Dose Form Definitions

Wiseman, priest, magician, smart person in tribe

Offical compendum, formulary, a book containing a compilation of pharmaceutical products with their formulas and methods of preparation

• Information on pharmaceutical products including, indications, dosage forms, side effects and pharmacology
• Drug substances and preparations
• Dietary ingrediants and supplements

Popular drugs and preps not admitted originally to the USP, pharmaceutical ingrediants

pupished by the World Health Organization (WHO)

Likes cure like

Safety and effectiveness

too dangerous for self medications

public abuse

manipulation of cells protein from lower organism

Manipulation of cells proteins from higher animals including the patient

Modification of genetic material of living cells

self renewing cells

end-stage differentiated cells

the ideal drug with full therapeutic effect with no side effects

Compound with the desired pharmcologic/biologic activity

A drug that is inactive until it is metabolized by the body to become pharmcologically active

the number of atoms per compound

The relative location of the atoms in the compound

United States Adopted Names, gives the non-proprietary names

National Drug Code, first 4 labelor code, product code, package code

investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects

????????????????

Instituitional Review Board (ethics committee)

is the physical form of a dose of a chemical compound used as a drug or medication intended for administration or consumption. Common dosage forms include pill, tablet, or capsule, drink or syrup, aerosol or inhaler, liquid injection, pure powder or solid crystal

Less soluable then the amorphous form

more soluable than the crystal form

Current Good Manufacturerng Practices

Drug concentration vs time

Drug loss is independant of concentration, contant with time

Drug loss is directly proportional to concentration remaining with respect to time

Method of shelf life estimation

excipients, non-therapeutic ingrediants

• Absorption
• Distribution
• Metabolism
• Elimination

• The study of the time course of drug concentration and in tissues
• The study of th rate and extent of absorption/excretion

Dissolution of drug in fluids and entrance into circulation

tablets/capsule into granules

Granules into fine powder

The fine particles get wet int the body fluids

• Fine particles into liquid
• RATE LIMITING STEP!!

Drug in a form of a liquid

Biomolecule lipid bilayer plus protein layer with water filled pores/channels

The rate of transport across a membrane is prortional to the difference in drug concentration on both sides of the membrane

Dirven against concentration gradient

the movement of molecules across a membrane from a region of high concentration to a region of low concentration that is assisted by proteins

The rate the extent of absorption and availability of the drug at the actve site

Comparison of bioavailbility

Approved drug products with therapeutic equivalance evaluations

The maximum concentration of drug in blood

The time it takes to get to the maximum concentration in blood

area under the curve, directly proportional to absorption, if the auc is the same then the amount absorbed and excreted is the same

Fate of drug after absorption

• Active
• Free to leave the circulation to enter tissues and cellular sites

• Inactive
• Is neither metabolized nor filter through the kids

which in living organisms is the sum of all chemical transformations catalyzed by enzymes and allowing the transformation of biological molecules

termination of drugs activity and presence in the body

• Volume of distribution
• Volume of the compartment into which the total amount of drug is distributed

• Half Life
• The time for the blood's concentration of drug to decrease by half

• Clearance
• Removal of drug from body

How much and how often

• pg 180
• Administration of a drug in a certain way then observing the therapeutic effect

Giving single dose then observing ADME

by self

Fine particles that can result from the comminution of any dry substances

the study of particle size

• pg 108
• Lipid and water soulability

• Grinding a drug in a mortar to reduce its particle size
• is the process in which solid materials are reduced in size, encompassing crushing, grinding

Small amount of potent drugs mixed with other powders

Blending small amounts of powers by movement of a spatula through them

Mixing and reduciton of particle size in one size

Fluffy product, mixed by passing thorugh a sifter

the powder in rotating champer

Agglomerates of smaller powers, gluing them together

Blended power + binder agent + sieve of desired mesh + dry at air or oven

Granules or course powder with effervesent mixture

Mechanism of degradation

a solid dosag form in which unit dose of powder, semisolid, or liquid drugs are enclosed with