552 MIDTERM QUESTIONS WITH CORRECT
ANSWERS 2024 - 2025
What,is,Modified,Release?,,ANS,-,,The,term,modified-
release,is,used,to,describe,dosage,forms,that,alter,the,timing,and/or,the,rate,of,release,of,a,conventional,
drug,product/dosage,form
-,FDA,does,define,this
Some,Modified,Release,Systems,,ANS,-,,-,some,of,these,have,overlap,
1.,Delayed,release
2.,Repeated,Release,or,Repeat,Action
4.,Extended,,Sustained,,Long-Acting,,Prolonged,,Controlled,Release,
5.,Targeted,Release
Delayed-release,,ANS,-,,-,dosage,forms,release,the,drug,at,a,later,time,than,an,immediate,dose,system
-,Delayed-release,can,include,enteric-coated,tablets,,where,timed,release,is,achieved,by,a,barrier,coating
-,takes,more,time,to,release,drug;,doesn't,start,dissolving,until,a,certain,point,of,time
Repeat-release,,ANS,-,,-,multiple,doses,of,immediate,release,drug,units,with,intermittent,dosing
-,Such,as,repeat-action,tablets,and,capsules
Extended,,Sustained,,Long-Acting,,Prolonged,,Controlled,Release,,ANS,-,,-,Extended,,Sustained-
release,systems,slowly,release,the,drug,over,an,extended,period,of,time
-,Rate,and,duration,are,not,always,designed,to,a,particular,profile
-
,If,the,system,can,maintain,predictable,levels,of,drug,in,the,target,tissue,or,cells,,it,is,considered,controlle
d-,release.,(Examples:,XL,SR,CR),
-,Controlled,release,systems,are,also,called,extended,or,sustained,(prolonged),release
-,dissolves,and,continues,dissolving,for,a,longer,time
,Targeted,Release,,ANS,-,,-,Site-
specific,or,targeting,refers,to,concentrated,drug,release,at,a,certain,site,such,as,a,tissue,,organ,,receptor,,
or,cell,
-,A,form,of,controlled,release
-,very,difficult,to,achieve,
-,trying,to,control,distribution,of,drug,to,target,area
What,is,Controlled,Release?,,ANS,-,,-
,Controlled,Drug,Delivery,attempts,to,deliver,the,precise,amount,of,a,therapeutic,agent,(drug),,to,a,specifi
c,site,(site,of,action),,for,a,specific,time,(duraterm-5tion,of,treatment),
-,OR,Achieve,both,spatial,(targeted),and/or,temporal,"control",of,the,drug
-,a,lot,of,prediction,involved,,very,precise,,and,targeted,
-,The,Drug,Delivery,System,attempts,to,control,the,drug,concentration,at,the,target,tissue
Disadvantages,of,Conventional,Delivery,,ANS,-,,-,Inconvenient,because,pt,can,forget,to,take,dose
-,Difficult,to,monitor,
-,Overdosing,possible
-
,Large,amounts,of,drug,can,be,"lost",when,it,does,not,get,to,the,target,organ,because,has,to,distribute,to,t
he,whole,body
-,Drug,goes,to,non-target,cells,and,can,cause,damage
-,Expensive,(using,more,drug,than,necessary)
The,Goal,of,Modified,Drug,Delivery,,ANS,-,,To,Alter,and,Control
-,Absorption,
-,Distribution,-,includes,Cellular,Uptake,
-,Metabolism,(reduce,it,so,more,drug,available),
-,Elimination,(reduce,how,fast,eliminated,to,prolong,effect,of,drug),
-,Toxicity,(reduce,it)
What,is,Sustained,Drug,Action?,,ANS,-,,-,ideal,dosage,form
,-,pt,only,has,to,take,one,time,rather,than,multiple,times
-
,minimize,side,effects,by,delivering,API,to,site,of,action,(target,receptors,,cells,,tissues,,or,area,in,the,body
),
-,re-patenting,without,new,drug,development.
Improving,Patient,Compliance,,ANS,-,,Minimize,Plasma,fluctuation
-,Plasma,Concentration,vs,Time
-
,Sustained,Release:,takes,longer,to,be,absorbed,and,in,therapeutic,range,for,longer,but,eventually,elimina
ted
-,Controlled:,absorbed,quickly,and,in,therapeutic,range,for,as,long,as,necessary,
-,the,more,times,you,have,take,a,medication,day,,the,lower,pt,compliance
Tries,to,Achieve:,Site,Specific,Drug,Delivery,,ANS,-,,Reduction,of,side,effects
-,Anticancer,drugs
-->,Cytosine,arabinoside-,Dpocyt®
-,Anti-fertility,Agents,
-,Anti-inflammatory,drugs
Site,Specific,Drug,Action,or,Drug,Targeting,,ANS,-,,-,Targeting,or,Spatial,Delivery
-,exclusive,drug,delivery,to,specific,organ,,tissues,,or,cell,types
-,Still,in,development,and,difficult
-,Designed,to,be,directed,to,a,specific,organ,,tissues,,cell,or,cell,compartment
-,Targets,include,surface,or,compartment,cell,markers,,proteins,or,even,nucleic,acids
-,can,locally,put,the,drug,through,patches
Routes,of,Administration,,ANS,-,,a.,Parenteral,
-,Refers,to,injections,and,IV,
, -,Fast,Absorption
-,No,First,pass
-,Painful
-,Inconvenient
b.,Transdermal,
-,Easy,access
-,Large,surface,area
-,Avoid,first,pass,metabolism
-,Avoid,GI,incompatibility,of,drugs
-,Good,patient,compliance
-,Slow,absorption
-,Transport,across,skin,can,be,a,challenge
-,Need,lipophilic
-,Low,MW,drugs
c.,Ocular,
-,Localized,delivery,for,eye,disorders
-,Good,absorption,for,many,drugs
-,Bypasses,certain,clearance,routes
-,Problems,with,loss,of,drug,in,tears
d.,Nasal,
-,Easy,administration
-,Local,delivery,of,drugs
-,Rapid,absorption
-,Can,bypasses,certain,clearance,routes
e.,Pulmonary,
ANSWERS 2024 - 2025
What,is,Modified,Release?,,ANS,-,,The,term,modified-
release,is,used,to,describe,dosage,forms,that,alter,the,timing,and/or,the,rate,of,release,of,a,conventional,
drug,product/dosage,form
-,FDA,does,define,this
Some,Modified,Release,Systems,,ANS,-,,-,some,of,these,have,overlap,
1.,Delayed,release
2.,Repeated,Release,or,Repeat,Action
4.,Extended,,Sustained,,Long-Acting,,Prolonged,,Controlled,Release,
5.,Targeted,Release
Delayed-release,,ANS,-,,-,dosage,forms,release,the,drug,at,a,later,time,than,an,immediate,dose,system
-,Delayed-release,can,include,enteric-coated,tablets,,where,timed,release,is,achieved,by,a,barrier,coating
-,takes,more,time,to,release,drug;,doesn't,start,dissolving,until,a,certain,point,of,time
Repeat-release,,ANS,-,,-,multiple,doses,of,immediate,release,drug,units,with,intermittent,dosing
-,Such,as,repeat-action,tablets,and,capsules
Extended,,Sustained,,Long-Acting,,Prolonged,,Controlled,Release,,ANS,-,,-,Extended,,Sustained-
release,systems,slowly,release,the,drug,over,an,extended,period,of,time
-,Rate,and,duration,are,not,always,designed,to,a,particular,profile
-
,If,the,system,can,maintain,predictable,levels,of,drug,in,the,target,tissue,or,cells,,it,is,considered,controlle
d-,release.,(Examples:,XL,SR,CR),
-,Controlled,release,systems,are,also,called,extended,or,sustained,(prolonged),release
-,dissolves,and,continues,dissolving,for,a,longer,time
,Targeted,Release,,ANS,-,,-,Site-
specific,or,targeting,refers,to,concentrated,drug,release,at,a,certain,site,such,as,a,tissue,,organ,,receptor,,
or,cell,
-,A,form,of,controlled,release
-,very,difficult,to,achieve,
-,trying,to,control,distribution,of,drug,to,target,area
What,is,Controlled,Release?,,ANS,-,,-
,Controlled,Drug,Delivery,attempts,to,deliver,the,precise,amount,of,a,therapeutic,agent,(drug),,to,a,specifi
c,site,(site,of,action),,for,a,specific,time,(duraterm-5tion,of,treatment),
-,OR,Achieve,both,spatial,(targeted),and/or,temporal,"control",of,the,drug
-,a,lot,of,prediction,involved,,very,precise,,and,targeted,
-,The,Drug,Delivery,System,attempts,to,control,the,drug,concentration,at,the,target,tissue
Disadvantages,of,Conventional,Delivery,,ANS,-,,-,Inconvenient,because,pt,can,forget,to,take,dose
-,Difficult,to,monitor,
-,Overdosing,possible
-
,Large,amounts,of,drug,can,be,"lost",when,it,does,not,get,to,the,target,organ,because,has,to,distribute,to,t
he,whole,body
-,Drug,goes,to,non-target,cells,and,can,cause,damage
-,Expensive,(using,more,drug,than,necessary)
The,Goal,of,Modified,Drug,Delivery,,ANS,-,,To,Alter,and,Control
-,Absorption,
-,Distribution,-,includes,Cellular,Uptake,
-,Metabolism,(reduce,it,so,more,drug,available),
-,Elimination,(reduce,how,fast,eliminated,to,prolong,effect,of,drug),
-,Toxicity,(reduce,it)
What,is,Sustained,Drug,Action?,,ANS,-,,-,ideal,dosage,form
,-,pt,only,has,to,take,one,time,rather,than,multiple,times
-
,minimize,side,effects,by,delivering,API,to,site,of,action,(target,receptors,,cells,,tissues,,or,area,in,the,body
),
-,re-patenting,without,new,drug,development.
Improving,Patient,Compliance,,ANS,-,,Minimize,Plasma,fluctuation
-,Plasma,Concentration,vs,Time
-
,Sustained,Release:,takes,longer,to,be,absorbed,and,in,therapeutic,range,for,longer,but,eventually,elimina
ted
-,Controlled:,absorbed,quickly,and,in,therapeutic,range,for,as,long,as,necessary,
-,the,more,times,you,have,take,a,medication,day,,the,lower,pt,compliance
Tries,to,Achieve:,Site,Specific,Drug,Delivery,,ANS,-,,Reduction,of,side,effects
-,Anticancer,drugs
-->,Cytosine,arabinoside-,Dpocyt®
-,Anti-fertility,Agents,
-,Anti-inflammatory,drugs
Site,Specific,Drug,Action,or,Drug,Targeting,,ANS,-,,-,Targeting,or,Spatial,Delivery
-,exclusive,drug,delivery,to,specific,organ,,tissues,,or,cell,types
-,Still,in,development,and,difficult
-,Designed,to,be,directed,to,a,specific,organ,,tissues,,cell,or,cell,compartment
-,Targets,include,surface,or,compartment,cell,markers,,proteins,or,even,nucleic,acids
-,can,locally,put,the,drug,through,patches
Routes,of,Administration,,ANS,-,,a.,Parenteral,
-,Refers,to,injections,and,IV,
, -,Fast,Absorption
-,No,First,pass
-,Painful
-,Inconvenient
b.,Transdermal,
-,Easy,access
-,Large,surface,area
-,Avoid,first,pass,metabolism
-,Avoid,GI,incompatibility,of,drugs
-,Good,patient,compliance
-,Slow,absorption
-,Transport,across,skin,can,be,a,challenge
-,Need,lipophilic
-,Low,MW,drugs
c.,Ocular,
-,Localized,delivery,for,eye,disorders
-,Good,absorption,for,many,drugs
-,Bypasses,certain,clearance,routes
-,Problems,with,loss,of,drug,in,tears
d.,Nasal,
-,Easy,administration
-,Local,delivery,of,drugs
-,Rapid,absorption
-,Can,bypasses,certain,clearance,routes
e.,Pulmonary,