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Drug delivery & formulation glossary & taxonomy
Evolving Terminology for Emerging Technologies
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Last revised March 04, 2014
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active transport of drugs: Carriage of a solute across a biological membrane, which requires a suitable carrier and the expenditure of energy. IUPAC Pharmaceutics

adjuvant: 1. Additive with no intended pharmacological action, used in the formulation of dosage forms.  2. In pharmacology, a substance added to a drug to speed or increase the action of the main component. 3. In immunology, a substance (such as aluminum hydroxide) or an organism (such as killed mycobacterium) that increases the response to an antigen.  IUPAC Pharmaceutics

adjuvants and delivery -- vaccines:

administration of drugs, parenteral route: Method of introducing substances into an organism, avoiding the gastrointestinal tract [1].Note 1: Parenteral routes may be employed whenever enteral routes are contraindicated or inadequate. Note 2: Parenteral administration includes some conventional (intravenous, intramuscular, subcutaneous) and some special (intradermal, intraventricular, etc.) routes. Note 3: Parenteral products can be solutions, suspensions, and emulsions. They are presented as sterile products. It is commonly used to imply administration by injection or infusion. IUPAC Pharmaceutics

bioavailability: 1. Ratio of the systemic exposure from extravascular (ev) exposure to that following intravenous (iv) exposure as described by the equation: where F is the bioavailability, A and B are areas under the (plasma) concentration-time curve following ev and iv administration, respectively, and Dev and Div are the administered ev and iv doses. 2. Relative amount of the administered dose of a drug that reaches systemic circulation from a certain dosage form in comparison to the amount that reaches the systemic circulation by iv administration. See also relative bioavailability. [7,12] IUPAC Pharmaceutics

bioequivalence: 1. Relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability.2. Dosage forms containing the same drug are said to be bioequivalent if they do not differ significantly in the bioavailability (e.g., AUC, cmax, tmax.) of the active constituent/ingredient, when administered in the same dose under similar experimental conditions. [12]  IUPAC Pharmaceutics

biologics delivery:  Sessions included penetration and distribution, selective targeting of tumors, engineering for delivery, delivery of antibodies, clinical challenges with RNAi therapeutics, novel formulations for RNAi delivery, and novel approaches for targeted delivery. 

biologics formulation:  Optimizing Biologics Formulation Development January 13-14, 2014 • PepTalk Palm Springs, CA Program | Register | Download Brochure

Biologics Formulation and Delivery May 5-7, 2014 • Boston, MA Program | Register | Download Brochure

biopharmaceutics: Branch of pharmaceutical science that deals with the fate of drugs in the living system; particularly the release of the drug from its dosage form into a biological medium, its passage across membranes into the systemic circulation, metabolism, and elimination, and the application of this knowledge to obtain the desired therapeutic effect.  IUPAC Pharmaceutics

Biopharmaceutics Guidelines, FDA http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm064964.htm

blood brain barrier: CNS diseases are a major focus of the pharmaceutical industry, with CNS drugs representing some of its most successful products. However, drug discovery and development researchers experience difficulty developing CNS drugs that complete clinical trials and win regulatory approval—especially drugs which meet major unmet needs in the CNS area, such as Alzheimer’s disease. The vast majority of drugs fail to cross the BBB, which is causing a major bottleneck in successful development of CNS drug candidates. Insight Pharma Reports, Blood Brain Barrier Overview, 2008

carrier-mediated drug transport: Transfer of a drug across a membrane by a transporter (often a protein) constituent of the cytosol membrane. Also known as active transport as opposed to passive diffusion/absorption. IUPAC Pharmaceutics

cosolvent: Vehicle (often ethanol) used in combination to increase the solubility of drugs. Frequently, the solubility of a drug in a mixed solvent system is greater than can be predicted from its solubility in each solvent component separately. IUPAC Pharmaceutics

crystalline: Term that describes a solid of regular shape and the presence of three-dimensional order on the level of atomic dimensions, for a given molecule. Note 1: Crystallinity may be detected by diffraction techniques, heat-of-fusion measurements, etc. Note 2: Crystalline forms are often preferred, over amorphous forms, in pharmaceutical dosage forms, due to uniformity, reproducibility, and sometimes lack of hygroscopicity IUPAC Pharmaceutics

dosage form: Formulated preparation of molecules/drugs that are rarely if ever suitable for administration to patients without additives. See also tablet, syrup, solution, cream, suppositories, etc. IUPAC Pharmaceutics

drug delivery system: Sophisticated dosage form, which, by its construction, is able to modify/control the availability of the drug substance to the body by temporal or spatial considerations. controlled release, extended release, delayed release, delayed action, dosage form, depot, embedding, gradual release, fast release or immediate release, i.e., conventional dosage form, implants, liposome, long-acting, modified release, prolonged action, pulsatile release slow release. : IUPAC Pharmaceutics

drug delivery technologies advanced: describes the reformulation of drugs to enable lower doses, more convenient delivery routes, and supplemental therapeutic indications. Includes use of nanotechnology for drug delivery, nucleic acid drug delivery, enabling role of medical devices and role of delivery technologies in drug lifecycle management. Insight Pharma Reports Advanced Drug Delivery Technologies 2011

drug-eluting stent: Refers to a stent with an active drug that is intended to produce a therapeutic effect (e.g., reduction of restenosis) [13]. IUPAC Pharmaceutics

drug targeting:  A strategy aiming at the delivery of a compound to a particular tissue of the body. IUPAC Medicinal Chemistry  

The Journal of Drug Targeting publishes papers and reviews on all aspects of drug delivery and targeting for molecular and macromolecular drugs including the design and characterization of carrier systems (whether colloidal, protein or polymeric) for both vitro and/or in vivo applications of these drugs. Papers are not restricted to drugs delivered by way of a carrier, but also include studies on molecular and macromolecular drugs that are designed to target specific cellular or extra-cellular molecules. As such the journal publishes results on the activity, delivery and targeting of therapeutic peptides/proteins and nucleic acids including genes/plasmid DNA, gene silencing nucleic acids (e.g. small interfering (si)RNA, antisense oligonucleotides, ribozymes, DNAzymes), as well as aptamers, mononucleotides and monoclonal antibodies and their conjugates. The diagnostic application of targeting technologies as well as targeted delivery of diagnostic and imaging agents also fall within the scope of the journal. In addition, papers are sought on self-regulating systems, systems responsive to their environment and to external stimuli and those that can produce programmed, pulsed and otherwise complex delivery patterns.   Aims and Scope, Journal of Drug Targeting, Informa 
http://informahealthcare.com/page/drt/Description 

formulation: Summary of operations carried out to convert a pharmacologically active compound into a dosage form suitable for administration. See also drug delivery systems, excipient, solubilizing agents. IUPAC  Pharmaceutics

Formulation and Drug DeliveryFormulation and Drug Delivery May 21-22, 2014 • Boston, MA Program | Register | Download Brochure

Formulation Strategies for Improved Delivery of Biologics May 5-6, 2014 • Boston, MA Program | Register | Download Brochure

gene therapy:
Use of products containing genetic material (e.g., pDNA, antisense DNA, siRNA) to treat a disease or condition, or to modify or manipulate the expression of genetic material or to alter the biological properties of living cells. IUPAC Pharmaceutics  more in Biologics

liposome: Artificial spherical lipid bilayer droplet formed mainly from phospholipids having a core of waterphase, small enough to form a relatively stable dispersion in aqueous media and with potential use in drug delivery. [3] IUPAC Pharmaceutics

micelle(s): Aggregates of colloidal dimensions (i.e., association of colloids) formed reversibly from amphiphile molecules. [3]  Note 1: A micelle is thus a structural unit of the dispersed phase (surfactant) in an emulsion, suspension, or a gel; a unit whose repetition in three dimensions constitutes the micellar structure of the gel; it does not denote the individual particles in free suspension or solution, or the unit structure of a crystal. Note 2: Arrangements of groups of molecules of hydrophobic liquids in aqueous environment, formed by surface-active agents. [7]  See also critical micelle concentration. IUPAC Pharmaceutics

microfiltration: Pressure-driven, membrane-based separation process in which particles and dissolved macromolecules larger than 0.1 μm are rejected. Note: Can be used for sterilization with 0.22-μm size filters. [18] IUPAC Pharmaceutics

microsphere:
Solid spherical particles of micron-size range, used as matrix dosage forms. IUPAC  Pharmaceutics

Microspheres are generally defined as small spheres made of any material and sized from about 0.5 µm to 100 µm. Similar, but smaller spheres sized 10 to 500 nm are called nanospheres. Ideally, microspheres are completely spherical and homogeneous in size, although less perfect particles are often termed microspheres as well. Depending on the preparation method and material used, microspheres show a typical size distribution which often deviates from the mono- sized ideal. [Urs Häfeli "Radioactive Microspheres for Medical Applications" High Care Bochum Germany Feb. 25-27, 2000] http://www.highcare.de/abstracts/HTML0051.htm      

molecular pharmaceutics: Molecular Pharmaceutics publishes the results of original research that contributes significantly to the molecular mechanistic understanding of drug delivery and drug delivery systems.,,, Scientific areas within the scope of the journal include physical and pharmaceutical chemistry, biochemistry and biophysics, molecular and cellular biology, and polymer and materials science as they relate to drug and drug delivery system efficacy. American Chemical Society, About Molecular Pharmaceutics http://pubs.acs.org/page/mpohbp/about.html   Broader term: pharmaceutics

nanodelivery: Nanomaterials for targeted delivery are uniquely capable of localizing delivery of therapeutics and diagnostics to diseased tissues. The ability to achieve high, local concentrations of drugs or image contrast agents at a target site provides the opportunity for improved system performance and patient outcomes along with reduced systemic dosing. Targeted Nanodelivery of Drugs and Diagnostics, Margaret A. Phillips, Martin L. Gran, and Nicholas A. Peppas, Nano Today 2010 April 1 5(2)”143-150 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2882307/

nanoencapsulation: Formation of nanoparticles encapsulating a drug. IUPAC Pharmaceutics

nanoparticles: Microscopic particle whose size is measured in nanometers, often restricted to so-called nanosized particles  (NSPs; <100 nm in aerodynamic diameter), also called ultrafine particles. Note 1: Drug may be embedded in (as in a matrix) or adsorbed or encapsulated. Note 2: Particles containing drug of sizes less than 0.5 μm are often named as nanoparticles. [3] IUPAC  Pharmaceutics  Wikipedia http://en.wikipedia.org/wiki/Nanoparticle   See also Miniaturization & Nanoscience

New Technologies for Biologics Delivery and Targeting May 6-7, 2014 • Boston, MA Program | Register | Download Brochure

ophthalmological delivery: Because nothing that concerns intervention with the visual system is trivial, highly innovative specialist companies dominate development on the pharmacological as well as on the drug delivery side, which is immensely important in ophthalmological medicine. Insight Pharma Reports Ophthalmological Therapeutics: Pipelines, Delivery Technologies, and Markets, Insight Pharma Reports, 2008

parenteral: See administration of drugs, parenteral. IUPAC Pharmaceutics

pharmaceutics: Science of preparation of drugs, dosage forms, and drug delivery systems taking into account the pharmacokinetics and pharmacodynamics of the drug as well as its physical and chemical properties. IUPAC Pharmaceutics Narrower term: molecular pharmaceutics

pharmacodelivery: Site-directed pharmacodelivery is a desirable but elusive goal. Endothelium and epithelium create formidable barriers to endogenous molecules as well as targeted therapies in vivo. Deidre P. MacIntosh et. al, Targeting endothelium and its dynamic caveolae for tissue-specific transcytosis in vivo: A pathway to overcome cell barriers to drug and gene delivery, PNAS 99 (4): 1996-2001, Feb. 19, 2002 http://www.pnas.org/cgi/content/full/99/4/1996 

polymorph: Solid material that exists at least in two different molecular arrangements, i.e., distinctly different crystal species. Note 1: The differences between polymorphs disappear in solution or in the vapor phase. Note 2: Solubility, melting point, density, crystal shape, crystal structure, and some other physical properties often differ from one polymorph to the other. IUPAC Pharmaceutics

polymorphic transition: Transition of a solid crystalline phase to another phase having the same chemical composition but a different crystal structure. Note: The transition may occur at a characteristic temperature and pressure, called the inversion point.  [3,20] IUPAC Pharmaceutics

polymorphism:
Existence of two or more different crystal structures for the same compound. IUPAC Pharmaceutics

preformulation: Exploratory activity that begins early in pharmaceutics, involving studies designed to determine the compatibility of excipients with the active substance for a biopharmaceutical; physicochemical and bioanalytical investigation in support of promising experimental formulations. [21] IUPAC Pharmaceutics

prodrug: Chemically modified form of a pharmacologically active compound that has to undergo biochemical or chemical transformation before exhibiting its pharmacological effect.  IUPAC Pharmaceutics

protein delivery: It is a safe bet that if a therapeutic protein is bringing in big money and its patent is nearing expiration, someone somewhere with a clever technology is planning a market invasion based on improving how the protein is delivered. Insight Pharma Reports Delivery Technologies for Protein Therapeutics: Assessment and Outlook  2007

protein device combinations: Protein-Device CombinationsProtein-Device Combinations January 15-16, 2014 • Palm Springs, CA Program | Register | Download Brochure

RNAi therapeutics delivery: Interfering RNA (RNAi) offers tremendous therapeutic promise to silence genes that give rise to bad, proteins and, therefore, disease.  Many products have already reached the market to test the promise that RNAi holds. As RNAi technology progresses, many companies are now trying to increase their shares in the research market by shifting some of their resources to in vitro and in vivo work. The real prize, however, is in therapeutics. Insight Pharma Reports RNAi Therapeutics: Challenges in Drug Development and Delivery, 2005

Tackling RNAi Delivery Part of the RNAI Summit, 2009  Order CD Sessions included exploring varied delivery systems and achieving targeted delivery.


Bibliography

Insight Pharma Reports Advanced Drug Delivery Technologies 2011
Insight Pharma Reports, Blood Brain Barrier Overview, 2008
Insight Pharma Reports, Delivery Technologies for Protein Therapeutics: Assessment and Outlook  2007
Insight Pharma Reports,  Ophthalmological Therapeutics: Pipelines, Delivery Technologies, and Markets, 2008   
Insight Pharma Reports RNAi Therapeutics 2010
Insight Pharma Reports, RNAi Therapeutics: Challenges in Drug Development and Delivery, 2005

Contract Pharma Glossary of Pharmaceutical and Biopharmaceutical Terms, revised annually 500 plus terms http://www.contractpharma.com/glossary 
IUPAC, Glossary of terms related to pharmaceutics, Pure and Applied Chemistry 81, 971–999, 2009, 168 definitions  http://www.iupac.org/publications/pac/pdf/2009/pdf/8105x0971.pdf 

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IUPAC definitions are reprinted with the permission of the International Union of Pure and Applied Chemistry.

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