Drug Formulation & Bioavailability Congress September 05-07, 2016 Beijing, China

Formulation is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. There are various anatomical routes which thought them medical drugs can be administered into the human body. The selection of the route depends on three factors which are: the effect desired the type of the disease and finally the type of the product. Oral route, this is the oldest route which has been used for conventional and novel drug delivery administration. Parenteral route, these routes include intramuscular, intravenous, intra-arterial and subcutaneous route. Transdermal route, this route the medical treatment will apply on the body surfaces such as the skin and / or mucous membrane. Inhalation route, In this type of medical treatment application route, the medical treatment will directly reach the lungs, by this way this route considers the route of choice to avoid systemic effect i.e., increase the bioavailability of the drug in the system.

Applications and various formulations for which contract manufacturing, research and packaging are widely used are also discussed separately in the report. The report also takes into account various new developments and regulatory aspects in this industry. The report also covers significant patents in each category. Analysis of global market trends, with data from 2012, estimates for 2013, and projections of compound annual growth rates (CAGRs) through 2018.The North American market is estimated to reach nearly $73 billion in 2011 and is expected to increase at a 7.9% compound annual growth rate to reach nearly $107 billion in 2016.

In the drug development process, the prospective drugs undergo a number of trials and are screened at various stages to generate the final potent drug for the treatment of various diseases. During the screening process, various properties are tested to see if the drug is suitable for the therapeutics and is non-toxic to the living system. After going through the different stages, the candidate found most suitable for the purpose is selected. 

A detailed analysis of the industry structure of contract manufacturing, contract research and contract packaging has been conducted. Revenues are broken down by type of industry. Sales figures are estimated for the five-year period from 2013 through 2018. The United States is currently spending almost $250 billion a year for prescription drugs. If drugs were sold in a competitive market, without government-imposed patent monopolies, this might achieve savings up to $200 billion a year.

The term drug delivery system was coined in the 1970 to describe a series of technologies that would be used to develop finished medicinal products that were not immediate release.Drug release, absorption, distribution, and elimination profiles to improve product efficacy and safety, as well as patient convenience & compliance, can be modified through drug delivery technologies. Oral and parenteral are the most common routes of drug delivery, but alternative drug delivery is preferred in many situations.Drug delivery system is really another term for formulation.

Drug development is divided into types. The first type is Pre-clinical phase, usually takes 3 to 4 years to complete. If fruitful, this phase is followed by an appeal to the FDA as an Investigational New Drug (IND). After the approval by IND, the next stages are of clinical phases 1, 2, & 3, which require approximately 1-3 years for completion. Importantly, throughout the process of FDA, an investigator leading the clinical trials to communicate with each other so that safety is monitored. The manufacturer then files a New Drug Application (NDA) with the FDA for approval. This appeal can either be approved/ rejected; otherwise the FDA might request further study before making a quick decision. Following the acceptance, the FDA can also request the manufacturer to conduct additional post-marketing studies.  On average the entire process takes between 8 to 12 years.

Traditional and enhanced approaches are not mutually exclusive & Today's competitive industrial environment requires drug manufacturing that continuously strives to improve product quality while reducing production costs.

There are numerous Pharmaceutical Industries all over the globe who delivers and manufacture the drugs where are advantages beyond a typical CMO (Contract Manufacturing Organization) to the drug product market. Many leading pharmaceutical developers and manufacturers, have a large and diverse scientific team who brings an extensive depth of knowledge and experience. Pharmaceutical Industries are making significant difference in their products from the development phases to commercialization. 

The global revenue for advanced drug delivery systems is estimated to be $151.3 billion in 2013. In 2018, revenues are estimated to reach nearly $173.8 billion, demonstrating a compound annual growth rate (CAGR) of 2.8%. Europe contributed about 27% of the total drug delivery market in 2010 and was $36 billion. BCC expects this market to grow to $49 billion by 2016 at a CAGR of 5.6%. The global generics sector reached $269.8 billion in 2012. This sector is expected to reach $300.9 billion in 2013 and $518.5 billion in 2018, with a compound annual growth rate (CAGR) of 11.5%.

Stability studies involve developing a preparation of the drug which is both stable and acceptable to the patient and are essential for drug product marketing approval.Stability studies are conducted at all phases of the drug development cycle for different purposes with the ultimate goal of having a stable product on the market.  During development, stability studies are conducted to support the formulation development and safety and efficacy claims of investigational new drugs.  At registration, they are conducted to ascertain the quality and shelf-life of the drug product in their intended packaging configuration.  After approval, the stability studies are conducted to ensure the quality of production and to support site or other changes to the product.

The global revenue for advanced drug delivery systems is estimated to be $151.3 billion in 2013. In 2018, revenues are estimated to reach nearly $173.8 billion, demonstrating a compound annual growth rate (CAGR) of 2.8%. Europe contributed about 27% of the total drug delivery market in 2010 and was $36 billion. BCC expects this market to grow to $49 billion by 2016 at a CAGR of 5.6%. The global generics sector reached $269.8 billion in 2012. This sector is expected to reach $300.9 billion in 2013 and $518.5 billion in 2018, with a compound annual growth rate (CAGR) of 11.5%.

Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability samples, testing of reference materials and to provide data to support specifications. It provides a comprehensive coverage of method development and validation requirements to progress a pharmaceutical compound, at each stage of product development.

The global revenue for advanced drug delivery systems is estimated to be $151.3 billion in 2013. In 2018, revenues are estimated to reach nearly $173.8 billion, demonstrating a compound annual growth rate (CAGR) of 2.8%. Europe contributed about 27% of the total drug delivery market in 2010 and was $36 billion. BCC expects this market to grow to $49 billion by 2016 at a CAGR of 5.6%. The global generics sector reached $269.8 billion in 2012. This sector is expected to reach $300.9 billion in 2013 and $518.5 billion in 2018, with a compound annual growth rate (CAGR) of 11.5%.

Biopharmaceutical Drug Disposition Classification System divides compounds into four categories supported their porosity and solubility. It is beneficial in predicting effects of outflow and uptake transporters on oral absorption further as on post absorption general levels following oral and endogenous dosing. To improve the efficiency of drug development and the review process by recommending a strategy for identifying expendable clinical bioequivalence tests and a class of immediate-release (IR) solid oral dosage forms for which bioequivalence may be assessed based on in vitro dissolution tests. To recommend methods for classification according to dosage form dissolution, along with the solubility and permeability characteristics of the drug substance.

An overview of biopharmaceutical single-use technologies, which aid the manufacturing process in overcoming such complex issues as sterilization and critical manufacturing parameters. Analysis of global market trends, with data from 2013 and 2014, and projections of CAGRs through 2019. In-depth discussion of key market segments, such as membrane adsorbers, bioreactors, mixing, tangential flow filtration, tubing, connectors, preassembled tubing and rigging, depth filtration, buffer containers, waste containers, samplers, media bags, and filter cartridges. The global revenue for single use technology reached $1.4 billion and $1.7 billion in 2013 and 2014, respectively. This market is expected to grow at a compound annual growth rate (CAGR) of 11.7% to nearly $3.0 billion for the period 2014-2019.

Amount of a substance that becomes available reaches the target organ or systemic circulation to an organism's body for bio-activity when introduced through ingestion, inhalation, injection, or skin contact. Rate of bioavailability depends on factors such as the type of the substance and the composition of diet.

The overall emerging markets for therapeutic drugs totalled $131.4 billion in 2009. These regions include Latin America, China, Eastern Europe, the Middle East, South Korea, India, Russia, and South Africa. These regions are estimated at $145.8 billion in 2010 and expected to continue aggressive growth through 2015, reaching a figure of $214.2 billion, yielding a compound annual growth rate (CAGR) of 8% from 2010 to 2015.

In pharmacology, bioavailability is a subcategory of absorption and is the fraction of an administered dose of unchanged drug that reaches the systemic circulation, one of the principal pharmacokinetic properties of drugs. 

The overall emerging markets for therapeutic drugs totalled $131.4 billion in 2009. These regions include Latin America, China, Eastern Europe, the Middle East, South Korea, India, Russia, and South Africa. These regions are estimated at $145.8 billion in 2010 and expected to continue aggressive growth through 2015, reaching a figure of $214.2 billion, yielding a compound annual growth rate (CAGR) of 8% from 2010 to 2015.

Nutrient Bioavailability refers to the proportion of a nutrient that is absorbed from the diet and used for normal body functions. It includes enhancers of nutrient bioavailability, factors playing a critical role in absorption of nutraceuticals and herbal products. The role of BPDM nutrient bioavailability is discussed under this track.

The global market for ethical nutrition was worth $26 billion in 2010. By 2015, it is anticipated that revenues are likely to reach nearly $44 billion, expanding at a 5-year compound annual growth rate (CAGR) of 10.9%.

In pharmacology, bioavailability BA is a subcategory of ingestion and is the part of a managed measurement of unaltered medication that achieves the systemic flow, one of the important pharmacokinetic properties of medications.

The overall emerging markets for therapeutic drugs totalled $131.4 billion in 2009. These regions include Latin America, China, Eastern Europe, the Middle East, South Korea, India, Russia, and South Africa. These regions are estimated at $145.8 billion in 2010 and expected to continue aggressive growth through 2015, reaching a figure of $214.2 billion, yielding a compound annual growth rate (CAGR) of 8% from 2010 to 2015.

Traditional medicine is the sum total of the knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.

Currently the total global market of Herbal Products and Medicinal Plants is US$ 60 billion with a double digit growth. The diversified use of plant derived products and its acceptance worldwide made the sector very promising one. According to the World Bank Report 1998, world trade in medicinal plants and related products is expected to be US$ 5 trillion by 2050.

China’s total output of medicinal plants from both cultivated and wild harvested sources is 1.6 million tonnes. The total value of the finished TCM in 1996 was US$ 3.7 billion. This estimate excludes domestic consumption, the inclusion of which would result in a far higher figure. Overall sale of botanical medicine products in China in 1995 was estimated at US$ 5 billion.

Medicinal chemistry and pharmaceutical chemistry are disciplines at the intersection of chemistry, especially synthetic organic chemistry, and pharmacology and various other biological specialties, where they are involved with design, chemical synthesis and development for market of pharmaceutical agents, or bio-active molecules (drugs).

In particular, medicinal chemistry in its most common practice —focusing on small organic molecules—encompasses synthetic organic chemistry and aspects of natural products and computational chemistry in close combination with chemical biology, enzymology and structural biology, together aiming at the discovery and development of new therapeutic agents. Practically speaking, it involves chemical aspects of identification, and then systematic, thorough synthetic alteration of new chemical entities to make them suitable for therapeutic use. It includes synthetic and computational aspects of the study of existing drugs and agents in development in relation to their bioactivities (biological activities and properties), i.e., understanding their structure-activity relationships (SAR). Pharmaceutical chemistry is focused on quality aspects of medicines and aims to assure fitness for purpose of medicinal products.

Chemicals, the building blocks of the world, represent one of the oldest and largest industries globally. The global market of chemistry is now trending towards quality products and processes with least impact on environment. The global chemical industry is estimated to be US $2.4 trillion dollars contributing significantly in the market growth of US, Europe, and Middle East Countries. The demand for chemical products is highest in the Asia, Japan and Korea. The annual US chemical output alone is US $750 billion dollars. The global chemical industry market is expected to grow at a CAGR of 3.7% by 2020.

These are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.

The global inpatient and outpatient pharmacy automation market was valued at $2.4 billion in 2011 and should reach $2.6 billion in 2012. Total market value is expected to reach nearly $3.9 billion in 2017 after increasing at a five-year compound annual growth rate (CAGR) of 8%.

Organization that provides support to the pharmaceutica, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.CROs provide biopharmaceutical development, preclinical research, clinical research and clinical trial management. Many CROs specifically provide clinical study and clinical trial support for drugs or medical devices..Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices. CROs range from large, international full-service organizations to small, niche specialty groups.

The Contract Research Organizations market research report provides key industry analysis and industry statistics, measures market size, analyses current and future industry trends and shows market share for the industry’s largest companies. IBIS World publishes the largest collection of industry reports so you can see an industry’s supply chain, economic drivers and key buyers and markets.

Regulatory Affairs conjointly includes a terribly specific which means among the attention industries pharmaceuticals, biologics, medical devices, and food industry. In recent years the growing quality of attention Regulatory Affairs has created nice challenges to satisfy the strain of native health authorities and regulatory agencies. Merely keeping up on changes within the needs for international and native markets will need a frenzied team of specialists.

The overall emerging markets for therapeutic drugs totaled $131.4 billion in 2009. These regions include Latin America, China, Eastern Europe, the Middle East, South Korea, India, Russia, and South Africa. These regions are estimated at $145.8 billion in 2010 and expected to continue aggressive growth through 2015, reaching a figure of $214.2 billion, yielding a compound annual growth rate (CAGR) of 8% from 2010 to 2015.

For entrepreneurs, this would be an ideal place to find out suitable investors and partners to start or expand their business.

If you’re thinking about a business opportunity that will require investment, then attend networking events in your area to identify key members of the investor community and meet other entrepreneurs. It is never too early to approach potential investors and it may be easier to create an informal relationship when you’re not actively seeking investment for your start-up.