13.5.5 Topical Drug Delivery

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nanocrystals (NCs) of brinzolamide (BRA) to enhance the solubility of the medica-

tion and reduce intraocular (eye) pressure. The BRA-NCs surpassed the perfor-

mance of the marketed product in terms of solubility, intraocular pressure reduction

in an ocular hypertension model, and cytotoxicity to corneal epithelial cells (ocular)

(Parmar etal. 2021).

13.5.5 Topical Drug Delivery

Nanocrystals (NCs) exhibit characteristics like improved permeation, bio-

adhesiveness, and heightened membrane penetration. However, sustained focus on

harnessing adhesion, rapid dissolution, and enhanced penetration for dermal and

mucosal applications was lacking for an extended period. This became advanta-

geous when formulating poorly soluble antioxidants such as apigenin, hesperidin,

and rutin as nanosuspensions for use in anti-aging and skin protective cosmetic

products. The nanocrystals are simply incorporated into the water phase of dermal

creams and oil-in-water (O/W) lotions. Despite containing nanosized crystals, these

products do not meet the criteria for nano products under the new European cosmet-

ics regulations. This is because the size of the NCs exceeds 100nm, and the parti-

cles are required to be biodegradable rather than bio-persistent (Sun etal. 2021).

The fundamental mechanism involves the NCs enhancing the solubility of poorly

water-soluble actives in the aqueous phase, resulting in a higher concentration gra-

dient. This principle is applicable to pharmaceutical dermal formulations as well. In

the case of diclofenac sodium nanosuspension for transdermal delivery, there was a

notable increase in the permeability ux of the drug across the skin, up to 3.8 times

higher compared to the control, as demonstrated in testing with the Yucatan micropig

(YMP) skin model (Patel etal. 2018).

13.5.6 Targeted Drug Delivery

The desire to targeting medications to particular locations using nanocrystals is

steadily growing, driven by both economic and therapeutic considerations.

Nanosuspensions provide a practical option for targeted (precise) delivery because

their external characteristics and invivo performances can be conveniently manipu-

lated. For example, in treating pulmonary aspergillosis, one can opt for amphoteri-

cin B nanosuspensions alternative of choosing pegylated liposomes. Achieving

effective intravenous targeting requires modifying the surface properties of the

nanocrystals (NCs). These surface properties play a crucial role in determining the

quantitative and qualitative composition of the blood protein pattern of adsorption.

By adjusting the surface properties, the particles can selectively adsorb to blood

proteins responsible for enrichment at the desired target site (Joseph and Singhvi

2019; Bansal and Kumria 2012; Bajwa et al. 2016).

To explore the intricacies of these application of nanocrystals, Table13.1 pres-

ents details on several drug nanocrystals, including examples such as albendazole,

celecoxib, and ibuprofen, along with their respective preparation methods.

Manshi et al.

343

Table 13.1 Formulations of drug nanocrystals

API

Stabilizers

Aqueous

phase Dosage form Method of prep. Route

Reference

Flubendazole Poloxamer 188 Water Nanocrystal Nanoprecipitation process Pulmonary Miyagi etal. (2023)

Valsartan Poloxamer 188 Puried

water

Nanosuspension Antisolvent precipitation Oral Sreeharsha etal. (2022)

Albendazole Tween 80, P127, or PVA

screened as stabilizer

Water Nanosuspension Wet media milling

technique

Parenteral Permana etal. (2021)

Curcumin

-α-Tocopherol polyethylene

glycol 1000 succinate (TPGS)

Water Nanosuspension Wet milling method Topical Pelikh etal. (2021)

Quercetin Poloxamer 188 (mg), Tween 80 Water Nanosuspension Wet milling technique Topical Manca etal. (2020)

Resveratrol Five different stabilizers, such as

HPMC, -α-tocopheryl

polyethylene glycol 1000

succinate (TPGS), Poloxamer

407, PVP K90, and Tween 80

Acetone,

water

Nanocrystal Antisolvent precipitation

technique

Oral Xiong etal. (2020)

Valero-

fenbendazole

HPMC, PVP, lactose, mannitol,

P407 or P188

Ultrapure

water

Nanosuspension Wet bead milling Oral Melian etal. (2020)

Ibuprofen Lutrol (poloxamer) F68 and Solu

plus, Natrosol 250, Methocel

K4M, Pharma coat 603, 606, 615

as suspension stabilizers

Distilled

water

Nanosuspension Wet media milling

technique

Oral Ouranidis etal. (2020)

Methotrexate Citric acid and PVA 10K Ultrapure

water

Nano

suspension

Acid-base neutralization

precipitation method

Intradermal

injection

Tekko etal. (2020)

(continued)

13 Advances andDevelopments inFormulation ofDrug Nanocrystals

344

API

Stabilizers

Aqueous

phase Dosage form Method of prep. Route

Reference

Irbesartan Poloxamer 407 as a stabilizer Puried

water

Nanocrystalline

suspension

Wet milling technique Oral Meruva etal. (2019)

Celecoxib Hydroxypropyl methylcellulose

acetate succinate and

hydroxypropyl cellulose,

polyvinylpyrrolidone as primary

stabilizer and sodium dodecyl

sulfate (SDS), used as secondary

stabilizer

Ultra

puried

Milli-Q

water

Nanosuspension Wet medium milling

technique

Oral Ding etal. (2019)

Silybin PEG-chitosan as stabilizer Ethanol Nanocrystal Antisolvent precipitation

method

Oral Liu etal. (2019)

Domperidone PVP, HPMC, PVA, Eudragit,

Pluronic F127, and ethyl

cellulose

Water Nanosuspension Antisolvent-precipitation

method

Oral Ndlovu etal. (2019)

Fenobrate HPMC, PVP, PVA, and sodium

dodecyl sulfate (SDS)

Puried

water

Nanoparticles Evaporation assisted

solvent-antisolvent

interaction

Oral Kumar and Siril (2018)

Budesonide Mannitol as stabilizer Methanol Nanoparticles Liquid antisolvent

precipitation

Oral or

pulmonary

delivery

Hu etal. (2018)

Lutein Soy phosphatidylcholine,

mannitol, and PVP K30

Double-

distilled

water

Nanosuspension Antisolvent

nanoprecipitation method

Oral Chang etal. (2018)

Acelofenac Sodium lauryl sulfate (SLS),

hydroxypropyl methylcellulose,

PVP K30

Ethanol Nanosuspension Precipitation-

ultrasonication approach

Oral Rahim etal. (2017)

Table 13.1 (continued)

Manshi et al.

345

API

Stabilizers

Aqueous

phase Dosage form Method of prep. Route

Reference

Diclofenac Poloxamer 188 Bi-distilled

11 water

Nanosuspension Wet media milling

technique

Topical Pireddu etal. (2016)

Spironolactone Poloxamers 407 and 188

(Pluronic F127 and F68), sodium

hydroxy cholate, hydroxypropyl

methylcellulose

Deionized

water

Nanosuspension Wet milling technique Oral Mu etal. (2016)

Indomethacin

and

itraconazole

Poloxamer 188, poloxamer 407,

polysorbate 80 (Tween 80), and

propylene glycol

Water Nanosuspension Wet milling technique Oral Liu etal. (2011)

13 Advances andDevelopments inFormulation ofDrug Nanocrystals

346

13.6 Marketed Products ofNanocrystals

Traditional treatments and certain innovative carrier systems face challenges related

to efcacy, stability, toxicity, and bioavailability. Consequently, certain drugs are

developed in the form of nanocarriers and introduced to the market to improve the

efcacy of treatment. Details about several marketed nanocarriers and their prepara-

tion methods can be found in the accompanying Table13.2 (Jia etal. 2023; Joshi

etal. 2019; Junghanns and Müller 2008).

13.7 Conclusion

The advances and developments in the formulation of drug nanocrystals repre-

sent a pivotal strategy for addressing the challenges associated with poorly solu-

ble drugs in the twenty-rst century. The adaptability of this technology is

remarkable, as it can be effortlessly employed for a broad spectrum of medica-

tions, making it a universal formulation principle analogous to micronization but

specically benecial for BCS class II drugs. One of the key advantages lies in

the ability to employ nanocrystal formulations for various routes of administra-

tion, including oral, parenteral (particularly intravenous), dermal, nasal, ophthal-

mic, vaginal, and pulmonary delivery. This broad applicability underscores the

potential of nanocrystals in tailoring drug delivery systems to specic therapeu-

tic needs.

Despite the widespread applications of nanocrystals, certain limitations exist,

for example, how the size of the end product affects the hardness of the original

crystals and the possibility of contamination. Overcoming these challenges, par-

ticularly with the introduction of bottom-up techniques, has expanded the scope of

nanocrystal technology. Notably, bottom-up methods like fast precipitation have

been enhanced to control particle size, and innovations such as binding organic

molecules in a network have mitigated issues related to excessive growth or size

enlargement. Recent developments in bottom-up approaches, specically those

involving seeding and mechanical pressure, have paved the way to organic nano-

crystals with dimensions spanning from 100 to 150nm across a variety of pharma-

ceuticals. It is crucial to acknowledge that while these advancements provide

promising solutions, the overarching consensus from reviews and studies afrms

that nanocrystal technology effectively addresses solubility and bioavailability

challenges in drug formulations. As we continue to rene and expand these meth-

odologies, the formulation of drug nanocrystals stands as a transformative and

indispensable facet in the quest for improved drug delivery and therapeutic

outcomes.

Manshi et al.

347

Table 13.2 Overview of current state of development of drugs using the Nanocrystal

technology

Trade name

API Category Company Preparation method

Route

Zanaex

capsules Tizanidine

hydrochloride

Muscle relaxant Acorda Ball milling Oral

Gris-PEG

Griseofulvin Antifungal Recro Gainesville LLC Precipitation Oral

Invega

™

Hafyera Paliperidone palmitate Antipsychotics Janssen

Pharmaceuticals Inc.

Media milling Intramuscular

Apretude Cabotegravir Antiretrovirals ViiV Healthcare Media milling Intramuscular

Anjeso

Meloxicam Anti-inammatory Baudax Bio Media milling Intravenous

Theo-Dur

Theophylline Bronchodilator Mitsubishi Ball milling Oral

Tricor

Fenobrate Hypercholesterolaemia Abbott Ball milling Oral

Avinza

Morphine sulfate Analgesic King Pharmaceutical Ball milling Oral

Ritalin

Methylphenidate

hydrochloride

ADHD Acorda Ball milling Oral

Cabenuva Cabotegravir and

rilpivirine

Antiviral combination ViiV Healthcare Media milling Intravenous

Herbesser

Diltiazem Antihypertensive Mitsubishi Ball milling Oral

Aristada™ Aripiprazole lauroxil Atypical antipsychotic Alkermes High pressure

homogenization

Intravenous

Invega Trinza

Paliperidone palmitate Schizophrenia Janssen

Pharmaceuticals Inc.

Ball milling Intramuscular

Vitoss

β-Tricalcium phosphate

Bone-grafting material Orthovita Inc. HPH Orthopaedic

Verelan

Verapamil HCL Antihypertensive Schwarz Pharma Ball milling Oral

Triglide

Fenobrate Hypercholesterolaemia Sciele Pharma Inc. Microuidizer Oral

Azopt

Brinzolamide Ocular hypertension Alcon Ball milling Ocular

(continued)

13 Advances andDevelopments inFormulation ofDrug Nanocrystals

348

Trade name

API Category Company Preparation method

Route

Focalin

Dexmethylphenidate

hydrochloride

Attention-decit/

hyperactivity disorder

(ADHD)

Novartis Ball milling Oral

Invega Sustenna

Paliperidone palmitate Antipsychotic Johnson-Johnson Ball milling Intramuscular

Cesamet

Nabilone Antiemetic Lilly Precipitation Oral

Megace ES

Megestrol Antianorexic Par Pharmaceutical

Companies, Inc.

Ball milling Oral

Rapamune

Sirolimus Immunosuppressive Wyeth Ball milling Oral

Emend

Aprepitant Antiemetic Merck Ball milling Oral

Naprelan Naproxen sodium Anti-inammatory Wyeth Ball milling Oral

Table 13.2 (continued)

Manshi et al.

349

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