Provided herein are oral dosage forms comprising a) a core tablet comprising (i) a drug layer comprising apremilast and hypromellose acetate succinate (HPMCAS) in an amorphous solid dispersion; and (ii) a swellable layer comprising one or more swellable polymers; and b) a coating layer disposed on the core tablet, wherein the oral dosage form surface comprises at least one drug release orifice. The disclosed oral dosage forms provide once-a-day dosing of apremilast and are suitable for treating diseases or disorders ameliorated by inhibiting phosphodiesterase subtype IV (PDE4).

The invention features solid dosage forms of N-1-pyrrolidine-N-5-(3-trifluoromethoxy)phenyl biguanide, or a pharmaceutically acceptable salt thereof, where the solid dosage form includes an enteric coating and uses thereof.

The invention features solid dosage forms of N-1-pyrrolidine-N-5-(3-trifluoromethoxy)phenyl biguanide, or a pharmaceutically acceptable salt thereof, where the solid dosage form includes an enteric coating and uses thereof.

Aspects of the present disclosure relate to compounds which have enhanced oral bioavailability. A transition metal complex includes a transition metal coordinated by a macrocycle comprising the pentaaza 15-membered macrocyclic ring corresponding to Formula A and two axial ligands having the formula OC(O)X.sub.1.

##STR00001## each of the two axial ligands has the formula OC(O)X.sub.1 wherein each X.sub.1 is independently substituted or unsubstituted phenyl or C(X.sub.2)(X.sub.3)(X.sub.4); each X.sub.2 is independently substituted or unsubstituted phenyl, or substituted or unsubstituted alkyl; each X.sub.3 is independently hydrogen, hydroxyl, alkyl, amino, X.sub.5C(O)R.sub.13 where X.sub.5 is NH or O, and R.sub.13 is C.sub.1-C.sub.18 alkyl, substituted or unsubstituted aryl or C.sub.1-C.sub.18 aralkyl, or OR.sub.14, where R.sub.14 is C.sub.1-C.sub.18 alkyl, substituted or unsubstituted aryl or C.sub.1-C.sub.18 aralkyl, or together with X.sub.4 is (O); and each X.sub.4 is independenly hydrogen or together with X.sub.3 is (O).

The present invention aims to provide a preparation containing a compound of the formula [I] or a pharmaceutically acceptable salt thereof or a hydrate thereof having improved pharmacokinetics, and a manufacturing method thereof. The present invention relates to a solid dispersion containing (1) an amorphous compound represented by the following formula [I]:

##STR00001##

or a pharmaceutically acceptable salt thereof or a hydrate thereof, and

(2) one to four kinds of pharmaceutically acceptable polymers selected from the group consisting of hydroxypropylmethylcellulose acetate succinate, methylcellulose, hypromellose and polyvinyl alcohol, and a manufacturing method thereof.

The disclosure provides products configured for oral use, and methods of making the products. The products include a plurality of granules, the granules including at least one filler; at least one sugar alcohol; a cellulose ether, polyvinylpyrrolidone, or a combination thereof; and at least one active ingredient, at least one flavorant, or a combination thereof. The products may be in a granular form, or in the form of a tablet or pellet.

An oral dosage form of ticagrelor includes a core and a semi-permeable membrane coating the core. The core comprises a first drug layer and a push layer. The first drug layer contains ticagrelor that is sufficient to deliver an effective amount of the drug over an intended delivery time. The push layer comprises a swelling agent and an osmogen agent. The semi-permeable membrane has at least one passageway formed therethrough, positionally configured to face the first drug layer, but not to face the push layer, of the core, and functionally configured to allow the ticagrelor to realize an extended release out of the core upon contacting an aqueous environment. The dosage form optionally further includes a second ticagrelor-containing drug layer coating the semi-permeable membrane, thereby providing a starting effective dose upon administration. The dosage form can realize once-a-day administration of ticagrelor of patients in need thereof.

The present invention is directed to a solid dose form comprising a film coating composition encapsulating a core, wherein: (i) the core comprises an active ingredient comprising at least one of a pharmaceutical, veterinary, or nutraceutical active ingredient; (ii) the film coating composition comprises ethylcellulose and guar gum, wherein the guar gum has an apparent viscosity ≥151.0 cps at a shear rate of 50 s.sup.−1 in a 1% aqueous guar gum solution measured rotationally at 20° C. after 1 minute equilibration using a 6 cm acrylic cone (1°) on a cone-plate viscometer wherein the shear is ramped up linearly from 1 to 50 s.sup.−1 in 25 steps over 29 seconds; (iii) the dose form provides controlled release of the active ingredient; (iv) the guar gum is present in an amount greater than 5 wt % based on the weight of the guar gum and ethylcellulose; and (v) the dose form is ethanol resistant.

The present invention relates to a monolithic tablet composition for oral administration of tofacitinib, or a pharmaceutically acceptable salt thereof.

The present disclosure provides veterinary formulations comprising rapamycin or rapalogs for administration to companion animals and methods of using the formulations to treat cardiac dysfunction, including hypertrophic cardiomyopathy, dilated cardiomyopathy, mitral valve disease, pressure-overload cardiac hypertrophy, cancer, effects of aging, inflammatory disease, and viral infection.