Pharmaceutics part B Flashcards
define drug
agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in human or other animals
sources of drugs
chemical synthesis
natural sources - plants, animals, humans
3 chemical classification of medications
inorganic
organic
biological
define dosage form
any physical form that consists of both active ingredient and pharmaceutical excipients
usually single dose of medication
6 reasons to make every drug compound into appropriate dosage forms
- prevent active ingredients from degradation
- conceal unpleasant flavor, taste, odor
- facilitate mass production
- use accurate dose of active ingredients
- provide various product choices
- enhance therapeutic outcome and compliance
what is the major goal of drug delivery
obtain highest drug effects in the simplest admin way
describe the new chemical entity stage (1)
the finding of a compound as a potential drug candidate including chemical synthesis, extraction, separation and purification
describe the preclinical study stage (2)
preliminary investigation of the suitability of NCE as a therapeutic agent
early stage: physical, chemical, pharmacological, toxicological evaluations and in vivo behaviours
later stage: long term toxicity, formulation, preparation for drug launch
describe investigation new drug application phase (3)
submission of basic info of a new chemical compound for review by health authority
safety major concern
clinical studies in human subjects can commence only after approval of IND application
describe clinical trials (4)
phase 1 - drug safety in 20-100subjects
phase 2 - drug efficacy in 100 subjects
phase 3 - drug efficacy and dose evaluation in 1000s subjects
describe new drug application stage (5)
submission of complete info of a chemical entity for review by the health authority
describe post marketing stage (6)
review of any possibility after product marketing for further improvement or modifications
4 biological stages in vivo
ADME
defien bioavailability
rate and extent of an active ingredient from a formulation to the site of action
used to evaluate effectiveness ofdosage form
define bioequivalence
comparison of bioavailability in diff formulation products or batches of the same activ eingredient
what may be the cause of different bioequivalence between different companies
manufacturing proceses
different excipients used
different quality control measure
how is most data for calculating the correct dose obtained
animal studies that are extrapolated into human doses
how do computers help speed up drug development
can simulate and predict experiments
may be able to predict in vivo drug behaviours
what are the 5 things we want in drug delivery
most effective appropriate form convenient application acceptable approach economic production
what does pharmaceutics invole research and development of in pharmaceutical dosage forms
formulation
manufacture
stability
effectiveness
how long does it take to make a drug
10-15 years
what do you study in drugs in vitro
physical/analytical chemistry
solubility, stability, compatibility, quality control, packaging, premarketing evaluation
what is the therapeutic outcome dependent upon
adme pk parameters dose dosing frequency patient conditions
why some drugs need fast onset of actions while some do not
to meet different therapeutic requirements
why medications come in variable forms
to accomodate different therapeutic outcomes
why oral dosage forms are the most of all products
most acceptable and concenient way of drug admin
how can future development save costs
new manufacturing excipients/techniques
more generic products
more product choices