The present invention relates to a process for preparing an orally administered pharmaceutical composition with colonic delivery, comprising at least one core and a coating layer, making it possible to obtain a pharmaceutical composition which exhibits uniform and reproducible dissolution and therefore likewise uniform and reproducible release of the active ingredient with low coefficients of variation, said process being characterized in that it comprises the following steps: a) Spraying onto a neutral support an aqueous suspension comprising at least one anionic (meth)acrylate copolymer that is soluble at a pH greater than 5.5 and at least one active ingredient intended to be delivered in the colon; or a′) Spraying onto a neutral support an aqueous suspension comprising at least one anionic (meth)acrylate copolymer that is soluble at a pH greater than 5.5 then b′) Dusting at least one active ingredient intended to be delivered in the colon onto the microgranules obtained after step a′); c′) carrying out steps a′) and b′) alternately until the desired content of active ingredient has been obtained and d) Coating the microgranules obtained after step a) or c′) by spraying a composition comprising at least one anionic (meth)acrylate copolymer that is soluble at a pH greater than 6, an anionic (meth)acrylate copolymer that is soluble at a pH greater than 7 and an anionic (meth)acrylate copolymer that is insoluble in an aqueous medium.

The present invention relates to a process for preparing an orally administered pharmaceutical composition with colonic delivery, comprising at least one core and a coating layer, making it possible to obtain a pharmaceutical composition which exhibits uniform and reproducible dissolution and therefore likewise uniform and reproducible release of the active ingredient with low coefficients of variation, said process being characterized in that it comprises the following steps: a) Spraying onto a neutral support an aqueous suspension comprising at least one anionic (meth)acrylate copolymer that is soluble at a pH greater than 5.5 and at least one active ingredient intended to be delivered in the colon; or a′) Spraying onto a neutral support an aqueous suspension comprising at least one anionic (meth)acrylate copolymer that is soluble at a pH greater than 5.5 then b′) Dusting at least one active ingredient intended to be delivered in the colon onto the microgranules obtained after step a′); c′) carrying out steps a′) and b′) alternately until the desired content of active ingredient has been obtained and d) Coating the microgranules obtained after step a) or c′) by spraying a composition comprising at least one anionic (meth)acrylate copolymer that is soluble at a pH greater than 6, an anionic (meth)acrylate copolymer that is soluble at a pH greater than 7 and an anionic (meth)acrylate copolymer that is insoluble in an aqueous medium.

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.

The present technology generally relates to compositions comprising cannabinoids for relieving pain in a subject and to methods of using such compositions for relieving pain in a subject.

The present technology generally relates to compositions comprising cannabinoids for relieving pain in a subject and to methods of using such compositions for relieving pain in a subject.

The invention provides methods and compositions for local administration of therapeutic agents to the rectum or colon, such as by enema. The methods and compositions are useful for treatment of inflammatory bowel disease, including Crohn's disease and ulcerative colitis.

The invention provides methods and compositions for local administration of therapeutic agents to the rectum or colon, such as by enema. The methods and compositions are useful for treatment of inflammatory bowel disease, including Crohn's disease and ulcerative colitis.

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.

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.