Process for encapsulation of caplets in a capsule and solid dosage forms obtainable by such process
First Claim
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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, 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.
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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.
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Citations
50 Claims
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1. A process for the encapsulation of caplets in a capsule, comprising the following steps:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47)
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12. A process for filling hard gelatin capsule comprising:
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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. - View Dependent Claims (13, 48, 49, 50)
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Specification