Drug Forms and Routes of Administration Before FDA

Drug Forms and Routes of Administration

Before FDA approval • Rx company must clearly state in what form or forms the drug will be manufactured • Rx company must clearly state what routes of administration are determined safe and effective

Tablets • Drug form which contains dried powdered active drug • Contains binders and fillers to provide bulk and proper size • Many different types of tablets

Scored Tablets • Indented line running across the top • Can easily be broken into two pieces with a knife to produce two doses

Enteric Tablets • Covered with a special coating that resists stomach acid but dissolves in the alkaline environment in small intestines

Slow-release Tablet • Provide a continuous, sustained release of a certain drug • Abb as SR slow-release or LA long acting

Caplets- Tablets • Coated tablets in the shape of a capsule • Easier to swallow

Lozenges- Tablets • Formed with a harden base of sugar , water and flavorings • never swallow • dissolve slowly in mouth

Capsule • Comes in two varieties • generally easier to swallow

Soft gelatin- Capsule • Manufactured in one piece in which the drug is in a liquid form inside the soft shell

Hard shell- Capsule • Manufactured in two pieces that fit together and hold the drug which is in a powder or granular form

Creams • A semisolid emulsion of oil and water- main ingredient water • emulsifying agent added to keep mixed

Ointment • Semisolid emulsion of oil and water- main ingredient oil • normally applied to skin without precise measurement nitroglycerin- exception

Lotion • Suspenion of an active drug in a water base

Powder • Finely ground form of an active drug • can be contained in a capsule • glass vials- sterile water • packaged- water

Liquids • Comes in one of 2 forms- Solution or suspension • Solution never need to be mixed • Solution drug fully dissolved

Types of Solutions • Elixirs-alcohol & water base with added sugar & flavoring • Syrups-sugar, water & flavoring thicker • Tinctures- alcohol & water base used topically

Liquid Sprays • Water & alcohol base • pump or aerosol spray • some dispened as foams

Suspensions • Contain fine, undissolved particles of a drug suspended in a liquid base • Important to always shake before use

Suspension Types • Water base- distilled or sterile • emulsion- fat particles & water • gel-suspended in a thicken water medium- does not have to be shaken

Suppository • A solid base of glycerin or cocoa butter containing the drug • Rectal or Vaginal • Adult or pediatric sizes

Transdermal • Consist of a multi-layered disk of a drug reservoir, a porous membrane and a adhesive layer to it to the skin • Patches

Pellet/Bead • Drug can be implanted in the body in the form of a pellet or bead that slowly releases into tissue