Drug-loaded microbead compositions include microbeads of a biodegradable material and vesicular agents located within or associated with the biodegradable material of the microbeads. The vesicular agents include a lipid bilayer and comprise liposomes or ethosomes. The drug-loaded microbeads include a first therapeutic agent associated with the vesicular agents, and a second therapeutic agent different from the first therapeutic agent. The vesicular agents include a lipid bilayer surrounding a vesicular core. The second therapeutic agent is contained within the microbeads or associated with the microbeads through ionic or non-covalent interaction and may or may not be associated with the vesicular agents. Drug-loaded biodegradable microbead compositions include microbeads of biodegradable material and a therapeutic agent.

A dosage form contains a) a core, containing a biologically active ingredient, which is stable to a degree of at least 95% at a pH of 3 for 2 hours at 22° C.; b) an intermediate coating layer (ICL) onto or above the core, containing an alkaline agent; and c) an enteric coating layer (ECL) onto or above the intermediate coating layer, containing an enteric polymer. The relation in percent of the alkaline agent in the ICL to the enteric polymer in the ECL is 5 to 95% when calculated by the formula:

[00001]$\frac{\begin{array}{cc}\mathrm{quantity}\mathrm{of}\mathrm{alkaline}\mathrm{agent}\mathrm{in}\mathrm{grams}\mathrm{in}\mathrm{the}\mathrm{ICL}& \times 100\end{array}}{\left(\mathrm{quantity}\mathrm{of}\mathrm{alkaline}\mathrm{agent}\mathrm{in}\mathrm{grams}\mathrm{in}\mathrm{the}\mathrm{ICL}+\mathrm{quantity}\mathrm{of}\mathrm{enteric}\mathrm{polymer}\mathrm{in}\mathrm{grams}\mathrm{in}\mathrm{the}\mathrm{ECL}\right).}$

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 present disclosure provides extended release trihexyphenidyl compositions suitable for once- or twice-daily administration. The compositions comprise a core comprising organic acid that is coated with at least one drug layer comprising trihexyphenidyl hydrochloride, and a functional coat over the drug-layered core. The extended release compositions of the disclosure provide extended release of trihexyphenidyl hydrochloride, with reduced C.sub.max, and a C.sub.min:C.sub.max ratio of ≥0.4, while maintaining a therapeutically effective concentration for a period of at least about 16 hours. The compositions of the disclosure improve solubility of trihexyphenidyl hydrochloride, at a pH of greater than or equal to 5, to maintain its minimum effective concentration at such pH. In certain embodiments, the compositions of the disclosure comprise an IR drug layer to provide extended release with a minimal lag time, while maintaining a therapeutically effective concentration of trihexyphenidyl hydrochloride for a period of at least about 16 hours.

Provided is a granule in which an unpleasant taste of an active ingredient is masked and immediate release of the active ingredient is maintained, and a method for producing the granule. In particular, provided is the granule containing zinc acetate as an active ingredient having an unpleasant taste, and a method for producing the granule.

A method for producing a granule in which an unpleasant taste of an active ingredient is masked and immediate release of the active ingredient is maintained. The method includes a step (1) of obtaining a core particle containing an active ingredient having an unpleasant taste, a step (2) of coating a surface of the core particle obtained in the step (1) with ethylcellulose to obtain a particle, and a step (3) of subjecting the particle obtained in the step (2) to a heat treatment in a closed state.

The present invention relates to pharmaceutical compositions containing 2-((3-(4-cyanonaphthalen-1-yl)pyridine-4-yl)thio)-2-methylpropanoic acid or a pharmaceutically acceptable salt (hereinafter referred to as the “Agent”), more particularly to orally deliverable compositions containing the Agent; to the use of said compositions as a medicament; and to processes for the preparation of said compositions.

Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.

Masking particles which comprise a drug-containing particle containing a drug, an acid, and a carbonate, the drug-containing particle being coated with a coating layer containing a water-insoluble polymer sufficiently suppress drug release in the oral cavity and pharynx, rapidly release a drug after swallowing, and easily control the release suppression time of a drug. The acid may be at least one organic acid. The carbonate may be at least one water-soluble carbonate. Oral pharmaceutical compositions include tablets, granules, fine granules, powders.

The present invention relates to an extended release multiparticulate composition comprising a plurality of discrete units, each discrete unit comprising ranolazine or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients. The said multiparticulate composition is sprinkled onto soft foods or liquids for oral administration. Further, the multiparticulate composition is bioequivalent to the marketed extended release tablet. It further relates to a process of preparation of said multiparticulate composition and method of treatment of patients suffering from angina by administering said composition.

The present invention relates to extended release liquid compositions of metformin. The extended release liquid compositions are in the form of suspensions or reconstituted powder for suspensions. Said extended release liquid compositions comprise cores of metformin coated with a release-controlling agent, wherein the coated cores are dispersed in a suspension base. Said extended release liquid compositions provide the desired uniform extended release profile throughout the shelf-life of the composition. Furthermore, said extended release liquid compositions are bioequivalent to a reference composition. It also relates to processes for the preparation of said extended release liquid compositions.