Controlled release therapeutic system for a liquid pharmaceutical formulations
AssigneeRecordati S.A., Chemical and Pharmaceutical Company
InventorsGiancarlo Santus, Roberto Golzi
Life of this patent
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Abstract
Disclosed is a controlled release pharmaceutical dosage form, including: (a) microgranules of a pharmaceutical and an excipient; (b) a plurality of polymeric lipidic and wax-like coatings applied to the microgranules, the coated microgranules having dimensions which allow suspension of the coated microgranules in a liquid administration vehicle; and (c) a liquid administration vehicle for the coated microgranules, the vehicle including an effective amount of the pharmaceutical in a form immediately available upon ingestion. A process for the preparation of the controlled release therapeutic system is also described.
Claims20
A controlled release pharmaceutical dosage form comprising
- microgranules comprising a pharmaceutical and excipients, said microgranules before being coated having a homogeneously smooth surface, which permits a uniform deposition of coatings, and no controlled release properties, said microgranules having a plurality of at least three coatings thereon at least one of said coatings imparting controlled release properties to said coated microgranules,
- the first of said coatings being a pH insensitive coating comprising a mixture of (i) a first component selected from the group consisting of derivatives of cellulose, acrylic acid and methacrylic acid, and derivatives thereof and mixtures thereof, and (ii) a second component selected from the group consisting of hydrogenated and partially hydrogenated vegetable oils, plasticizers and mixtures thereof, said first coating constituting a barrier allowing regulation of the release of said pharmaceutical;
- and
- the others of said coatings comprising at least one polymeric hydrophilic coating and at least one hydrophobic coating, wherein the hydrophobic and hydrophilic coatings alternate;
- said microgranules with the plural coatings thereon having dimensions which allow stable suspension of the plural coated microgranules in a liquid administration vehicle;
- and
- a liquid administration vehicle for said plural coated microgranules, said vehicle including an additional amount of said pharmaceutical in a form immediately available upon ingestion.
A controlled release pharmaceutical dosage form comprising
- microgranules comprising a pharmaceutical and excipients and having a homogeneously smooth surface, which permits a uniform deposition of coatings, with a plurality of at least three coatings deposited thereon,
- the first of said coatings being a pH insensitive coating comprising a mixture of (i) a first component selected from the group consisting of derivatives of cellulose, acrylic acid, and methacrylic acid and mixtures thereof, and (ii) a second component selected from the group consisting of hydrogenated and partially hydrogenated oils and mixtures thereof, said first coating constituting a barrier allowing regulation of the release of said pharmaceutical;
- and
- the others of said coatings comprising at least one polymeric, hydrophilic coating and at least one hydrophobic coating, wherein said hydrophilic and hydrophobic coatings alternate;
- said microgranules with the plural coatings thereon having dimensions which allow stable suspension of the plural coated microgranules in a liquid administration vehicle.
Dependencies are inferred from the claim text.