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Claims for Patent: 6,352,717

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Claims for Patent: 6,352,717

Title: Process for encapsulating shear sensitive fill masses into capsules and capsules containing shear sensitive fill masses
Abstract:The present invention provides a process for encapsulating a shear sensitive fill mass which contains a pharmaceutical active agent or nutrient, characterized in that said fill mass is heated and subsequently cooled, prior to the encapsulation. The invention also provides capsules comprising shear sensitive fill material obtained by the said process which have a high and constant dissolution rate.
Inventor(s): Alex; Rainer (Weil am Rhein, DE), Gerhards; Jurgen (Arlesheim, CH), Kraemer-Pittrof; Ingeborg (Rheinfelden, DE), Oeschger; Richard (Rheinsulz, CH), Rades; Thomas (Dunedin, NZ)
Assignee: Hoffman-La Roche Inc. (Nutley, NJ)
Application Number:09/440,731
Patent Claims: 1. A process for encapsulating a shear sensitive fill mass comprising saquinavir into a capsule, comprising the following steps in order:

a) heating a shear sensitive fill mass selected from the group consisting of emulsions, dispersions and solutions and comprising saquinavir;

b) cooling the fill mass; and

c) encapsulating the fill mass into the capsule essentially immediately after said cooling.

2. The process according to claim 1, wherein the capsule is from the group consisting of soft gelatin capsule, a hard gelating capsule and a HPMC capsule.

3. The process according to claim 2, wherein the capsule is a soft gelatin capsule and the fill mass is heated to a temperature between 0.degree. C. and about 20.degree. C. above its melting point, and cooled to a temperature between about 35.degree. C. and about 20.degree. C.

4. The process according to claim 2, wherein the capsule is a hard gelatin capsule and the fill mass is heated to a temperature between 0.degree. C. and about 20.degree. C. above its melting point, and subsequently cooled to a temperature between about 60.degree. C. and about 20.degree. C.

5. The process according to claim 1, wherein said fill mass is heated to a temperature between about 70.degree. C. and about 100.degree. C.

6. The process according to claim 1, wherein the fill mass provided in step a) is a solution.

7. The process according to claim 1, further comprising prior to step a), transporting the fill mass through a pump, to control the flow rate of the fill mass.

8. The process according to claim 7, wherein the fill mass in said pump is heated.

9. The process according to claim 8, wherein the fill mass in said pump is heated to between about 35.degree. C. and about 80.degree. C.

10. The process according to claim 1, further comprising prior to step, a) placing the pharmaceutical fill mass in a chamber and feeding the fill mass from the chamber to a heating unit.

11. The process according to claim 10, wherein the fill mass in said chamber is heated.

12. The process according to claim 11, wherein the fill mass in said chamber is heated to a temperature between about 35.degree. C. and about 95.degree. C.

13. A process for encapsulating a shear sensitive fill mass comprising saquinavir into a capsule comprising the following steps in order:

a) mixing a shear sensitive fill mass selected from the group consisting of emulsions, dispersions and solutions and comprising saquinavir;

b) heating the fill mass in a chamber;

c) transporting the fill mass from the chamber to a pump;

d) heating the fill mass in the pump;

e) controlling the flow of the fill mass from the pump;

f) heating the fill mass from the pump;

g) cooling the fill mass; and

h) encapsulating the fill mass into the capsule essentially immediately after said cooling.

14. A capsule containing a shear sensitive fill mass which comprises saquinavir, wherein said fill mass is encapsulated in accordance with the process of claim 1.

15. A capsule containing a shear sensitive fill mass which comprises saquinavir, said capsule having a constant dissolution rate of saquinavir of a least 70% within 30 minutes after administration.

16. A capsule containing a shear sensitive fill mass which comprises saquinavir, wherein the fill mass has a linear relationship between shear rate and shear stress from the origin of a plot of such relationship.
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