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.

Inactive Publication Date: 2004-09-08
WARNER-LAMBERT CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the use of enteric-coated formulations as part of the formulation pr...

Method used

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  • Compaction process for manufacture of sodium phenytoin dosage form
  • Compaction process for manufacture of sodium phenytoin dosage form
  • Compaction process for manufacture of sodium phenytoin dosage form

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] The blends of phenytoin and excipients were provided in the amounts shown in Table 1. The mixture was blended in the Patterson-Kelly(R) for 10 minutes.

[0046] Composition % (total weight)

Embodiment 2

[0048] To determine the extent to which compressive forces play a role in the dissolution of granules produced by the process of the present invention, the roller gap and speed process parameters were held constant as described below. Table 2 provides the dissolution data for portions of the blend described in Example 1 compressed at various roller pressures. The percentage of drug dissolved is determined using standard methods well known in the art. Specifically, each phenytoin formulation was tested using the USP dissolution test. Specifically, the test involved placing each capsule in 900 mL of water maintained at a temperature of 37°C ± 0.5°C and stirred at 50 rpm. Samples were taken at 30, 60 and 120 minutes and the amount of dissolved phenytoin was determined.

[0049] Table 2. Effect of compression force on dissolution

[0050] Method Parameters: Dissolved (%)

[0051] Roll gap = 2mm (sd)

[0052] Roll speed = 3rpm, n = 12

[0053] Roller pressure 30 minutes 60 mi...

Embodiment 3

[0062] To determine the extent to which compression force alone affects dissolution, all processing parameters except roller pressure were held constant as shown in Table 2 above. However, Table 3 provides dissolution data for various blend samples described in Example 1 at different roller pressures, roller gap widths (distance between the outer edges of the rollers at their closest point) and roller speeds. Similar to Example 2, the percentage of drug dissolved was determined using standard methods well known in the art.

[0063] Table 3. Influence of Processing Parameters

[0064] Processing parameters Dissolution (%)

[0065] (sd)

[0066] n=12

[0067] Batch Roller Roller Roller 30 minutes 60 minutes 120 minutes

[0068] Gap Velocity Pressure

[0069] (MM) (RPM) (KN)

[0070] 1 2.5 6.0 7.0 29(2.0) 49(3.2) 66(4.4)

[0071] 2 2.0 3.0 3.0 33(2.9) 62(57) 81(4.7)

[0072] 3 2.5 6.0 11.0 27(...

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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.

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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Application Information

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IPC IPC(8): C07D233/74A61J3/06A61J3/07A61J3/10A61K9/16A61K9/20A61K31/4166A61K47/02A61K47/10A61K47/12A61K47/26A61K47/38A61P25/08
CPCA61K9/1617A61K9/1694A61K9/1623A61P25/08A61K9/16
Inventor G·H·克罗茨三世M·G·费希海S·R·贾迪拉朱J·J·加韦尔I·盖布雷-塞拉斯A·K·谢斯
Owner WARNER-LAMBERT CO
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