Drug Manufacturing
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Drug Manufacturing
Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others. Scale-up considerations Cooling While a laboratory may use dry ice as a cooling agent for reaction selectivity, this process gets complicated on an industrial scale. The cost to cool a typical reactor to this temperature is large, and the viscosity of the reagents typically also increases as the temperature lowers, leading to difficult mixing. This results in added costs to stir harder and replace parts more often, or it results in a non-homogeneous reaction. Finally, lower temperatures can result in crusting of reagents, intermediates, and byproducts to the reaction vessel over time, which will impact the purity of the product. Stoichiometry Different stoichiometric ratios of reagents c ...
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Year Book - Photo Flashes Showing Toledo's Phenomenal Progress, Thriving Industries And Wonderful Resources - DPLA - Ac95c5ef8efd2394c21e2b6edcd01d94 (page 60) (cropped)
A year or annus is the orbital period of a planetary body, for example, the Earth, moving in Earth's orbit, its orbit around the Sun. Due to the Earth's axial tilt, the course of a year sees the passing of the seasons, marked by change in weather, the hours of daylight, and, consequently, vegetation and soil fertility. In temperate and subpolar climate, subpolar regions around the planet, four seasons are generally recognized: spring (season), spring, summer, autumn and winter. In tropics, tropical and subtropics, subtropical regions, several geographical sectors do not present defined seasons; but in the tropics#Seasons and climate, seasonal tropics, the annual wet season, wet and dry seasons are recognized and tracked. A calendar year is an approximation of the number of days of the Earth's orbital period, as counted in a given calendar. The Gregorian calendar, or modern calendar, presents its calendar year to be either a common year of 365 days or a leap year of 366 days, a ...
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Hydrolyze
Hydrolysis (; ) is any chemical reaction in which a molecule of water breaks one or more chemical bonds. The term is used broadly for substitution, elimination, and solvation reactions in which water is the nucleophile. Biological hydrolysis is the cleavage of biomolecules where a water molecule is consumed to effect the separation of a larger molecule into component parts. When a carbohydrate is broken into its component sugar molecules by hydrolysis (e.g., sucrose being broken down into glucose and fructose), this is recognized as saccharification. Hydrolysis reactions can be the reverse of a condensation reaction in which two molecules join into a larger one and eject a water molecule. Thus hydrolysis adds water to break down, whereas condensation builds up by removing water. Types Usually hydrolysis is a chemical process in which a molecule of water is added to a substance. Sometimes this addition causes both the substance and water molecule to split into two parts. In s ...
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Pharmaceutical Packaging
Pharmaceutical packaging (or drug packaging) is the packages and the packaging processes for pharmaceutical preparations. It involves all of the operations from production through drug distribution channels to the end consumer. Pharmaceutical packaging is highly regulated but with some variation in the details, depending on the country of origin or the region. Several common factors can include: assurance of patient safety, assurance of the efficacy of the drug through the intended shelf life, uniformity of the drug through different production lots, thorough documentation of all materials and processes, control of possible migration of packaging components into the drug, control of degradation of the drug by oxygen, moisture, heat, etc., prevention of microbial contamination, sterility, etc. Packaging is often involved in dispensing, dosing, and use of the pharmaceutical product. Communication of proper use and cautionary labels are also regulated. Packaging is an integral ...
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Pharmaceutical Formulation
Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word ''formulation'' is often used in a way that includes dosage form. Stages and timeline Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. For orally administered drugs, this usually involves incorporating the drug into a tablet or a capsule. It is important to make the distinction that a tablet contains a variety of other potentially inert substances apart from the drug itself, and studies have to be carried out to ensure that the encapsulated drug is compatible with these other substances in a way that does not cause harm, whether direct or indirect. Preformulation involves the characterization of a drug's physical, chemical, and mechanical properties in order to choose what other ingredients (excipients) should be used in the pre ...
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Medical Science Liaison
A medical science liaison (MSL) is a healthcare consulting professional who is employed by pharmaceutical, biotechnology, medical device, and managed care companies. Other job titles for medical science liaisons may include medical liaisons, clinical science liaisons, medical science managers, regional medical scientists, and regional medical directors. The term "MSL" was originally trademarked by Upjohn as "Education services – namely, initiation of drug studies in laboratory and clinical settings and development of workshops, symposia, and seminars for physicians, medical societies, specialty organizations, academicians, in concert, concerned with drug related medical topics" in 1967 and with first use in commerce in 1967. As the number of MSL programs in healthcare increased, subsequent peer-reviewed journal publications and books became available to examine the emerging role of medical affairs and the use of MSLs in an increasingly vertically integrated biotechnology industry. ...
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Chemical Reactor
A chemical reactor is an enclosed volume in which a chemical reaction takes place. In chemical engineering, it is generally understood to be a process vessel used to carry out a chemical reaction, which is one of the classic unit operations in chemical process analysis. The design of a chemical reactor deals with multiple aspects of chemical engineering. Chemical engineers design reactors to maximize net present value for the given reaction. Designers ensure that the reaction proceeds with the highest efficiency towards the desired output product, producing the highest yield of product while requiring the least amount of money to purchase and operate. Normal operating expenses include energy input, energy removal, raw material costs, labor, etc. Energy changes can come in the form of heating or cooling, pumping to increase pressure, frictional pressure loss or agitation.Chemical reaction engineering is the branch of chemical engineering which deals with chemical reactors and their d ...
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Chemical Engineering
Chemical engineering is an engineering field which deals with the study of operation and design of chemical plants as well as methods of improving production. Chemical engineers develop economical commercial processes to convert raw materials into useful products. Chemical engineering uses principles of chemistry, physics, mathematics, biology, and economics to efficiently use, produce, design, transport and transform energy and materials. The work of chemical engineers can range from the utilization of nanotechnology and nanomaterials in the laboratory to large-scale industrial processes that convert chemicals, raw materials, living cells, microorganisms, and energy into useful forms and products. Chemical engineers are involved in many aspects of plant design and operation, including safety and hazard assessments, process design and analysis, modeling, control engineering, chemical reaction engineering, nuclear engineering, biological engineering, construction specification, ...
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Good Manufacturing Practice
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality managemen ...
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Manufacturing Operations
Manufacturing operations concern the operation of a facility, as opposed to maintenance, supply and distribution, health, and safety, emergency response, human resources, security, information technology and other infrastructural support organizations. Personnel that make up "operations" are * operators * engineers * technicians * management This is mainly in a manufacturing Manufacturing is the creation or production of goods with the help of equipment, labor, machines, tools, and chemical or biological processing or formulation. It is the essence of secondary sector of the economy. The term may refer to a r ... setting. Manufacturing {{Econ-stub ...
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Pharmaceutical Company
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%. History Mid-1800s – 1945: From botanicals to the first synthetic drugs The modern era of pharmaceutical industry began with local apothecaries that expanded from their traditional role of distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid-1800s, and from discoveries resulting from applied research. Intentional ...
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Bioavailability
In pharmacology, bioavailability is a subcategory of absorption and is the fraction (%) of an administered drug that reaches the systemic circulation. By definition, when a medication is administered intravenously, its bioavailability is 100%. However, when a medication is administered via routes other than intravenous, its bioavailability is generally lower than that of intravenous due to intestinal endothelium absorption and first-pass metabolism. Thereby, mathematically, bioavailability equals the ratio of comparing the area under the plasma drug concentration curve versus time (AUC) for the extravascular formulation to the AUC for the intravascular formulation. AUC is used because AUC is proportional to the dose that has entered the systemic circulation. Bioavailability of a drug is an average value; to take population variability into account, deviation range is shown as ±. To ensure that the drug taker who has poor absorption is dosed appropriately, the bottom value o ...
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Stoichiometry
Stoichiometry refers to the relationship between the quantities of reactants and products before, during, and following chemical reactions. Stoichiometry is founded on the law of conservation of mass where the total mass of the reactants equals the total mass of the products, leading to the insight that the relations among quantities of reactants and products typically form a ratio of positive integers. This means that if the amounts of the separate reactants are known, then the amount of the product can be calculated. Conversely, if one reactant has a known quantity and the quantity of the products can be empirically determined, then the amount of the other reactants can also be calculated. This is illustrated in the image here, where the balanced equation is: : Here, one molecule of methane reacts with two molecules of oxygen gas to yield one molecule of carbon dioxide and two molecules of water. This particular chemical equation is an example of complete combustion. St ...
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