Pharmaceutica Analytica Acta

Employing design of experiment approach in the optimization of a generic drug product formula in reaction with the similarity index of dissolution profile for the drug product Innovator

5^th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems

March 16-18, 2015 Crowne Plaza, Dubai, UAE

Ahmed Rakha

Posters & Accepted Abstracts: Pharm Anal Acta

Abstract:

Design of experiment (DOE) concept was conducted thoroughly during the optimization of drug formula (using half factorial 23 design). An investigation matrix of active substances including Paracetamol, Phseudoephdrine and Pholcodine with a concentration of 500mg/Cap, 30 mg/cap and 5 mg/cap respectively was mixed with three excipients which affect of dissolution profile of the drug. Factors of this experiment comprises different concentrations specified for three excepient coded as A, B & C, these concentration were changed systematically to determine the optimum concentration for each excipient to define the optimum dissolution profile matches the innovator?s drug product profile. The dissolution test is preformed according to matrix design between different pH media 2, 4.5, 6.8 and different time intervals 10, 20, 30 minutes, then the dissolved amount of each active substances are calculated in reference to the predefined matrix design. Innovator dissolution is the reference result which is compared with experiments response. Accordingly, using design of experiment approach provides the researcher with the ability study the effect of each excipient concentration and their interactions. The most similar dissolution profile of generic drug product to the innovator product concluded the excipients ratios in the generic drug formula as A, B and C are 16.3mg/cap, 2.8 mg/cap and 5.6mg/Cap respectively.