Week 1 Content Flashcards
Monographs of USP-NF
-USP Monographs: info about drug substances, dosage forms, and compounded preps
-NF Monographs: provides excipient info
-Dietary supplement monographs
General chapters of USP-NF
Provides info about tests and procedures
<795> Non-sterile prep
<797> Sterile prep
<800> HD Handling in Healthcare settings
United States Pharmacopeia and the National Formulary (USP-NF)
Divided into general chapters and monographs
United States Pharmacopeia (USP)
-Sets standards for medications, food ingredients, and dietary supplements including identity, strength, purity and quality
-Enforceable by the FDA and are often adopted by state boards of pharmacy
-Has no role in enforement
Intensity
How strong the drug action will be; associated with concentration
Duration
How long drug action will last; associated with concentrations above a certain level
Onset
How quickly drug action will be seen; associated with how quickly drug appears in blood/plasma
Biopharmaceutics
The study of how the properties of drugs, dosage forms, and routes of administration affect the onset, duration, and intensity of drug action
Steps in designing a dosage form
- Preformulation
- Dosage form selection and formulation
- Determine processes for manufacturing/ compounding
Ionization
The conversion of neutral molecules to electrically charged molecules
Solubility
The extent to which a drug dissolves in a given solvent at a given temperature
Examples of physiochemical properties
MW, solubility, lipophilicity, dissolution rate, ionization, stability, solid-state properties
Preformulation
-Involves the characterization of physiochemical properties of the drug
-Helps to determine the optimum drug candidate for further development
Processes by which elimination occurs
- Metabolism
- Excretion of unchanged drug
a) Urine –> Urination
b) Bile –> Feces
Elimination
The removal of drug from the body
Drug distribution
Drug moves from its administration site to site of action and/or other parts of the body
Metabolism
Takes a drug molecule and chemically modifies it
First pass loss
The drug that is lost to metabolism and biliary elimination before reaching systemic circulation
Systemic absorption
Movement into the systemic circulation
Absorption
-When the dissolved drug moves across the cell membrane and enters the cell
Permeability
The ability of a molecule to pass through a cell membrane
Define dissolution
The transfer of molecules from solid state into solution
Define disintegration
The breakdown of the dosage form into smaller particles
ROA that have only systemic effects
Parenteral (IV, IM, SubQ), Transdermal
ROA that have only local effects
Topical, Ophthalmic
ROA that are both local and systemic
Sublingual, buccal, oral, rectal, nasal, inhalations
Systemic administration
-Enters systemic circulation
-Puts patient at higher risk of adverse effects
Local administration
-Affects that particular area
-Minimizes systemic side effects
Ideal qualities of a dosage form
-Provides an accurate dose
-One dose in a manageable size unit
-Palatable or comfortable
-Convenient and easy to use
-Appropriate stability and compatibilty
What makes up a dosage form?
Active ingredient and excipients (inactive ingredients)
Parenteral routes
Administration by injection, infusion or implantation (IV, IM, SubQ)
Enteral routes
Refer to ROA to a part of the ailmentary canal: Mouth –> Esophagus –> Stomach –> Intestines –> Rectum (buccal, sublingual, oral, rectal)
Examples of excipients
-Fillers
-Disintegrants
-Binders
-Flow enhancers
-Preservatives
-Emulsifying agents
-Suspending agents
-Flavors
-Colors
-Antioxidants
What are excipients?
Pharmacologically inactive substances formulated with the active ingredient
What is compounding?
The preparation of a medication by a licensed pharmacist to meet the unique needs of a patient that would otherwise not be met by commercially available preparations
Drug delivery systems allow for….?
-Enhanced safety
-Improved efficacy
What is a drug delivery system?
-A type of dosage form with engineered technologies for the targeted delivery and/or controlled release of therapeutic agents
-May be a formulation of the drug or a particular device used to deliver the drug
What is a dosage form?
The entity administered to a patient so they receive the correct dose of the drug
Examples: tablets, suspensions, ointments
What is pharmaceutics?
-The design and manufacture of dosage forms and drug delivery systems
-Converts a drug substance into medicine
