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.

A solid oral dosage form is provided, comprising a compound of Formula I or a pharmaceutically acceptable salt thereof, tenofovir alafenamide or a pharmaceutically acceptable salt thereof, and emtricitabine or a pharmaceutically acceptable salt thereof.

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.

Fixed-dose combination drugs comprising an NSAID as a first drug component and a GABA-type calcium channel blocker as a second drug component are contemplated. Further contemplated aspects also include methods of administration of combination drugs and drugs contained herein.

An oral pharmaceutical dosage form that comprises both acetaminophen and a glutathione replenishing agent, such as N-acetylcysteine. This allows co-administering the glutathione replenishing agent along with acetaminophen, which may be beneficial in rapidly counteracting the toxic effects of acetaminophen overdose. The oral dosage form could be in the form of a tablet or capsule. The dosage form may be designed to compartmentally separate the glutathione replenishing agent from having chemical interaction with the acetaminophen. The dosage form may be designed to mask the taste or smell of the glutathione replenishing agent.

This invention relates to a nicotine lozenge giving an immediate release and uptake of nicotine and an extended release and uptake of nicotine as well as describing suitable manufacturing processes for such lozenge formulations and the use of the lozenge for the treatment of a human being suffering from cravings from tobacco and/or e-cigarette dependency.

An aspect provides a pharmaceutical composite formulation containing: a first layer comprising a proton pump inhibitor or a pharmaceutically acceptable salt thereof as an active ingredient, a disintegrant, and a binder; and a second layer comprising, as an active ingredient, an antacid selected from magnesium hydroxide, magnesium oxide, or a mixture thereof.

A bilayer composition for amelioriation of, or prophylaxis against, SARS-CoV-2 infection comprising a: (i) a first layer consisting of 250 mg to 1600 mg of 5-aminolevulinic acid (ALA), or salt thereof, and pharmaceutically acceptable excipients that allow for immediate release of the 5-aminolevulinic acid; (ii) a second layer consisting of hydroxychloroquine (HCQ), and/or a salt thereof, in a dose of 100 mg-1500 mg, or salt thereof, and at least one pharmaceutically acceptable excipient comprising a release modifier for sustained release of the hydroxychloroquine or chloroquine.

Described herein, in part, are tablets, such as immediate release multi-layer or bilayer tablets for orally delivering olanzapine and samidorphan, methods of using said tablets in the treatment of disorders described herein, and kits comprising said tablets.

Disclosed herein are compositions comprising an NSAID such as meloxicam and/or rizatriptan in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of pain such as migraine, arthritis, and other conditions. Also disclosed herein are methods of treating pain, such as migraine, comprising administering meloxicam and rizatriptan to a human being suffering from pain, such as migraine. For migraine, these methods may be particularly useful when the meloxicam and rizatriptan are administered while the human being is suffering from an acute attack of migraine pain or migraine aura. In some embodiments, the combination of meloxicam and rizatriptan may be administered in a manner that results in a T.sub.max of meloxicam of 3 hours or less.