objective 1: Case Study and Identifying Problematic Excipients Flashcards
what is the first place you should look for issues related to adverse events?
API
a substance capable of triggering a response that starts in the immune system and results in an allergic reaction
allergen
the labeling of drug products to allow patients and healthcare providers to identify any possible problems with the formulation should follow what act?
food allergen labeling and consumer protection act (FALCPA)
a situation in which a person has difficulty digesting a particular food which can lead to symptoms such as intestinal gas, diarrhea, and abdominal pain
sensitivity
a protein that is found in wheat, barely, rye that leads to exacerbation of celiac symptoms
gluten
what are 7 excipients that may possibly contain gluten or gluten impurities?
- wheat flour
- starch
- modified starch derivatives
- starch hydroslates
- sugar alcohol
- anhydrous citric acid
- wheat germ oil
what are 3 excipients that are considered as modified starch derivatives?
- modified starch
- pregelatinized starch
- sodium starch glycolate
what are 4 excipients that are considered as starch hydroslates?
- maltodextrin
- dexstrates
- dextrose
- maltose
what are 3 excipients that are considered as sugar alcohol?
- sorbitol
- xylitol
- mannitol
a reaction to different compounds which may or may not have some structural similarity
cross sensitivity
children with a documented sulfa allergy should not be given what types of sweetners?
saccharin or saccharin sodium
what are 3 things that need to be the same in order to have pharmaceutical equivalence?
- identical dosage forms
- containing identical drug API at identical potency/strength
- identical compendial standards (quality characterisitics, purity, drug delivery profiles)
what is one thing that may be different in pharmaceutical equivalence?
shape, packaging, appearance, excipients
