The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and a partner drug, processes for the preparation thereof, and their use to treat certain diseases.

The present invention relates to a solid oral dosage form comprising naproxen and vitamin B6. Preferably, it is a solid oral dosage form for use in the treatment of pain such as low back pain. It is a fixed-dose combination (FDC) which increases patient compliance. The method of preparing such solid oral dosage form comprises the extragranular addition of vitamin B6 to an intragranular composition, wherein said intragranular composition comprises naproxen or a pharmaceutically acceptable salt thereof and at least one binder.

The present invention relates to a pharmaceutical preparation comprising a granule comprising a compound of Chemical Formula 1 or a pharmaceutically acceptable salt thereof, and a diluent. The pharmaceutical preparation has a high productivity of the preparation due to excellent tableting properties, friability, and mass uniformity. The pharmaceutical preparation has low generated amount of impurities and high stability.

The present disclosure relates to a stable, reproducible and bioequivalent apixaban compositions, wherein the composition comprising apixaban having a D.sub.90 particle size of more than 100 microns, preferably between 300 and 1000 microns, and more preferably between 350 and 800 microns, and further comprising one or more pharmaceutically acceptable excipients. The present disclosure further provides a process for preparation of a pharmaceutical composition comprising apixaban by wet granulation.

In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 C.

A nanosuspension comprising (a) a pharmaceutical active ingredient or nutraceutical active ingredient having low solubility; (b) at least one alginate selected from the group consisting of (i) sodium alginate having a viscosity of 100 mPa.Math.s or less in a 1% solution in water at 20° C. and (ii) potassium alginate; and (c) water. Also, a drug dosage form prepared from such a nanosuspension.

An extended release pharmaceutical composition of Clozapine The extended release composition of Clozapine provides an extended release pharmaceutical composition having Clozapine, a seal coating, an acidic coating, and an extended release coating. The composition is particularly suitable for dispensing a once-a-day solid oral pharmaceutical formulation which releases a therapeutically effective amount of Clozapine over an extended time period.

The present invention relates to the field of coating pharmaceutical substrates. In particular, the invention relates to methods of coating of pharmaceutical substances, pharmaceutical ingredients or a blend of them. The invention also provides a method of making a pharmaceutical formulation which may be processed into a pharmaceuticalcal dosage form, which utilizes solid pharmaceutical particles and a pharmaceutical formulation obtained by the method. The methods of the invention utilize atomic layer deposition technology. The novel methods allow difficult, moisture sensitive and electrically charged pharmaceutical substrates to be easily processable.

Disclosed are a solid preparation, and a preparation method therefor and the use thereof. The solid preparation comprises an immediate-release part and a sustained-release part, which contains active ingredients, wherein the weight ratio of the active ingredient in the sustained-release part to the active ingredient in the immediate-release part is 1:1 or higher. In particular, the solid preparation is a tofacitinib preparation.

A pharmaceutical composition comprising Compound 1, (3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid), and at least one excipient selected from: a filler, a disintegrant, a surfactant, a binder, and a lubricant, the composition being suitable for oral administration to a patient in need thereof to treat a CFTR mediated disease such as Cystic Fibrosis. Processes of preparing pharmaceutical compositions comprising Compound 1 are also disclosed.