Active ingredient

Engineering

Friability

Factorial experiment

Statistics

Materials science

Chromatography

Box–Behnken design

Ethyl cellulose

Computer science

Chemical engineering

Dissolution

Polymer

Response surface methodology

Mathematics

Process engineering

Pharmacology

Composite material

Medicine

Chemistry

Machine learning

Macedonian Pharmaceutical Bulletin

The objective of this study was to develop diazepam orally disintegrating tablets and to optimize tablets characteristics using response surface methodology (RSM). Tablets were prepared by direct compression of mixture containing mannitol, copovidone, crosspovidone flavor and lubricant. A full factorial design for 2 factors at 3 levels each was applied to investigate the influence of 2 formulation variables on the mechanical strength/hardness, the percent of friability, disintegration time and dissolution of the poorly soluble active ingredient. The amounts of copovidone and crosspovidone were taken as independent variables. All data were analyzed by using statistical program. The results of multiple linear regression analysis revealed that for obtaining a rapidly disintegrating dosage form, tablets should be prepared using an optimum concentration of crospovidone and copovidone. A contour plot is also presented to graphically represent the effect of the independent variables on the tablet hardness, disintegration time, percentage friability and dissolution. A checkpoint batch was also prepared to prove the validity of the evolved mathematical model. 3 level factorial design allowed us to obtain ODT with rapid disintegration and dissolution of the active ingredient with desirable properties of low tablet friability and appropriate mechanical strength (hardness) of the tablet.

Orally disintegrating tablet: formulation design and optimisation using Response Surface Methodology