Multiple unit controlled food effect-independent release pharmaceutical preparations and method for preparing the same
AssigneeBayer Aktiengesellschaft
InventorsVenkata-Rangarao Kanikanti, Roland Rupp, Erich Brendel, Claus Weisemann, Ernst Chantraine
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Abstract
The present invention relates to orally administrable multiple-unit sustained-release dose forms having controlled agitation-independent release of active compound and processes for their production using a selected erodable hydrophilic polymer (HPC) and a limitation of the maximum size of the active compound-containing polymer particles to ≦3 mm.
Claims12
A process for the production of an orally administratable multiple-unit sustained-release pharmaceutical composition having controlled agitation-independent release, consisting essentially of the steps of (a) combining hydroxypropylcellulose polymer having a molecular weight of 250000 to 1200000 and a molar degree of substitution of at least 3 in an amount from 40 to 95% by weight with a pharmaceutically active compound and optionally with one or more pharmaceutically acceptable additional polymers and/or excipients which do not contribute significantly to a sustained-release effect, to obtain a mixture of containing said hydroxypropyl cellulose polymer and said active compound;
- (b) converting said mixture into particles having a diameter of 0.2 to 3.0 mm;
- (c) optionally lacquering said particles, and (d) incorporating said particles into an orally administratable multi-unit sustained release dosage form.
A pharmaceutical composition consisting essentially of a mixture of hydroxypropylcellulose polymer and a pharmaceutically active compound and optionally one or more pharmaceutically acceptable additional polymers and/or excipients which do not contribute significantly to a sustained-release effect, wherein said hydroxypropylcellulose polymer has a molecular weight of between 250,000 and 1,200,000 and a molar degree of substitution of ≧3 and is 40-95% by weight of said mixture and further wherein said mixture is granulated to particles having a diameter of between 0.2 and 3.0 mm, said particles being optionally lacquered, and said composition being in a agitation independent, orally administratable multi unit, sustained release dosage form.
Dependencies are inferred from the claim text.