OBTAINING MEDICINAL FORMS OF SKELETAL MUSCLE MYRELAXANTS WITH CONTROLLED RELEASE

摘要

1. A method of obtaining a pharmaceutical composition, comprising:! a) coating inert particles with a drug layering composition comprising cyclobenzaprine or a pharmaceutically acceptable salt, solvate and / or ester thereof and a pharmaceutically acceptable solvent, thereby forming IR granules; and! b) coating the IR granules of the ER with an opaque composition comprising a pharmaceutically acceptable water-insoluble polymer in an atmosphere with a dew point in the range of about 5-20 ° C., thereby forming ER granules. ! 2. The method according to claim 1, further comprising:! c) maintaining the ER granules at about 60 ° C for about 4-12 hours in an atmosphere with a dew point in the range of about 5-20 ° C. ! 3. The method according to claim 1, further comprising coating IR granules of step a) with an insulating coating composition comprising a pharmaceutically acceptable water-soluble polymer, before said step b) of the ER coating. ! 4. The method according to claim 3, where these inert particles have a particle size of approximately 20-25 mesh. ! 5. The method according to claim 1, where the specified insulating covering composition further comprises water. ! 6. The method according to claim 1, where the indicated coating steps a) and b) are carried out in an atmosphere with a dew point in the range of about 5-20 ° C. ! 7. The method according to claim 1, where the ER coating composition further includes a plasticizer. ! 8. The method according to claim 7, where the ER coating composition is obtained by mixing a pharmaceutically acceptable water-insoluble polymer, a plasticizer and a pharmaceutically acceptable solvent for at least about 1 hour after adding the plasticizer to the pharmaceutically acceptable water-insoluble floor