashwagandha that exhibit enhanced bioactivity and bioavailability comprising of enriched withanolide glycosides and saponins; with negligible amount of alkaloids, withanolide aglycones and oligosaccharides. The extract as disclosed prepared from root, stems, leaves and whole plant of Ashwagandha further shows improved immunomodulatory activity, anti-inflammatory activity, anti stress activity, antidiabetic activity and sleep quality. The disclosure also provides a method of improving bioactivity of withanolide glycosides even at lower doses, by the administration of an enteric coated formulation of extract of Ashwagandha to humans. The enteric coating protects the composition from hydrolysis in the acidic environment of the stomach to release the withanolide glycoside in neutral/alkaline pH in gastrointestinal tract (GIT) thus enhancing the absorption. Further the process of preparation of the extract of Ashwagandha enriched with withanolide glycosides and saponins are disclosed along with various formulations.

The invention relates to an extract of Ashwagandha that exhibit enhanced bioactivity and bioavailability comprising of enriched withanolide glycosides and saponins; with negligible amount of alkaloids, withanolide aglycones and oligosaccharides. The extract as disclosed prepared from root, stems, leaves and whole plant of Ashwagandha further shows improved immunomodulatory activity, anti-inflammatory activity, anti stress activity, antidiabetic activity and sleep quality. The disclosure also provides a method of improving bioactivity of withanolide glycosides even at lower doses, by the administration of an enteric coated formulation of extract of Ashwagandha to humans. The enteric coating protects the composition from hydrolysis in the acidic environment of the stomach to release the withanolide glycoside in neutral/alkaline pH in gastrointestinal tract (GIT) thus enhancing the absorption. Further the process of preparation of the extract of Ashwagandha enriched with withanolide glycosides and saponins are disclosed along with various formulations.

The invention provides oral terpene cyclodextrin inclusion complex delivery vehicles, including formulations in which the cyclodextrin inclusion complex is provided together with enzyme having a cyclodextrin-degrading activity capable of digesting the cyclodextrin, so that upon delivery of the vehicle to a target the enzyme is activated and releases the guest molecule from the cyclodextrin cavity. In alternative aspects, these cyclodextrin inclusion complex delivery vehicles are for example provided in the form of time release formulations, for example for treatment of airway mucus dysfunction. Formulations are also provided with erectogenic efficacy.

The invention provides oral terpene cyclodextrin inclusion complex delivery vehicles, including formulations in which the cyclodextrin inclusion complex is provided together with enzyme having a cyclodextrin-degrading activity capable of digesting the cyclodextrin, so that upon delivery of the vehicle to a target the enzyme is activated and releases the guest molecule from the cyclodextrin cavity. In alternative aspects, these cyclodextrin inclusion complex delivery vehicles are for example provided in the form of time release formulations, for example for treatment of airway mucus dysfunction. Formulations are also provided with erectogenic efficacy.

Provided are methods and devices useful for treating a respiratory disease or disorder involving the central or upper airways. The methods and devices deliver to central or upper airways of a subject a vapor or aerosol comprising an effective amount of an active ingredient selected from the group consisting of menthol, menthone, neomenthol, isomenthol, and menthofuran. The methods are useful for treating conditions including cough, asthma, bronchitis, and allergic rhinitis.

Provided are methods and devices useful for treating a respiratory disease or disorder involving the central or upper airways. The methods and devices deliver to central or upper airways of a subject a vapor or aerosol comprising an effective amount of an active ingredient selected from the group consisting of menthol, menthone, neomenthol, isomenthol, and menthofuran. The methods are useful for treating conditions including cough, asthma, bronchitis, and allergic rhinitis.

A method of preventing or treating solid and soft tumors and proliferative diseases in a subject in need thereof is provided. The method comprising administering to the subject an effective amount of a plant species or genus thereof-derived component selected from the group consisting of a plant part, extract thereof, fraction thereof, active ingredient thereof, synthetic analog thereof, mimetic thereof or combination thereof, wherein the component is capable of treating solid and soft tumors and proliferative diseases and wherein the plant species is selected from the group consisting of Nigella sativa, Thymuscapitatus, Thymus vulgaris, Origanum syriacum, Thymbra spicata, Satujera thymbra, Sesamum indicum, Rhus coriaria, Gynostemma pentaphyllum, Boswellia sacra and Panaxginseng, preventing or treating solid and soft tumors and proliferative diseases in the subject.

A method of preventing or treating solid and soft tumors and proliferative diseases in a subject in need thereof is provided. The method comprising administering to the subject an effective amount of a plant species or genus thereof-derived component selected from the group consisting of a plant part, extract thereof, fraction thereof, active ingredient thereof, synthetic analog thereof, mimetic thereof or combination thereof, wherein the component is capable of treating solid and soft tumors and proliferative diseases and wherein the plant species is selected from the group consisting of Nigella sativa, Thymuscapitatus, Thymus vulgaris, Origanum syriacum, Thymbra spicata, Satujera thymbra, Sesamum indicum, Rhus coriaria, Gynostemma pentaphyllum, Boswellia sacra and Panaxginseng, preventing or treating solid and soft tumors and proliferative diseases in the subject.

Disclosed herein are formulations of a poly-herbal synergistic composition which exhibit marked immunomodulatory, anticancer, antiviral and anti-inflammatory properties. Also disclosed are the methods of preparing and using the same.