The invention relates to a multiparticulate modified release composition that in operation delivers an active ingredient in a pulsed or bimodal manner. The multiparticulate modified release composition comprises an immediate release component and a modified release component; the immediate release component comprising a first population of active ingredient containing particles and the modified release component comprising a second population of active ingredient containing particles coated with a controlled release coating; wherein the combination of the immediate release and modified release components in operation deliver the active ingredient in a pulsed or a bimodal manner. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition. The plasma profile achieved by the multiparticulate modified release composition is advantageous in reducing patient tolerance to the active ingredient and in increasing patient compliance by reducing dosage frequency.

Multiparticulate modified release composition

The present invention provides a method of achieving the time-specific delivery of a pharmaceutically active agent to a patient in need of the therapeutic effects of the pharmaceutically active agent. The method includes administering a pharmaceutical formulation comprising (a) a core including the pharmaceutically active agent to be delivered, and (b) a swellable polymeric coating layer substantially surrounding the core. The swellable polymeric coating layer delays the release of the pharmaceutically active agent from the core for a predetermined period of time dependent upon the thickness of the swellable polymeric coating layer. The swellable polymeric coating layer surrounding the core is provided by a new method which includes alternately (I) wetting the core with a binder solution, and (ii) coating the core with powdered polymeric particles a sufficient number of times to produce a time-specific dosage formulation having the desired thickness of swellable polymeric coating layer.

Time-specific controlled release dosage formulations and method of preparing same

A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.

Controlled release hydrocodone formulations

The present invention relates to a pharmaceutical composition in a unit dosage form for peroral administration in a human or lower animal, having a gastrointestinal tract comprising a small intestine and a colon with a lumen therethrough having an inlet to the colon from the small intestine, comprising: (a) a safe and effective amount of a therapeutically active agent incorporated into or coated on the surface of a dosage form selected from the group consisting of a spherical substrate, an elliptical substrate, a hard capsule, or a compressed tablet, with a maximum diameter of about 3 mm to about 10 mm; and (b) an enteric polymer coating material comprising at least one inner coating layer and one outer coating layer; wherein the dosage form has a smooth surface free from edges or sharp curves; the elliptical substrate and the hard capsule have a ratio of the long to short diameters of no greater than about 1.5; the therapeutically active agent is released at a point near the inlet to, or within the colon; each of the inner coating layer(s) is an enteric polymer that begins to dissolve in an aqueous media at a pH between about 5 to about 6.3; and the outer coating layer is an enteric polymer that begins to dissolve in an aqueous media at a pH between about 6.8 to about 7.2.

Pharmaceutical dosage form with multiple enteric polymer coatings for colonic delivery

An oral pharmaceutical dosage form comprising an acid susceptible proton pump inhibitor and one
or more NSAIDs in a fixed formulation, wherein the proton pump inhibitor is protected by an
enteric coating layer. The fixed formulation is in the form of an enteric coating layered tablet, a
capsule or a multiple unit tableted dosage form. The multiple unit dosage form are most preferred.
The new fixed formulation is especially useful in the treatment of gastrointestinal side-effects
associated with NSAID treatment.

Oral pharmaceutical dosage forms comprising a proton pump inhibitor and a nsaid

Soft capsules coated with an enteric coating comprising a 1:1 copolymer of methacrylic acid and methyl or ethyl acrylate or methyl or ethyl methacrylate and a plasticizer without need for a subcoating and optionally additionally coated with a protective coating comprising hydroxypropyl methylcellulose or hydroxypropyl cellulose or a mixture thereof and a plasticizer and method of preparation thereof are disclosed.

Enteric coated soft capsules and method of preparation thereof

PURPOSE: To produce a soft capsule coated with an enteric coating without requiring undercoating of optionally and further coated with a protective coating. CONSTITUTION: This enteric coating soft capsule is a filled soft capsule coated with an enteric coating contg. a copolymer consisting of methacrylic acid and methyl or ethyl (meth)acrylate in a ratio of 1:1 and a plasticizer without carrying out undercoating or optionally and further coated with a protective coating contg. hydroxypropyl methyl cellulose, hydroxypropyl cellulose or a mixture of them and a palsticizer.

Shrikant Narayan Pagay

Papers

Enteric coated soft capsules and method of preparation thereof

Enteric coating soft capsule and manufacture therfof