Asia Pacific Pharmaceutics & Drug Delivery Congress September 25-26, 2019 Singapore

\r\n Nano pharmaceuticals and Advanced Drug Delivery offer the ability to detect diseases at much earlier stages and the diagnostic applications could build upon conventional procedures using nanoparticles. Nano pharmaceuticals represent an emerging field where the sizes of the drug particle or a therapeutic delivery system work at the Nano scale. In the pharmaceutical industry, a long standing issue is the difficulty of delivering the appropriate dose of a particular active agent to specific disease site. Nano pharmaceuticals have enormous potential in addressing this failure of traditional therapeutics which offers site-specific targeting of active agents. Such precision targeting via Nano pharmaceuticals reduces toxic systemic side effects, resulting in better patient compliance. In today world economy, a pharmaceutical industry faces enormous pressure to deliver high-quality products to patients while maintaining profitability. Therefore pharmaceutical companies are applying nanotechnology to enhance or supplement drug target discovery and drug delivery. Nano pharmaceutical reduces the cost of drug discovery, design & development and enhances the drug delivery process.

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\r\n Major Challenges in Drug Delivery Systems are delivery of poorly soluble drugs and bioavailability hurdles for poorly soluble clinical candidates. There are several Novel approaches in the delivery, Overcoming bioavailability hurdles and Rationale formulation design of poorly soluble drugs. Other Major Challenges in Drug Delivery are protein drug delivery, paediatric and geriatric drug delivery.  Self-emulsifying drug delivery systems (SEDDS) possess unparalleled potential in improving oral bioavailability of poorly water-soluble drugs. Taking dosage form into consideration makes the event Pharmaceutica 2018 a dosage form meeting.

\r\n There is an increasing demand for effective and, ideally, non-invasive drug-delivery methods. This is especially the case for the biopharmaceutical sector, which has experienced an overwhelming growth due to advances in biotechnology. In 2009, over $12 billion were invested in biologics / biotechnology research and development (R&D), representing a 26% share in the total R&D expenditure. A recent report by the Pharmaceutical Research and Manufacturers of America (PhRMA) states that in 2015 there were 901 biological in development, targeting more than 100 diseases.

\r\n New classes of pharmaceuticals and biologics (peptides, proteins and DNA-based therapeutics) are fueling the rapid evolution of drug delivery technology. These new drugs typically cannot be effectively delivered by conventional means. Additionally, it has been determined that, for many conventional pharmaceutical therapies, the efficacy may be improved and the side effects reduced if the therapy is administered continuously (although potentially variable rate), rather than through conventional burst release techniques (oral ingestion, injection, etc).

\r\n The global market for Business Development of Drug Delivery Technology in 2010 was $131.6 billion and is expected to rise at a compound annual growth rate (CAGR) of 5% and reach nearly $175.6 billion by 2016. The U.S. constituted approximately 59% of the total drug delivery market in 2010 and was $78 billion. It is forecast to reach nearly $103 billion in 2016 at a CAGR of 4.7%. Europe contributed about 27% of the total drug delivery market in 2010 and was $36 billion and is expected to grow to $49 billion by 2016 at a CAGR of 5.6% for 2013, Drug Delivery Global market reached $150.3 billion, according to BCC research. This was an increase from $142 billion the previous year. Given its predicted annual growth the market represents a considerable business opportunity, which has been reflected in the increasing number of drug delivery specialists. Consistent quality and competitive costs of product improves Production performance and continuity of supply and Product and technology auditing and due diligence with minimizing Regulatory Issues, quality control, and business development Business opportunities in drug delivery

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\r\n A particle with at least one dimension less than 100nm is a nanoparticle. They are composed of synthetic or semisynthetic polymers carrying drugs or proteinaceous substances. Nanoparticles have developed as capable vehicles to deliver drugs in the body. Nanoparticles comprising encapsulated, dispersed, absorbed or conjugated drugs have exceptional characteristics that can lead to higher performance in a variety of dosage forms. Nanoparticles are one of the novel drug delivery systems which can be of potential use in controlling and targeting drug delivery as well as in cosmetic textiles and paints. There are recent developments in the use of nanoparticles as drug delivery systems to treat a wide variety of diseases.

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\r\n  Chromatography and MS are extensively used in the formulation development stage of generic drug products. The ICH Q3B guidelines address the reporting threshold, identification threshold, and qualification threshold for impurities in the drug product.  Chromatography (LC) and Gas Chromatography (GC) are extensively used to analyze stable compounds. However, for labile compounds require derivatization prior to LC or GC analysis. For certain selected analyses, Liquid Chromatography- Ultraviolet Detection (LC-UVD) and Gas Chromatography-Flame Ionization Detection (GC-FID) techniques may be deemed suitable. However, Liquid Chromatography-Mass Spectrometry (LC-MS) and Gas Chromatography-Mass Spectrometry (GC-MS) are usually the techniques of choice when higher specificity and sensitivity are required. Gas Chromatography-Electron Capture Detection (GC-ECD)techniques are commonly used for halogenated PGIs/GIs to enhance sensitivity and selectivity. Occasionally, some spectroscopic techniques like Nuclear Magnetic Resonance (NMR), light scattering, and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) are used in analyzing PGIs/GIs.

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\r\n Currently North America has surpassed the entire continent in terms of novel drug delivery market in cancer research with a market share of around 38%. Due to excellent research & development in the field of drug delivery system, exceptional adoption rate of new technologies, helpful reimbursement policy – North America has surpassed all the continents in terms of market share. Europe also hold the 2^nd position with a very respective market share of around 29% due to large number of cancer patient, development of clinical research facilities, awareness & the novel therapy to the cancer patient.

\r\n But Asia is the fastest growing novel delivery market & it shows a huge elevation in growth curve during recent times due to vast research activities, awareness, new therapy procedure, increased no. of cancer patient in china & japan. Currently in holds the 3^rd position in global market with a share of around 20% but in future it is expected to boost the market growth. The total value of global NDDS market in 2016 was $4.31 Billion. The growth is boosted at a rate of 22.9% during recent period according to CGAR report.

\r\n Various novel pharmaceutical formulations are including the Nano medicine, transdermal patches, enteric coated tablets & capsule, implantable tablet, injectable intravenous & intramuscular preparation, micro bubbles & micro sponges, various Nano particles, microsphere etc.

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\r\n Nanotechnology drug delivery system  mainly improves and elevates the efficacy & action of any medicaments, creating new and better product. Nanoparticle brings revolutionary changes by simplifying the complex tissue culture through reconstruction. Hence the nanoparticle used to deliver the drugs particle or medicament to the specific site, receptors or disease cell. Then the drug particle attached to the specific receptors & attracted by the disease cell. After that they started working & provide treatment. The main advantage of nanotechnology is proper & specific action and less damage of the healthy tissue.

\r\n There are many types of nanotechnology dependent detectors and devices are available like nanotubes, nanowires, Nano probes Nano arrays, polymer nanoparticle, gold nanoparticle, magnetic nanoparticle, Nano capsule, Nano shell etc. Nanotechnology is the engineering of functional systems at the molecular level & manipulating matter at the Nano scale. Nano medicines are widely used in the cancer therapy. There are four types of nanotechnology based drug delivery systems – 1. Smart drug delivery systems, 2. Polymer–drug conjugates, 3. Multifunctional drug carriers, 4. Organic/inorganic composites.

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\r\n International Organization for Standardization (ISO) 9000 requirements do not have the same status as “the law” in the U.S. as do requirements listed in the Code of Federal Regulations (CFR). Because 21 CFR 210 and 211 have legal status, the U.S. Justice Department has extensive powers to ensure compliance. For example, product in the marketplace can be seized, fines can be levied, and personal liability can be assigned. So, management must understand that auditing must be taken seriously, and the requirements listed are just that – requirements. While audits are commonplace in the pharmaceutical industry, the preparedness for those events varies. The companies that develop a risk-based approach to audits are able to remain competitive while meeting quality and government compliance standards on a regular basis. Conversely, the companies that have not implemented strong processes are putting themselves at risk for non-compliance. According to the Federal Food, Drug and Cosmetic Act, “Registered domestic drug establishments shall be inspected by the FDA at least once every two years.” Under some conditions the inspections may be even more frequent, As regulations become more stringent, regulatory authorities are likely to step up audits which are even more reason for companies to be prepared.

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\r\n The Research Pharmaceutical Industry is currently facing a number of increasingly complex challenges. Today indeed, the discovery and marketing of innovative medicines is linked: not only to Compagnies' abilities to solve relatively basic and traditional difficulties which have deeply changed over the past few years, for instance: the regulatory constraints, the dramatic increase in development costs, the critical mass required for investments, the development time periods and the protection of innovation, human resources and organization; but also to the acceptance of recent factors which the Research Pharmaceutical Industry must imperatively overcome, such as: the new Research channels and namely biotechnologies, the building of a pharmaceutical Europe and the internationalization of molecules, the needs of the third world, the innovation financing and the control of Health expenditures, the public opinion's shift in expectations regarding ethical and environmental issues. The Pharmaceutical Industry is currently in a shake-up phase during which it will undergo deep changes, with regard both to its activities and in relations with its environment.

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\r\n The pharmaceutical sector is a high-technology, knowledge intensive and heavily regulated industry. All aspects of the life-cycle of new drugs are regulated, from patent application to marketing approval, commercial exploitation, patent expiration and competition with generics. All the important actors in the pharmaceutical industry: the manufacturers, wholesalers, retailers and prescribing physicians are subject to regulatory controls. This helps to ensure the product efficacy and safety which are not immediately observable. This article discusses about the regulatory practice in pharmaceutical industry with respect to various facets of drug development.

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