Methods and apparatus for determining formulation orientation of multi-layered pharmaceutical dosage forms

• US 7,521,067 B1
• Filed: 06/02/1999
• Issued: 04/21/2009
• Est. Priority Date: 06/03/1998
• Status: Expired due to Fees

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Geerke, Johan H, Stone, Steven F.
• Primary Examiner(s): Padmanabhan; Sreeni
• Assistant Examiner(s): CHONG, YONG SOO
• Application Number:
  US09/324,343
• Time in Patent Office: 3,611 Days
• Field of Search: 424/461, 424/464, 424/465, 424/467, 424/468, 424/473, 424/474, 424/477, 424/451, 424/452, 424/453, 424/483, 424/454, 514/654
• US Class Current: 424/461
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61P 25/14 for treating abnormal movements, e.g. chorea, dyskinesia
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: G01N 21/9508 Capsules; Tablets

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.

Claims

1. A method of making a three-layer capsule-shaped tablet comprising:

formulating a first layer containing a drug ingredient and a second layer containing a drug ingredient, wherein one of the layers comprises a first colorant;

formulating a non-drug ingredient containing third layer comprising a second colorant that is distinguishable from the first colorant or from no color and not containing any drug ingredient;

compressing the first, second and third layers into a capsule-shaped osmotic tablet wherein the first layer is located at one end of the capsule-shaped osmotic tablet and the third layer is located at the other end of the capsule-shaped osmotic tablet and the second layer is located between the first layer and the third layer 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 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 the side of the tablet.

2. The method of claim 1 wherein the first colorant is light and the second colorant is dark.

4. The method of claim 1 wherein said second layer comprises a larger concentration of drug ingredient than said first layer.

5. The method of claim 1 wherein said first and second layers comprise methylphenidate chloride.

6. The method of claim 1 wherein said first layer comprises about 9% to about 10% by weight methylphenidate chloride and said second layer comprises about 13% to about 14% by weight methylphenidate chloride.

3. A method of making a three-layer capsule-shaped tablet comprising:

formulating a first layer containing a drug ingredient and not containing any colorant;

formulating a second layer containing a drug ingredient and a first colorant, the first colorant being complementary to no color;

formulating a third layer containing a second colorant that is distinguishable from the first colorant or from no color and not containing any drug ingredient;

compressing the first, second and third layers into a capsule-shaped osmotic tablet the first layer is located at one end of the capsule-shaped osmotic tablet and the third layer is located at the other end of the capsule-shaped osmotic tablet and the second layer is located between the first layer and the third layer 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 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 in the side of the tablet.

7. The method of claim 3 wherein said second layer comprises a larger concentration of drug ingredient than said first layer.

8. The method of claim 3 wherein said first and second layers comprise methylphenidate chloride.

9. The method of claim 3 wherein said first layer comprises about 9% to about 10% by weight methylphenidate chloride and said second layer comprises about 13% to about 14% by weight methylphenidate chloride.