Investigational New DrugThe United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. Regulations are primarily at . Similar procedures are followed in the European Union, Japan, and Canada. Commercial INDs are filed by companies to obtain marketing approval for a new drug.
Drug deliveryDrug delivery refers to approaches, formulations, manufacturing techniques, storage systems, and technologies involved in transporting a pharmaceutical compound to its target site to achieve a desired therapeutic effect. Principles related to drug preparation, route of administration, site-specific targeting, metabolism, and toxicity are used to optimize efficacy and safety, and to improve patient convenience and compliance. Drug delivery is aimed at altering a drug's pharmacokinetics and specificity by formulating it with different excipients, drug carriers, and medical devices.
LipophilicityLipophilicity (from Greek λίπος "fat" and φίλος "friendly"), refers to the ability of a chemical compound to dissolve in fats, oils, lipids, and non-polar solvents such as hexane or toluene. Such non-polar solvents are themselves lipophilic (translated as "fat-loving" or "fat-liking"), and the axiom that "like dissolves like" generally holds true. Thus lipophilic substances tend to dissolve in other lipophilic substances, but hydrophilic ("water-loving") substances tend to dissolve in water and other hydrophilic substances.
Membrane biologyMembrane biology is the study of the biological and physiochemical characteristics of membranes, with applications in the study of cellular physiology. Membrane bioelectrical impulses are described by the Hodgkin cycle. Membrane biophysics is the study of biological membrane structure and function using physical, computational, mathematical, and biophysical methods. A combination of these methods can be used to create phase diagrams of different types of membranes, which yields information on thermodynamic behavior of a membrane and its components.
Grapefruit–drug interactionsSome fruit juices and fruits can interact with numerous drugs, in many cases causing adverse effects. The effect is most studied with grapefruit and grapefruit juice, but similar effects have been observed with certain other citrus fruits. The effect was first discovered accidentally in 1991, when a test of drug interactions with alcohol used grapefruit juice to hide the taste of the ethanol. A 2005 medical review advised patients to avoid all citrus juices until further research clarifies the risks.
Octanol-water partition coefficientThe n-octanol-water partition coefficient, Kow is a partition coefficient for the two-phase system consisting of n-octanol and water. Kow is also frequently referred to by the symbol P, especially in the English literature. It is also called n-octanol-water partition ratio. Kow serves as a measure of the relationship between lipophilicity (fat solubility) and hydrophilicity (water solubility) of a substance. The value is greater than one if a substance is more soluble in fat-like solvents such as n-octanol, and less than one if it is more soluble in water.
Carboxymethyl celluloseCarboxymethyl cellulose (CMC) or cellulose gum is a cellulose derivative with carboxymethyl groups (-CH2-COOH) bound to some of the hydroxyl groups of the glucopyranose monomers that make up the cellulose backbone. It is often used as its sodium salt, sodium carboxymethyl cellulose. It used to be marketed under the name Tylose, a registered trademark of SE Tylose. Carboxymethyl cellulose is synthesized by the alkali-catalyzed reaction of cellulose with chloroacetic acid.
Environmental impact of pharmaceuticals and personal care productsThe environmental effect of pharmaceuticals and personal care products (PPCPs) is being investigated since at least the 1990s. PPCPs include substances used by individuals for personal health or cosmetic reasons and the products used by agribusiness to boost growth or health of livestock. More than twenty million tons of PPCPs are produced every year. The European Union has declared pharmaceutical residues with the potential of contamination of water and soil to be "priority substances".
Methyl celluloseMethyl cellulose (or methylcellulose) is a compound derived from cellulose. It is sold under a variety of trade names and is used as a thickener and emulsifier in various food and cosmetic products, and also as a bulk-forming laxative. Like cellulose, it is not digestible, non-toxic, and not an allergen. In 2020, it was the 422nd most commonly prescribed medication in the United States, with more than 100 thousand prescriptions. Methyl cellulose has a wide range of uses. Methyl cellulose is used to treat constipation.
DruglikenessDruglikeness is a qualitative concept used in drug design for how "druglike" a substance is with respect to factors like bioavailability. It is estimated from the molecular structure before the substance is even synthesized and tested. A druglike molecule has properties such as: Solubility in both water and fat, as an orally administered drug needs to pass through the intestinal lining after it is consumed, be carried in aqueous blood and penetrate the lipid-based cell membrane to reach the inside of a cell.
