Research Of Direct Compression Prepare Orally Disintegrating Tablets Adjuvant Of Advance Mix

Objective: Recently, A new pharmaceutical dosage form, orally disintegrating tablets (ODT) which can disintegrate rapidly(15-30s) in the oral cavity without drinking water, has attracted the interests of many researchers. This type of tablets offers the advantage of taking with ease, disintegrating quickly, good compliance of patients.Orally disintegrating tablets preparation artwork main contain:lyopyilization,spray drying,solid state solute method direct compression。Before preparation artwork because of clipping of technology operative procedure complex,praeparatum technique,equipage request severity, incongruity Industrialization produce。But direct compression adoptive common spring clip artwork and equipage,adjuvant bulk water-soluble substances,add high performance disintegrant ,tabella disaggregation quickly。Respecting direct compression request higher to adjuvant ,so research suit powder direct compression preparation adjuvant of advance mix of Orally disintegrating tablets in experiment.Method: On the basis of preliminary experiments ,Consideration flour nature of direct compression general all purpose adjuvant, contain: angle of repose,bulk density,reality density,efflux velocity,powder compressibility,powder forming,on the basis of effect recall suitable bulking agent。Make manufacture determinator of adjuvant hydrophilia, determine disintegrant water regain and hydrating rate, recall disintegrant.On second part, first of all, compare dispensatory method,weeping method,flasket method,anthropometrics method,recall nearest method with effect anthropometrics。Then compare angle of repose,efflux velocity of Gum Acacia,magnesium stearate,talc powder,recall glidant of suit to experiment. Single factor analysis to manicol dosage,MCC,PVPP dosage,effervescent dosage,correctant dosage,tablet hardness,On the basis of Single factor analysis,Then based on the analysis of the factors that influenced the drug ,disintegration time,the orthogonal experiment L9(34) was used to prepare Orally disintegrating tablets。grading-up anagraph of direct compression prepare Orally disintegrating tablets adjuvant of advance mix。Then consideration contain of drug water solubility and non water solubility。Result: Result of consideration of flour qualitative ,discover MCC is superordinary bulking agent,profit tablet quickly disaggregation , Suitable to Direct compression。Although manicol flowability different from MCC,but shaping good, to improve flowability through add glidant。Disaggregation function good of PVPP。We can discern Pharmacopeia rated measure method of common tablet disintegration time have distinction with disintegration time of volunteer cavitas oris,so Pharmacopeia rated measure method of common tablet disintegration time is not suit to Orally disintegrating tablets. The optimal technology and formula were defined through simple factor test and orthogonal experiments. Orally disintegrating tablets made from the optimal formula was round and whole with surface clean,size uniform,disaggregation quickly and suitable rigidity. Preparation technology stabilization.The friability of Orally disintegrating tablets of Enalapril Maleate was 0.17%.Uniformity of dosage units:The average content of Enalapril Maleate was 101.37%..HPLC was used to detect contents of ingredients. The linearity range of Enalapril Maleate was 0.1mg/ml～0.3mg/ml, regression equation was Y=8E+06x-6593,r=0.9999. The RSD values of precision and reproducibility were 0.41 % and 0.85 % respectively. The average recovery was 99.62%and RSD was 0.52%. Orally disintegrating tablets of Enalapril Maleate had good reproducibility in vitro.The dissolution percentage of Enalapril Maleate at 10min was less than 90%.The friability of Orally disintegrating tablets of nicergolent was 0.53%.Uniformity of dosage units:The average content of nicergolent was 101.37%..HPLC was used to detect contents of ingredients. The linearity range of nicergolent was 1.012μg/ml～16.096μg/ml, regression equation was Y=10681X+20139,r=0.9999. The RSD values of precision and reproducibility were 0.41 % and 0.85 % respectively. The average recovery was 100.5%and RSD was 0.52%. Orally disintegrating tablets of nicergolent had good reproducibility in vitro.The dissolution percentage of nicergolent at 10min was less than 90%.Conclusions: Establishment vitro disintegration time assay method of Orally disintegrating tablets,so to supply method of dependable for consideration Orally disintegrating tablets disintegration time. Direct compression prepare adjuvant of advance mix of Orally disintegrating tablets have good contain to water solubility drug and non water solubility, Orally disintegrating tablets made from the optimal formula was round and whole with surface clean,size uniform,disaggregation quickly and suitable rigidity. Preparation technology stabilization.