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US 6,245,350 B1Granted
Process for encapsulation of caplets in a capsule and solid dosage forms obtainable by such process
AssigneeWarner-Lambert Company
InventorsJames Amey, Dominique Cade, Paul Maes, Robert Scott
Life of this patent
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Abstract
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 a process are tamper-proof in that they cannot be opened in a way to be reassembled without showing such opening process.
Claims50
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, wherein the clearance between the capsule part and the caplet is in the range of from −0.5-0.5 mm.,
- c. putting said capsule parts together,
- d. treating the combined capsule parts by cold shrinking,
- wherein the empty capsule parts are either kept after production at humid conditions in the range of from about 40 to about 90% relative humidity to retain a moisture content in the range of from about 14 to about 19% by weight of the capsule shell 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.
2 more elements
A process for filling hard gelatin capsule comprising:
- maintaining empty capsule bodies and caps or pre-assembled capsule bodies after production at humid conditions of about 40 to about 90% relative humidity to retain a moisture content of about 14 to about 19% by weight of the capsule shell or are re-humidified to said moisture content before feeding into a capsule filling machine;
- maintaining the capsule body under humid conditions within the filling machine at said moisture content during rectifying and filling;
- and
- maintaining the capsule cap under the same conditions until assembled with the body, and the encapsulated dosage form is dried at about 20 to about 40% relative humidity and a temperature of about 15 to about 60 C.
1 more element
Dependencies are inferred from the claim text.