OBJECTIVE To prepare the controlled-release matrix tablets with ideal properties by quantitatively controlled method.METHODS Experiments were arranged using uniform design method.Aspirin controlled-release matrix tablets were prepared.The tensile strength,fragility,dissolution were determined.The effects of each factor could be acquired according to multivariate regression equations.An optimum experimental condition was chosen according to the stipulated target ranges of responses and their regression equations,and the verification experiment was made using this experimental condition.RESULTS Tableting strength,humidity in granules and granule strength were the leading factors which affect tensile strength,fragility,dissolution percentage of tablets.Verification experiment showed that the observed results were closed to the predicted.CONCLUSION The controlled release tablets with ideal properties could be prepared when leading influencing factors would be quantitatively controlled with the guidance of multivaiate regression equations.
Key words
tableting technology /
multivariate regression analysis
{{custom_keyword}} /
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
References
［1］Jarosz PJ,Parrott EL.Factors influencing axial radial tensile strengths of tablets［J］.J Pharm Sci,1982,71:607.
［2］Hoffman A,Danenberg HD,Katzhendler L,et al.Pharmacodynamic and pharmacokinetic rationales for the development of an oral controlled-release amoxicillin dosage form［J］.J Con-trolled Release,1998,54(1):29～37.
［3］Tahikdar MM,Rembaut P,Kinget R.The release mechanism of an oral controlled release delivery system for indomethasin［J］.Pharm Dev Techol,1998,3(1):1～6.
［4］Shlieout G,Wiesem M,Zessin G.A new method to evaluation the con-solidation behavior of pharmaceutical materials by using the Fraser-Suzuki function［J］.Drug Dev Ind Pharm,1999,25(1):29～36.
［5］Ruiz A,Paronen P.Time dependent densification behavior of cyclo-dextrins［J］.J Pharm Pharmacol,1996,48(8):790～797.
［6］Leitritz M,Krumme M,Schmidt PC.Force-time curves of a rotary tablet press.Interpretion of the compressibility of a modified starch containing various amounts of moisture［J］.J Pharm Pharmacol,1996,48(5):456～462.
［7］Lipps DM,Sakr AM.Characterization of wet granulation process pa-rameters using response surface methodology.I.Top-spray fluidized bed［J］.J Pharm Sci,1994,83(7):937～947.
［8］王晋，张汝华，张显志，等.高速搅拌制粒工艺的定量化控制用于阿司匹林骨架片的制备［J］.中国医药工业杂志，1999，30(3)：104～109.
{{custom_fnGroup.title_en}}
Footnotes
{{custom_fn.content}}
