Jame Fine Chemicals, Inc.

Jfc Technologies, LLC

Jfct Technologies, LLC

Jfc Technolries, LLC

Sham N Redkar

Vilas M Chopdekar

James R Schleck

Raja G Achari

Hemant S Desai

Angelo Mellozzi

Michelle Y McGough

Timothy N Truong

James G Schleck

Dina Donatiello

A stabilized glucosamine base composition comprising a glucosamine base having a purity level of at least 99.0 wt. % and a maximum halide content of about 0.01 wt. % coated with at least one pharmaceutically acceptable polymer comprising a water-soluble, water-immiscible and/or water-swellable homopolymer and/or copolymer. The resultant coated glucosamine base composition will be stable at ambient temperatures and upon exposure to the atmosphere. Suitable polymers include carboxypolymethylene homopolymers and copolymers; polyethylene glycol homopolymers and copolymers; polypropylene glycol homopolymers and copolymers; ethylcellulose; povidone homopolymers and copolymers; polyacrylic acid homopolymers and copolymers; polyacrylamide homopolymers and copolymers; polysaccharides; and mixtures of two or more of the foregoing polymers.

Stabilized halide-free glucosamine base and method of preparation

A glucosamine base having a pure level of at least about 99.0 wt. % and a maximum halide content of 0.01 wt. %. The pure glucosamine base is prepared by reacting a glucosamine halide, e.g., glucosamine hydrochloride, with a lithium base in the presence of a C-Calcohol to thereby generate a C-Calcohol solution of a lithium halide and an insoluble halide-free glucosamine base and thereafter separating the insoluble halide-free glucosamine base from the C-Calcohol solution of the lithium halide. Preferably, the lithium base comprises anhydrous lithium hydroxide and the preferable alcohol comprises methanol.

Halide-free glucosamine base and method of preparation

A method for preparing n-acetylglucosamine starting from glucosamine base having a purity level of at least about 99 wt. % and a maximum halide content of about 0.01 wt %. The glucosamine base is slurried in a diluent comprising a C-Cstraight or branched-chain alcohol, e.g., isopropyl alcohol, sec. butyl alcohol, tert. butyl alcohol, etc. Thereafter, an acylating agent, e.g., acetic anhydride, present in at least a stoichiometric amount, is slowly added to the slurry while maintaining the reaction mixture at a temperature below about 20&#xb0; C. The n-acetylglucosamine prepared by the process of the invention will be quite pure, e.g., it will have a purity of at least 98%, as measured by HPLC, a melting point in the range of 196-205&#xb0; C. and a specific rotation, measured at room temperature after standing in water for several hours, of [&#x3b1;]=39-43&#xb0;.

Method for preparing N-acetylglucosamine

Glucosamine phosphate having a purity of at least about 99 wt. %, and a maximum halide content of about 0.01 wt. %. Preferably, the glucosamine phosphate is stabilized by coating it with at least one pharmaceutically acceptable polymer comprising a water-soluble, water-immiscible and/or water-swellable homopolymer and/or copolymer. Suitable polymers include carboxypolymethylene hompolymers and copolymers; polyethylene glycol homopolymers and copolymers; polypropylene glycol homopolymers and copolymers; ethylcellulose; povidone homopolymers and copolymers; polyacrylic acid homopolymers and copolymers; polyacrylamide homopolymers and copolymers; polysaccharides; and mixtures of two or more of the foregoing polymers. The resultant coated glucosamine phosphate composition will be stable at ambient temperatures and upon exposure to the atmosphere.

Halide-free glucosamine phosphate compositions and methods of preparation

Glucosamine sulfate having a purity of at least about 99 wt. %, and a maximum halide content of about 0.01 wt. %. Preferably, the glucosamine sulfate is stabilized by coating it with at least one pharmaceutically acceptable polymer comprising a water-soluble, water-immiscible and/or water-swellable homopolymer and/or copolymer. Suitable polymers include carboxypolymethylene homopolymers and copolymers; polyethylene glycol homopolymers and copolymers; polypropylene glycol homopolymers and copolymers; ethylcellulose; povidone homopolymers and copolymers; polyacrylic acid homopolymers and copolymers; polyacrylamide homopolymers and copolymers; polysaccharides; and mixtures of two or more of the foregoing polymers. The resultant coated glucosamine sulfate composition will be stable at ambient temperatures and upon exposure to the atmosphere.

Halide-free glucosamine sulfate compositions and methods of preparation

The invention pertains to a method for preparing diphenhydramine tannate by reacting diphenhydramine free base at a temperature of about 75 to about 150&#xb0; C. with tannic acid neat or as an aqueous slurry containing up to about 20 wt. % water. The diphenhydramine free base may be obtained by reacting a commercially available diphenhydramine salt such as diphenhydramine maleate with a base such as aqueous sodium hydroxide. The resultant diphenhydramine tannate has extended release properties and is useful in pharmaceutical compositions as an antihistamine for human beings.

Hot melt method for preparing diphenhydramine tannate

The invention pertains to a method for preparing dexchlorpheniramine ('dexchlor') tannate by reacting dexchlorpheniramine free base at a temperature of about 75 to about 150&#xb0; C. with tannic acid neat or as an aqueous slurry containing up to about 20 wt. % water. The dexchlorpheniramine free base may be obtained by reacting a commercially available dexchlorpheniramine salt such as dexchlorpheniramine maleate with a base such as aqueous sodium hydroxide. The resultant dexchlor tannate has extended release properties and is useful in pharmaceutical compositions as an antihistamine for human beings.

Method for preparing dexchlor tannate

The invention pertains to carbinoxamine tannate and to a method for preparing carbinoxamine tannate by reacting carbinoxamine free base at a temperature of about 50 to about 150&#xb0; C. with tannic acid neat or as an aqueous slurry containing about 5 to about 30 wt. % water.

Carbinoxamine tannate

The invention pertains to a method for preparing pseudoephedrine tannate by reacting pseudoephedrine free base at a temperature of about 70 to about 110&deg; C. with tannic acid neat or as an aqueous slurry containing about 5 to about 30 wt. % water.

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Bound Brook, NJ, United States of America

Sham N Redkar