Study on Cefdinir Dispersible Tablet
|School||Guangzhou University of Traditional Chinese Medicine|
|Keywords||Cefdinir Dispersible tablet Preparation Quality research Stability|
Cefdinir is the third generation oral cephalosporin with an extended antibacterial spectrum, well treated-effect and low toxicity,which has been developed by Fujisawa Pharmaceutical in 1988. It has not only kept a high stability toβ-lactamase, but also compensated the third generation of cephalosporins’ weak fuction to the Gram-positive bacterial. Cefdinir is used for the treatment of post-operative infection,respiratory tract infection, urinary tract infection, gynecological infection,shin infection, oral cavity infection, eye and ENT infection etc.The dosage form of cefdinir include capsules and dispersible tablets. As its poor water solubility and low bioavailability, the study designed the dispersible tablets of cefdinir, which could incresse the dissolution rate and the bioavailability of cefdinir.The basic prescription and preparation technology was initially defined by the study about formulation screening and technology optimizing,based on the appearance, rigidity and the disintegrating time as indicator. Orthogonal project was employed to screen the prescriptions which based on the study of mono-factor experiment. In the optimized prescription, MCC101 is 30% of the prescription quantity, and PVPP is 5%, the concentration of aqueous solution for PVPK-30 is 3%. And then we optimized the preparation technology with the better prescription in order to improve the dissoulution rate of cefdinir in dispersible tablets.The quality study of the dispersible tablet of cefdinir was done. The main comtents included that the identification methods were set up(HPLC method, UV method); the auto control method was adopted in testing on related substances, showing high sensitivity and high specificity; the HPLC method was established for the content determination of cefdinir, showing great accuracy and precision, the exipients show no interference with the assay of the aimed medication, and the calibration curve was linear in the range of 0.15 mg. ml-1～ 0.24mg. ml1 for cefdinir(r=0.9999).Further more, the dispersible tablet of cefdinir examing method of the dissolubility was founded. The test showed that the optimized cefdinir dispersible tablets could completely disintegrated with 30s and the dissolution rate of cefdinir was over 90% in 15 minutes. the dissolution results was correspond to the reference preparation.In the stability study, the investigation methods of all indications consulted the correlation methods in the quality study of the dispersible tablet of cefdinir.It showed that high temperature had little effect on the dispersible tablet. but humidity had obvious effects on the appearance and the related substances increased slightly. The light had obvious effects which resulted in the low content and dissolubility of cefdinir, and the more related substances. The results suggest that the dispersible tablet of cefdinir should be packed in moistureproof material and preserved under dry,cold and dark environment.