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SYED NAZRIN RUHINA RAHMAN *AND TAMILVANAN SHUNMUGAPERUMAL

Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Guwahati, Assam, India

1 2.1. Introduction

2 2.2. FDA‐approved oils, emulsifiers, and auxiliary or miscellaneous excipients 2.2.1. Issues related to oil selection to make the o/w nanosized emulsions for medical application 2.2.2. Issues related to emulsifiers selection to stabilize the o/w nanosized emulsions for medical application 2.2.3. Importance of charge‐stabilized nanosized emulsions 2.2.4. Importance of neutral‐charged (sterically‐stabilized) nanosized emulsions 2.2.5. Advantages of nanosized emulsions stabilized by mixed or multicomponent emulsifier molecules 2.2.6. ‘Stealth’ property of nanosized emulsions: in vitro demonstrations 2.2.7. Advantages of stabilizers in nanosized emulsions 2.2.8. Miscellaneous additives

3 2.3. Current and near future direction2.3.1. Colloidal particles‐stabilized emulsions

4 2.4 Lipophilic API incorporation pattern into nanosized emulsions 2.4.1. Extemporaneous API Addition 2.4.2. De Novo Emulsion Preparation 2.4.3. Interfacial Incorporation Approach 2.4.4. Incorporation of Antibodies, DNA Protein, Oligonucleotide, or Heat Labile Molecules

5 2.5 QbD approach to optimize emulsion 2.5.1. Case study for optimizing systematically a formula to make o/w nanosized Emulsions

6 2.6. Conclusion References

apoapolipoproteinAIartificial intelligenceAPIactive pharmaceutical ingredientCCDcentral composite designCKCcetalkonium chlorideCMAscritical material attributesCMCchemistry, manufacturing, and controlCPPscritical process parametersCQAscritical quality attributesCTABcetyltrimethyl ammonium bromideDBPdi‐butyl‐phthalate2DEHPAbis(2‐ethylhexyl) hydrogen phosphateDMPCdimyristoylphosphatidylcholineDMPEdimyristoylphosphatidylethanolamine DOTAP1,2‐dioleoyl‐sn‐glycero‐3‐trimethylammoniumpropane2D PAGEtwo‐dimensional polyacrylamide gel electrophoresisDPPCdipalmitoylphosphatidylcholineELMemulsion liquid membranesFbDFormulation by DesignFMEAfailure mode effect analysisHLBhydrophilic–lipophilic balanceICimpression cytologyICHInternational Council for HarmonisationIVCMin vivo confocal microscopyMAmaterial attributeMCTmedium‐chain triglyceridesMLmachine learning MPSmean particle sizeNCEnew chemical entityNPEO10nonylphenol‐poly (ethylene oxide)OFATone‐factor‐at‐a‐timeO/Woil‐in‐waterPBCApoly(n‐butylcyanoacrylate)PCphosphatidyl choline 6‐PCn‐hexanoyl lysolecithinPDIpolydispersity indexPEOpolyoxyethylenePFOBperfluorooctyl bromidePPprocessing parameterPPOpolyoxypropyleneTPGStocopheryl polyethylene glycol 1000 succinateQACquaternary ammonium compoundQbDQuality by DesignQbTQuality by TestingQRMquality risk managementQTPPquality target product profileREMrisk estimation matrixRPNrisk priority numberSDSsodium dodecyl sulfate ZPzeta potential

Therapeutically, the oil‐in‐water (o/w) nanosized emulsions are used mainly as delivery carriers for lipophilic active pharmaceutical ingredient (API) molecules that show pharmacological activities after administration via parenteral, ocular, and transdermal routes. Furthermore, the o/w nanosized emulsions having anionic, cationic, or neutral charged dispersed oil droplets can be made especially by changing the emulsifiers so that the first step of engineered droplet surfaces could be obtained to extract multifunctional activities. The second step of engineered droplet surfaces in emulsions usually attains by decorating the droplet surface with anchoring or homing moiety either by conjugation or simple adsorption reaction. By combining both the surface charge optimization and engineered droplet surfaces, the o/w nanosized emulsions are indeed in recent years useful for API delivery and/or targeting to otherwise inaccessible internal organs of the human body (Tamilvanan 2009).