Method of manufacturing modified release dosage forms
First Claim
1. A dosage form comprising:
- a molded matrix; and
at least one active ingredient dispersed in the molded matrix,wherein the matrix comprises 10-100% of a thermal reversible carrier having a melting point of less than about 100 degrees C. selected from (a) polyethylene glycols having molecular weight from about 100 to about 20,000 Daltons; and
(b) a release-modifying excipient comprising a combination of croscarmellose sodium and shellac, andwherein the matrix is capable of providing modified release of the active ingredient upon contacting the dosage form with a liquid medium.
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Accused Products
Abstract
In one embodiment a dosage form comprises at least one active ingredient and a molded matrix which comprises 10-100% of a material having a melting point of less than about 100 degrees C. selected from the stamp consisting of thermoplastic polyalkylene oxides, low melting hydrophobic materials, thermoplastic polymers, thermoplastic starches and combinations thereof, and the matrix is capable of providing modified release of the active ingredient upon contacting of the dosage form with a liquid medium. The dosage form may additionally comprise uncoated particles which may contain at least one active ingredient. In another embodiment, a dosage form comprises at least one active ingredient, a plurality of particles and a molded matrix, wherein at least a portion of the particles are coated. The coated particles, the matrix or both may comprise at least one active ingredient, and the coated particles or the matrix or a combination thereof is capable of providing modified release of the active ingredient upon contacting of the dosage form with a liquid medium.
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Citations
14 Claims
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1. A dosage form comprising:
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a molded matrix; and at least one active ingredient dispersed in the molded matrix, wherein the matrix comprises 10-100% of a thermal reversible carrier having a melting point of less than about 100 degrees C. selected from (a) polyethylene glycols having molecular weight from about 100 to about 20,000 Daltons; and
(b) a release-modifying excipient comprising a combination of croscarmellose sodium and shellac, andwherein the matrix is capable of providing modified release of the active ingredient upon contacting the dosage form with a liquid medium.
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2. A method for manufacturing a dosage form comprising a molded matrix and at least one active ingredient dispersed in the molded matrix comprising:
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injecting a matrix in flowable form into a molding chamber to form said dosage form, wherein the matrix comprises 10-100% of a thermal reversible carrier having a melting point of less than about 100 degrees C. selected from (a) polyethylene glycols having molecular weight from about 100 to about 20,000 Daltons; and
(b) a release-modifying excipient selected from the group consisting of croscarmellose sodium, shellac and combinations thereof, andwherein the matrix is capable of providing modified release of the active ingredient upon contacting of the dosage form with a liquid medium. - View Dependent Claims (4, 6, 8, 9, 10, 11, 13)
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3. A method for manufacturing a dosage form comprising a molded matrix and at least one active ingredient dispersed in the molded matrix at a level of more than about 20 weight percent comprising:
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injecting a matrix in flowable form into a molding chamber to form said dosage form, wherein the matrix comprises 10-100% of a material having a melting point of less than about 100 degrees C. selected from (a) polyethylene glycols having molecular weight from about 100 to about 20,000 Daltons; and
(b) a release-modifying excipient comprising a combination of croscarmellose sodium and shellac, andwherein the matrix is capable of providing modified release of the active ingredient upon contacting of the dosage form with a liquid medium. - View Dependent Claims (5, 7, 12, 14)
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Specification