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US 6,635,680 B2Granted
Controlled release pellet formulation
AssigneeNostrum Pharmaceuticals, Inc.
InventorNirmal Mulye
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AssigneeNostrum Pharmaceuticals, Inc.
InventorNirmal Mulye
Estimating the term…
The present invention describes an aqueous pharmaceutical coating formulation which can be used for coating core elements containing one or more medicaments to achieve controlled release. The coated pharmaceutical formulation provides a release of medicaments in a controlled manner at highly acidic environment such as that of stomach and shows relatively faster release in media with basic pH such as that of the intestine. The coating composition is a heterogenous mixture which comprises (a) at least 75% by weight of a water insoluble polymer which is insoluble in both acidic as well as basic pH; and (b) 1 to 25% by weight of an enteric polymer which is substantially insoluble in water at a pH below 4.5 and which is substantially soluble in water at a pH between above about 6.0, said enteric polymer and water insoluble polymer being present in an amount effective to control-the release of said medicament. The pharmaceutical composition comprises a solid medicament present in effective amounts and the coating composition thereover.
A composition comprising a core element containing a therapeutically effective amount of a solid medicament and a coating composition on said core element which coating composition comprises a mixture comprising:
A sustained release pharmaceutical composition comprising a core element containing a therapeutically effective amount of a solid medicament and a coating composition on said core element, wherein said coating composition is applied to said core element and subjected to drying, said coating composition comprising a mixture comprising:
A method for the preparation of a sustained release pharmaceutical composition for administration to a patient which comprises forming a core element containing a therapeutically effective amount of a solid medicament and coating said core element with a coating composition comprising a mixture comprising:
Dependencies are inferred from the claim text.
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From the US filing history. Foreign family members aren’t listed.
Having two or more different coatings optionally including drug-containing subcoatings: with drug-free core
Drugs for disorders of the alimentary tract or the digestive system
Drugs for disorders of the alimentary tract or the digestive system: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of…
Drugs for disorders of the alimentary tract or the digestive system: laxatives
Term ended 30 Aug 2020 (estimated)
The present invention relates to a sustained release pharmaceutical composition and to a method of using and preparing same in order to control the rate of release and the site of release of the pharmaceutical composition.
It is desirable in the treatment of a number of diseases, both therapeutically and prophylactically, to provide the active pharmaceutical ingredient in a sustained release form. Desirably, the sustained release form provides a controlled rate of release of a medicament over an extended period.
It is well known that well absorbed sustained release therapeutic drug dosage forms provide many advantages over conventional release dosage forms. The advantages include less frequent dosing of a medicament and resultant patient compliance, a more sustained drug blood level response, therapeutic action with less ingested drug and the mitigation of side effects. By providing a slow and steady release of the medicament over time, absorbed concentration spikes are mitigated or even eliminated by effecting smoother and more sustained blood level response.
The manufacture of a substrate containing medicaments for the coating is as follows. The substrate can be pellets or tablets or drug particles.
The drug containing pellets is manufactured using the following known techniques:
1. pelletization techniques such as extrusion followed by spheronization or