Compaction process for manufacture of sodium phenytoin dosage form

A technology of sodium phenytoin and preparations, which is applied in the field of preparation of dosage forms of sodium phenytoin, which can solve the problems of delayed absorption and inability to change drugs, etc.
CN1527700AInactive Publication Date: 2004-09-08WARNER-LAMBERT CO
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
WARNER-LAMBERT CO
Publication Date
2004-09-08
Estimated Expiration
Not applicable · inactive patent

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Abstract

A process for the roller compaction and manufacture of a pharmaceutical formulation comprises the steps of adding sodium phenytoin to a vessel of a blender and adding at least one excipient to the vessel. The mixture is blended and transferred to a roller compactor, where pressure is applied to the blend of sodium phenytoin and excipient. Next, the resultant compaction is milled to form a granulation, which is blended a second time and is suitable for further processing into a dosage form. Preferably, the excipients include magnesium stearate, sugar, lactose monohydrate, and talc. In an alternative embodiment, talc is added immediately prior to the granulation being blended for a second time.
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Description

field of invention

[0001] The invention relates to a method for preparing a dosage form of phenytoin sodium. In particular, the present invention relates to a process for the preparation of phenytoin capsules for oral administration with extended release. Background of the invention

[0002] In the field of drug development, a sustained release dosage form can be defined as a formulation that releases the drug in vivo at a significantly slower rate than a conventional dosage form (non-sustained release) of equivalent dose. The purpose of using sustained-release products is to obtain a satisfactory drug response while reducing dosing frequency and maintaining biological efficacy equivalent to existing phenytoin formulations. An example of a drug commonly used in sustained release form is chlorpheniramine maleate. The drug can be given in 4 mg doses every 4 hours in the regular dosage form or in 12 mg doses every 12 hours in the sustained release form. ...

Claims

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