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Sink Condition
In pharmaceutics, sink condition is a term mostly related to the dissolution testing procedure. It means using a sheer volume of solvent, usually about 5 to 10 times greater than the volume present in the saturated solution of the targeted chemical (often the API, and sometimes the excipients) contained in the dosage form being tested. During the dissolution testing, "sink condition" is a mandatory requirement, otherwise when the concentration begins to get too close to the saturation point, even though the total soluble amount still remains constant, the dissolution rate will gradually begin to reduce in significant amounts, enough to corrupt the test results. See also * Absorption (pharmacokinetics) * Dissolution testing * Pharmaceutical formulation * Tablet (pharmacy) * Tablet hardness testing Tablet hardness testing is a laboratory technique used by the pharmaceutical industry to determine the breaking point and structural integrity of a tablet and find out how it change ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutics
Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) or an existing drug into a medication to be used safely and effectively by patients. The patients could be either humans or animals. Pharmaceutics helps relate the formulation of drugs to their delivery and disposition in the body. Pharmaceutics deals with the formulation of a pure drug substance into a dosage form. Description Pharmaceutics is also called the science of dosage form design. There are many chemicals with pharmacological properties, but need special measures to help them achieve therapeutically relevant amounts at their sites of action. Branches Branches of pharmaceutics include: *Pharmaceutical formulation * Pharmaceutical manufacturing * Dispensing pharmacy * Pharmaceutical technology * Physical pharmacy * Pharmaceutical jurisprudence History Pharmaceutics deals with the formulation of a pure drug substance into a dosage form. Pure drug substanc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Absorption (pharmacokinetics)
Absorption is the journey of a drug travelling from the site of administration to the site of action. The drug travels by some route of administration ( oral, topical-dermal, etc.) in a chosen dosage form (e.g., tablets, capsules, or in solution). Absorption by some other routes, such as intravenous therapy, intramuscular injection, enteral nutrition, is even more straightforward and there is less variability in absorption and bioavailability is often near 100%. Intravascular administration does not involve absorption, and there is no loss of drug. The fastest route of absorption is inhalation. Absorption is a primary focus in drug development and medicinal chemistry, since a drug must be absorbed before any medicinal effects can take place. Moreover, the drug's pharmacokinetic profile can be easily and significantly changed by adjusting factors that affect absorption. Dissolution Oral ingestion is the most common route of administration of pharmaceuticals. Passin ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 Milling may refer to: * Milling (minting), forming narrow ridges around the edge of a coin * Milling (grinding), breaking solid materials into smaller pieces by grinding, crushing, or cutting in a mill * Milling (machining), a process of using ro ..., Granulation (process), granulation, Coated tablet, 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 part ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Chemical Engineering
Chemical engineering is an engineering field which deals with the study of the 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 engineering, process design and analysis, modeling and simulation, modeling, control engineering, chemical reaction engineering, nuclear engineering, biologi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Tablet Hardness Testing
Tablet hardness testing is a laboratory technique used by the pharmaceutical industry to determine the breaking point and structural integrity of a tablet and find out how it changes "under conditions of storage, transportation, packaging and handling before usage" The breaking point of a tablet is based on its shape. It is similar to friability testing, but they are not the same thing. Tablet hardness testers first appeared in the 1930s. In the 1950s, the Strong-Cobb tester was introduced. It was patented by Robert Albrecht on July 21, 1953. and used an air pump. The tablet breaking force was based on arbitrary units referred to as Strong-Cobbs. The new one gave readings that were inconsistent to those given by the older testers. Later, electro-mechanical testing machines were introduced. They often include mechanisms like motor drives, and the ability to send measurements to a computer or printer. There are 2 main processes to test tablet hardness: compression testing and 3 poi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Tablet (pharmacy)
A tablet (also known as a pill) is a pharmaceutical oral dosage form (''oral solid dosage'', or OSD) or solid unit dosage form. Tablets may be defined as the solid unit dosage form of medication with suitable excipients. It comprises a mixture of active substances and excipients, usually in powder form, that are pressed or compacted into a solid dose. The main advantages of tablets are that they ensure a consistent dose of medicine that is easy to consume. Tablets are prepared either by moulding or by compression. The excipients can include diluents, binders or granulating agents, glidants (flow aids) and lubricants to ensure efficient tabletting; disintegrants to promote tablet break-up in the digestive tract; sweeteners or flavours to enhance taste; and pigments to make the tablets visually attractive or aid in visual identification of an unknown tablet. A polymer coating is often applied to make the tablet smoother and easier to swallow, to control the release rate ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 patients. 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 t ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Dissolution Testing
In the pharmaceutical industry, drug ''dissolution testing'' is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles.Bai, G., Wang, Y., Armenante, P. M., "Velocity profiles and shear strain rate variability in the USP Dissolution Testing Apparatus 2 at Different Impeller Agitation Speeds, " International Journal of Pharmaceutics, 403 (1-2), Pages 1–14, 2011 There are three typical situations where dissolution testing plays a vital role: (i) formulation and optimization decisions: during product development, for products where dissolution performance is a critical quality attribute, both the product formulation and the manufacturing process are optimized based on achieving specific dissolution targets. (ii) Equivalence decisions: during generic product development, and also when ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Test Method
A test method is a method for a test in science or engineering, such as a physical test, chemical test, or statistical test. It is a specified procedure that produces a test result. To ensure accurate and relevant results, a test method should be "explicit, unambiguous, and experimentally feasible.", as well as effective and reproducible. A test is an observation or experiment that determines one or more characteristics of a given sample, product, process, or service, with the purpose of comparing the test result to expected or desired results. The results can be qualitative (yes/no), quantitative (a measured value), or categorical and can be derived from personal observation or the output of a precision measuring instrument. Usually the test result is the dependent variable, the measured response based on the particular conditions of the test defined by the value of the independent variable. Some tests may involve changing the independent variable to determine the level at ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Dissolution Testing
In the pharmaceutical industry, drug ''dissolution testing'' is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles.Bai, G., Wang, Y., Armenante, P. M., "Velocity profiles and shear strain rate variability in the USP Dissolution Testing Apparatus 2 at Different Impeller Agitation Speeds, " International Journal of Pharmaceutics, 403 (1-2), Pages 1–14, 2011 There are three typical situations where dissolution testing plays a vital role: (i) formulation and optimization decisions: during product development, for products where dissolution performance is a critical quality attribute, both the product formulation and the manufacturing process are optimized based on achieving specific dissolution targets. (ii) Equivalence decisions: during generic product development, and also when ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Rate Of Solution
In chemistry, solubility is the ability of a substance, the solute, to form a solution with another substance, the solvent. Insolubility is the opposite property, the inability of the solute to form such a solution. The extent of the solubility of a substance in a specific solvent is generally measured as the concentration of the solute in a saturated solution, one in which no more solute can be dissolved. At this point, the two substances are said to be at the solubility equilibrium. For some solutes and solvents, there may be no such limit, in which case the two substances are said to be "miscible in all proportions" (or just "miscible"). The solute can be a solid, a liquid, or a gas, while the solvent is usually solid or liquid. Both may be pure substances, or may themselves be solutions. Gases are always miscible in all proportions, except in very extreme situations,J. de Swaan Arons and G. A. M. Diepen (1966): "Gas—Gas Equilibria". ''Journal of Chemical Physics'', ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Solubility
In chemistry, solubility is the ability of a chemical substance, substance, the solute, to form a solution (chemistry), solution with another substance, the solvent. Insolubility is the opposite property, the inability of the solute to form such a solution. The extent of the solubility of a substance in a specific solvent is generally measured as the concentration of the solute in a wikt:saturated#Chemistry, saturated solution, one in which no more solute can be dissolved. At this point, the two substances are said to be at the solubility equilibrium. For some solutes and solvents, there may be no such limit, in which case the two substances are said to be "miscibility, miscible in all proportions" (or just "miscible"). The solute can be a solid, a liquid, or a gas, while the solvent is usually solid or liquid. Both may be pure substances, or may themselves be solutions. Gases are always miscible in all proportions, except in very extreme situations,J. de Swaan Arons and G. A. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
