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ceutics review 1

questionDefinition
Liberation Particle size, surface area, solubility, dissolution rate
absorption aq solubility, ionization state, pH lipophilicity directly affects permeability
Distribution lipophilicity, plasma protein binding, membrane permeability increased lipophilicity->greater tissue distribution
Metabolism the higher the lipophilicity->extensive metabolism ionization state
Excretion bile, sweat,milk,urine,lungs urine->hydrophilic + ionized drugs
Portition coefficient non polar environment compared to polar
ANDA abbreviated new animal drug application
BLA biologics lisence application bio->vaccine/protein
IND investigational new drug application submit to FDA before a new drug can be tested in clinical trials
USP united states pharmacobeia identity,strength,quality,purily of meds, food ingredients & dietary supplements
FDA food and drug administration saftey, efficacy, security
SNDA supplemental new drug application FDA submitted before a new formulation
In vitro in lab/petri dish
Ex vivo helacells, in tissues/cells
In vivo in animals/ rats
NDA new drug application must be submitted to FDA before new drug is marketed for human use
NAPA New animal drug application FDA submitted before a new drug is marketed in animals
Drug approval process Discovery->pre-clinical development-> INDA-> clinical-> NDA/BLA->market->p4 clinical
phase 1 saftey + tolerability 20-100
phase 2 efficacy + optimal dose 100s
phase 3 confirm safely + efficacy establish risk/benefit 100s-thousands
PK pharmacokinetics
PD pharmacodynamics
After market adverse reactions, produce defect, sNDA ex: tab->solution
Solutions ADME
Liquids/sometimes solids higher IMF, lower vp, higher bp, mp, osp, viscosity, s.ten
amorphous weaker
crystalline stronger
solids different polymorphs->different mp stronger IMF-> higher mp
solution aq: strong electrolytes ionize completley in h20 ex: NaCl, HCl, NaOH, KCl
solutions aq: weak electrolytes partially ionize in h20 most drugs/bases ex: HOAc, NH4OH, vinegar
Acid solute to solvent? lower vp, higher bp, lower fp, higher os.p more solute=more osp
osmolarity permeable + nonpermeable
Tonicity nonpermeable
hypertonic solution cell shrinks
hypotonic solution cell swells
Boric acid eye drops not IV injection
ionic NaCl.....Na^s+....Cl^s- Strongest IMF dipole forces
ionic dipole NaCl + h20 forces of attraction between an ionic molecule and a polar molecule with permanent dipoles
dipole-dipole H^s+-Cl^s-... H^s+-Cl^s- polar +permanent dipoles
ion induced dipole forces forces of attraction between an ionic molecule and a non polar molecule
dipole-induced dipole forces of attraction between a polar molecule and a non polar molecule that is polarizable
recall 1 severe adverse health issues, high
recall 1 severe adverse health issues, high
recall 2 temporary/reversible adverse health isssues, moderate
recall 2 temporary/reversible adverse health isssues, moderate
recall 3 no harm of health issues, low
induced dipole-induced dipole weakest IMF
hydrogen bond second strongest ex Fluorine, oxygen, nitrogen
solutions of nonelectrolytes no ions present sugars,alcohols
polymorph: metastable unstable polymorph
polymorph: stable stable polymorph
induced dipole-induced dipole weakest IMF
polymorph: enantiotropic reversible
polymorph: monotropic irreversible
what happens to the bioavailability of a drug that undergoes an irreversible polymorphic change? lower bioavailability freely soluble->poorly soluble
chemical stability hydrolysis, oxidation, maillard reaction more in liquid state than solid
hydrogen bond second strongest ex Fluorine, oxygen, nitrogen
solutions of nonelectrolytes no ions present sugars,alcohols
polymorph: metastable unstable polymorph
polymorph: stable stable polymorph
polymorph: enantiotropic reversible
polymorph: monotropic irreversible
what happens to the bioavailability of a drug that undergoes an irreversible polymorphic change? lower bioavailability freely soluble->poorly soluble
chemical stability hydrolysis, oxidation, maillard reaction more in liquid state than solid
recall 1 severe adverse health issues, high
recall 2 temporary/reversible adverse health isssues, moderate
recall 3 no harm of health issues, low
induced dipole-induced dipole weakest IMF
hydrogen bond second strongest ex Fluorine, oxygen, nitrogen
solutions of nonelectrolytes no ions present sugars,alcohols
polymorph: metastable unstable polymorph
polymorph: stable stable polymorph
polymorph: enantiotropic reversible
polymorph: monotropic irreversible
what happens to the bioavailability of a drug that undergoes an irreversible polymorphic change? lower bioavailability freely soluble->poorly soluble
chemical stability hydrolysis, oxidation, maillard reaction more in liquid state than solid
Created by: Acasi23
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