Study On Ondansetron Oral Disintegrating Tablets With MCM-41 As Taste-Masking Agent

In oral preparations,taste is the most important factor affecting the compliance of patients.Many drugs have unpleasant taste,especially bitter taste,which has become one of the problems restricting the application of bitter taste.How to effectively improve the taste of bitter drugs as many health workers in the pursuit of goals,especially in pediatric patients,this work is particularly important and urgent,the main traditional taste masking method is to add flavoring agent and other accessories,but the existing in the application of great limitations,so as to effectively cover the bitter taste of drugs,enhance the quality of the preparation is a problem to be solved urgently.MCM-41 is a kind of ordered mesoporous silica material,non-toxic and harmless.It has good application value in the field of medicine due to its large pore size,large specific surface area and large amount of drug loading.At present,the preparation of orally disintegrating tablets with MCM-41 as masking agent has not been reported.In this paper,bitter drug ondansetron hydrochloride as a model drug,synthesized MCM-41-ondansetron(M-A)inclusion complexes and explore the MCM-41 as a taste masking agent for the feasibility of preparing oral disintegrating tablets.Using cationic surfactant CTAB as template,MCM-41 was synthesized by hydrothermal method,BET surface area is 905.01m2/g,the average diameter is3.86 nm,the bulk density is 0.121g/cm3,the most tight density 0.199g/cm3,compression degree is 64.46%,can be good pressure.Prepared by the impregnation method M-A complexes,using XRD,IR,N2 adsorption desorption and TGA characterizations demonstrated successfully prepared inclusion complexes and the drug into the pores,rather than gather on the surface of the material;the best drug concentration of ondansetron hydrochloride 12 mg/mL,the best loading time for 2.5h,the loading peak of 38.47%.Bitter drug ondansetron by molecular sieve loading after the bitter by "unbearable bitterness" to "no bitterness or almost no bitterness",effectively improve the taste.The inclusion complexes of drugrelease curve shows that the mechanism not only for bitter taste masking drugs into the channel of MCM-41 to avoid drugs and the taste of the contact,and inclusion of delayed diffusion bitter drug in the oral cavity.Using single factor experiment method,the M-A complexes as the active ingredient,L-HPC and PVPP as combined disintegrants crospovidone?The liquidity of the prescription before pressing the powder and bulk density,tabletting process easily,the prepared tablet appearance,hardness,weight variation index,screening of mannitol as filler.According to optimize the prescription verification: the preparation process is not sticking,not one-sided smooth lobes,no pitting and no defect,moderate hardness,friability of qualified.The dissolution rate of tablets in 30 min was greater than 80%,which was in accordance with the requirements of pharmacopoeia.And not because of ondansetron in MCM-41 mesoporous molecular sieve pore and the effect of drug dissolution in the preparation.The content of the powder was qualified,and the fluidity of the powder was good,which could meet the requirement of the content of oral disintegrating tablets(4mg).Disintegration time is less than 30 s,more than half of the time than the standard prescribed in the Pharmacopoeia of the 60 s,good disintegration.The oral disintegrating tablet has no bitterness,and has the advantages of sour taste and good taste.The accelerated test showed that the taste masking of ondansetron hydrochloride orally disintegrating tablets for 6 months at a temperature of 40±2?,relative humidity of 75±5% conditions,traits,disintegration time,content and dissolution of tablets have no obvious change,stability,the prescription pressed by the high repeatability.Conclusion MCM-41 mesoporous molecular sieve as ondansetron masking agent for the preparation of orally disintegrating tablets showed good taste masking effect,the prescription screening powder preparation process of pressing straight with good reproducibility,the prepared oral disintegrating tablets quality and stability.This study provides a further theoretical basis for MCM-41 as a new excipient.