Back to results
US 7,018,658 B2Granted
Pharmaceutical pellets comprising tamsulosin
AssigneeSynthon BV
InventorJohannes J. Platteeuw
Life of this patent
Estimating the term…
Abstract
Tamsulosin pellets having an advantageous release profile are formed. The pellets have an enteric coating and release less than 10% of the tamsulosin in two hours in SGF.
Claims21
A pharmaceutical dosage form comprising a plurality of pellets, wherein each pellet comprises:
- a. a pellet core having a diameter within the range of 0.3-0.9 mm and comprising a tamsulosin hydrochloride, microcrystalline cellulose, a pharmaceutically acceptable water permeable acrylic polymer and water;
- and
- b. an outer layer coat surrounding said core which comprises a pharmaceutically acceptable acid-resistant acrylic polymer, wherein the mass of said outer layer coat, calculated on a dry pellet core basis, is within the range of 2.5-15%;
- and
- wherein the plurality of pellets exhibits a dissolution release profile in simulated gastric fluid using Ph. Eur. basket method at 100 rpm which includes releasing less than 10% of the tamsulosin during the first two hours.
2 more elements
A process, which comprises:
- a. granulating a mixture of tamsulosin hydrochloride, microcrystalline cellulose, acrylic polymer, water and optionally auxiliary ingredients to form wet pellet cores,
- b. drying said wet pellet cores to a residual amount of water of 2-10%;
- c. sieving said dried pellet cores to obtain a fraction within the size range of 0.3-0.9 mm;
- d. coating said sieved dried pellet cores with a coating composition that comprises an acid-resistant water soluble acrylic polymer;
- and
- e. drying said coated pellet;
- wherein said coating step (d) is sufficient to provide said dried coated pellet with 2.5-15 mass % of said coating composition, calculated on the dry pellet core basis.
4 more elements
A process, which comprises:
- (a) granulating a mixture of tamsulosin hydrochloride, microcrystalline cellulose, acrylic polymer, water and optionally auxiliary ingredients to form wet pellet cores,
- (b) drying said wet pellet cores to a residual amount of water of 2-10%;
- sieving said dried pellet cores to obtain a fraction within the size range of 0.3-0.9 mm;
- (c) coating said sieved dried pellet cores with a coating composition that comprises an acid-resistant water soluble acrylic polymer;
- (d) drying said coated pellet;
- (e) testing a sample of said dried coated pellets for dissolution rate in a simulated gastric fluid;
- and
- (f) repeating the coating process on the remaining dried coated pellets until a desired amount of release is achieved in said testing step (e).
5 more elements
Dependencies are inferred from the claim text.