Purpose of the research work was aimed to develop a optimised controlled release dosage form of L-arginine with minimum efforts by using a combination of statistical and analytical approach by applying Quality by Design (QbD). Controlled release formulation of L- Arginine was developed by using ionotropic gelation technique and effect of various independent variables like concentration of Sodium Alginate (SA) and concentration of Calcium Chloride (CC) was studied employing QbD approach; on dependent variables like Microbeads size (MS), Entrapment Efficiency (EE) and drug release in 10 h (Q10). The comprehensive evaluation of formulated microbeads was done using 32 Central Composite design (CCD). The computer optimization process, contour plots and response surface plots predicted the concentration of independent variables SA 7.506 mg and CC 7.92 mg fulfilled the desired criteria by giving best response; MS1.615 mm; EE 95.96%; and Q10 95.52%;. Optimized formulation of L- Arginine was developed without exhaustive experimental study with help of Qbd approach.
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