Quality by design approach to understand the process of nanosuspension preparation

Design and evaluation of famotidine mucoadhesive nanoparticles for aspirin induced ulcer treatment

“…the detachment stress (g), was determined from the minimal weights of water that detached the glass slides. The experiments were carried out in triplicates (Verma et al 2009;Sheikh et al 2009). …”

An Overview of the Role of Mathematical Models in Implementation of Quality by Design Paradigm for Drug Development and Manufacture

“…Modeling approaches such as mechanistic, empirical, or hybrid can be used for design space development wherein as discussed in the following examples, models can be used to support its various facets, including defining a design space at pilot scale based on DOE data, scaling up pilot scale design space to commercial scale, and understanding the limitations of the proposed design space. a) Design space based on DOE data: As presented by Verma et al [10], the effects of key formulation process variables for a microfluidization unit operation was investigated via fractional factorial statistically based DOE. Microfluidization was used in the preparation of nanosuspensions for poorly water-soluble drugs.…”

Preclinical studies of N3-O-toluyl-fluorouracil-loaded lipid-based nanosuspensions in H22-bearing mice

“…16 Nanosuspensions also exhibit many advantages, including: 1) high efficiency of drug loading; 2) easy scale-up for manufacture; 3) relatively low-cost preparation; and 4) applicability for various administration routes, such as oral, parenteral, ocular, and pulmonary delivery. 11,17 A number of nanosuspensions have been used in clinic to combat cancer and other diseases, such as fenofibrate, aprepitant, sirolimus, megestrol, and paliperidone. 18,19 Recently, lipid-based nanosuspensions (LNS), an innovative lipid-based nanocarrier, have been reported.…”