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

There is provided a composition comprising a plurality of particles of a weight-, number-, or volume-, based mean diameter that is between amount 10 nm and about 700 .Math.m, which particles are made up of: (a) a solid core, which solid core preferably comprises a biologically active agent; (b) one or more discrete layers surrounding said core, said one or more layer s each comprising at least one separate coating material; and (c) a final overcoating layer of a coating material, which overcoating layer surrounds, encloses and/or encapsulates said core and said previously-applied layers of coating material, and which final layer is of a thickness that is less than said previously-applied layers. Said layers (b) and (c) are preferably applied by way of a gas phase coating technique, such as atomic layer deposition. When the cores comprise biologically active agent, the compositions may provide for the delayed or sustained release of said active agent without a burst effect.

This invention relates to a tablet containing, as an active ingredient, 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof, that has excellent disintegration ability, storage stability and photostability.

The tablet of the present invention comprising an uncoated tablet containing 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof as an active ingredient, excipients such as lactose, corn starch, and microcrystalline cellulose; disintegrants such as low-substituted hydroxypropylcellulose, croscarmellose sodium, and sodium carboxymethyl starch; binders such as hydroxypropylcellulose; lubricants such as stearate; and further comprising a coating layer, containing hypromellose; talc; titanium oxide; colorant; and the like, the coating layer being applied to the surface of the uncoated tablet.

Methods for improving the gastrointestinal tolerability of biguanide compounds and for treating metabolic disorders and/or inducing weight loss in patients in need thereof, particularly in individuals having a contraindication for treatment with biguanide compounds, are provided comprising administering delayed release formulations of such biguanide compounds, including metformin, targeted to the small intestine.

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 present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and/or a SGLT-2 inhibitor drug, and metformin XR, processes for the preparation thereof, and their use to treat certain diseases.

This invention relates to a dosage form of cabozantinib and a method of employing the dosage form to treat cancer.

A dosage form contains a biologically active ingredient for treating or preventing a disease in the animal or human body, where the 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 intermediate coating layer, containing an enteric polymer. The relation of the alkaline agent to the enteric polymer is 5 to 95% when calculated by the formula:

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

Provided herein are methods and compositions related to Prevotella bacteria for the reduction of IL-8, IL-6, IL-Iβ, and/C or TNFα expression and/or for the treatment of viral infections.

Formulations of mazindol having superior stability and methods of administering same are provided. The formulations may be immediate, enhanced, or otherwise delayed release formulations of mazindol.