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Details for Patent: 8,936,810

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Details for Patent: 8,936,810

Title:Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms
Abstract: Rapid and accurate determination of the formulation orientation of multi-layer capsule-shaped tablets with respect to different internal formulation layers proximate to the opposite narrow and rounded ends of the tablets is required. By including an appropriate color scheme in multi-layer osmotic tablets, detection of the formulation orientation is achieved by detecting the color at a spot location on a side of the tablet corresponding to one or another formulation layer or to one or another interface of two formulation layers depending on the formulation orientation of the tablet.
Inventor(s): Stone; Steven F. (Los Altos, CA), Geerke; Johan H. (Saratoga, CA)
Assignee: ALZA Corporation (Palo Alto, CA)
Filing Date:Oct 18, 2012
Application Number:13/654,958
Claims:1. A method of preparing a capsule-shaped tablet having a push end and a dispensing end for laser drilling of a delivery port in said dispensing end, wherein the tablet comprises adjacent first and second formulation layers each containing methylphenidate or a pharmaceutically acceptable salt thereof, and a further formulation layer not containing methylphenidate or a pharmaceutically acceptable salt thereof and being located at the push end of the tablet, the method comprising the steps of: detecting the formulation orientation of the tablet by detecting the color at a spot location on a side of the tablet corresponding to one or another formulation layer depending on the formulation orientation of the tablet, wherein at least one layer contains a colorant; determining the formulation orientation of the tablet on the basis of the color detected; passing the tablets through a tablet rectifier wherein the orientation of any improperly oriented tablets is rectified and the orientation of any properly oriented tablets is maintained; and collecting the uniformly oriented tablets from said tablet rectifier for transportation to a laser drilling station.

2. The method of claim 1 wherein the colorant is a dark colorant.

3. The method of claim 2 wherein the formulation layer containing the dark colorant does not contain methylphenidate or a pharmaceutically acceptable salt thereof and another formulation layer containing methylphenidate or a pharmaceutically acceptable salt thereof also contains a light colorant.

4. A method of making a multi-layer tablet having a pushing end and a dispensing end, wherein the tablet comprises adjacent first and second formulation layers each containing a drug ingredient, and a further formulation layer not containing a drug ingredient and being located at the push end of the tablet, comprising: adding a first colorant to one formulation layer containing methylphenidate or a pharmaceutically acceptable salt thereof proximately positioned at the dispensing end of the multi-layered tablet, the first colorant being complementary to no color; adding a second colorant to at least one formulation layer not containing any methylphenidate or a pharmaceutically acceptable salt thereof proximately positioned at the push end of the multi-layered tablet, the second colorant distinguishable from the first colorant or from no color; compressing the formulation layers into a capsule-shaped osmotic tablet such that the formulation orientation of the tablet can be determined by detecting the color at a spot location on a side of the tablet corresponding to one or another differently-colored formulation layer depending on the formulation orientation of the tablet, and detecting the formulation orientation of the tablet with a color detector directed at a spot location on a side of the tablet.

5. The method of claim 1 wherein the formulation layer containing the colorant does not contain methylphenidate or a pharmaceutically acceptable salt thereof and another formulation layer containing methylphenidate or a pharmaceutically acceptable salt thereof also contains a lighter colorant.

6. The method of claim 1 wherein the formulation layer containing the colorant contains methylphenidate or a pharmaceutically acceptable salt thereof and another formulation layer that does not contain methylphenidate or a pharmaceutically acceptable salt thereof contains a lighter colorant.

7. The method of claim 1 wherein the formulation layer containing the colorant contains methylphenidate or a pharmaceutically acceptable salt thereof and another formulation layer that does not contain methylphenidate or a pharmaceutically acceptable salt thereof does not contain a colorant.
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