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.

An implant for the control of parasites in livestock comprising an isoxazoline compound of Formula (I) or salt or solvate thereof, wherein the implant comprises one or more pellets each of which comprises the isoxaxoline compound and a pharmaceutically acceptable excipient and a method of preventing or treating a parasite infestation using the same. ##STR00001##

The present invention relates to delayed release pharmaceutical compositions comprising linaclotide or pharmaceutically acceptable salts thereof, as well as to various methods and processes for the preparation and use of the compositions.

The present invention relates to Rapid melt granules prepared by encapsulation and complexation processes. The present invention specifically relates to Rapid melt granules prepared by novel process of particulate coating comprising the steps of encapsulation of active ingredient with encapsulation polymer and/or pore former, drying, blending, optionally polymer coating, drying before blending and filling into sachets or compressing into tablets. The present invention more specifically relates to Rapid melt granules prepared by novel process of complexation comprising the steps of complexation of active ingredient with sulfonated polymers of ion exchange resin, drying, blending, optionally polymer coating, drying before blending and filling into sachets or compressing into tablets.

Provided herein are methods of treating or ameliorating a pediatric cholestatic liver disease by non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTI) or a pharmaceutically acceptable salt thereof. Also provided are methods for treating or ameliorating a pediatric liver disease, decreasing the levels of serum bile acids or hepatic bile acids, treating or ameliorating pruritis, reducing liver enzymes, or reducing bilirubin comprising non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an ASBTI or a pharmaceutically acceptable salt thereof.

The present invention relates to a modified-release composition comprising orlistat and acarbose, comprising individually distinct parts with different release patterns: a) a first part, G1, comprising from about 5 to about 70% w/w of the total dose of acarbose, b) a second part, G2A, comprising from about 30 to about 95% w/w of the total dose of acarbose, c) a third part, G2B, comprising from about 10 to about 90% w/w of the total dose of orlistat, and d) a fourth part, G3, comprising from about 10 to about 80% w/w of the total dose of orlistat, and the total concentration of acarbose and orlistat, respectively, in the composition is 100% w/w.

Described herein are stable orally disintegrating tablets containing a proton pump inhibitor, methods for making the same, and methods for treating subjects in need thereof. In particular, the orally disintegrating tablets are composed of a plurality of coated units admixed with a disintegrant that demonstrate decreased friability and increased hardness.

Temperature-stable, gastric-resistant formulation suitable for oral and sustained delivery of proteins, including insulin, and for nucleic acids (e.g., DNA, RNA), and related methods of making and use are described. In an embodiment, The thermostable and acid-stable pharmaceutical composition includes an inclusion complex, where the inclusion complex includes a lipophilic active pharmaceutical ingredient-carrier ionic association complex encapsulated in a β-cyclodextrin or derivative thereof. In an embodiment, the pharmaceutical composition ion-pair complex encapsulated in the β-cyclodextrin or derivative thereof is in the form of a convenient dissolvable tablet dosage form.

This application relates to pharmaceutical compositions, comprising solabegron that are useful for the treatment of lower urinary tract symptoms such as, for example, overactive bladder and prostate disorders. Additionally, this application relates to methods for treating lower urinary tract symptoms utilizing the pharmaceutical compositions, comprising solabegron. In some embodiments, the pharmaceutical compositions, comprising solabegron comprise a dual release drug delivery system.

A solid or semi-solid pharmaceutical dosage form comprising non-steroidal-anti-inflammatory drugs, in particular propionic acid derivatives such as ibuprofen, along with a second active ingredient having a shorter therapeutically effective plasma concentration duration, such as phenylephrine, and methods of administering the same are provided. This method provides improved therapeutic effect, in particular pain relief along with decongestant relief, over extended time periods.