Process for preparing solid pharmaceutical dosage forms
AssigneeR.P. Scherer Corporation
InventorsRichard J. Yarwood, Patrick Kearney, Andrew R. Thompson
Life of this patent
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Abstract
A process for the preparation of an oral solid rapidly disintegrating dosage form of a pharmaceutically active substance which has an unacceptable taste which process comprises forming a solution or a suspension in a solvent of a form of the pharmaceutically active substance which is less soluble in water and more palatable than the form with the unacceptable taste together with a water-soluble or water-dispersible carrier material, forming discrete units of the suspension or solution and removing the solvent from the discrete units under conditions whereby a network of the carrier material carrying a dosage of the less soluble and more palatable form of the pharmaceutically active substance is formed.
Claims15
A process for the preparation of an oral solid rapidly disintegrating dosage form of a pharmaceutically active substance which has an unacceptable taste, which process comprises the steps of:
- forming a system selected from the group consisting of an aqueous solution and a suspension in an aqueous medium of an uncoated and uncomplexed form of the pharmaceutically active substance which is present in its free base form, said free base form being less soluble in water and more palatable than the corresponding salt form form with the unacceptable taste together with a carrier material selected from the group consisting of water-soluble and water-dispersible carrier materials and a compound which converts said pharmaceutically active substance, which is present in its salt form, into its free base form;
- forming discrete units of the system;
- and
- removing the aqueous medium from the discrete units under conditions whereby a network of the carrier material carrying a dosage of the less soluble and more palatable uncoated and uncomplexed form of the pharmaceutically active substance is formed.
A process for the preparation of an oral solid rapidly disintegrating dosage form of a pharmaceutically active substance which has an unacceptable taste, which process comprises the steps of:
- forming a system selected from the group consisting of an aqueous solution and a suspension in an aqueous medium of an uncoated and uncomplexed form of the pharmaceutically active substance which is less soluble in water and more palatable than the form with the unacceptable taste together with a carrier material selected from the group consisting of water-soluble and water-dispersible carrier materials;
- forming discrete units of the system;
- and
- removing the aqueous medium from the discrete units under conditions whereby a network of the carrier material carrying a dosage of the less soluble and more palatable uncoated and uncomplexed form of the pharmaceutically active substance is formed;
- wherein the pharmaceutically active substance is loperamide hydrochloride which is converted into the form of the loperamide free base during the preparation of the system.
A process for the preparation of an oral solid rapidly disintegrating dosage form of a pharmaceutically active substance which has an unacceptable taste, which process comprises the steps of:
- forming a system selected from the group consisting of an aqueous solution and a suspension in an aqueous medium of an uncoated and uncomplexed form of the pharmaceutically active substance which is less soluble in water and more palatable than the form with the unacceptable taste together with a carrier material selected from the group consisting of water-soluble and water-dispersible carrier materials;
- forming discrete units of the system;
- and
- removing the aqueous medium from the discrete units under conditions whereby a network of the carrier material carrying a dosage of the less soluble and more palatable uncoated and uncomplexed form of the pharmaceutically active substance is formed;
- wherein the less soluble pharmaceutically active substance is free domperidone base.
Dependencies are inferred from the claim text.