Method for manufacture of extended release dosage form
First Claim
1. A process for manufacturing a pharmaceutical formulation comprising the steps of:
- adding sodium phenytoin to a vessel;
adding at least one excipient to said vessel;
heating said sodium phenytoin and said excipient;
mixing said sodium phenytoin and said excipient to form a mixture; and
chopping said mixture to form a granulation.
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Accused Products
Abstract
A process for the dry granulation and manufacture of a pharmaceutical formulation comprises the steps of adding sodium phenytoin to a vessel of a mixer/granulator and adding at least one excipient to the vessel. Heat is then applied from the vessel to the sodium phenytoin and excipient to achieve the desired target temperature. Next, while the heat is applied from the vessel, the sodium phenytoin and excipient are mixed and chopped in the vessel to form a granulation suitable for encapsulating into a dosage form. Preferably, the excipients include magnesium stearate, sugar, lactose monohydrate, and talc. In an alternative embodiment, talc is added after chopping and blended into the formulation to form a blend suitable for encapsulating into a dosage form.
26 Citations
37 Claims
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1. A process for manufacturing a pharmaceutical formulation comprising the steps of:
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adding sodium phenytoin to a vessel;
adding at least one excipient to said vessel;
heating said sodium phenytoin and said excipient;
mixing said sodium phenytoin and said excipient to form a mixture; and
chopping said mixture to form a granulation. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 25, 26, 27, 28, 29, 30)
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24. A process for the dry granulation and manufacture of a pharmaceutical formulation, the method comprising the steps of:
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adding sodium phenytoin to a vessel having an insulating jacket;
adding at least one excipient to said vessel, wherein said excipient is selected from the group consisting of stearic acid, magnesium stearate, microcrystalline cellulose, sorbitol, mannitol, sugar, glucose, and lactose monohydrate;
heating said sodium phenytoin and said excipient to 30°
C. to 70°
C.;
mixing said sodium phenytoin and said excipient for about 0.1 to 2 hours and at speed of about 0.5 to 115 revolutions per minute to form a mixture;
chopping said mixture at a speed of 0.5 to 2400 revolutions per minute for a period of 0.1 to 2 hours;
adding talc to said mixture; and
blending said mixture to form a blend.
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31. A process for the dry granulation and manufacture of a pharmaceutical formulation, the method comprising the steps of:
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adding sodium phenytoin to a vessel having an insulating jacket;
adding at least one excipient to said vessel, wherein said excipient is selected from the group consisting of stearic acid, magnesium stearate, microcrystalline cellulose, sorbitol, mannitol, sugar, glucose, lactose monohydrate, and talc;
heating said sodium phenytoin and said excipient to 30°
C. to 70°
C.;
mixing said sodium phenytoin and said excipient for about 0.1 to 2 hours and at speed of about 0.5 to 115 revolutions per minute to form a mixture; and
chopping said mixture at a speed of 0.5 to 2400 revolutions per minute for a period of 0.1 to 2 hours to form a granulation. - View Dependent Claims (32, 33, 34, 35, 36, 37)
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Specification
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- Resources
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Current AssigneeWarner-Lambert Company (Pfizer Inc.)
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Original AssigneeWarner-Lambert Company (Pfizer Inc.)
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InventorsLeung, Sau-Hung Spence, Ha, Qing, Sabouni, Adam, Ifan, Agber, Gadiraju, Srinivas R.
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Application NumberUS10/117,742Publication NumberTime in Patent OfficeDaysField of SearchUS Class Current424/499CPC Class CodesA61K 9/1694 resulting in granules or mi...
