18.5.2 Polymeric Nanoparticles

Nanoparticulates employing biodegradable polymers are one of the promising and

effective delivery systems offering diverse biopharmaceutical roles (Korting and

Monika 2010; Jain et al. 2015a, b; Jose et al. 2018). Various polymeric delivery

systems fruitfully developed using FbD encompass nanocapsules, nanoparticles,

nanogels, nanocomposites, nanofibres and lipid-polymer hybrids (Cun et al. 2011;

Hunter et al. 2012; Cheng et al. 2015; Nagpal et al. 2019). Various CMAs and CPPs

for polymeric nanoparticulate systems comprise of nature and amount of polymer

and surfactant, pH, homogenization time and stirring speed, while cumulative %

drug release, particle size, zeta potential, PDI and entrapment constitute the vital

CQAs (Gajra et al. 2015; Li et al. 2017; Beg et al. 2019).

18.5.3 Other Nanostructured Systems

Table 18.2 enlists some recent reported studies on FbD-developed polymeric drug

delivery nanoconstructs of varied kinds, along with those of nanocrystals, metallic

nanoparticles, nanotubes, nanosuspensions and quantum dots.

18.5.3.1 Nanosuspensions

Nanosuspensions are submicron colloidal drug particulate dispersions stabilized

using various types of surfactants or polymers. Such systems are commonly devel-

oped using wet milling techniques, that tend to reduce drug particle size, thereby

enhancing the oral bioavailability of various lipophilic drugs (Attari et al. 2016;

Karakucuk et al. 2016). CMAs/CPPs employed during systematic development of

nanosuspensions encompass drug-to-stabilizer ratio, bead size, milling time and mill

speed. These CMAs/CPPs tend to possess a significant effect on CQAs of

nanosuspensions like particle size, PDI, zeta potential, etc. (Verma et al. 2009;

Beg et al. 2019).

Table 18.1 (continued)

Lipid-based nanoconstructs

Carrier

Drug

Design

IF

RV

References

Solid SNEDDS

Polypeptide-k

BBD

3

4

Garg et al. (2017b)

Lovastatin

CCD

2

6

Beg et al. (2015a)

Valsartan

BBD

3

4

Beg et al. (2012)

IF input factor, RV response variable, FD factorial design, FFD fraction factorial design, BBD

Box-Behnken design, CCD central composite design, TgD Taguchi design, PBD Plackett–Burman

design, IV-OD IV-optimal design, D-OD D-optimal design, MD mixture design, SNEDDS self-

nanoemulsifying drug delivery systems

18

QbD-Steered Systematic Development of Drug Delivery Nanoconstructs:. . .

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