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Pharmaceutics

Pharmacy

QuestionAnswer
Drug Approval Process Pre-clinical research and development, clinical research and development, NDA review, post marketing surveillance
Pharmaceutics The art, science, and technology of preparing and dispensing drugs
hygroscopic Taking up moisture/humidity
DDS Drug delivery system - formulation or device that safely bring a therapeutic agent to a specific body site at a certain rate to achieve an effective concentration at the site of drug action
Phase I Involves narrowing down analogs of a compound and assessing safety. 20-100 healthy volunteers
Phase II Several hundred volunteers with the target condition
Phase III hundreds to thousands in controlled and uncontrolled trials
NDA new drug application - gain permission to market the drug product in US
Phase IV studies post marketing. side effects, adverse effects, interactions
NCE New chemical Entity
DMF Drug Master Files
ANDA Abbreviated new drug application
SNDA Supplemental new drug application
Particle size and surface area relationship Inverse
BCS Biopharmaceutics classification system
Class I BCS High permeability, high solubility
Class II BCS High permeability, low solubility
Class III BCS Low permeability, high solubility
Class IV BCS low permeability, low solubility
Dissolution Necessary for drug absorption. affects bioavailabilty
Absorption Potential dissolution rate data, solubility, dissolution constant, and partition coefficient
Disintegration Into granules or aggregate
Disaggregation into fine particles
Formulation Combination of drugs and excipients
API Active pharmaceutical ingredients - drug substances that produce pharmacological action and are rarely administered alone
Viscosity Agent Example Hydroxy propyl methyl cellulose
Lubricant Example Mg Stearate
Diluting Agent Lactose
Emulsifying Agent Cetyl Alcohol
Antioxidant Agent Prevents deterioration by oxidation: Sodium ascorbate
Diluent Filler for bulk Lactose, dibasic calcium phosphate
Binding Agent Carboxymethylcellulose Na
Disintegrant Microcrystalling Cellulose
Humectant Agent Glycerin
Buffering Agent Citric Acid or Ammonia Solution
Preservative Sodium Benzoate
Colorant FD&C red, yellow
Flavor menthol, peppermint oil
Created by: llschwartz
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