PHARMACEUTICAL NANOSUSPENSION: AN OVERVIEW

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Nimmi et al. World Journal of Pharmacy and Pharmaceutical Sciences

PHARMACEUTICAL NANOSUSPENSION: AN OVERVIEW

Nimmi R.*, Shripathy D. and Shabaraya A. R.

Department of Pharmaceutics, Srinivas College of Pharmacy Valachil, Arkula-575029,

Mangalore, Karnataka.

ABSTRACT

Nanosuspensions, a form of this technology, have proven their value in

the medical field. Nanosuspension technology was used to make drugs

that were poorly soluble in aqueous as well as inorganic media visible.

Nanosuspensions have proved to be a safer alternative to other

currently available methods for increasing bioavailability of low-

solubility drugs. Nanosuspension is characterised as very finely

colloid, biphasic, dispersed, solid drug particles in an aqueous vehicle,

size below 1um, without any matrix content, stabilised by surfactants

and polymers, prepared by suitable methods for Drug Delivery

applications, through oral, topical, parenteral, ocular, and pulmonary

routes. Wet mill, high pressure homogenizer, precipitation-

ultrasonication process, emulsionsolvent evaporation, melt emulsification method, and

supercritical fluid extraction method are also used to make nanosuspensions. The following

work focuses on the preparation of nanosuspensions, as well as the benefits of such methods,

and their applications, in the hopes of simplifying future research in this field.

KEYWORDS: Nanosuspension, solubility, Bioavailability, High pressure homogenizer,

Precipitation- ultrasonication, Super critical fluid extraction, Emulsion-solvent extraction.

INTRODUCTION

Nanotechnology has the potential to drastically alter our lives in general, and our health

situation in particular. In today's world, it is one of the most critical areas of research and

development. Nanotechnology is a subset of the larger field of nanoscience, which is one of

the most promising, demanding, and rewarding research areas in today's scientific

landscape.[1]

It's the study of small particles with distinct properties that vary as the particle's

size changes.[2]

A pharmaceutical nanosuspension is characterised as very finely colloid[3]

,

WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES

SJIF Impact Factor 7.632

Volume 10, Issue 6, 921-936 Review Article ISSN 2278 – 4357

*Corresponding Author

Nimmi R.

Department of

Pharmaceutics, Srinivas

College of Pharmacy

Valachil, Arkula-575029,

Mangalore, Karnataka.

Article Received on

12 April 2021,

Revised on 02 May 2021,

Accepted on 23 May 2021,

DOI: 10.20959/wjpps20216-19123


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biphasic[4]

, dispersed solid drug particles in an aqueous vehicle with a size less than 1 m,

stabilised by surfactants[5]

and polymers[6]

, and prepared for drug delivery[7]

applications

using appropriate methods. Reduced particle size (10-1000nm) leads to increased dissolution

rate and therefore enhanced bioavailability.[8]

Used for oral or topical application, as well as

parentral and pulmonary administration.[9]

Nanosuspension has been shown to improve

adsorption and bioavailability, which could lead to lower doses in convectional oral dosage

types.[10]

Micronization, solubilization with co-solvents, salt form, surfactant dispersions,

precipitation procedure, and oily solution are only a few of the traditional methods for

improving the solubility of poorly soluble drugs. Liposomes, emulsions, microemulsions,

solid dispersion, and inclusion complexation with cyclodextrins are examples of other

techniques. More than 40% of drugs are poorly soluble in water, rendering typical dosage

forms difficult to formulate. The problem is even more complicated for class II drugs, which

are poorly soluble in both aqueous and organic media. Nanosuspensions are preferred in the

cases described above.[9]

Drugs that are insoluble in both water and organic solvents will

benefit from nanosuspension technology.[11]

Nanosuspension not only eliminates the issue of

low solubility and bioavailability, but it also changes the drug's pharmacokinetics, improving

its protection and efficacy.[12]

Pharmaceutically acceptable crystalline or amorphous states

exist for drugs encapsulated in nanosuspensions.The brick dust molecules can be successfully

formulated by Nanaosuspensions for better dissolution and absorption.[10]

Nanosuspension

Surfactants stabilise colloidal dispersions of nanosized drug particles in nanosuspensions.

They can also be described as a biphasic system that consists of pure drug particles dispersed

in an aqueous vehicle with a suspended particle diameter of less than 1m. Nanosuspensions

can be lyophilized or spray dried, and their nanoparticles can be integrated into a solid

matrix.[10]

Advantage[13,14]

Increase drug solubility and bioavailability.

Appropriate for hydrophilic drugs.

It is possible to reach a higher drug loading.

It is possible to reduce the dose.

Improve medication physical and chemical safety

Only drugs that are poorly soluble can be used.


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The IV route allows for rapid dissolution and tissue targeting.

Reduced tissue irritation.

Reduced tissue irritation.

Increased drug dissolution rate and saturation solubility improve biological efficiency.

Physical consistency over time in the presence of a stabiliser.

In the case of ocular administration and inhalation drug delivery, bioavailability is higher.

Nanosuspension can be used in cream, gel, pellet, pill, and tablet formulations.

Disadvantages[15,16]

Physical stability, sedimentation, and compaction are all issues that may arise.

Since it is bulky, extra caution must be exercised while storing and transporting it.

It is impossible to obtain a uniform and precise dosage.

incorrect dosage

Preparation of nanosuspension

As shown in Figure 1, the most popular methods for preparing nanosuspensions are "Bottom

up technology" and "Top down technology."Bottom-up technology includes the

disintegration of larger particles into nanoparticles, such as high-pressure homogenization

and milling methods, while top-down technology involves the disintegration of larger

particles into nanoparticles, such as precipitation, microemulsion, and melt emulsification

methods.[17]

The principles of these methods are detailed, and their advantages and

disadvantages are listed in Table 1.[18]


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Figure 1: Approaches for preparation of nanosuspension.

a) Precipitation method

The precipitation method is a general method for preparing submicron particles of drugs that

are poorly soluble.[19]

Precipitation has been used to prepare submicron particles in the last

decade, especially for poorly soluble drugs.[20]

After dissolving the substance in a solvent, it

is combined with a miscible antisolvent in the presence of surfactants. When a drug solution

is added quickly to an antisolvent, the drug is suddenly supersaturated, resulting in the

formation of ultrafine crystalline or amorphous drug solids.[21]

This method entails nuclei

formation and crystal growth, both of which are primarily temperature dependent. The

preparation of a stable suspension with minimal particle size necessitates a high nucleation

rate and a low crystal growth rate.[22]

In order to use this method, the drug must be soluble in

at least one solvent that is miscible with the nonsolvent.[23]

Advantage[22]

Simple process.

Stable products.

Low need of energy.


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Low cost of equipment.

Ease of scale up

Disadvantage.[19]

surfactant Addition is required.

Narrowing the application space, a broad size distribution, and nonaqueous solvent

toxicity.

A minimum of one solvent is needed for the drug to be soluble.

b) High-Pressure Homogenization

Many poorly water soluble drugs have been nanosuspended using high pressure

homogenization. The instrument can be used at pressures of 100–1500 bars (2800–21300 psi)

and up to 2000 bars with a 40ml range (for laboratory scale). A drug and surfactant

suspension is placed under pressure through a nanosized aperture valve of a high pressure

homogenizer in this method.[24]

The theory is based on aqueous phase cavitation.

The cavitation forces between the drug microparticles are strong enough to transform them to

nanoparticles. This method is needed for small sample particles prior to loading and because

several homogenization cycles are required.[25]

Dissocubes, Nanopure, Nanoedge, and

Nanojet technology[26]

are examples of nano suspension preparation methods based on this

theory.

Figure No 2: Schematic representation of the high-pressure homogenization process.[27]


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Advantages[25]

Simple technique.

General applicability to most drugs.

Can be used to make nanosuspensions that are both very dilute and very concentrated.

Aseptic production possible.

Low risk of product Contamination.

ease of scale-up.

Disadvantages.[25]

A large number of homogenization cycles are needed.

Micronized medication particles and presuspending compounds must be pretreated and

presuspended before homogenization.

Metal ions passing through the homogenizer's wall may potentially contaminate the

substance.

c) Milling Techniques

a. Media Milling

High-shear media mills or pearl mills are used to make nanosuspensions. A milling chamber,

milling shaft, and recirculation chamber make up the mill. The drug is then fed into a mill

with small grinding balls/pearls in an aqueous suspension.[28]

Under regulated temperature,

these balls spin at a high shear rate and pass through the grinding jar interior, crashing into

the sample on the opposite grinding jar wall. The combined forces of friction and effect result

in a significant reduction in particle size.[29]

The milling media or balls are made of abrasion-

resistant highly cross-linked polystyrene resin or ceramic-sintered aluminium oxide or

zirconium oxide. One piece of machinery that can be used to achieve a grind size of less than

0.1 m is a planetary ball mill. Wet milling was used to create a nanosuspension of Zn-Insulin

with a mean particle size of 150 nm. degradation of the thermolabile drugs due to heat

generated during the process and presence of relatively high proportions of particles ≥5

μm.[30]


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Figure No 3: Schematic representation of media milling process.[31]

Advantages[29]

High degree of adaptability in managing.

Very few batch to batch variation in particle size.

Large-scale drug handling requires a lot of versatility.

Ease of scale up.

Disadvantages[29]

Erosion of material from milling pearls is a possibility.

Require milling process for hours to days.

Long-term milling can cause amorphous lead to form, which can lead to instability.

b. Dry-Co-grinding

Dry milling has recently been used to make a lot of nanosuspensions.

Dry-co-grinding is a simple and cost-effective process that does not require the use of organic

solv[25]

ents.[32]

Because of an increase in the surface polarity and transition from a crystalline

to an amorphous compound, Co-grinding improves the physicochemical properties and

degradation of poorly water soluble products.[33]

Advantages[25]

Easy process.

Require short grinding time.

No organic solvent.


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Disadvantages[33]

Generation of residue of milling media.

d) Emulsification-solvent evaporation technique

This method entails making a drug solution and then emulsifying it in a liquid that isn't a non-

solvent for the drug. Evaporation of the solution causes the substance to precipitate. A high-

speed stirrer can be used to monitor crystal growth and particle aggregation by generating

high shear forces. In this step, the drug is dissolved in an organic solvent and then emulsified

with suitable surfactants in an aqueous phase.[34]

The organic solvent is then slowly evaporated under reduced pressure to form drug particles

in the aqueous process, resulting in an aqueous suspension of the drug with the desired

particle size. The shaped suspension can then be diluted to obtain nanosuspensions.

Microemulsions can also be used as models to make nanosuspensions. Microemulsions are

isotropically pure dispersions of two immiscible liquids, such as oil and water, that are

stabilised by an interfacial layer of surfactant and co-surfactant. The substance can be loaded

into the internal process or saturated into the preformed microemulsion by intimate mixing.

The drug nanosuspension is generated by diluting the microemulsion appropriately.[35]

Figure No 4: Schematic representation of emulsification-solvent evaporation process[31]

Advantages[34]

Small size particles.

Stable products.

Low need of energy.

High drug solubilization.

Uniform particle distribution.

Ease of manufacture.


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Disadvanatges.[34]

Surfactant and stabiliser concentrations are high.

Use of hazardous solvent

e) Melt emulsification method

This approach involves dispersing the drug in an aqueous solution of stabiliser, heating it past

the drug's melting point, and homogenising it to produce an emulsion. The sample holder was

wrapped in a heating tape with a temperature controller during this process, and the

temperature of the emulsion was held above the drug's melting point. The emulsion was then

slowly cooled to room temperature or placed in an ice bath.[36]

The key advantage of the melt

emulsification technique over the solvent diffusion approach is that organic solvents are

completely avoided during the manufacturing process. This process was used to make an

ibuprofen nano suspension. When ibuprofen Nano suspension is made using the melt

emulsification process, it dissolves faster than when it is made using the solvent diffusion

method.[37]

Advantages[36]

As opposed to solvent diffusion, organic solvents are avoided.

Disadvantages[36]

Formation of large particles.

Solvent diffusion.

f) Supercritical Fluid Method

Nanoparticles can be made from drug solutions using supercritical fluid technology. Rapid

expansion of supercritical solution process (RESS), supercritical anti-solvent process, and

precipitation with compressed anti-solvent process are some of the approaches that have been

tried (PCA).[38]

The RESS involves expanding a drug solution in supercritical fluid through a

nozzle, which causes the supercritical fluid's solvent strength to be lost, resulting in the drug

precipitating as fine particles. This method was used by Young et al to make cyclosporine

nanoparticles in the size range of 400-700 nm.[39]

The drug solution is atomized into a

chamber containing compressed CO2 in the PCA process. As the solvent is extracted, the

solution becomes supersaturated, and fine crystals form. The supercritical anti-solvent

method employs a supercritical fluid in which a poorly soluble drug is present, as well as a

drug solvent that is miscible with the supercritical fluid. The drug solution is pumped into the


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supercritical fluid, which extracts the solvent and causes the drug solution to become

supersaturated. The drug then crystallises into fine crystals.[40]

Advantages[41]

High drug solubilization.

Long shelf life.

easy to manufacture

Disadvantages[41]

Use of hazardous solvent

Use of high amount of surfactant and stabilizers

Application of nanosuspensions

Nanosuspensions are used as oral, parenteral, ocular, and pulmonary drug delivery systems.

1. Oral administration

Because of the painless and noninvasive nature of oral administration, it is the preferred

method by patients.[42]

Oral formulations also have a number of advantages for the

pharmaceutical industry, including ease of manufacture, quick turnaround time, and low

production costs.[43]

Oleanolic acid has a low aqueous solubility, resulting in irregular

pharmacokinetics after oral administration. It has many uses, including hepatoprotective,

antitumor, antibacterial, anti-inflammatory, and antiulcer impact. As oleanolic acid is applied

as a nanosuspension, the dissolution rate increases to around 90% in the first 20 minutes,

compared to just 15% for micronized drug powder.[44]

Increased dissolution rate and

improved adhesion of drug particles to the mucosa can be achieved by reducing drug particle

size to the nanoscale. Drug intestinal absorption is increased by better interaction with

intestinal cells (bioadhesive phase) and a greater concentration gradient between blood and

GIT Infections are also regulated with nanosuspensions. Because of their poor bioavailability,

atovaquone and buparvaquone are useful in high doses for the treatment of leishmaniasis and

opportunistic Pneumocystis carinii infections in HIV patients.[45]

A comparison of

atovaquone in the form of micronized particles and nanosuspensions revealed that the latter

reduced infectivity by 40% to 15%. In another study, buparvaquone nanosuspensions

decreased infection from 2.0 to 1.02, but only to 1.47 in micronized particles.[46]


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2. Parenteral administration

In emergency cases such as cardiac arrest and anaphylactic shock parenteral administration is

the first choice.[46]

Subcutaneous, intravenous, intramuscular, and intra-arterial administration

of drug formulations are all examples of parenteral administration.[47]

The avoidance of first-

pass metabolism, consistent doses, and higher bioavailability are all advantages of this

method of administration. As opposed to oral administration, i.v. administration allows for

more stable pharmacodynamic and pharmacokinetic profiles due to dose and rate control.[48]

To avoid capillary blockage, administered drug particles must be smaller than 5 m in

diameter.[49]

A mouse study looked at the rate of tumour growth inhibition and found that

oridonin in the form of nanosuspension significantly reduced the tumor's volume and weight.

Oridonin nanosuspension increased the rate of tumour inhibition to 60.23 percent, compared

to 42.49 percent for the standard type.[50]

Nanosuspensions increase treatment efficacy and

lower therapy costs by reducing injection sizes and improving dosing efficiency.

3. Pulmonary Drug Delivery

Several respiratory disorders, such as asthma and chronic obstructive pulmonary disease

(COPD), are trseated with pulmonary drug delivery.[51]

Direct delivery to the site of action, which leads to reduced dosage and side effects, is an

advantage of pulmonary drug delivery over oral and parenteral drug administration.[52]

Only

rapid drug release, a short residence period, and a lack of selectivity are provided by

traditional pulmonary delivery systems.[53]

Via direct delivery to target pulmonary cells, nanosuspensions can solve problems including

low drug solubility in pulmonary secretions and a lack of selectivity. Because of reduced

drug loss and a longer residence period at the target site, the adhesion of nanosuspensions to

mucosal surfaces improves selectivity. In pulmonary nanosuspensions, drug diffusion and

dissolution concentrations are increased, increasing bioavailability and avoiding unwanted

drug accumulation in the mouth and pharynx. Surface engineered nanosuspensions can

provide a rapid onset followed by managed drug release, which is an ideal drug delivery

pattern for the majority of pulmonary diseases. Furthermore, in each actuation[54]

,

nanosuspensions for treating lung infections showed a good proportion between actual and

delivered drug concentrations.[55]

The rate of internalisation of nanoparticles with a diameter

of 0.5 m into pulmonary epithelial cells has been stated to be 10 times higher than that of


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particles with a diameter of 1 m and 100 times higher than that of particles with a diameter

ofs 2-3 m.[56]

4.Ocular Administration

(i)Poor drug solubility in lachrymal fluids, (ii)repeated instillation of traditional eye drops

due to leakage through the nasolacrimal duct, and (iii)repeated instillation and systematic

drug absorption frequently inducing side effects are all major issues in ocular therapy.[57]

CONCLUSION

Nanosuspensions tend to be a novel and commercially feasible approach to addressing issues

including poor bioavailability associated with the delivery of hydrophobic products, such as

those that are poorly soluble in both aqueous and organic media. To boost drug absorption

and bioavailability, the dissolution issues of poorly water soluble drugs have been largely

solved. For large-scale production of nanosuspensions, production strategies such as media

milling and high-pressure homogenization have proven to be effective. Advances in

manufacturing methodologies, such as the use of emulsions or microemulsions as models,

have made manufacturing much simpler, but there are still limitations. Nanosuspensions have

been used in pulmonary and ocular transmission, and their uses in parental and oral routes

have been thoroughly investigated. As a result, nanotechnology can help improve aqueous

solubility and bioavailability of poorly soluble drugs in drug development programmes.

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PHARMACEUTICAL NANOSUSPENSION: AN OVERVIEW