United States Patent:  6,080,426

Assignee:  Warner-Lamberg Company (Morris Plains, NJ)

Filed:  January 11, 1996

A process for encapsulation of caplets in a capsule comprises the following steps: a. providing empty capsule parts; b. filling at least one of said capsule parts with one or more caplets; c. putting said capsule parts together; and d. treating the combined parts by cold shrinking. The solid dosage forms obtainable by such aprocess are tamper-proof in that they cannot be opened in a way to be reassembled without showing such opening process.

SUMMARY OF THE INVENTION

According to a first aspect, the present invention provides a process for encapsulation of a caplet in a capsule by cold shrinking together capsule parts, which are filled with a caplet. According to another aspect, the present invention provides a solid dosage form obtainable by such a process. The solid dosage form according to the present invention is tamper-proof in that the caplet contained in the capsule cannot be removed from the capsule without destroying same.

The process according to the present invention furthermore provides a capsule product comprising several parts, which are combined with each other in a way that no visible slits between the capsule parts are present after the cold shrink procedure. The solid dosage forms of the present invention have a completely smooth surface, so that same can be swallowed easily by patients. More specifically, a process for encapsulating caplets in a capsule is provided, which comprises the following steps:

a. providing empty capsule parts,

b. filling at least one of said capsule parts with one or more caplets,

c. putting said capsule parts together, and

d. treating the combined capsule parts by cold shrinking.

Moreover, a solid dosage form comprising a caplet and a capsule coating obtainable by such process is described.

Claim 1 of 38 Claims

1. A process for the encapsulation of caplets in a capsule, comprising the following steps:

a. providing empty first and second capsule shell parts,

b. filling at least one of said capsule parts with one or more caplets,

c. putting said capsule parts together,

wherein the empty capsule parts are either kept after production at humid conditions in the range of from about 40 to 90% relative humidity to retain a moisture content in the range of from about 16 to 18% by weight of the capsule or are re-humidified to said moisture content before feeding into a capsule filling machine and wherein the first capsule part is kept under humid conditions within the filling machine at said moisture content during rectifying and assembling with a caplet having a moisture content in the range of from about 0 to about 12 by weight, the second capsule part is processed in the same manner, and the encapsulated dosage form is dried at a relative humidity in the range of from about 20 to about 40% and a temperature in the range of from about 15 to about 60 C. and wherein after drying and shrinking of the capsule parts the encapsulated dosage form is film-coated.

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