A dosage form contains a biologically active ingredient for treating or preventing a disease in the animal or human body, where treatment or prevention requires release of 50% or more of the biologically active ingredient in the small intestine within the pH range from 3 to 5.5. The dosage form contains: a) a core, containing the biologically active ingredient; 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 ICL, containing an enteric polymer. The relation of alkaline agent to enteric polymer is 5 to 95% when calculated by the formula:

[00001]$\frac{\mathrm{quantity}\mathrm{of}\mathrm{alkaline}\mathrm{agent}\mathrm{in}\mathrm{grams}\mathrm{in}\mathrm{the}\mathrm{ICL}\times 100}{\begin{array}{c}(\mathrm{quantity}\mathrm{of}\mathrm{alkaline}\mathrm{agent}\mathrm{in}\mathrm{grams}\mathrm{in}\mathrm{the}\mathrm{ICL}+\\ \mathrm{quantity}\mathrm{of}\mathrm{enteric}\mathrm{polymer}\mathrm{in}\mathrm{grams}\mathrm{in}\mathrm{the}\mathrm{ECL}).\\ \mathrm{The}\mathrm{ICL}\mathrm{has}a\mathrm{thickness}\mathrm{of}\mathrm{about}22\mu m\mathrm{or}\mathrm{more}.\end{array}}$

The presently disclosed subject matter relates to a composition and method of using the composition for oral delivery of a bioactive agent to a subject. More particularly, the presently disclosed subject matter relates to a composition comprising an effective amount of at least one bioactive agent layered over a substrate and a method of reducing zoonotic infectious disease by administering the composition to a subject. The presently disclosed subject matter further relates to a method of preparing the composition.

The invention is related to the fully effective gastro-protected universal oral delivery device of gastro-protected nanoparticles for the transport of intact biologically active polypeptides into the circulatory system. This universal oral delivery device is made of gastro-protected nanoparticles that transport intact therapeutic polypeptides through the gastrointestinal system and it successfully performs the paracellular transepithelial passage of all therapeutic polypeptides from the intestinal lumen into the circulatory system, fully preserving the integrity and biological activity of those therapeutic polypeptides.

A multi-particle dosage form that can deliver phenylephrine in controlled pulsed doses. The dosage form can contain an immediate release form that can contain phenylephrine or a salt thereof and a plurality of delayed release particles with a coating that can contain phenylephrine or salt thereof and a pH sensitive coating.

The invention is directed to oral modified/controlled release drug formulations which provide a rapid initial onset of effect and a prolonged duration of effect. Preferably, the peak concentration is lower than that provided by the reference standard for immediate release formulations of the drug, and the duration of effect falls rapidly at the end of the dosing interval.

Disclosed is a pharmaceutical composition containing dabigatran etexilate and a preparation method thereof. The pharmaceutical composition comprises a pharmaceutically active ingredient, dabigatran etexilate and/or dabigatran etexilate mesylate, and a amphiphilic polymer of polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer. The mass ratio of the two is 1:0.23 to 1:3. The pharmaceutical composition not only increases the bioavailability of the pharmaceutically active ingredient, but also reduces absorption variability, and provides a more stable concentration of dabigatran in plasma, thereby reducing adverse side effects.

The present invention relates to a gastroretentive extended release suspension composition, wherein the composition is characterized by having no substantial change in the in-vitro dissolution release profile upon storage for at least seven days. The invention also relates to processes for the preparation of said gastroretentive extended release suspension compositions.

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.

An abuse deterrent pharmaceutical composition including a drug susceptible to abuse, a first acid soluble ingredient, a first buffering ingredient, and a delayed release buffering component.