A Rifaximin polymorphic mixture of α/β form in a relative ratio of 85/15±3 and a process for its preparation. The polymorphic mixture of Rifaximin is for use as a medicament, in particular in the treatment of traveler's diarrhea and hepatic encephalopathy. A pharmaceutical composition comprises the polymorphic mixture of Rifaximin as active ingredient, in particular, a solid formulation, more in particular, a film coated tablet. A polymorphic form of crude wet rifaximin and of purified wet rifaximin their use are used as intermediates in a process for the preparation of Rifaximin polymorphic mixture of α/β form in a relative ratio of 85/15±3.

Disclosed is a method of manufacturing a cardiovascular fixed-dose combination pharmaceutical dosage form that includes an anti-hypertensive active agent, a cholesterol-lowering active agent, and optionally, an enteric-coated aspirin or platelet inhibitor. The fixed-dose combination is prepared with at least two granulation solutions that are free of citric acid and enhance the aqueous solubility of the cholesterol-lowering agent in fixed-dose combination. The active agents in the resulting dosage form, which is also free of citric acid, have the same strength and release profiles as the same active agents prepared as a single formulation.

The present invention provides a new preparation which is a tablet containing (1) ferric citrate, (2) a polyvinyl alcohol-polyethylene glycol graft copolymer, and (3) a polyvinyl alcohol-acrylic acid-methyl methacrylate copolymer.

This invention relates to dosage forms comprising pseudoephedrine or a salt thereof, for extended-release up to 24 hours, and process of making such dosage forms. This invention provides a non-osmotic extended-release dosage form comprising pseudoephedrine hydrochloride which can be administered to patients who need and/or desire a decongestant medication up to 24 hours. This invention also relates to dosage forms comprising pseudoephedrine or a salt thereof and cetirizine or levocetirizine or its salts thereof for extended-release up to 24 hours, and process of making such dosage forms.

A method of producing a tablet in which an uncoated tablet is coated by a coating agent, the method including: a coating process of coating uncoated tablets with a coating agent by spray coating the coating agent onto tablets that are churned and tumbled inside a container, and drying the tablets inside the container by supplying drying air into the container and exhausting air from the container, wherein spray coating conditions, including air supply temperature, air supply rate, and spray speed, are controlled according to the weight of the coating agent with which the uncoated tablets are coated, such that the humidity of air exhausted during spray coating is within a range of from 14% RH to 30% RH.

A traditional Chinese medicine composition for treating cardiovascular disease, and a preparation thereof, particularly a micro drop pill preparation thereof, and a method for preparing the preparation; the method for preparing the micro drop pill preparation can be used to prepare drop pills, coated drop pills, and drop pill capsules with a high drug loading capacity.

The present invention relates to a stable pharmaceutical formulation comprising omeprazole, its enantiomer, or its pharmaceutically acceptable salt, and sodium bicarbonate, and a method for preparing the same. Specifically, the present invention provides a stable formulation by preventing omeprazole, its enantiomer, or its pharmaceutically acceptable salt, from coming in direct contact with sodium bicarbonate, to reduce the production of impurities.

Disclosed are a pharmaceutical composition, an osmotic pump controlled-release drug delivery system comprising the pharmaceutical composition and a preparation method therefor. The pharmaceutical composition comprises a tablet core and a coating film. The tablet core comprises a drug-pulling layer, and the coating film comprises 50-90 wt % of cellulose acetate and 10-50 wt % of Copovidone. The Copovidone can be obtained by means of the polymerization of vinyl pyrrolidone and vinyl acetate in a molar ratio of 40:60-80:20.

A method produces a coatable core for a delayed release drug formulation for oral administration, to deliver a drug to the colon. The method involves forming a core containing a drug. An outer layer coating preparation is formed by combining a first aqueous preparation of an enzymatically degradable polymer, which is degradable by colonic bacterial enzymes; a second aqueous preparation of a film-forming enteric polymer having a pH threshold of about pH 6 or above; and an organic anti-tack agent. The core is then coated with the outer layer coating preparation to form an outer layer coated core.

A delayed release drug formulation contains a core containing a drug and a delayed release coating for intestinal release, where release of the drug in the colon is not hindered by the absence of an alkaline middle layer between the core and the outer layer. The delayed release coating contains an outer coating, and optionally, an isolation layer. The outer coating contains a mixture of an enzymatically degradable polysaccharide which is degradable by colonic enzymes selected from the group of starch, amylose, amylopectin, chitosan, chondroitin sulfate, cyclodextrin, dextran, ptallulan, carrageenan, scleroglucan, curdulan, and levan and a film-forming enteric polymer having a pH threshold at about pH 6 or above. The enzymatically degradable polysaccharide and the enteric polymer are present in the outer coating in a ratio of more than 60:40.