The Pharmaceutical Study Of Paroxetine Hydrochloride Osmotic Pump Tablet

Paroxetine hydrochloride is a kind of selective serotonin reuptake inhibitor of antidepressant agents. It is indicated for treatment of different kinds of depression. The paper discussed the preparation of paroxetine hydrochloride osmotic pump tablet taking paroxetine hydrochloride as the active ingredient. The release mechanism, influencing factors, quality study and stability were also systematically investigated.We studied the physical and chemical characters of drug and properties of CA free film for prescription screening. We had done some research on the interaction of drug and excipients to screen out suitable excipients. High-performance liquid chromatography was developed for the determination content and release in vitro assay.In this paper, we studied the fators of effecting drug release from the osmotic pump tablet, such as sort and amount of the osmotic pressure promoting agent, osmoplymers, hardness of tablet core, sort and amount of plasticizer, coating thickness, the size of release orifice, etc. we optimized formulation of tablet core and coating with irthogonal design. The result indicated that the amount of NaC1, osmoplymers, plasticizer, and the coating thickness, had significant influence on the drug release. The optimized prescription is as follows: tablet core contain: 27.8mg paroxetine hydrochloride(equivalent to 25mg paroxetine); 180mg NaC1; 72mg PEO(2×105); 56mg PEO(5×106); 52.2mg Pregelatinized starch; 12mg talc, coat contain: 3％CA acetone solution; PEG1500 30％(g/g); coating thickness 3.5％; delivery orifice 0.8mm; weight 414mg. The release rate from the tablet is insensitive to variation of the pH and stirring speed.We researched the quality of paroxetine hydrochloride osmotic pump tablets, including identification, related substance, assay and release, and we determined the content and release of paroxetine hydrochloride osmotic pump tablet by HPLC and the analytical methods validationWe did the stability test of paroxetine hydrochloride osmotic pump tablets. The result of the influencing factor test showed this osmotic pump tablets is sensitive to high temperature and humidity. The drug release character, appearance and the content did not chang after illumination test, accelerated test and long-term test. So the paroxetine hydrochloride osmotic pump tablet should be stored in condition of cool and dry packing with blister pack。...