Tamsulosin HCL SR Pellets

Tamsulosin hydrochloride is in the treatment of BPH (Benign Prostatic Hyperplacia). Tamsulosin hydrochloride is a white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether. The innovator is Flomax. Each FLOMAX capsule for oral administration contains tamsulosin hydrochloride 0.4 mg, and the inactive ingredients: methacrylic acid copolymer dispersion, microcrystalline cellulose, triacetin, calcium stearate, talc.

The objective is to develop Tamsulosin hydrochloride SR pellets by aqueous technology. Pellets developed by aqueous technology has also advantage of avoiding the use of organic solvents.
Tamsulosin hydrochloride SR pellets can be developed by two processes.Fluid bed coating or Extrusion Spheronization.

In case of Fluid bed coater, the solution of Tamsulosin hydrochloride along with other ingredients like povidone (k-30), hydroxy propyl methyl cellulose, hydroxy propyl cellulose, talc, sodium lauryl sulfate, sucrose. The solution of Tamsulosin hydrochloride can be sprayed on sugar spheres 25 – 30# or 30 – 40# to get drug loaded pellets of Tamsulosin hydrochloride. 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.

In case of Extrusion Spheronization, the Tamsulosin hydrochloride SR pellets can be develop by preparing wet mass of API & Excepient. This wet mass will get extruded and then spheronized 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.

To achieve the desired sustained release profile equivalent to innovator, this drug loaded pellets will be coated with polymers like Ethyl cellulose (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 and Extrusion Spheronization. All the equipments and Analytical Instruments like HPLC, FTIR, GC, and Dissolution apparatus are available to develop Tamsulosin hydrochloride SR pellets.