Middleeast Pharmacy and Pharmaceutical conference September 24-25, 2018 Abu Dhabi, UAE

Drug delivery is the process of administering the drug or pharmaceutical product, in order to achieve desired therapeutic effect. The method by which drug delivered is important, as it has significant effect on its efficacy. Novel drug delivery system involves various approaches like medical devices or drug-device combination products. NDDS involves combining pharmaceutics polymer science, and molecular biology. Novel drug delivery systems are designed based on physical and biochemical mechanisms. Physical mechanism or controlled drug delivery system includes dissolution, osmosis, erosion and diffusion. Biochemical mechanism includes gene therapy, liposomes, nanoparticles, monoclonal antibodies. NDDS we can make ideal drugs, controlled delivery, selective targeting at site of action. Various drug delivery and drug targeted systems are developed, in order to minimize drug degradation, drug adverse effect, and in order to increase the drug bioavailability (amount of drug available at site targeted region). Drug delivery technology alter drug release profile, absorption, distribution and elimination for the benefit of enhancing product efficacy and safety, as well as patient convenience and compliance 

Nanotechnology is a study related to nanosized particles, their function and practice with respect to different systems. The role of nanotechnology in the field of pharmaceutics has exceptionally altered the way of our understanding about drugs, nanodrugs or the use of nanoparticles as carrier of drug has become the basic fundamental or criteria for the production or design of a drug. Pharmaceutical nanotechnology is appliance of nanoscience to pharmaceuticals as nanomaterials, and devices like diagnostic,drug delivery, biosensor, and imaging . Pharmaceutical nanotechnology has tuned diagnosis and focused treatment of disease at  a molecular level.  Nanotechnology is highly specialized field, which will revolutionize the pharmaceutical industry.Clinical researchers also are exploring the capacity to use microscopic robots known as nanobots, which can be pre-programmed to execute the given tasks inside the human body.

Bioavailability and bioequivalence studies play a important role during the drug development for both new drugs and generic drugs and thus have gained great attention over the past few decades. Bioavailability is the rate and extent to which the active moeity or is absorbed from the dosage form and is available at the required site of action. Relative bioavailability of drug after administered orally is compared with that of an oral standard of the same drug aqueous or non-aqueous solutions.  Absolute bioavailability It compares the bioavailability of the active drug administered through non intravenous routes such as after transdermal route, oral route, rectal route, sublingual route , subcutaneous route,  of administration and comparing the bioavailability of the same drug administered intravenously.

Bioequivalence studies are as vital concern in drug development process, which are required for small changes in drug products that develop during drug development to ensure that the dosage forms prove to be safe and effective. Moreover, bioequivalence has proven even more significant in case of drugs with narrow therapeutic index. Pharmaceutical equality indicates that the identical amount of a similar active substance(s), in the comparative measurements shape, for a similar route of administration additionally meeting the same or else practically identical standards.

Pharmacy Practice acknowledge to the needs and wants of the people who use the pharmacists services to provide the best or most favourable, evidence-based care. The pharmacists concentrate on effective medicines management and aim to optimise the ease that patients acquire from their prescribed treatment as well as the supply of medicines.

The Pharmacy Practice is to provide medications and other health care products and services and to help people and society to make the best of them. The scope of pharmacy practice includes synthesizing and dispensing medications, modern services related to health care, which includes clinical services, considering medications for safety and efficacy, and furnishing drug information. Pharmacists practice includes community pharmacies, hospitals, clinics, skilled nursing facility, psychiatric hospitals, and regulatory agencies.

Pharmaceutical formulation is a part of the drug development procedure. In this process Active ingredient is formulated into a final dosage form using proper excipients and Technological procedures. A drug can have many forms depending upon how it is manufactured, route to be taken or the desired effects. The most common forms of drugs are tablets, capsules or solutions. Drug Formulation include Novel dosage forms, like tablets, sterile products, capsules,  topical preparations, sustained-release and controlled release. 

Clinical trials are medical research studies involving people. They aim to test whether different treatments are safe and how well they work. Some trials involve healthy members of the public. Others involve patients who may be offered the option of taking part in a trial during their care and treatment. Clinical trials are carried out to try to answer specific questions about health and illness. Clinical trial is a systematic investigation in human subjects for evaluating the safety & efficacy of any new drug. Clinical trials are a set of tests in medical research and drug development that generate safety and efficacy data for health interventions in human beings.  

Four phases of clinical trials and medicine development exist and are defined below.

Phase1: It is the first stage and usually involves small groups of healthy people or sometimes patients. Phase 1 trials are mainly aimed at finding out how safe a drug

Phase2: Objectives focus on dose-response, type of patient, frequency of dosing, or numerous other characteristics of safety and efficacy.

Phase3: clinical trials generate data on both safety and efficacy in relatively large numbers of patients in both controlled and uncontrolled trials.

Phase4:  Trials conducted after a medicine is marketed to provide additional details about the medicine's efficacy or safety profile. Different formulations, dosages, durations of treatment, medicine interactions, and other medicine comparisons may be evaluated.

Packaging is the science, art and technology of enclosing or protecting products for Distribution, storage, sale and use. A final product is not accepted except it is properly packaged, and in some cases the major part of the formulation process may be concerned with selecting the correct package for the product. Packaging also refers to the process of design, evaluation and fabrication of packages.

Advances in Packaging System

Blow- fill- seal technology was initially used for filling many categories of liquids, such as non-sterile devices, foods and cosmetics. Recently, Blow- fill- seal technology is used to produce aseptically sterile pharmaceuticals such as respiratory solutions, ophthalmics, and wound care products.

Induction Cup sealing technology is used to create airtight and hermetic seals on the neck of the container.  The process of Induction cup sealing is based on the principle that a conductive material like aluminum foil heats up on exposure to high frequency magnetic field generated by an induction unit.

Tamper Evident Pharmaceutical Packaging can be defined as Packaging having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible or audible evidence to consumers that tampering has occurred. Tamper-evident packaging involves immediate-container/carton systems or any combination.

Novel Laser Coding Technology for Pharmaceutical Glass Containers Glass syringes can now be individually coded / safe process free of micro-cracks / Reliable Track & Trace. A completely new laser-coding system enables glass containers for parenteral use to be clearly coded at the glass syringe manufacturer and tracked from production to end customer

The pharmaceutical analysis is a branch of chemistry, which deals with determination of the quality and quantity of the pharmaceutical products. It is used for the separation of chemical components from the mixture and for the determination of the structure of the compounds. Analysis plays a vital role in the pharmacy. There are various methods for separation, identification and purification of chemical components by using Chromatography method, High performance liquid chromatography, Gas chromatography, Liquid chromatography, UV spectrometry, Mass Spectrometry.

Quality assurance is to prevent defects in deliverables in the planning process itself to avoid the rework, which cost a lot. Quality assurance is a proactive process, and it starts at the early stage of the project to understand the product stated and non-stated requirement and expectations, and then develop the plan to meet these requirements and expectations. Quality control is concerned with the operational activites and techniques that are used to fulfill the requirements of quality. The quality control process includes the activities focus on identifying defects in the actual product being produced.

Pharmacokinetics is study of absorption, distribution, metabolism and excretion of a drug, and pharmacodynamics is the study of relationship between the drug and its receptors, its mechanism of action and therapeutic effect. Both can play a role in drug–drug interactions. Many drugs share the same metabolic pathways or target the same receptors. This leads to the occurrence of pharmacokinetic and pharmacodynamic differences, respectively. Drug–drug interactions occur mainly during drug absorption, distribution (plasma drug binding protein), biotransformation and excretion.

Pharmacology is the science of drugs, it deals with the interaction of externally administered chemical entity (drugs) with living systems. It encircles all aspects of knowledge about drugs, but most essentially those that are relevant to effective and safe use for medicinal purposes. Pharmacology is an innovative discipline of biochemistry, chemistry, physiology, health sciences, clinical medicinal drug, and engineering. The important areas of pharmacology are pharmacodynamics and pharmacokinetics. Pharmacodynamics studies the effects of a drug on body, and Pharmacokinetics studies the effects of body on a drug.

Toxicology is the study of the poisonous effect of drugs and other chemicals (household, the environmental pollutant, industrial, agricultural, homicidal) with emphasis on detection, prevention, and treatment of poisonings. It also includes the study of adverse effects of drugs, since the same substance can be a drug or a poison, depending on the dose.

Target drug delivery system is a special form of drug delivery system where the pharmacologically active agent or medicament is selectively targeted or delivered only to its site of action or absorption and not to the non-target organs or tissues or cells. Targeted drug delivery implies for selective and effective localization of pharmacologically active moiety at pre identified (preselected) target in therapeutic concentration, while restricting its access to non-target normal cellular linings, thus minimizing toxic effects and maximizing therapeutic index. Targeting of drugs to special cells and tissues of the body without their becoming a part of systemic circulation is a very novel idea. A drug can be administered in a form such that it reaches the receptor sites in sufficient concentration without disturbing the extraneous tissue cells.

Pharmacovigilance is “the science and activities relating to the assessment, understanding, detection, and prevention of adverse effects or any other drug-related problems.” Pharmacovigilance is the process and science of controlling the safety of medicines and taking action to decrease risks and increase benefits from medicines. It provides complete and clear information related to drug safety and various risks and benefits associated with them. Pharmacovigilance can help in providing information of unintended and severe adverse events which could not be provided by clinical trials involving in-vivo method. It increases the impact of pharmacovigilance on patient welfare and public health and to know what is pharmacovigilance. Pharmacovigilance is concerned by recognizing the dangers linked with pharmaceutical products also with minimizing the risk of any harm that might come to patients.

Biopharmaceutics is the study of the physical and chemical properties of a drug and its dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption. Biopharmaceutics is an integral component of the overall drug development cycle. The vitality of the drug substance and the medication regardless detailing ahead absorption, Furthermore in vivo conveyance of the drug of the site about action, will be portrayed as an arrangement for occasions that precede elicitation of a drug’s restorative impact. Pharmaceutical researchers have assessed the relative drug availability to the body in vivo after giving a drug by different routes to an animal or else human, then comparing specific pharmacologic, clinical, or possible toxic responses

Pharmacogenomics (constitute both branch i.e. pharmacology and genetic) is the study of the role of genetics in drug response. It deals with the effect of genetic variation on drug response in patient by correlating the gene expression with the pharmacokinetic parameter i.e. absorption, distribution metabolism and excretions. The Pharmacogenomics is used in the research to increase the safety and efficacy of the drug by targeting the drug at the particular site of genes. Pharmacogenetics also play important role in the study of effect of multiple genes in the pharmacological action of drugs.  Most of the drugs fail to show therapeutic effect at the latter stages it may be due to unexpected adverse effect of drug that may be due to the effect of various component of genes. Pharmacogenetics studies can be used at various stages of drug development. In clinical studies, pharmacogenetics can be used in stratification of patient based on their genotype, which correspond to their metabolizing capacity. This helps in prevention of various adverse drug reaction and better outcomes of clinical trials. Pharmacogenomics aims to develop reasonable way to optimize drug therapy, with respect to the patients' genotype, to make sure utmost efficacy by means of negligible adverse effects

Regulatory Affairs a blend of science and administration to achieve an important objective within a drug development organization. Everything relating to drugs from the earliest non-clinical studies, through development, into routine manufacture and marketing. It can add compelling impact for patients and drug companies. The role of regulatory affairs is to establish and execute a regulatory strategy to ensure that the collective efforts of the drug development team results in a product that is approvable by global regulators but is also differentiated from the competition in some way and also is to ensure that the company’s activities, from non-clinical research through to advertising and promotion, are conducted in accordance with the regulations and guidelines established by regulatory authorities.