Methylphenidate Hydrochloride → Methylphenidate

Participants

Reaction Conditions

Reaction Steps

Methylphenidate hydrochloride (850 g), talc (24 g) and hydroxypropyl methylcellulose (HPMC, 48.5 g) were dissolved in water (4800 g) to prepare a coating solution. Microcrystalline cellulose CP102 (106-212 μm, Celphere® Asahi Kasei, Japan, 425 g) was loaded in a GPCG-1 (Glatt, Germany) flow coater. While spraying the prepared coating solution by bottom spraying, coating was performed while maintaining the product temperature at 29-35° C. until the coating solution was exhausted. Then, after drying at 50° C., a core material (1330 g) comprising methylphenidate was obtained. The drug content measured by HPLC was about 65.4%. The obtained core material mostly passed through a 300 μm sieve. When analyzed by scanning electron microscopy (SEM), most of the particles had a diameter in the range from 180 to 300 μm.

Provenance & Evidence