Ceutics exam 4 voacb

The study of how the physicochemical properties of drugs, dosage forms, and route of administration affect the rate and extent of drug absorption

Biopharmaceutics

The rate and extent of therapeutically active drug reaching the systemic circulation

Bioavailability

IV reference (absolute or relative F)

Absolute

Compare formulation to a recognized standard

Relative F

The absence of a significant difference in the rate and extent to which the active moiety in pharmaceutical equivalents or alternatives becomes available at the site of drug action when administered at the same molar dose

Bioequivalence (B/E)

Passage through cells

Transcellular

Passage between cells

Paracellular

Drugs must pass through _____ barrier(s)

Multiple

A process of mass transfer of molecules across the plasma membrane from high concentration to low concentration

Simple diffusion

This law is used to describe the diffusion of a drug across the rate limiting barrier of the cell

Fick’s

Chemical and physical integrity of the dosage unit and when appropriate the ability of the dosage unit to maintain protection against microbiological contamination

Stability according to <1150>

Time from date of manufacture that a drug product will remain in its approved product specifications while stores under defined conditions

Shelf life

t(90)

Time after manufacture or preparation until the product contains 90% of its original strength

Final day that the manufacture guarantees the full potency and safety of a drug or shortest time at which the article may be expected to meet the requirements of the compendia, monograph under prescribed storage conditions

Expiration date

Increase in the number of C-O bonds in a molecule (loss of electrons) or a reduction in the number of C-H bonds

Oxidation

Absorb wavelengths of light to induce photolysis, primarily oxidation type reactions

Photodegradation

Breaking of molecular bonds by reaction with water

Hydrolysis

Most common cause of chemical degredation

Hydrolysis

The date after which an article shall no be used

Beyond use date

Amide in a ring

Lactams

Ester in a ring

Lactones

Due to free radicals and is often catalyzed by trace metals, light, heat

Oxidation

Oxidative reactions generally result in the ______ of ______ and/or removal of _____

Additional, oxygen, hydrogen

Conversion of a hydrogen to a hydroxyl group

Hydroxylation

Conversion of a hydroxyl group to a carbonyl group

Dehydrogenation

Conversion of carbonyl group to a carboxyl group

Carboxylation

Conversion of an amino group to a carbonyl group

Deamination

Conversion of a methyl group to a hydrogen

Demethylation

__ are readily oxidized to quinones

Catechols

___ oxidized via complex pathways and yield various products

Phenothiazines

These molecules are susceptible to oxidation

Polyunsaturated molecules

__oxidized to disulfides

Thiols

___ interrupt the propagation by interacting with the free radical

Antioxidants

More susceptible to oxidation and are preferably oxidized to consume the available oxygen

Suicide substrate

SLC15

proton of oligopeptide cotransporters

SLC21/SLCO

organic anion trasnporting polypeptides

SLC22

organic cation/anion/zwitterion transporters

SLC29

facilitative nucleoside transporter

ABCB1

P-gp, MDR1

ABCB11

bile salt export protein

ABCC1-C9

multi-drug resistance

ABCG2

breast cancer resistance protein

this ABC typically transports drug conjugates since too hydrophilic to move passively

ABCC1-C9

Define tablet

compressed solid dosage forms that consist of one or more active ingredients together with various excipients

True or false: sublingual tablets have a faster onset than buccal

true

what are the two types of FDC

layered and tablet in tablet

define layered tablet

compression of an additional granulation on a previous compressed granulation

define tablet in tablet

compress second granulation on first performed tablet

what releases in effervescent tablets

carbon dioxide

what does the carbon dioxide to for the effervescent tablets 

assist with flavor, disintegration and dissolution

true or false: lubricants in tablets have nothing to do with physiological properties

true

define wicking

water is pulled into pores by disintegrant and reduce the physical bonding forces between particles

define swelling

particles swell and breakup the matrix from within; blows the tablet apart

what do hard gelatin capsules also contain other than gelatin and water

colorants and opacifying agents

the smaller the capsule size, the _____ the drug capacity

bigger

enteric coatings wait to release drug in a less ____ environment

acidic

true or false: because there is a coating, means the tablet can not be crushed or split

false

define reservoir

dosage form where the drug is enclosed within a rate controlling memBrane

define matrix

drug is embedded in an insoluble excipient to achieve sustained release