Delayed release pharmaceutical oral dosage form and method of making same
AssigneeIntelgenx Cporp.
InventorsPompilia Szabo, Horst Zerbe
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Abstract
The present invention relates to a delayed release pharmaceutical oral dosage form and method of making same. The delayed release dosage form comprises one or more active ingredients within a granulated composition, which further comprises one or more excipients selected from the group of solid aliphatic alcohols, fatty acid esters, mixtures of esters of saturated fatty alcohols and saturated fatty acids, natural waxes, synthetic waxes, hydrogenated castor oil, hydrogenated vegetable oil, gums, and mixtures thereof; and one or more polymers or copolymers exhibiting a pH-dependent solubility. The present invention also related to method of making these delayed release dosage form.
Claims27
A delayed release oral dosage form comprising one or more active ingredients within a granulated composition, which further comprises:
- a) one or more excipients selected from the group of solid aliphatic alcohols, fatty acid esters, mixtures of esters of saturated fatty alcohols and saturated fatty acids, natural waxes, synthetic waxes, hydrogenated castor oil, hydrogenated vegetable oil, gums, and mixtures thereof;
- and
- b) one or more polymers or copolymers exhibiting a pH-dependent solubility.
A delayed release oral dosage form comprising one or more active ingredients essentially uniformly distributed in a granulated composition comprising:
- a) one or more excipients selected from the group of solid aliphatic alcohols, mixtures of esters of saturated fatty alcohols and saturated fatty acids or natural or synthetic waxes, hydrogenated castor oil, hydrogenated vegetable oil, gums, or mixtures thereof;
- b) acrylic and methacrylic acid polymers and copolymers exhibiting a pH-dependent solubility;
- c) one or more light opacifying pigments;
- and
- d) an extra-granular phase comprising a disintegrant.
Dependencies are inferred from the claim text.