METHODS: The parameters of spray-dried 'cempedak' fruit powder under study include inlet air temperature (140-180°C) and maltodextrin (DE 10) concentrations (5-15% w/w). Response surface methodology involving 14 runs was used to assess the effects of inlet temperature and maltodextrin on the powder flow properties and reconstitution properties of the spray-dried 'cempedak' powder.
RESULTS: Out of the tested responses, only bulk density, change in cake height ratio, and water solubility index had a high coefficient of determination value. Inlet air temperature was found to be the main parameter to affect the bulk density, caking and water solubility index, when compared to maltodextrin concentration. By setting minimization of caking and maximization of water solubility index as the main determinants, the optimal parameters of 160°C inlet temperature and 15% (w/w) maltodextrin DE10 were generated, with a desirability of 0.697.
CONCLUSIONS: The powder produced under optimal conditions (160°C and 15% w/w maltodextrin) had a low bulk density (480.01 kg/m3), low caking properties (0.17 change in cake height ratio), and a high solubility index (88.69). This indicates that the powder is stable to be stored (without caking) and will have good reconstitution when added to water.
METHODS: Extensive information related to nanosuspensions and its associated patents were collected using Pub Med and Google Scholar.
RESULTS: Over the last decade nanosuspensions have attracted tremendous interest in pharmaceutical research. It provides unique features including, improved solubility, high drug loading capacity, and passive targeting. These particles are cost-effective, simple, and have lesser side effects with minimal dose requirements. However, the stability of nanosuspensions still warrants attention.
CONCLUSION: Nanosuspensions play a vital role in handling the numerous drug entities with difficult physico-chemical characteristics such as solubility and can further aid with a range of routes that include nasal, transdermal, ocular, parenteral, pulmonary etc. This review highlights the relevance of nanosuspensions in achieving safe, effective and targeted drug delivery.
PURPOSE: A Central Composite Rotatable Design (CCRD) of Response Surface Methodology (RSM) was used purposely to optimize process parameters conditions for formulating nanoemulsion containing aripiprazole using high emulsification methods.
METHODS: This design is used to investigate the influences of four independent variables (overhead stirring time (A), shear rate (B), shear time (C), and the cycle of high-pressure homogenizer (D)) on the response variable namely, a droplet size (Y) of nanoemulsion containing aripiprazole.
RESULTS: The optimum conditions suggested by the predicted model were: 120 min of overhead stirring time, 15 min of high shear homogenizer time, 4400 rpm of high shear homogenizer rate and 11 cycles of high-pressure homogenizer, giving a desirable droplet size of nanoemulsion containing aripiprazole of 64.52 nm for experimental value and 62.59 nm for predicted value. The analysis of variance (ANOVA) showed the quadratic polynomial fitted the experimental values with F-value (9.53), a low p-value (0.0003) and a non-significant lack of-fit. It proved that the models were adequate to predict the relevance response. The optimized formulation with a viscosity value of 3.72 mPa.s and pH value of 7.4 showed good osmolality value (297 mOsm/kg) and remained stable for three months in three different temperatures (4°C, 25°C, and 45°C).
CONCLUSION: This proven that response surface methodology is an efficient tool to produce desirable droplet size of nanoemulsion containing aripiprazole for parenteral delivery application.