Duloxetine HCL DR Pellets – Suitable for filling 20mg, 40mg & 60mg Capsules.
- Release pattern compared with innovator
- MKPPL objective is to develop duloxetine pellets by aqueous technology. Pellets developed by aqueous technology have advantage of avoiding the use of organic solvents.
- All the ingredients are available for both FBC process and all the equipment’s including analytical instruments like HPLC, FTIR, GC and dissolution apparatus are available to develop duloxetine pellets.
- Offer complete technical package for registrations in all regulated/semi regulated markets.
Additional information
| Percentage | 17%, 20% |
|---|---|
| Quality Standard | USP43 |
| Documentation Available: | DMF in CTD Format |
| Release Type | Delayed Release |
| Forms of PFI | Pellets/Micro pellets (for capsules) |
| Target Formulations | Capsules |
Description
INDICATIONS AND USAGE:
Duloxetine delayed-release capsules are used for treating depression and generalized anxiety disorder. It is used for managing chronic musculoskeletal pain, including osteoarthritis and chronic low back pain
MECHANISM OF ACTION:
Duloxetine inhibits the reuptake of serotonin and norepinephrine (NE) in the central nervous system. Duloxetine increases dopamine (DA) specifically in the prefrontal cortex, where there are few DA reuptake pumps, via the inhibition of NE reuptake pumps (NET) which is believed to mediate reuptake of DA and NE.
INNOVATOR: Cymbalta
DOSE: 20mg, 30 mg and 60mg
The objective is to develop Duloxetine DR pellets by aqueous technology. Pellets developed by aqueous technology has also advantage of avoiding the use of organic solvents.
Duloxetine DDR pellets is developed by Fluid bed coating processes.
In case of Fluid bed coater, the solution of Duloxetine along with other ingredients like povidone (k-30), hydroxy propyl methyl cellulose, hydroxy propyl cellulose, talc sodium lauryl sulfate, sucrose. The solution of Duloxetine is sprayed on sugar spheres 20 – 25# or 30 – 35# to get drug loaded pellets of Duloxetine. To achieve the desired release profile equivalent to innovator, this drug loaded pellets will be coated with polymers like ethylcellulose (Surelease aqueous), hydroxy propyl methyl cellulose E5/E15/E50, Eudragit L30D, Eudragit RL 30D, Eudragit RS 30D, Eudragit NE 30D, either single polymer or in combination with different ratios.
All the ingredients are available for both FBC process. All the equipments and Analytical Instruments like HPLC, FTIR, GC, and Dissolution apparatus are available to develop Duloxetine pellets.
