This disclosure concerns oral pharmaceutical compositions comprising a solid dosage form (SDF). The SDF comprises (i) a solid amorphous dispersion (SAD) comprising a poorly water soluble active agent and a matrix material comprising poly[(methyl methacrylate)-co-(methacrylic acid)] (PMMAMA), and (ii) a concentration-sustaining polymer (CSP), wherein the CSP is not dispersed in the SAD, and the SAD is at least 35 wt % of the SDF. The SAD and CSP together may be at least 50 wt % of the SDF. The SDF may be, for example, a tablet, a caplet, or a capsule.

The present disclosure relates to a solid oral dosage form comprising: (i) (S)-4-amino-5-chloro-N-[{4-[(1-hydroxyacetyl-4-piperidinyl)methyl]-2-morpholinyl}methyl]-2-methoxybenzamide, a pharmaceutically acceptable salt thereof, or a hydrate or solvate of the same; (ii) a disintegrating agent; and (iii) a water-soluble polymer binder. The present disclosure also relates to a medicinal composition, a therapeutic agent and/or a preventive agent, which comprise the medicine according to the present disclosure, for treating and/or preventing digestive diseases, digestive symptoms, psychoneurological diseases or urinary diseases, a preferable example thereof being a solid oral dosage form.

The present application relates to a pregabalin sustained release composition, comprising: (a) an active ingredient; (b) a matrix-forming agent; (c) a swelling agent; (d) a gelling agent; and optionally a filler. The pregabalin sustained release composition provided in the present application can rapidly swell in volume when exposed to aqueous medium until exceeding the diameter of human gastric pyloric (13 mm). It thereby prolongs the gastric emptying time to increase the retention time of pregabalin in the stomach and enhances absorption of pregabalin in the small intestine and ascending colon. Moreover, the pregabalin sustained release composition provided herein achieves a sustained release for 24 h, which allows QD (once a day) administration, reduces administration number, and improves patient compliance.

The invention provides an oral disintegrating tablet (ODT) for administration to oral mucosa comprising an amphiphilic compound capable of self-assembling into liquid crystalline particles when contacted with a hydrophilic solvent, a therapeutically effective amount of a 1 to 10 kDa active ingredient and a pharmaceutically acceptable disintegrant, wherein the 1 to 10 kDa active ingredient is orally bioavailable. The water channels of the liquid crystalline particle may be increased in size. ODTs with enhances water channels may also be useful for delivery of active ingredients of less than 1 kDa.

The present invention relates to the transmucosal dosage forms like sublingual pharmaceutical compositions comprising antiviral molecules like favipiravir, remdesivir, baloxavir marboxil, molnupiravir, besifovir, raltegravir, GS-441524, ravidasvir, and other antiviral drugs. The present invention also relates to methods for preparing these transmucosal pharmaceutical compositions. Compositions prepared as per the present invention are able to increase bioavailability by avoiding first-pass metabolism. The compositions prepared as per the present invention exhibit desired pharmaceutical technical attributes such as pH, assay, related substance, disintegration, and dissolution. The compositions prepared as per the present invention are useful in the treatment of viral infections including coronavirus infection (COVID-19).

A modified release benzonatate solid tablet or capsule is described which comprises a benzonatate adsorbate in a matrix with a sufficient amount of one or more pharmaceutically acceptable modified release pH-independent, substances to provide a modified release profile to the benzonatate, wherein there is substantially no benzonatate release from the tablet or capsule in the buccal cavity and no more than about 25% release of the benzonatate within 1 hour as determined in an in vitro dissolution assay.

The present invention relates to delayed release pharmaceutical compositions comprising linaclotide or pharmaceutically acceptable salts thereof, as well as to various methods and processes for the preparation and use of the compositions.

Disclosed is a solid dispersion and a preparation method therefor. The solid dispersion contains a glucokinase activator, an isotopic label thereof, or a medicinal salt thereof and a polymer support. Further disclosed is a solid dispersion composition containing the solid dispersion and an excipient. Also disclosed is an oral preparation of the glucokinase activator, containing the solid dispersion or the solid dispersion composition. Also disclosed is a tablet and a capsule of the glucokinase activator and a preparation method therefor. In addition, also disclosed is the uses of the solid dispersion, the solid dispersion composition and the oral preparations comprising the tablet and the capsule, which can be used for treating and/or preventing selected diseases or medical conditions and especially one or more diseases selected from type I diabetes mellitus, type II diabetes mellitus, impaired glucose tolerance, impaired fasting glucose and hyperglycemia.

The present invention is directed to a composition in the form of an orodispersible tablet comprising a non-steroidal anti-inflammatory drug (NSAID) and a taste-masking agent wherein the NSAID is uncoated and has an average particle size of less than 100 μm. The present invention is further directed to the use of malic acid as a taste-masking agent.

The present invention relates to a sustained release composition comprising Tapentadol or a pharmaceutically acceptable salt thereof for oral administration for the treatment of severe chronic pain in adults.