Applications of Nanosuspensions

By: Pharma Tips | Views: 4789 | Date: 02-Jun-2011

Nanosuspension technology is applicable to all poorly soluble drugs and an outstandingfeature of this technology is its simplicity.

Nanosuspension technology is applicable to all poorly soluble drugs and an outstanding
feature of this technology is its simplicity.

Nanosuspensions can be applied to various administration routes such as oral, parenteral, pulmonary, otic,
ophthalmic, and nasal routes.

Administration of poorly water-soluble drug in the form of nanosuspensions has shown increased onset of action,
increased bioavailability,and dissolution rate. For example, the tmax for the nanosuspension formulation
of naproxen, a nonsteroidal antiinflammatory drug, was 23.7 min versus
33.5 min for unmilled formulation (Liversidge and Conzentino 1995).

Nanosuspension formulations of naproxen reduced the time required to achieve
Cmax by approximately 50% compared with marketed suspension (Naprosyn) and
tablets (Anaprox) (Merisko-Liversidge et al. 2003). The dissolution rate of
naproxen tablet formulation made from naproxen particles ranging from 100 to
600 nm in size was compared with a commercially available product (Aleve) that
was prepared from macro-sized naproxen (Jain et al. 2000).

Dissolution rate of naproxen from the nanoparticulate formulation was found to be significantly
higher compared with the drug release from the marketed product. This study
showed that if properly formulated with suitable excipients, nanosuspensions can
be processed into conventional dosage forms such as tablets and capsules, using
standard equipment. Reducing the mean particle size of a poorly soluble investigational
compound from 7 mm to 280 nm showed four times higher bioavailability
compared with micrometric size particles of the compound (Jia et al. 2002).

Nanoparticle formulation was rapidly absorbed with a tmax of 1 h, whereas the tmax
for microparticle formulation was prolonged for another 3 h. Oleanic acid nanosuspension
containing particles with an average particle size of 284.9 nm was
reported to have a faster dissolution rate and enhanced therapeutic effect (Chen
et al. 2005). Kocbek et al. (2006) developed ibuprofen nanosuspensions prepared
by a melt emulsification method traditionally used to prepare solid lipid nanoparticles.
Ibuprofen nanosuspensions either in the form of lyophilized powder or
granules showed enhanced dissolution rate compared with micronized drug. For
lyophilized nanosuspension formulation, more than 65% of the drug dissolved in
the first 10 min as opposed to only 15% of the micronized drug (Fig. 1.7).

Drugs that are not absorbed through the GI tract or that undergo extensive first
pass metabolism can be administered intravenously as nanosuspensions.

Nanosuspensions are ideal for intravenous route and offer many special advantages.

A rapid onset of action can be achieved in case of an emergency and high concentrations
of the drug can be administered without employing toxic cosolvents and
solubility excipients. Nanosuspensions are potential targeted systems as their
surface properties can be easily altered.

In addition, capillary blockade is avoided,
since the particle size in the nanosuspensions is less than 5 mm, which is the inner diameter
of the smallest blood capillaries in the body. A chemically stable, intravenously
injectable nanosuspension formulation for omeprazole, a poorly soluble, chemically
labile drug with a high degradation rate in aqueous media was developed by
Moschwitzer et al. (2004).

Injectable nanosuspension of the poorly soluble drug
tarazepide has been prepared to overcome the limited success achieved using conventional
solubilization tecniques, such as the use of mixed micelles or cycodextrins
to improve the bioavailability of the drug (Jacobs et al. 2000). Rabinow et al.
(2007) evaluated an intravenous itraconazole nanosuspension dosage form, relative
to a solution formulation, in the rat. The formulation of itraconazole as a nanosuspension
enhanced the efficacy of this antifungal agent, and exhibited altered pharmacokinetics,
leading to increased tolerability and high drug levels in target organs.

Pulmonary administration of nanosuspensions increases rapid diffusion and dissolution
of the drug at the site of action. Budesonide, a poorly water-soluble antiinflammatory
corticosteroid, has been successfully formulated as a nanosuspension
for pulmonary delivery (Jacobs and Muller 2002).

The advances in nanosuspension technology are described in more detail in Chap. 10.
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