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Review Article Nanosuspension - A Novel Carrier For Lipidic Drug Transfer

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Scholars Academic Journal of Pharmacy (SAJP) ISSN 2320-4206 (Online)

Sch. Acad. J. Pharm., 2014; 3(1): 82-88 ISSN 2347-9531 (Print)


©Scholars Academic and Scientific Publisher
(An International Publisher for Academic and Scientific Resources)
www.saspublisher.com

Review Article
Nanosuspension – A Novel Carrier For Lipidic Drug Transfer
Abhyangshree Nandkumar Mane*, Sagar Suresh Gilda, Amruta Avinash Ghadge, Nikhil Rajendra Bhosekar,
Rohit Rajendra Bhosale
Department of Pharmaceutics, Satara College of Pharmacy, Satara, Maharashtra, India.

*Corresponding author
Abhyangshree Nandkumar Mane
Email:

Abstract: Solubility is the crucial factor for drug effectiveness, independence of the route of administration. Large
proportion of newly discovered drugs are water insoluble & therefore poorly bioavailable contributing to desert
development effort. Nanosuspensions have emerged as a promising strategy for the efficicent delivery of hydrophilic
drugs because of their versatile features &unique advantages. The reduction of drug particles into submicron range leads
to a significant increase in dissolution rate & therefore enhances bioavailability. Nanosuspension contain submicron
colloidal dispersion of the pharmaceutical active ingredient particles in a liquid phase stabilised by surfactant.
Nanosuspensions can be delivered by oral & non-oral route of administration. Study is focused on various methods of
preparation with advantages & disadvantages, characterization properties, applications.
Keywords: Nanosuspension, Bioavailability, Colloid, Surfactant, Solubility enhancement.

INTRODUCTION Nanosuspensions differ from nanoparticles [11].


A nanosuspension is a submicron colloidal dispersion Nanoparticles are commonly polymeric colloidal carrier
of drug particles. A pharmaceutical nanosuspension is of drugs whereas solid lipid nanoparticles are lipidic
defined as a very finely colloid, biphasic, dispersed, carriers of drugs. In nanosuspension technology, the
solid drug particles in aqueous vehicle, size below 1µm, drug is maintained in the crystalline state with reduced
without any matrix material, stabilised by surfactants & particle size, leading to increase dissolution rate &
polymers, prepared by suitable methods for drug therefore improved bioavailability. Drugs encapsulated
delivery applications, through various routes of within nanosuspensions exist in pharmaceutically
administration like oral, topical, parenteral, ocular & accepted crystalline or amorphous state.
pulmonary routes. A nanosuspension not only solves Nanaosuspensions can successfully formulate the brick
the problem of poor solubility & bioavailability but also dust molecules for improved dissolution & good
alters the pharmacokinetics of drug & that improves absorption [18].
safety & efficacy. Nanosuspension formulation
approach is most suitable for the compounds with high
log P value, high melting point & dose. Nanosuspension
has been reported to enhance adsorption &
bioavailability it may help to reduce the dose of the
convectional oral dosage forms. Drug particle size
reduction leads to an increase in surface area &
consequently in the rate of dissolution as described by
Nernst-Brunner & Levich modification of the Noyes-
Whitney equation. In addition, an increase in saturation
solubility is postulated by particle size reduction due to
an increase dissolution pressure explained by the
Ostwald-Freundlich equation. Depending on the
production technique applied changes in crystalline Fig. 1- Various kinds of nanosuspensions.
structure of the drug particles may also occur. An
increasing amount of amorphous drug fraction could Advantages of Nanosuspension Drug Delivery
induce higher saturation solubility. Furthermore, a System-
general adhesiveness to tissue has been described for 1. Its general applicability to most drugs & simplicity
nanoparticles. The aim of present study were to 2. Can be applied for poorly water sluble drugs.
evaluate whether providing drug in the form of a 3. Can be given by any route
nanosuspensions will enhance drug flux resulting from 4. Reduced tissue irritation in case of subcutaneous/
higher transmembraneous concentration gradients. intramuscular administration.

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5. Rapid dissolution & tissue targeting can be Top down techniques


achieved by IV route of administration. The techniques in which nano size range of particles is
6. Oral administration of nanosuspension provide obtained by reduction in size of larger particles.
rapid onset, reduced fed/fasted ratio & improved
bioavailability. Methods for preparation of Nanosuspension-
7. The absorption form absorption window can be There are different methods for the preparation of
increased, due to reduction in the particle size. nanosuspensions [22],
8. Higher bioavailability & more consistent dosing in 1. Homogenization in water (Disso Cubes).
case of ocular administration & inhalation delivery. 2. Media milling (Nanocrystal).
9. Drug with higher log P value can be formulated as 3. Homogenization in non-aqueous media
nanaosuspensions to increase the bioavailability of (Nanopure).
such drugs. 4. Combined precipitation & homogenization
10. Improvement in biological performance due to high (Nanoedge).
dissolution rate & saturation solubility of the drugs. 5. Nanojet technology.
11. Long term physical stability (due to absence of 6. Emulsifying-solvent evapouration technique.
Ostwald ripening). 7. Hydrosol method.
12. Nanosuspensions can be incorporated in tablets, 8. Supercritical fluid methd.
pellets, hydrogel & suppositories are suitable for 9. Dry co-grinding.
various routes of administration. 10. Emulsion as template.
13. Increasing the amorphous fraction in the particles
leading to a potential change in the crystalline High pressure homogenization (Disso Cubes) -
structure & higher solubility. Disso cubes are engineered using piston-gap-type high
14. Possibility of surface-modification of pressure homogenizers [19]. High pressure
nanosuspension for site specific delivery. homogenization has been used to prepare
15. Possibility of large-scale production, the pre- nanosuspension of many poorly water soluble drugs.
requisite for the introduction of delivery system to Homogenization involves the forcing of the suspension
the market [26]. under pressure through a valve having a narrow
aperture. The instrument can be operated at pressure
Disadvantages for Nanosuspension Drug delivery varying from 100-1500 bars & upto 2000 bars with
system volume capacity of 40ml. The concern with this method
1. Physical stability, sedimentation & compaction can is the need for small sample particles before loading &
cause problems. the fact that many cycles of homonization are required.
2. It is bulky sufficient care must be taken during Before subjecting the drug to the homogenization
handling & transport. process, it is essential to form a pre-suspension of the
3. Improper dose. microsized drug in a surfactant solution using high
4. Uniform & accurate dose cannot be achieved [32]. speed stirrer. During the homogenization process, the
drug suspension is pressed through the homogenization
Techniques for Nanosuspensions- gap in order to achieve nanosizing of the drug. In piston
Current techniques used to obtain drug nanoparticles gap homogenizer, particle size reduction is based on the
can be divided into two categories: cavitation principle. A piston-gap homogenizer like
APV Gaulin type has been shown. Particles are also
Bottom up techniques reduced due to high shear forces & the collision of the
It is the technique in which nano size is obtained by particles against each other. The dispersion contained in
increasing the size of particle from molecular range to 3cm diameter cylinder, suddenly passes through a very
nano range [21]. The convectional method of narrow gap of 25µm. The reduction in diameter of 3cm
precipitation (Hydrosol) are called as Bottom up to 25µm leads to increase in dynamic pressure &
techniques. Using a precipitation technique, the drug is decrease of static pressure below the boiling point of
dissolved in an organic solvent & this solution is mixed water at room temperature. Due to this water starts
with miscible anti-solvent. In the water solvent mixture, boiling at room temperature & forms bubbles, which
the solubility is low & drug precipitates. Basic implode when the suspension leaves the gap & normal
challenge is that during the precipitation procedure air pressure, are reached [22].
growing of the crystals need to be controlled by
addition of surfactant to avoid formation of Media milling (Nano Crystals) -
microparticles. The use of simple & low cost In this method, the nanaosuspensions are produced
equipments is the advantage of bottom up technique. using high-shear media mills or pearl mills. The media
But the drug needs to be soluble in at least one solvent mills consists of a milling chamber, a milling shalf & a
& the solvent needs to be miscible with non-solvent. recirculation chamber. The milling chamber charged
Moreover, it is not applicable to the drugs, which are with polymeric media is the active component of the
poorly soluble in both aqueous & non-aqueous media. mill. The mill can be operated in a batch or
recirculation mode. Crude slurry consisting of drug,

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Abhyangshree NM et al., Sch. Acad. J. Pharm., 2014; 3(1):82-88

water & stabilizer is fed into the milling chamber & temperatures. The typical residence time generated for a
processed into nano-crystalline dispersion & the milling nanometer-sized dispersion with a mean diameter of
media or pearls are then rotated at a very high shear <200nm is 30-60min [19].
rate. The milling process is performed under controlled

Fig.2- Schematic representation of high-pressure homogenizer process

Fig. 3- Schematic representation of the media milling process.

Homogenization in non-aqueous media (Nanopure) - below the freezing point & hence are called “deep-
Nanopure is suspension homogenized in water free freeze” homogenization. The result obtained were
media or water mixtures i.e. the drug suspensions in the comparable to dissocubes & hence can be used
non-aqueous media were homogenized at 0oC or even

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Abhyangshree NM et al., Sch. Acad. J. Pharm., 2014; 3(1):82-88

effectively for thermolabile substance at milder such as PVP, PEG, HPMC has been used.
conditions. Physiochemical properties & dissolution of poorly
water soluble drugs were improved by co-grinding
Combined precipitation & homogenization because of an improvement in the surface polarity &
(Nanoedge) - transformation from a crystalline to an amorphous drug.
The drug is dissolved in an organic solvent & this Dry co-grinding can be carried out easily &
solution is mixed with a miscible anti-solvent for economically & can be conducted without organic
precipitation. In the water-solvent mixture the solubility solvents. The co-grinding technique can reduce
is low & the drug precipitates. Precipitation has also particles to the submicron level & a stable amorphous
been coupled with high shear processing. The basic solid can be obtained [18].
principles of Nanoedge are the same as that of
precipitation & homogenization. A combination of Emulsion as template –
these techniques results in smaller particle size & better Apart from the use of emulsion as a drug delivery
stability in a shorter time [26]. vehicle, they can also be used as template to produce
nanosuspensions. The use of emulsion as templates is
Nanojet technology – applicable for those drugs that are soluble in either
This technique is also called as „opposite stream‟ uses a volatile organic solvent or partially water-miscible
chamber where a stream of suspension is divided into solvents. Such solvents can be used as the dispersed
two or more parts, which colloid with each other at high phase of the emulsion. There are two ways of
pressure upto 4000 bar at high velocity of 1000m/s. The fabricating drugs nanosuspensions by emulsification
high shear force produces during the process result in method. In the first method, an organic solvent or
particle size reduction [25]. mixture of solvents loaded with drug is dispersed in the
aqueous phase containing suitable surfactant to form an
Emulsification-solvent evapouration techniques - emulsion. The organic phase is then evaporated under
This technique involves preparing a solution of drug reduced pressure so that the drug particles precipitates
followed by its emulsification in another liquid that is a instantaneously to form a nanosuspension stabilized by
non-solvent for the drug. Evaporation of the solvent surfactants. Since one particle is formed in each
leads to precipitation of the drug [20]. emulsion droplet, it is possible to control the particle
size of the nanosuspension by controlling the size of the
Supercritical fluid method – emulsion. Optimizing the surfactant composition
Supercritical fluid technology can be used to produce increases intake of organic phase & ultimately the drug
nanoparticles from drug solutions. The various methods loading in the emulsion. Originally, organic solvents
attempted are rapid expansion of supercritical solution such as methylene chloride & chloroform were used.
process (RESS), supercritical anti-solvent process &
precipitation with compressed anti-solvent process Characterization of Nanosuspension-
(PCA). The RESS involves expansion of the drug 1) Mean particle size & particle size distribution.
solution in supercritical fluid through a nozzle, which The mean particle size & the width of particle size
leads to loss of solvent power of the supercritical fluid distribution are important characterization parameters
resulting in precipitation of the drug as fine particles. In as they govern the saturation solubility, dissolution
the PCA method, the drug solution is atomized into a velocity, physical stability & even biological
chamber containing compressed Co2. As the solvent is performance of nanosuspensions [27].
removed, the solution gets supersaturation & thus
precipitates as fine crystals. The supercritical anti- 2) Crystalline state & particle morphology.
solvent process uses a supercritical fluid in which a The assement of the crystalline state & particle
drug is poorly soluble & a solvent for the drug that is morphology together helps in understanding the
also miscible with the supercritical fluid. The drug polymorphic or morphological changes that a drug
solution is injected into the supercritical fluid & the might undergo when subjected to nanosizing.
solvent gets extracted by the supercritical fluid & the Additionally, when nanosuspensions are prepared drug
drug solution gets supersaturated. The drug is then particles in an amorphous state are likely to be
precipitated as fine crystals [26]. generated. Hence, it is essential to investigate the extent
of amorphous drug nanoparticles generated during the
Dry co-grinding – production of nanosuspensions. The changes in the
Nanosuspensions prepared by high pressure physical state of the drug particles as well as the extent
homogenization & media milling using pearl ball mill of the amorphous fraction can be determined by X-ray
are wet –grinding processes. Recently, nanosuspensions diffraction analysis & can be supplemented by
can be obtained by dry milling techniques. Successful differential scanning calorimetry. In order to get a
work in preparing stable nanosuspensions using dry- actual idea of particle morphology, scanning electron
grinding of poorly soluble drugs with soluble polymers microscopy is preferred [6].
& copolymers after dispersing in a liquid media has
been reported. Many soluble polymers & co-polymers 3) Particle charge (Zeta potential)

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Abhyangshree NM et al., Sch. Acad. J. Pharm., 2014; 3(1):82-88

The determination of zeta potential of nanosuspension increase in their oral absorption & subsequently
is essential as it gives an idea about the physical biovailability. The oral administration of naproxen
stability of the nanosuspension. The zeta potential of a nanoparticles leads to an area under the curve of 97.5
nanosuspension is governed by both the stabilizer & the mg-h/l compared with just 44.7 mg-h/l for naprosyn
drug itself. In order to obtain a nonosuspension suspensions & 32.7 mg-h/l for anapro tablets. Oral
exhibiting good stability, for an electrostatically administration of gonadotrophin inhibitor Danazol as a
stabilized nanosuspension a minimum zeta potential of nanosuspensions leads to an absolute bioavailability of
30mV is required whereas in the case of a combined 82.3 & the convectional dispersion only to 5.2%. A
electrostatic & steric stabilization, a minimum zeta nanosuspension of Amphotericin B developed by
potential of 20mV is desirable [28]. Kayser el al.Showed a significant improvement in its
oral absorption in comparison with the convectional
4) pH commercial formulation [6].
The pH of the nanosuspensions can be easily measured
by using pH meter [26]. 2) Parenteral Drug Delivery
One of the important applications of nanosuspension
5) Osmolarity technology is the formulation of intravenously
Practically, osmolarity of nanosuspension can be administered products. IV administration results in
measured by using Osmometer [26]. several advantages, such as administration of poorly
soluble drugs without using a higher concentration of
6) Saturation solubility & Dissolution velocity toxic co-solvent, improving the therapeutic effect of the
Nanosuspensions have an important advantage over drug available as convectional oral formulations &
other techniques, that it can increase the dissolution targeting the drug to macrophages & the pathogenic
velocity as well as the saturation solubility. The micro-organism residing in the microphages. Injectable
saturation solubility of the drug in different nanosuspensions of poorly soluble drug tarazepide have
physiological buffer as well as at different temperature been prepared to overcome the limited success achieved
should be assessed using methods described in the using convectional solubilising techniques, such as use
literature. The investigation of the dissolution velocity of surfactants, cyclodextrins etc. To improve
of nanosuspensions reflects the advantages that can be bioavailability [2].
achieved over convectional formulations, especially
when designing the sustained-release dosage forms 3) Pulmonary Drug Delivery
based on nanoparticulate drugs. The assessment of Aqueous nanosuspensions can be nebulized using
saturation solubility & dissolution velocity helps in mechanical or ultrasonic nebulizer for lung delivery.
determining the vitro behaviour of the formulation [1]. Basically the nanosuspensions can be used in all
nebulizers. The dispersions can be relatively high
7) Surface Hydrophilicy concentrated. Due to presence of many small particles
For intravenous injected nanosuspensions, additional instead of a few large microparticles, all aerosol droplet
parameters need to be determined which affect the in are likely to contain drug nanoparticles. Budesonide, a
vivo fate of the drug nanoparticles. Surface poorly water-soluble corticosteroid, has been
hydrophilicy is considered as one of the important successfully prepared as a nanosuspension for
parameters affecting the in vivo organ distribution after pulmonary delivery. A good relationship was obtained
i.v. injection. The surface hydrophobicity determines between increasing the drug concentration in the
the interaction with cells prior to phagocytosis & in formulation & the number of micrograms of drug
addition, it is a relevant parameter for the adsorption of delivered per actuation. In addition, buparvaquone
plasma proteins the key factor for organ distribution. To nanosuspensions were formulated for treatment of lung
avoid artefact, the surface hydrophobicity needs to be infections by using nebulizers [18].
determined in the original environment of the drug
nanoparticles, which means in aqueous dispersion 4) Topical Formulations
medium. A suitable technique is hydrophobic Drug nanoparticles can be incorporated into creams &
interaction chromatography (HIC), previously water free ointments. The nanocrystalline forms leads to
employed to determine the surface hydrophobicity of an increased saturation solubility of drug in the topical
bacteria, & then transferred to the characterization of dosage form, thus enhancing the diffusion of the drug
nanoparticluate drug carriers. into the skin [23].

Applications of Nanosuspensions- 5) Ocular Drug Delivery


1) Oral Drug Delivery Nanosuspension can be boon for drug that exhibit poor
The oral route is the preferred route for drug delivery solubility in lachrymal fluids. Nanosuspensions, by
because of its numerous well-known advantages. Orally their inherent ability to improve the saturation solubility
administered antibiotics such as atoaquone & of drug, represented an ideal approach for ocular
bupravaquone reflect this problem very well. delivery of hydrophobic drugs & nanoparticulate nature
Nanosizing of such drugs can lead to a dramatic

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Abhyangshree NM et al., Sch. Acad. J. Pharm., 2014; 3(1):82-88

of the drug allows its prolonged residence in the cul-de- delivery of ibuprofen, European journal of
sac, giving sustained release of the drug [10]. pharmaceutical science, 2002; 16, 53-61.
8. Panayiotis P, Mahesh V, Robert S; Advance in
CONCLUSION lipid nanodispersions for parenteral drug delivery
Nanosuspensions appear to be unique & yet & targeting, Advance drug delivery reviews, 2008;
commercially viable approach to combating problems 757-767.
such as poor bioavailability that are associated with the 9. Shobha R, Hiremath R, Hota A; Nanoparicles as
delivery of hydrophobic drugs, including those that are drug delivery systems, Ind.J.Pharma.Sci, 1999;61,
poorly soluble in aqueous as well as organic media. The 69-75.
dissolution problems of poorly water soluble drugs have 10. Mehnertw , Mader K, Solid lipid nanoparticles:
been largely solved to improve drug absorption & production, characterization & applications, Adv.
bioavailability. Nanosuspension technology can be Drug delivery review, 2000; 47, 165-169.
combined with traditional dosage forms: tablets, 11. Nayak S, Panda D, Sahoo J; Nanosuspension : A
capsules, pellets, & can be used for parenteral products. novel drug delivery system, Journal of pharmacy
Totake advanateg of nanosuspension drug delivery, research, 2010; 3:2, 241-246.
simple formulation technologies & variety applications, 12. Kumar S, Vedha H, Subramanian N, Kumar S;
nanosuspensions will continue to be interest as oral Novel metronidazole nanosuspension as a
formulations & non-oral administration develop in the controlled drug delivery system for antihelmintic
future. activity, Journal of pharmacy research, 2010; 3:10,
110-115.
Acknowledgement- 13. Dressman J, Amindon C, Shaha V; Dissolution
We, the authors are very much thankful to (Prof) Dr. testing as a prognostic tool for oral drug
S.P. Gawade (Principal, Satara College Of Pharmacy, absorption: immiediate release dosage forms,
Satara ), Dr. A.S. Kulkarni (Vice-principal, Satara Pharma research, 1998; 15:1, 11-22
College Of Pharmacy, Satara ), Dr. N.H. Aloorkar ( 14. Mosharraf M, Sebhatu T, Nstrom C; The effects of
H.O.D., Department of Pharmaceutics, Satara College disordered structure on the solubility & dissolution
Of Pharmacy, Satara) & to Dr. S.S. Gilda (H.O.D., rates of some hydrophilic sparingly soluble drugs,
Department of Quality Assurance Technique, Satara Int.J. Pharm., 1999; 177:1, 29-51.
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