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Claims for Patent: 5,457,895

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Claims for Patent: 5,457,895

Title: Method of identifying freeze-dried dosage forms
Abstract:The invention permits the application of an identifying mark onto a freeze-dried tablet without the need for application of pressure or for printing directly on the tablet. The invention comprises the preparation of a freeze-dried unit that is embossed with an identifying mark such as a manufacturer's logo, medicinal component strength, or other information relating to the unit. The desired identifying mark is first embossed onto the base of a container such as a blister pocket. Liquid suspension is then filled into the container and freeze-dried therein. The resulting freeze-dried unit in the container is thereby embossed with substantial copy of the identifying mark that was embossed on the base of the container. The embossed identifying mark on the base of the container remains thereon as well, providing at reduced manufacturing cost the added ability to learn the identifying mark on the enclosed freeze-dried unit without opening the blister pack.
Inventor(s): Thompson; Andrew R. (Swindon, GB3), Yarwood; Richard J. (Buckland, GB3), Kearney; Patrick (Swindon, GB3)
Assignee: R. P. Scherer Corporation (Troy, MI)
Application Number:08/104,486
Patent Claims: 1. A method of applying an identifying mark to a fast-dissolving dosage form, comprising:

forming a blister pocket having at least one generally continuous blister pocket surface bearing an identifying embossment, said identifying embossment being discernable from said generally continuous blister pocket surface and representing a dosage identifying mark; and

forming said fast-dissolving dosage form directly in said blister pocket such that said fast-dissolving dosage form includes a generally continuous dosage surface corresponding to said generally continuous blister pocket surface and a tactile embossed identifying mark thereon corresponding to said identifying embossment.

2. A method as claimed in claim 1, wherein the step of forming said fast-dissolving dosage form comprises freeze-drying a liquid suspension in said blister pocket.

3. A method as claimed in claim 1, wherein said tactile embossed identifying mark is an elevated identifying mark.

4. A method as claimed in claim 1, wherein said tactile embossed identifying mark is a depressed identifying mark.

5. A method as claimed in claim 1, wherein the step of forming said blister pocket comprises thermoforming.

6. A method as claimed in claim 1, wherein the step of forming said blister pocket comprises cold-forming.

7. A method as claimed in claim 1 wherein said blister pocket comprises aluminum laminate.

8. A method as claimed in claim 1 wherein said blister pocket comprises plastic laminate.

9. A fast-dissolving dosage form bearing an embossed identifying mark applied by a process as claimed in claim 1.

10. A method as claimed in claim 1, wherein said dosage identifying mark comprises indicia of component strength of said fast dissolving dosage form.

11. A method as claimed in claim 1, wherein said dosage identifying mark comprises indicia of a manufacturer of said fast dissolving dosage form.

12. A combination comprising (i) a blister pocket having a generally continuous blister pocket surface embossed with an identifying embossment and (ii) a fast-dissolving dosage form contained in said blister pocket having a generally continuous dosage surface bearing a tactile embossed identifying mark corresponding to said identifying embossment, said tactile embossed identifying mark being applied to said generally continuous dosage surface by a process as claimed in claim 11.

13. A fast dissolving dosage form formed in a blister pocket and bearing an overall shape defined by the shape of the blister pocket including at least one generally continuous dosage surface formed by contact with a corresponding generally continuous blister pocket surface, said fast dissolving dosage form comprising:

a predetermined tactile identifying mark embossed on said generally continuous dosage surface formed by contact with a substantially identical embossment on said generally continuous blister pocket surface, said predetermined tactile identifying mark being three-dimensionally discernable from said generally continuous dosage surface.

14. A fast dissolving dosage form as claimed in claim 13, wherein said fast dissolving dosage form is freeze-dried in said blister pocket.

15. A fast dissolving dosage form as claimed in claim 13, wherein said predetermined tactile identifying mark comprises an elevated embossment.

16. A fast dissolving dosage form as claimed in claim 13, wherein said predetermined tactile identifying mark comprises a depressed embossment.

17. A fast dissolving dosage form as claimed in claim 13, wherein said predetermined tactile identifying mark comprises indicia of component strength of said fast dissolving dosage form.

18. A method as claimed in claim 13, wherein said predetermined tactile identifying mark comprises indicia of a manufacturer of said fast dissolving dosage form.
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