Pharmaceutics, Formulations & Novel Drug Delivery Systems

Pharmaceutical research is the process through which potential new medicines are identified. It involves a wide range of scientific disciplines, including biology, chemistry and pharmacology. Research Drug development is the process of bringing a new pharmaceutical drug into the market once a lead compound has been identified through the process of drug discovery. Research and development used in developing the new series or products or improvement of existing products and services. 

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  Pharmacoepidemiology


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  Pharmaceutical Cell Biology


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  Pharmaceutical regulatory sciences


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  Recent trends in pharma technology


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  Prevalance of Potential drugs

Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.

• Prospective Validation This type of validation is performed before production, during a product's development stage
• Concurrent Validation
• Retrospective Validation
• Revalidation

A drug goes from being an idea in the lab to something that a doctor prescribes. To do this, it must go through a long development and approval process. During this process, researchers make sure the drug is safe for people to take and effectively treats cancer. This process often takes many years and significant resources. But the actual amount of time and money needed depends on the drug.

There are 3 main steps in finding and developing a new drug:

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  Preclinical research, which is when the drug is found and first tested


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  Clinical research, which is when the drug is tested in people


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  Post-clinical research, which takes place after the drug is approved

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  Controlled Drug Delivery System


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  Ocular Drug Delivery System


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  2D & 3D Printing in Drug Delivery


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  Drug Delivery: Devices And Equipments

Novel Drug delivery System can be referred as, approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effects.

In current research, Drug delivery systems has described in four broad categories:

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  Routes of delivery,


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  Delivery vehicles,


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  Cargo


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  Targeting strategies.

Drug delivery can be in a variety of ways by:

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  Swallowing


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  Inhalation


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  Absorption through the skin


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  Intravenous injection.

Drug delivery systems can be:

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  Controlled Drug Delivery System


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  Ocular Drug Delivery System


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  2D & 3D Printing in Drug Delivery


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  Drug Delivery: Devices And Equipment’s

Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active the drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form.

Pharmacology is a branch of medicine or pharmaceutical sciences. It mainly deals with the study of the body's reaction to drugs.

Interactions that occur between a living organism and chemicals that affect a normal or abnormal biochemical function. Any substances that possess medicinal properties are considered to be pharmaceuticals.

Sub-divisions of Pharmacology mainly include:

• Pharmacotherapeutics
• Toxicology
• Experimental pharmacology
• Clinical Pharmacology
• Chemotherapy

Toxicology studies the negative consequences of pharmaceuticals and chemical substances as well as treatment options, while pharmacology studies the positive effects of drugs.

All pharmaceutical products are formulated to specific dosage forms for drugs to be effectively delivered to patients. Typical pharmaceutical dosage forms include oral tablets, capsules, solutions, suspensions, topical ointments, gels, and solutions, and injections for intravenous (IV), intramuscular (IM), or subcutaneous (SC) administration. In addition, various drug delivery systems have been developed for transdermal, intranasal, and pulmonary deliveries. Different dosage forms require different pharmaceutical technologies and usually present different technical challenges for formulation development.

Because of the complex technical challenges scientists encounter during formulation development, it is important to use an effective methodology. Design of experiments and statistical analysis have been applied widely to formulation development, and are useful in process optimization and process validation. The major advantage of using Design of experiments to develop formulations for pharmaceutical products is that it allows all potential factors to be evaluated simultaneously, systematically, and quickly.

Pharmacogenomics is an important example in the field of precision medicine aimed at tailoring treatment to an individual or group of individuals. Pharmacogenomics studies how DNA affects the response to drugs. In some cases, your DNA can affect whether you react badly to a drug, or whether a drug helps or doesn't work for you. Pharmacogenomics can improve your health by helping you know in advance if a drug can benefit you and if you are safe to take.

Modern Drug discovery includes screening hit identification, medicinal chemistry, and affinity, selectivity(to reduce the potential for side effects), efficacy, metabolic stability (toextend half-life), and oral. Includes optimization of those hits to determine for increased bioavailability

Screening methods based on phenotypic Drug detection have been used to discover new natural products mainly of terrestrial origin. Examples of exploring marine natural products are provided. The Future Trends section provides a comprehensive overview of recent advancements that will benefit the Pharmaceutical industry.

Pharmaceutical microbiology and animal biotechnology have developed as a useful field for the assembly of biological products from microbial cells or animal or human cell biological concepts and manipulations within the field have improved the assembly, variety and kinds of biological products produced.These areas must be further developed with in the future. 

Pharmacokinetic activity depends on the amount of drug levels at the target site . Recent advances in analytical and quantitative methodologies are often non-invasive assessments of drug pharmacokinetics at the site of action for better understanding of pharmacokinetic properties.

Pharmacodynamics is affected by various factors including receptor binding and sensitivity, post receptor effects, chemical interactions,  physiologic changes due to genetic mutations, diseases, aging, or impact of other drugs. Pharmacodynamics and pharmacokinetics explain the effects of drugs to the host body.

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  Drug disposition


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  Applied Pharmaceuticals


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  Causality Evaluation


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  In-vivo and In-vitro studies


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  Stability tests

Medicinal chemistry is a discipline at the overtone of chemistry, particularly 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. Earlier, medicinal chemists often optimized and developed compounds without much knowledge of the drug target or pathway in mind. New skills have had an enormous impact on drug discovery since the mid-20th century. Once hits are identified from high throughput screening (or other sources) the chemists may become involved in hit to lead (h2l) studies when hits from screens are effectively triaged and closely scrutinized for ability to serve as full blown lead compounds. Medicinal chemistry has, therefore, grown to encompass a greater range of scientific disciplines in the drug discovery process in order to minimize the cost, time and risk of development. The arrival of newer high powered computational capabilities was one catalyst for this approach. to succeed in the discovery process medicinal chemists have to perform these initial important tasks: identification of lead molecules which have the desired biological activity using new technologies such as hits and combinatorial chemistry, the lead modification or optimization which could be done by employing structure-activity analysis and scale-up of the optimized lead for further drug development process and efficacy testing.

Pharmaceutical analysis is a branch of practical chemistry that involves the series of process of identification, determination, qualification and purification of a substance, separation of the components of a solution or mixture, or determination of structure of chemical compounds. Pharmaceutical analytic studies uses instruments and methods used to separate, identify and quantify matter. In practice, separation, identification or quantification may constitute the entire analysis or be combined with other method. Separation isolates analytes, while quantitative analysis determines the numerical amount or concentration, and qualitative analysis determines the quality of product.

• GMP method development and validation
• Drug analysis
• Spectroscopy and its techniques
• Modern technologies used in analysis
• Bio analysis
• Quality assurance and quality control

A biologic drug that closely resembles another biologic drug (called a reference drug) has been approved by the U.S. Food and Drug Administration (FDA). Biosimilars and reference drugs are made from living organisms, but they can be made in different ways and froms lightly different substances. To qualify as a biosimilar, a biologic drug must demonstrate that it is safe, works well, and functions like its reference drug.The drug should also be administered in the same manner, in the same dose and condition as the reference drug. A biosimilar drug must be approved by the FDA and may cost less than a reference drug.

Nanotechnology is manipulation of matter on an atomic, molecular and supra molecular scale. Nanotechnology advances the utilization of materials and devices with extremely small dimensions. Nanotechnology is designed to provide a new and improved approach to cancer diagnosis and treatment. Nano scale devices can interact with large biological molecules on the both surface and inside cells involved in cancer.  

• Nanobiotechnology
• Nanomedicine
• Nanomaterials for Drug Delivery
• Personalized Nanomedicine
• Nano Drug Delivery and Nanotoxicity

Drug discovery is the processing which new candidate medications are discovered. From this process potential new drugs are obtained. Drug designing is the effort to develop a new drug by molecular modification of for optimization of desired effects and minimization of side effects if drug. The goal of drug discovery is to deliver one or more clinical candidate molecules, each of which has sufficient evidence of biological activity at the target relevant to disease as well as sufficient safety and drug like properties so that it can be entered into human testing.

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  Drug Delivery Technologies
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  Drug Development and Therapy
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  Drug marketing
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  Drug Regulations
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  Computer Aided Drug Design

Pharmaceutical engineering is branch of engineering focused on Discovering, Manufacturing and formulating the medications. This includes designing and operating the machines, determining product presentation, designing and packaging of labels. This mainly consists of a data that is related to devices used in pharmaceutical industry.

• Biomedical Industries
• Biopharmaceutical Plants
• Production and quality systems
• Drug Tolerance
• Designing quality drugs for diseases
• Significance and scope

Basically, it consists of assorted pieces of identifiable proof, and then an efficient, intensive engineered transformation of new fictitious elements to make them suitable for restorative use. This includes specialist research being developed on the engineering and computational components of existing drugs and their bioactivity, i.e. understanding their structure-action connections (SARs). Science is centered on the quality components of the solution and well-being is guaranteed due to restorative factors.

• Protein structure prediction and molecular simulation
• Biochemistry
• Exploratory development
• Complementary medicine
• Protein structure prediction and molecular simulation

In the world of medicine, drug safety is known as drug safety. This has to do with the opposing effects of pharmaceutical items, as well as many other logical considerations, such as drug reactions, the nature of the solution, and prescription error in drug use, drug viability, and counterfeit pharmaceuticals. Supports holistic health programs by providing reliable data for effective assessment of the risk-benefit profile of pharmacovigilance solutions.

Biomaterials have enhanced oral and injectable drug delivery, the most common modes of drug administration, while also creating new avenues for Drug Delivery including via pulmonary, Transdermal, ocular, and Nasal routes. The application of Biomaterials in the drug delivery system has overcome the limitation we were facing in delivering drugs. It has increased the Bioavailability at the site, reducing the side effect of drugs.

• Colloidal gold
• Hydrogel
• Osmotic-controlled release oral delivery system

Nanomaterials are materials with at minimum one exterior dimension of 100 nanometres or internal structures of 100 nanometers or less. Nanoparticles, nanotubes, rods, and Nanofilaments are some examples. Nanomaterials with the same content as known materials in the compound state may have distinct physical and chemical characteristics and react differently in the body than the same substances in bulk form. As a result, they may pose a variety of risks. Accumulated nanomaterials must also be considered in this perspective, as they may have qualities comparable to single nanoparticles, especially if they have a disproportionately high surface area for a given quantity of material.

• Biocomposites made of new magnetic-carbon materials
• Biosensors and Metallic Nanoparticles
• Nanocomposites of Industrial Relevance
• Multiferroic Materials with Thin Films and Nanostructures

Industrial Pharmacy also plays a crucial role in any drug discovery. To any novel drug discovery the industrial approach is very important to get massive commercial application. Few things which have to be considered by industries to provide a safe and cost affective medicine to the patients like Supply chain, Waste management, Product management, Post- marketing surveillance, Good manufacturing practices and Marketing.

The U.S. pharmaceutical market is the world’s most important national market. Together with Canada and Mexico, it represents the largest continental pharma market worldwide.

• Waste management
• Product management
• Post- marketing surveillance
• Good manufacturing practices

Biotherapy is also termed as Biological Therapy or Immunotherapy. It is a type of treatment that uses the substances made from living organisms such as a virus, gene, or a protein to treat a disease. Those substances may occur naturally in the body or may be made in the laboratory. Common biological agents used are:

• Tumor necrosis factor (TNF) inhibitors
• B-cell inhibitors
• Interleukins (IL) inhibitors
• Selective co-stimulation modulators

Radiopharmaceuticals are also known as medicinal radio compounds are unique medicinal formulations that contain radioisotopes. Radioisotopes are bound to biological molecules able to target specific organs, tissues, or cells within the human body. The radioactive drugs can be used in the diagnosis and, for the therapy of diseases. Radiopharmaceuticals emit radiation themselves, which is different from contrast media which alter or absorb external electromagnetism or ultrasound. Radio pharmacology is the branch of pharmacology that specializes in these agents.

• Radiopharmaceuticals can be divided into four categories:
• Radiopharmaceutical preparation
• Radionuclide generator
• Radiopharmaceutical precursor
• Kit for radiopharmaceutical preparation