Dosage form holder device and methods for immersion testing

Abstract

The present invention comprises a device and methods for dissolution or immersion testing and, in particular, a device and methods that improve the consistency of test results by limiting the ability of pharmaceutical or other dosage forms to move or reorient during testing.

1 . A device for holding a dosage form during immersion testing, said device comprising: 
 an enclosure surrounding a chamber sufficiently large to receive a dosage form therein;    a retaining means;    wherein said retaining means engages with said enclosure to limit the movement of a dosage form within said chamber and the immersion testing is performed in a USP 25 <711> Dissolution type 2 apparatus.    
   
   
       2 . The device recited in  claim 1  wherein the enclosure is cylindrical.  
   
   
       3 . The device recited in  claim 1  wherein the enclosure is rectangular.  
   
   
       4 . The device recited in  claim 1  wherein the enclosure is cubical.  
   
   
       5 . (canceled)  
   
   
       6 . The device recited in  claim 1  wherein the enclosure is a coil having a plurality of connected rings and two ends, at least two of said plurality of connected rings being moveable relative to each other and a support member on at least one end for supporting at least one surface of said dosage form.  
   
   
       7 . The device recited in  claim 6  wherein said coil is cylindrical.  
   
   
       8 . The device recited in  claim 6  wherein said coil is rectangular.  
   
   
       9 . The device recited in  claim 6  wherein said coil is cubical.  
   
   
       10 . The device recited in  claim 6  wherein the retaining means is attached to at least one end of the coil and wherein said retaining means further comprises a holding portion that engages with said coil to retain a dosage form in said chamber.  
   
   
       11 . The device recited in  claim 1  wherein the retaining means is permanently attached to the enclosure and wherein said retaining means further comprises a holding portion that engages with said enclosure to retain a dosage form in said chamber.  
   
   
       12 . The device recited in  claim 1  wherein the retaining means removably engages with said enclosure to retain a dosage form in said chamber.  
   
   
       13 . The device recited in  claim 1  wherein said enclosure and/or retaining means are formed of an acid-resistant material.  
   
   
       14 . The device recited in  claim 1  further comprising a secondary holder with a means for engaging said enclosure.  
   
   
       15 . (canceled)  
   
   
       16 . The device recited in  claim 14  wherein the enclosure is engaged with the engaging means by the use of magnetic force.  
   
   
       17 . The device recited in  claim 14  wherein said secondary holder is formed of an acid-resistant material.  
   
   
       18 . The device recited in  claim 14  wherein at least one side of said enclosure conforms to the shape of a testing vessel.  
   
   
       19 . (canceled)  
   
   
       20 . A method of performing immersion testing comprising the steps of: 
 placing a dosage form in a device that holds the dosage form in a specific orientation;    placing said device and the dosage form in an apparatus for immersion testing wherein the apparatus is a USP 25 <711> Dissolution type 2 apparatus; and    conducting immersion testing.    
   
   
       21 . The method of  claim 20  wherein the step of placing the dosage form in said device comprises horizontally orienting a dosage form in the enclosure.  
   
   
       22 . The method of  claim 20  wherein the step of placing the dosage form in said device comprises vertically orienting a dosage form in the enclosure.  
   
   
       23 . (canceled)  
   
   
       24 . The method of  claim 20  wherein the dosage form is an osmotic tablet with at least one passageway.  
   
   
       25 . The method of  claim 20  wherein the dosage form is a matrix tablet.  
   
   
       26 . (canceled)  
   
   
       27 . The method of  claim 24  wherein the device orients the tablet such that a passageway of the tablet faces in the upward direction.  
   
   
       28 . The method of  claim 24  wherein the device orients the tablet such that a passageway of the tablet faces in the downward direction.  
   
   
       29 . The method of  claim 24  wherein the device orients the tablet such that a passageway of the tablet faces to a side.  
   
   
       30 . The method of performing immersion testing of  claim 20  further comprising the steps of: 
 attaching the device to a secondary holding means;    placing the secondary holding means with the attached device and the dosage form in a vessel for conducting immersion testing; and    conducting immersion testing.    
   
   
       31 . (canceled)  
   
   
       32 . (canceled)  
   
   
       33 . The method of  claim 30  wherein the secondary holding means holds the device and dosage form in an off-center position in a vessel of a 25 USP <711> Dissolution type 2 apparatus.  
   
   
       34 . The method of  claim 20  wherein the dosage form is a tablet.  
   
   
       35 . The device of  claim 1  wherein the dosage form is a tablet.  
   
   
       36 . The method of  claim 30  wherein the dosage form is a tablet.