Mebeverine HCL Extended Release Pellets – Suitable for filling in 135mg & 200mg Capsules.
- MKPPL achieved the desired sustained release profile equivalent to innovator
- Mebeverine is an antispasmodic medicine which is taken to relieve bloating and cramp pain in the lower abdomen. These symptoms are commonly associated with the gastrointestinal condition called irritable bowel syndrome.
- MKPPL aims to deliver Mebeverine as an inhibitor of calcium-depot replenishment. Musculotropic compounds act directly on the gut muscles at the cellular level to relax them. This relieves painful muscle spasms of the gut without affecting its normal motility.
- Offer complete technical package for registrations in all regulated/semi regulated markets.
Additional information
| Percentage | 76%, 80% |
|---|---|
| Release Type | Extended Release |
| Quality Standard | USP43 |
| Documentation Available: | DMF in CTD Format |
| Forms of PFI | Pellets/Micro pellets (for capsules) |
| Target Formulations | Capsules |
INDICATIONS AND USAGE:
Mebeverine is an antispasmodic medicine which is taken to relieve bloating and crampy pain in the lower tummy (abdomen). These symptoms are commonly associated with the gastrointestinal condition called irritable bowel syndrome. MECHANISM OF ACTION: Mebeverine is an inhibitor of calcium-depot replenishment. Musculotropic compounds act directly on the gut muscles at the cellular level to relax them. This relieves painful muscle spasms of the gut, without affecting its normal motility.
INNOVATOR: COLOFAC MR CAPSULES
DOSE: 200MG
Mebeverine hydrochloride SR pellets can be developed by two processes.
- Coating Pan
- Fluid bed coating
In case of Coating pan, the Mebeverine hydrochloride pellets can be develop by preparing blend of API & Excepient. This blend will be layered on sugar spheres to get spherical shape drug loaded pellets. The excepients which can be tried are Lactose, microcrystalline cellulose, povidone (k-30), hydroxy propyl methyl cellulose, hydroxy propyl cellulose, Aerosil.
In case of Fluid bed coater, to achieve the desired sustained 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 Coating pan and FBC process. All the equipments and Analytical Instruments like HPLC, FTIR, GC, and Dissolution apparatus are available to develop Mebeverine hydrochloride SR pellets.
