Drug delivery technologies for reformulation of parenteral therapeutics has received a lot of attention in recent years, due to significant advances in the field. There is a growing need for patient compliant dosage forms within the cancer therapeutics and biotechnology areas. Besides patient compliance, ease of administration, enhanced therapeutic efficacy, and reduced side effects, are additional factors that differentiate drug delivery products from conventional dosage forms, thus providing a competitive advantage.
This article reviews some salient trends in the parenteral drug delivery sector, within the realms of a changing regulatory environment. Drivers to growth as well as recent advances in this field have been reviewed. Finally, challenges associated with bringing parenteral drug delivery concepts to commercialization have also been discussed.

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Many contributions have been shown for new drug launch by drug delivery research and development in pharmaceutical companies. These come from long effort by their scientists and make scientist in other department and top management understand their approaches and idea, and also they have answered their expectation. DDS is used to make recognition of their effort. Whereas, business of DDS companies are now in somehow more difficult to create new products because of longer development time and higher cost. Specialty pharma is highlighted because of their approach and strategy.

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PLGA nanospheres are known as valuable carriers to deliver active pharmaceutical substances. Depending on the drug formulations, their size and surface properties can be controlled and modified to increase the drug encapsulation ratio and to improve the drug stability, dispersibility and other functional properties. For practical use, it is necessary to compound the drug loaded nanospheres into a desirable form having the structure and characteristics suitable for drug administration. Particulate engineering plays a critical role on the commercialization of drug loaded PLGA nanospheres.
Our laboratory has established various particle design and processing technologies with drug loaded PLGA nanospheres for pharmaceutical and cosmeceutical delivery systems. For examples, insulin loaded PLGA nanospheres were optimized based on the required drug characteristics for pulmonary drug delivery systems^1∼5). PLGA nanospheres were found capable of improving the subcutaneous permeability of drug, which could lead to many applications in transdermal drug delivery systems^6,7), not only for skin care^8∼12) but also for systemic treatments. Furthermore, by encapsulating fluorescent substances and test reagents, PLGA nanospheres were used for bio-kinetics modeling in the medical research. As to the development of commercial products, our laboratory has begun marketing not only first high performance skin care cosmetics, “NanoCrysphere”, with pro-vitamin C loaded PLGA nanospheres in 2005¹¹⁾ but also new hair growth tonic as a functional cosmetic, “NanoImpact”, with several plant extract loaded PLGA nanospheres in 2006^11,12).
In this paper, we would focus on the PLGA nanospheres technologies for creating functional skin care cosmetics.

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With recent advances in biotechnology, numerous promising proteins and peptides are being developed mostly as injectable drug preparations. From a patient viewpoint, these injectable preparations are associated with various problems in terms of convenience, safety, pain and needle phobia. In order to maximize the potential of these drugs, drug delivery systems other than injection preparations are needed. Recently, pulmonary delivery of dry powder inhalants has been extensively studied as an administration route for the systemic absorption of protein and peptide drug preparations. They do not negatively affect the patient or the environment (ozone layer destruction and global warming).
In this review, I would like to introduce the present and future of dry powder inhalation system.

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Nasal route has been gaining attention as an alternative systemic delivery route to injection for peptide drugs. Although high bioavailability can be expected by intranasal administration due to the physiological characteristics of the nasal cavity, there are still several barriers to be overcome for peptide drugs : mucus, penetration and enzymatic barriers.
Recently, we have established new strategies for improving nasal peptide absorption by concurrently using two kinds of enhancers having different mode of action, or by powdery formulation using non-water-absorbable carrier.
This paper, starting with the basis for developing nasal drug delivery systems, will review marketed products from formulational aspects, and introduce our recent approaches for improving nasal absorption of peptide drugs.

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We succeeded overproduction of the HBV envelope L particles with an approximate average particle size of 80 nm in yeast cells. Because the L particle is an empty bionanoparticles containing no viral DNA, it can be used as a safe and efficient carrier for human liver-specific delivery (pinpoint delivery) of drug and gene. In addition, genetically engineered L particles that are able to target to various organs were constructed by deleting the hepatocyte binding domain of L protein (pre-S region) and displaying targeting peptide or protein ligands. Therefore, bionanoparticles are a novel nano-carrier applicable to the broad range of pinpoint DDS.

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We have developed two advanced nanotechnologies, NANOEGG^® and NANOCUBE^TM. They are useful technologies for not only drug but also cosmetics. Today, we have long span of life because of advanced medical science. Therefore, anti-aging drugs, foods, and cosmetics strongly attract us. NANOEGG^®-atRA, nanocapsuled all trans retinoic acid (atRA) with coated inorganic salts, showed enhanced pharmacological activity, compared with atRA as such. NANOEGG^® methods could be applied to other cosmetic compounds.
The topical administration of lyotropic liquid crystal NANOCUBE^TM on stratum corneum rapidly broke down the lipid lamella structure which would be recognized as a wound without organ-change. This can activate a variety of biological processes. Using small angle X-ray scattering (SAXS) analysis, the response to the transient structural change of lipid was detected because it might result the diffusion of oil and/or water from NANOCUBE^TM liquid crystal towards lipid lamella phase. This method actually succeeded the improvement of photo-induced hyperpigmentation on human face.
These observations suggest that the structural change of lipid may stimulate to trigger recognition of a slight injury in the wound defense and repair response by homeostasis.

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