Derived from plant, animal, or mineral sources, hundreds or even thousands of years ago. 45% effective.
Chemicals Discovered in the Environment
From plants from animals from the ocean, or from the soil. (EX. chemotherapy drug Taxol is derived from needles of the Pacific yew tree, antituberculosis drug streptomycin is derived from the stomach of a sick chicken, fungus from which cephalosporin antibiotic drugs were derived)
Chemicals Can Be Derived From
From molecular manipulation of the drug that is already in use. (EX. Penicillin G is derived from the mold Penicillium chrysogenum)
It is a drug that has the same chemical formula (same type and number of atoms in its molecule) as another drug, but has those atoms arranged in a different structural relationship to each other (mirror images).
Recombinant DNA Technology
A totally new chemical can be created through genetic manipulation, gene splicing, genetic engineering, enzymes in test tubes (in vitro), gene cloning, human insulin (Humulin).
Stem Cell Therapy
Involves the use of stem cells to repair or replace damaged cells in the body. In 2001, the first embryonic stem cell was manipulated with the use of umbilical cord blood harvesting of adult stem cells.
A normal version of the gene is lended to a harmless virus. The virus (know as vector) then carries the gene into body cells affected by the disease.
Drug Discovery and Creation, In the Past
Designing a new drug by changing the molecular structure of an existing drug was a slow process of trial and error. Using intution and molecular models made from wood and wire (EX. Pencillin G, terfenadine [seldane] = fexenadine [allegra])
Computers in Drug Discovery
Displays the molecular structure of any drug with very slight molecular changes. The original drug may be significantly changed; absortion, metabolism, half life, therapeutic effects. ID unsuccessful chemicals before time and money are invested in extensive testing. Can manipulate chemicals at the molecular level, such as design new drugs – involves molecular pharmacology.
Medicne fits on target cell like lock and key.
It is assigned by the International Union of Pure and Applied Chemistry (IUPAC). The name accurately describes its molecular structure and distinguishes it from all other chemicals.
Drug company, together with an organization known as the United States Adopted Names (USAN) Council, determines a second chemical name.
Trade Name or Brand Name
When the FDA gives final apporval for marketing, the drug company creates a third name for the drug. It is easy for MD and patients to remember.
Topical – eye drops, Oral – tablets, Parenteral – injected, Sublingual – under tongue, Buccal – cheek and teeth, Rectal – rectum, Vaginal – vagina, Patch – transdermal, Nasogastic – tube down throat to stomach, Gastrosotomy Tube – tube directly to stomach through abdomen, Inhalation – breathing in medication.
Testing of New Drug
All drugs must be thoroughly tested by the company before marketing it according to FDA guidelines. It is tested to determine: drug’s effectiveness and drug’s safety.
In Vitro Testing
Chemical analysis of drug done in a laboratory in test tubes. Latin for in glass.
In Vivo Testing
Testing carried out in animals or humans. Latin or in living.
Frequency Distribution Curve
The number of animals that respond or do not respond to the drug and at what dose.
The time required for the drug level in the serum to decrease form 100 percent to 50 percent .
Median Effective Dose (ED50)
The dose at which 50% of animals tested show a therapeutic response to the drug.
Median Toxicity Dose (TD50)
The dose at which 50% of animals tested had toxic levels of the drug.
Therapeutic Index (TI)
The relative margin of safety between the dose that products a therapeutic effect and the dose that produces a lethal effect in animals.
Investigational New Drug (IND) Application
Sent to the FDA to request permission to test the drug in humans. Contains information about animal trials, shows that drug is not a risk to humans, includes information, chemistry of drug, and manufacturing process.
There are three phases of human testing.
Phase 1 Drug Testing
1-10 healthy volunteers are used to study a safe dose range, evalute side effects, and establish a final correct dose. Must have informed consent, takes about 1 1/2 years to complete.
Phase ll Drug Testing
Given to 50-500 patients who have the disease that the drug is intended to treat. This is done to determine the extent of its therapeutic effect. Takes about 2 years to complete.
Phase lll Drug Testing
Uses several hundred or several thousand ill patients. Administered same way that it will be used on the market, compared with other drugs that are currently on the market, double-blind studies are done, usually last 3 years to complete. The drug company submits its documentation on the drug to the FDA in a New Drug Application (NDA) and awaits for a final FDA decision. Only 20% of submissions get FDA approval.
It is a sugar pill that has no effect. Used in double-blind studies with the real drug and a placebo.
A solid form. Comes in different colors and shapes, scored, effervescent, enteric-coated, slow release, caplet, lozenge, troche (in mouth).
Ingredient that cause the therapeutic effect.
Binders, fillers, as well as different preservatives, antioxidants, and buffers in the drug
Capsule (Cap or Caps)
One-piece gelatin shell, liquid inside. Hard shell in two pieces, powder granules inside.
It is thick and greasy. Semisolid emulsion of oil and water. Absorbed into the area applied, local effect.
Oil based. Semisolid emulsion of oil and water. Absorbed into the skin, local effect.
Water based. Suspension, absorbed into the skin, local effect.
Finely ground drug, can be found within capsules, can be reconstituted. It can be sprinkled topically on skin, sprayed on skin, inhaled into the lungs.
Aqueous (watery, thin). Viscous (non watery, thick).
Liquid that has something added. A drug dissolved in liquid base for topical or oral administration. (EX. aqueous, syrups, tinctures, elixirs, liquid spray, foams, mousse)
Solid particles that are suspended in the liquid. Fine undissolved particles, suspended in a water or oil base, particles gradually settle, important to shake.
A tablet that is dissolved in a glass of water before being swallowed. (EX. Alka-Seltzer)
A tablet that is covered with a special coating that resists stomach acid but dissoves in the alkaline environment of the small intestine to avoid irritating the stomach.
Slow Release Tablet
It is designed to provide a continuous sustained release of the drug. (LA = long acting, SR = slow release, XL = extended length)
A hardened base of sugar and water containing the drug and disolved in the mouth. (EX. Halls Cough Drops)
It is an oblong tablet that has a base of sugar and disintegrates into a paste to release the drug topically in the mouth.
French word that means little lump of bread and other name or troche.
It is composed of a solid base of glycerin and cocoa butter that contains the drug, for vaginal or rectal insertion.
Contains drugs and are applied to the skin. It releases small amounts of the drug over a period of time. It exerts a systemic effect, unlike topical drugs.
Pellet, bead, wafer, inser and device
A drug in a form of a pellet, bead, wafer, or insert can be placed within the bodyspace or body cavity, where it slowly releases a drug in the surrounding tissues.
Inhaled. (EX. Asthma Inhaler)