A delayed release drug formulation for oral administration delivers a drug to the colon of a subject. The formulation includes a core containing a drug and a coating for the core. The coating contains an outer layer and an inner layer. The outer layer contains a film-forming enteric polymer having a pH threshold at about pH 6 or above, and the inner layer contains a film-forming non-ionic polymer that is soluble in intestinal or gastrointestinal fluid and a buffer agent in an amount from more than 20 wt % to about 60 wt % based on the dry weight of the non-ionic polymer.

A method produces a coatable core for a modified release drug formulation for oral administration. The coatable core has a high drug load of at least 70 wt % based on the total weight of the coatable core. The method involves the steps of granulating a composition containing a drug and at least one binder to form granules; blending the granules with a pharmacologically acceptable disintegrant and optionally, one or more additional pharmacologically acceptable excipients, to form a compression blend, wherein the disintegrant is present in an amount from about 0.5 wt % to about 5 wt %, based on the total weight of the coatable core; and compressing the compression blend using an external lubrication compression method to form a coatable core.

Disclosed are compounds of general formula (I): ##STR00001##
and pharmaceutically acceptable salts thereof, formulations, methods and uses in, for example, the treatment of disease.

The disclosure encompasses systems and methods for performing high temperature and high humidity curing of tablets using air flow delivered from a recirculating air handler to a pan coater of a tablet coating device. The recirculating air handler may be integrated into a preexisting tablet coating device so that the air flow may be delivered by the preexisting air handler or by the recirculating air handler as desired.

The present invention relates to novel sugar-coated solid forms having improved stability, in particular a superior humidity resistance, and to a sugar-coating method which is particularly useful for the preparation of same.

The present invention relates to a pharmaceutical composition comprising a combination of mirabegron and solifenacin or their pharmaceutically acceptable salts, wherein the composition comprises mini-tablets, multiparticulates, inlay tablets, or bilayer tablets. The prior art discloses restrictive formulation techniques and suggests complexity for preparing the combination in a single formulation to achieve the desired technical attributes. The test formulations are stable and exhibit desired pharmaceutical technical attributes. The invention also relates to the use of the pharmaceutical composition of the present invention in the treatment of various diseases like overactive bladder and other related therapeutic indications.

Controlled release dosage forms are described herein. The controlled release formulations described herein provide prolonged delivery of high dose drugs that are highly water soluble and highly hygroscopic. In specific embodiments, controlled release dosage forms for delivery of a drug selected from GHB and pharmaceutically acceptable salts, hydrates, tautomers, solvates and complexes of GHB. The controlled release dosage forms described herein may incorporate both controlled release and immediate release formulations in a single unit dosage form.

The present disclosure provides chewable tablets comprising (i) a compressed core including a bioactive molecule; (ii) a protective layer over said compressed core, and (iii) one or more soft-coating layers over said protective layer, each soft coating layer comprises gum base powder; wherein the protective layer comprises water-insoluble cellulose based polymers, preferably ethyl cellulose based polymer.

The main object is to provide a novel pharmaceutical solid preparation containing a pharmaceutically active ingredient, wherein the solid preparation is coated with a light shielding agent in a nano-order thickness.

The present invention can include a pharmaceutical solid preparation containing at least one pharmaceutically active ingredient, wherein the surface of the solid preparation is coated with a light shielding agent or a metal oxide to a thickness in a range of 1 nm to 500 nm to form a coating layer, or is coated with a light shielding agent or a metal oxide which is present in a range of 5×10.sup.−6 mg/mm.sup.2 to 3×10.sup.−3 mg/mm.sup.2 to form a coating layer, and a process for producing a solid preparation containing at least one pharmaceutically active ingredient, comprising a step of coating a light shielding agent or a metal oxide by sputtering on the surface of the solid preparation to a thickness in a range of 1 nm to 500 nm.

The present invention relates to a delayed-release pharmaceutical composition comprising an active ingredient prednisone and one or more pharmaceutical excipient(s). The invention further relates to a process for preparation of said pharmaceutical composition for oral administration, particularly a tablet, comprising prednisone with one or more pharmaceutically acceptable excipient(s), wherein the tablet is formulated using a coating technique which has a significant impact on drug release.