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delivery & formulation
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<%end if%> Chemistry term index Drug discovery term index Informatics term index Technologies term index Biology term index Finding guide to terms in these glossaries Site Map Related glossaries include Biologics Drug Discovery & development active
transport of drugs: Carriage
of a solute across a biological membrane, which requires a suitable carrier and
the expenditure of energy. 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: Adjuvants and Novel Delivery Systems are widely accepted as key to creating more efficacious vaccines with improved methods for storage and delivery. This leading vaccine meeting addresses the ongoing achievements of creating the next generation of vaccines, including toll-like receptor technology and DNA vaccines. Though lack of FDA approval for new adjuvants presents a major hurdle, researchers continue to delineate adjuvants’ mode of action in the quest to improve vaccines for human use. Adjuvants & Delivery
Systems August
15-16, 2012 • Cambridge, MA Program | Register | Download Brochure 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] 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.
Delivery of Biologics Molecular Medicine conference Feb 3-5, 2010 • San
Francisco, CA Program | Order
CD | Biopharmaceutics
Classification System BCS Guidance: Goals of the BCS Guidance:
To improve the efficiency of drug development and the review process by
recommending a strategy for identifying expendable clinical bioequivalence
tests. To recommend a class of immediate-release (IR) solid oral dosage forms
for which bioequivalence may be assessed based on in vitro dissolution tests. To
recommend methods for classification according to dosage form dissolution, along
with the solubility and permeability characteristics of the drug substance. blood brain barrier: Achieving blood-brain barrier (BBB) penetration remains a significant hurdle for successfully prosecuting CNS targets. Decades of research have failed to yield a single “sure-fire” approach to ensure CNS penetration. The current state of CNS drug discovery suggests that a more holistic approach is necessary, one that considers a balance of ADME and physicochemical properties. Dealing with the Blood-Brain Barrier DVD, Molecular Medicine 2010 Dealing with the Blood-Brain Barrier DVD June 14, 2010 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 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 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 dosage
form: Formulated preparation
of molecules/drugs that are rarely if ever suitable for administration to
patients 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 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 formulation proteins high
concentration: At higher concentrations, proteins or antibodies exhibit
characteristic problems including aggregation, precipitation, gelation, and
increased viscosity. Development of these high protein concentration
formulations results in several manufacturing, stability, analytical, and
delivery challenges. Thus, development of formulations for protein drugs
requiring high dosing and subcutaneous (SC) delivery requires specific
strategies. High-Concentration
Protein Formulations August
22, 2012 • Boston, MA Program | Register | Download Brochure 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 microfiltration:
Pressure-driven,
membrane-based separation process in which particles and dissolved
macromolecules 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 Google = about 26,800 Aug. 8, 2002; about 112,000 June 23, 2004 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: Targeted therapy offers the promise of creating drugs that by the specificity of their design and delivery make them both more effective and less toxic. Multifunctional devices offer novel capabilities, including the possibility of delivering a detection, imaging agent, and drug in one vehicle. This creates the unique advantage of being able to give distribution data and traceability through the use of one agent, that can in tandem detect, address, and monitor disease. This functionality can be leveraged to deliver multiple combinations of drugs by extended release. Nanotechnology promises to create a break-through class of imaging agents that offer distinct advantages and can be used for the early detection and diagnosis of disease. Diagnostic molecules have the potential to act as biomarkers in drug development and diagnostics, and can be used in the imaging of cancer in living subjects. Targeted Nanodelivery for therapeutics and molecular imaging, Oct. 11-12, 2006, Baltimore MD Order CD nanoencapsulation:
Formation
of nanoparticles encapsulating a drug. IUPAC Pharmaceutics
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:
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 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
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
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 Combinations
January 11-12, 2012 • Coronado, 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
Insight
Pharma Reports Advanced
Drug Delivery Technologies 2011
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