Factorial Methodology Essay

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4.4 EXPERIMENTAL METHODOLOGY : To achieve the objective of the present study various procedural steps were followed. The studies and test that were performed for the development of CA nanosuspension have been explained as under. 4.4.1 : Preformulation study of CA : 4.4.1.1 Drug Characterization: 4.4.1.1.1 Organoleptic properties: The CA was analysed Organoleptic properties. The qualitative evaluation like colour, odour and taste of the drug was performed. Results have been depicted in table IV and that complies with USP standard for CA. Table No. IV: Characterization of Cefuroxime axetil. Sr.No Characteristics Observations Standard 1. Colour Pale yellow Off white to pale Yellow 2. Odour Odourless Odourless 3. Taste Bitter Bitter 4. Appearance…show more content…
The table no. X presents levels of variables in coded and actual forms. The factorial batches of CA loaded nanosuspension in coded and decoded form have been shown in table no. XI and XII respectively. Accurately weighed CA was dissolved in Acetone to form organic solutions containing of drug followed by addition of required quantity of Eudragit E-100. Pluronic F-127 was dissolved in water to obtain a series of anti-solvents with the concentrations of 2%, 4% (w/v). Both solutions were passed through a 0.45µm milli pore filter. The anti-solvent Pluronic F-127 water system was cooled to below3ºC in an ice-water bath. Then, 2ml of organic solution was quickly introduced into 100 ml of the precooled anti-solvent at a stirring speed of ultra turrax at 1000 rpm. After the anti-solvent precipitation, the samples were immediately transferred to a test tube of 2cm in diameter and 10cm in length and subjected to ultra sonication (PS 150 probe sonicator) at ultrasonic power input 150 W for (5, 10, 15 and 20 min respectively).The probe with a tip diameter of 6mm was immersed 10mmin the liquid, resulting in the wave traveling downwards and reflecting upwards. The period of ultrasound burst was set to9 s with a pause of 1 s between two ultrasound bursts. During the process, the temperature was controlled using an ice-water bath. The obtained nanosuspensions were concentrated by centrifugation at 16,000rpm for 40 min using an ultracentrifuge (REMI), followed by replacement of the supernatant with 2ml of acetone solution. The solid residue was redispersed using a bath sonicator (micro tonics) and the final drug content was adjusted to 20 mg/ml (drug weight/volume of nanosuspension) using an appropriate volume acetone solution. The optimized batch was freeze dried using Labcono freeze

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