Oil-in-Water Nanosized Emulsions for Drug Delivery and Targeting. Tamilvanan Shunmugaperumal. Читать онлайн. Newlib. NEWLIB.NET

Автор: Tamilvanan Shunmugaperumal
Издательство: John Wiley & Sons Limited
Серия:
Жанр произведения: Химия
Год издания: 0
isbn: 9781119585251
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the homogenization speed was kept at a constant value of 15,000 rpm. For PDI and ZP, none of the formulation and process variables has shown significant influence (Fig. 2.5b, c) as they did not cross the t value limit in the Pareto chart. However, the premixing time deliberately omitted and considered as dummy factor since this variable involves in the initial dispersion/mixing of oil and water phases during the emulsion preparation step. The formulation and process variables such as premixing time, homogenization time, homogenization speed, and probe sonication time were decided to fix at constant values of 10 min, 15 min, 15,000 rpm, and 5 min, respectively, due to their insignificant influence on the selected three CQAs of the topical ophthalmic emulsions. By taking our previous experience in making of topical ophthalmic emulsions into consideration, the formulation and process variables such as the amounts of castor oil, chitosan, and poloxamer were, however, selected as critical formulation and process variables that were ultimately needed to be further optimized using the face‐centered CCD.

       2.5.1.4. Formulation Optimization by QbD: Experimental Design

Graphs depict the half-normal and Pareto charts for screening of influential formulation and process variables as per Taguchi design using selected critical quality attributes: (a) mean particle size, (b) polydispersity index, and (c) zeta potential. (See color insert.)

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Run Type Critical Process Parameters (CPPs, also Called as Independent Variables) Critical Quality Attributes (CQAs, also Called as Dependent Variables)
Castor Oil (ml) Chitosan (mg) Poloxamer (mg) MPS (nm) PDI ZP (mV)
1 Axial 2 12 87.5 676.4 0.655 27.6
2 Center 1.5 12 87.5 609.8 0.655 27.2
3 Factorial 1 18 75 247.6 0.376 24.6
4 Axial 1.5 12 75 396.4 0.275 35.5
5 Axial 1.5 18 87.5 449.4 0.661 29.1
6 Center 1.5 12 87.5 609.8 0.655 27.2
7 Factorial 2 6 100 417.1 0.62 17.1
8 Factorial 2 18 100 438.1 0.469 23.2
9 Factorial 2 6 75 390.5 0.438 28.5
10 Center 1.5 12 87.5 609.8 0.655 27.2
11 Axial 1.5 12 100 441.5 0.488 18.8
12 Axial 1 12 87.5 374.2 0.435 33.6