Lecture 1 Review Flashcards
What are some of topics dosage form 1 covers?
Aerosols, capsules, emulsion, film, granules, implants, lipstick and liquids
How many drug candidates are there and how many make it to manufacturing?
10,000 candidates to start and 1 makes it to manufacturing
What are the cardinal rules to making a medicine?
- Know what you have 2. Make the same thing every day (controlled by specifications which are the binding quality standards)
What is the timeline of the United States Pharmacopeia and National Formulary?
1820: The USP (United States Pharmacopeia) established by physicians
1830: Pharmacist become involved (enter the chat)
USP under continuous revision.
The National Formulary (NF) published in 1888 by the APhA.
1975: the USP purchased the NF.
2006: a Spanish edition of the USP-NF was introduced.
Today, the USP-NF is revised annually in hardcopy and online.
What is included in an monograph? EX: amoxicillin
Assay, impurities, procedure for making a solution, suitability requirements, etc
What is included in an IND (Document to allow first in human trials)
Drug substance specifications, drug substance specifications (components, quantity, function)
What are excipients? How many people have died from wrong excipients?
Excipients are anything besides the API that is used to keep the drug stable and allow it to become absorbed and metabolised once in the body. More than 200 people have died in the history of medicine to the wrong excipients.
What are the universal tests for new drug substances?
description (state, color), identification (IR,HPLC-MS), assay (stability procedure to determine potency of new drug substance), impurities
What are the more specific tests for new drug substances?
Physicochemical properties, particle size, polymorphic forms, tests for chiral new substances, impurities, assay and identity
What are the more specific tests for new drug products?
Dissolution, disintegration, hardness/friability, microbial, water
