Dosage Form Design Flashcards
Definition of Drug
An agent intended for use in the diagnosis, mitigation, treatment cure or prevention of disease in humans/animals
Chemical syntheses is the major source of drug for most compounds due to what?
Advancements in chemistry, purification and engineering
What are the four main sources of drug compounds?
Chemical syntheses
Plants
Animals
Humans
Define drug delivery
Development of the most appropriate dosage form (preparation, formulations) that allow for patient to take the medication in the most convenient and acceptable manner
Define “Dosage Forms”
Any physical form that consists of both active ingredients and pharmaceutical excipients
How many medication doses do most dosage forms usually contain?
One
What are the 6 major reasons to make appropriate dosage forms out of drug compounds?
1) To prevent active ingredients from degradation (physical/chemical/biological, in vitro and in vivo)
2) To conceal unpleasant flavor, taste or odor of active ingredients or pharmaceutical excipients
3) To facilitate mass industrial production of drug products
4) To use accurate dose of active ingredients
5) To provide various product choices to patients and consumers
6) To enhance therapeutic compliance and outcome
What is the major goal of drug delivery?
To obtain the highest drug effects in the simplest administration way
Routes of drug administrations:
Oral, parenteral, transdermal, nasal, buccal, sublingual, ophthalmics, pulmonary, rectal, topical, etc.
Therapeutic effects can be either:
Systemic or Site-specific
True or False: Systemic products can only have systemic effects
False: systemic formulations can have site specific effects and topical formulations can have systemic effects
What are the 6 stages in drug discovery that must be done before becoming a product for human application?
1) New Chemical Entity
2) Preclinical Studies
3) Investigational New Drug Application
4) Clinical Trials
5) New Drug Application
6) Post-marketing
The finding of a compound as a potential drug candidate is apart of what stage?
1) New chemical entity
What is entailed in finding a New Chemical Entity?
Syntheses, extraction, separation and purification
What do Preclinical Studies determine?
The suitability of an NCE as a therapeutic agent
What do preclinical studies investigate?
Early stage: physical/chemical characterization, pharmacological/toxicological evaluations and in vivo behaviours.
Late stage: long term toxicity, formulation development/assessment, and prep for new drug product launch.
When can clinical trials on human subjects begin?
After the health authority has reviewed the Investigational New Drug application and approved it for safety.
Describe the three phases of clinical trials.
1) drug safety in 20-100 subjects
2) drug efficacy in 100’s of people
3) drug efficacy and evaluation in 1000’s of people
What is involved in the New Drug Application?
Submission of complete information of a chemical entity for review by the health authorities, including everything from physiochemical characterization, pharmacology, toxicology, clinical results, to formation, production and quality control.
How long does it take for a new drug product to go through whole process?
5-10 years
What are the two major areas that are explored completely before final decision is made to market?
Drugs In vitro
Drugs In vivo
In vitro drug testing includes:
Assessing basic characteristics of chemical compounds (physical and chemical properties, interaction with other dugs, stability)
What are the four biological stages in vivo that all drugs undergo?
Absorption
Distribution
Metabolism
Excretion
Bioavailability is one of the principle criteria to evaluate effectiveness of dose form, define it.
The rate and extent of an active ingredient from a formulation to the site of action
