Programmed release oral solid pharmaceutical dosage form
AssigneeZambon Group S.p.A.
InventorsFranco Pozzi, Pia Furlani
Life of this patent
Estimating the term…
Abstract
A programmed release pharmaceutical dosage form comprising a core, containing the active ingredient, coated by a hydrophobic layer is described. Such dosage forms release the active ingredient after a pre-established no-release interval which does not depend on physiological factors.
Claims21
A programmed release oral solid pharmaceutical dosage form comprising a core, containing the active ingredient, coated by a layer comprising a mixture of a hydrophobic material selected from the group consisting of esters of higher fatty acids with higher alcohols, higher alcohols, higher fatty acids, salts of higher fatty acids, esters of glycerine with higher fatty acids, esters of higher fatty acids with polyethyleneglycol, wax, paraffin oil and mixtures thereof having a melting point between 50.degree. C. and 90.degree. C. and a non-ionic surfactant having a HLB value between 10 and 16, the amount of the surfactant being from 5 to 20% by weight with respect to the hydrophobic material, and a pharmaceutically acceptable water-soluble film forming material selected from the group consisting of hydroxyalkyl cellulose, polymethacrylic acid esters and polyvinylpyrrolidone in an amount of from 5 to 30% by weight with respect to the hydrophobic material.
A method for time-specific release of an orally administered pharmaceutical composition comprising:
- coating a core containing a pharmaceutical active ingredient with a layer comprising a mixture of hydrophobic material selected among esters of higher fatty acids with higher alcohols, higher alcohols, higher fatty acids, salts of higher fatty acids, esters of glycerine with higher fatty acids, ester of higher fatty acids with polyethyleneglycol, wax, paraffin oil and mixtures thereof having a melting point between 5.degree. C. and 90.degree. C. and a non-ionic surfactant having a HLB value between 10 and 16, the amount of surfactant being from 5 to 20% by weight relative to the hydrophobic material and a pharmaceutically acceptable water-soluble film forming material selected from the group consisting of hydroxyalkyl cellulose, polymethacrylic acid esters and polyvinylpyrrolidone in an amount of from 5 to 30% by weight with respect to the hydrophobic material;
- orally administering the resulting composition to an individual in need thereof.
A method for site-specific release of an orally administered pharmaceutical composition comprising:
- coating a core containing a pharmaceutically active ingredient with a layer comprising a mixture of hydrophobic material selected from the group consisting of esters of higher fatty acids with higher alcohols, higher alcohols, higher fatty acids, salts of higher fatty acids, esters of glycerine with higher fatty acids, esters of higher fatty acids with polyethyleneglycol, wax, paraffin oil and mixtures thereof having a melting point between 50.degree. C. and 90.degree. C. and a non-ionic surfactant having an HLB value between 10 and 16, the amount of surfactant being from 5 to 20% by weight relative to the hydrophobic material and a pharmaceutically acceptable water-soluble film forming material selected from the group consisting of hydroxyalkyl cellulose, polymethacrylic acid esters and polyvinylpyrrolidone in an amount of from 5 to 30% by weight with respect to the hydrophobic material;
- orally administering the resulting composition to an individual in need thereof.
Dependencies are inferred from the claim text.