Medicated chewing gum and a process for preparation thereof
First Claim
1. A process for the preparation of medicated chewing gum comprising(a) forming an inclusion complex of one or more active agents within cyclodextrin,(b) drying the inclusion complexes of step (a),(c) mixing the dried inclusion complexes with a granulated gum base and and at least one excipient in the absence of added water or organic solvents under a temperature of below 20°
- C. and a maximum relative humidity of 50%, and(d) cold-pressing the mixture of step (c) under a temperature of below 20°
C. and a maximum relative humidity of 50% to produce a tablet of medicated chewing gum.
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Accused Products
Abstract
The present invention relates to a medicated chewing gum comprising a pharmaceutically active agent incorporated therein. The medicated gum is used as a means for administering the active agent to a subject. The invention also relates to a method of preparing the medicated chewing gum. The process involves the formation of a cyclodextrin-active agent inclusion complex, which is dried and mixed with a granulated gum base without adding water or other solvents. The process is carried out under controlled temperature and humidity and the blended components are cold-pressed to produce a final gum product.
107 Citations
44 Claims
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1. A process for the preparation of medicated chewing gum comprising
(a) forming an inclusion complex of one or more active agents within cyclodextrin, (b) drying the inclusion complexes of step (a), (c) mixing the dried inclusion complexes with a granulated gum base and and at least one excipient in the absence of added water or organic solvents under a temperature of below 20° - C. and a maximum relative humidity of 50%, and
(d) cold-pressing the mixture of step (c) under a temperature of below 20°
C. and a maximum relative humidity of 50% to produce a tablet of medicated chewing gum. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 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)
- C. and a maximum relative humidity of 50%, and
Specification