The Preparation Of Orally Disintegrating Tablets Of Clindamycin Phosphate

Clindamycin Phosphate mainly use for various Infectious Diseases originated from sensitive bacteria,for example,Tonsillitis,Suppurative Otitis Media,nasal sinusitis, empyema,abscess of lung,Soft Tissue Infections of skin,acute bronchitis,intra-abdomi-nal infection,female cavitas pelvis and genital infection and so on.It is reported on the documents that there was lots kind of adverse reaction which was originated form Clindamycin Phosphate,especially form Clindamycin Phosphate injection,such as the case of "xinfu". However,it absorb rapidly and completely after taking orally,and the adverse reaction is fewer compared to the injection,so the tablets of Clindamycin Phosphate will be more safe to people.Clindamycin Phosphate was chosen as a model drug,cross-linked polyvinyl pyrrolidone(PVPP),low-substituted hydroxypropyl cellulose(L-HPC) and microcry-stalline cellulose(MCC) as disintegrant, lactose as diluents, Aspartame as correctant,magnesium stearate as lubricants to prepare orally disintegrating tablets,which is a new dosage forms of Clindamycin Phosphate.Polyacrylic resin was chosen as coating material to prepare taste masking solid dispersion of the drug by solvent method,and then combine with other granulated excipients to compress tablets.Using disintegration time as target,the test adopt orthogonal experiment to optimize formula.The final tablet was mainly composed of 8%PVPP,4%L-HPC, 20% MCC,and 0.1% magnesium stearate.The disintegration time of the tablets were all less than 30s.Orally disintegrating tablets of Clindamycin Phosphate quality standard including characteristics,tablet weight variation,disintegration time,friability,content,content uniformity,dissolution rate and so on.According to the standard three batch tablets were assayed,and the results showed that all samples complied with the standard.Stress testing,accelerated testing and long-term testing were carried out to investi-gate the stability of orally disintegrating tablets of Clindamycin Phosphate. Charac-teristics,disintegration time,content and dissolution rate were studied.The results showed in relative humidity of 92.5% circumstance for 5 days,the surface of the tablets became rough and the disintegration time extended.Accelerated testing for three months the tablets complied with the quality standard,which suggested that the tablets should be stored at room temperature and dry place.The pharmacokinetics and relative bioavailability were studied by animal experiment.Rats were divided to two sets randomly,then gived orally disintegrating tablets and compressed tablets separately.Assayed blood drug level by microorganism method,and then calculation pharmacokinetics parameter.The result showed that the relative bioavailability of orally disintegrating tablets of Clindamycin Phosphate is 105.05%.