pr1154 (pharm cal + ic 1-6)

definition of a drug (1)

substance intended for diagnosis, mitigation, treatment, or prevention of disease in humans or other animals

systemic effects of drug (2)

• drug entrance into circulatory system to be transported to the cellular site of function

• effects are generalised

local effects of drug (2)

• achieved by direct application of drug to desired site of action

• limited to area of application

why does local effect have fewer side effect (2)

• reduced amount of drug traveling through the rest of the body

• smaller overall dose is required

how are local or systemic effects achieved (2)

• using a variety of medicinal products (dosage forms)

• administering by different routes

define dosage form (1)

combination of drug components and an assortment of non-drug components (excipients) used for administration of drug by an appropriate route

define excipients (1)

any additive or inert substance in the formulation that is not the active drug substance

function of excipients (3)

• to bulk up the active ingredient or

• to guarantee stability and bioavailability of API or

• for other specific purpose (eg texture and taste)

define pharmaceutical compounding (1)

act of preparing, mixing, assembling, packaging, and/or labelling a medicinal product as a result of a prescription or as pharmacy stock in anticipation

when is compounding required (1)

for drugs in forms that are not commercially available

such small scale product preparation is typically performed iin a hospital / retail pharmacy and is known as... (1)

extemporaneous compounding

how long are prescriptions valid for (1)

1 year

what are examples of legal requirements in a prescription (7)

• patient's name

• patient's ic number + address

• name of API + strength

• direction of use

• quantity of medication to be dispensed

• date of prescription

• prescriber's name + signature

step 1 of compounding process (1)

read & evaluate the order carefully

what checks regarding the prescription must be performed during step 2 of compounding process (3)

• it is legally correct and authentic

• dose of drug

• pharmacological action of drugs are compatible

what documentation must be recorded on compounding worksheet in step 3 of compounding process (3)

• full formula

• required calculations

• complete compounding methodology

what critical verification must occur during step 6 of compounding process before mixing the components (1)

ingredients should be counter checked

what key factors should be considered when selecting a container in step 7 of compounding process (2)

• product stability

• interaction of product with material used for container

what actions are performed on the compounding worksheet in step 9 of compounding process (2)

• countercheck compounded products

• sign & date on compounding worksheet

what should be done to the compounding worksheets in step 10 of compounding process (1)

file for record keeping

define pharmacopoeia (1)

an official collection of standards for pharmaceutical substances (active drugs and excipients) and medicinal products (dosage forms)

components of main label (9)

• name & dosage form

• name & strength of API (_g/5mL)

• quantity dispensed

• directions for use

• patient’s name

• name & address of pharmacy

• pharmacy ref no

• date of dispensing

• expiry date

which of the following directions for use written on the main label is correct (1)

take two 5mL spoonfuls two times a day

recommended shelf-life for this preparation stored as pharmacy stock (2)

• total 12 months (incl after issue)

• if opened, 3 months

recommended shelf-life for this preparation after issue to patient (1)

4 weeks

recommended shelf-life for this preparation stored as pharmacy stock (1)

to be recently prepared

total 1 month —> 2 weeks as stock

recommended shelf-life for this preparation after issue to patient (1)

to be recently prepared

2 weeks

recommended shelf-life for this preparation stored as pharmacy stock (1)

to be freshly prepared

prepared not more than 24h before issue

recommended shelf-life for this preparation after issue to patient (1)

to be freshly prepared

2 weeks

suggested shelf-life for ‘unofficial’ unresearched formulation to be stored as pharmacy stock (1)

prepared not more than 24h before issue

suggested shelf-life for ‘unofficial’ unresearched formulation after issue to patient (1)

2 weeks

suggested shelf-life for diluted ‘official’ formulation to be stored as pharmacy stock (1)

usually prepared not more than 24h before issue

suggested shelf-life for diluted ‘official’ formulation after issue to patient (1)

2 weeks

define auxiliary labels (1)

supplementary labels placed on drug product containers in addition to main labels

purpose of auxiliary labels (2)

• to provide important information needed for storing / using the drug product

• reinforce information provided during counselling

what are black auxiliary labels used for (1)

drugs to be taken internally / swallowed

what are red auxiliary labels used for (1)

drugs not meant to be swallowed

what auxiliary labels are to be placed on all liquid preparations (1)

shake the bottle

why are oral solid dosage forms most commonly used (2)

• easier to carry around

• greater stability than liquid

define capsules (1)

medicinal agents with / without inert substances enclosed within a gelatin shell

hard vs soft capsule shell composition (2)

• both contain gelatin, water sugar

• in addition, soft capsule shell contains plasticisers

purpose of plasticisers in soft capsule shell (1)

to make gelatin more malleable / flexible

at what temperature are capsule shells soluble in water (1)

37°C

solid medicaments are enclosed in hard / soft capsules (1)

hard

liquid / semi-solid medicaments are enclosed in hard / soft capsules (1)

soft

medicaments are added to cap / body of hard capsule shells (1)

body

minimum weight of hard capsules (1)

100mg

how are hard capsule sizes designated numerically (1)

largest 000, 00, 0, 1, 2, 3, 4, 5 smallest

what capsule size should be used for 125mg medicament (1)

4

what capsule size should be used for 160mg medicament (1)

3

what capsule size should be used for 225mg medicament (1)

2

what capsule size should be used for 290mg medicament (1)

1

what capsule size should be used for 450mg medicament (1)

0

what capsule size should be used for 550mg medicament (1)

00

what capsule size should be used for 950mg medicament (1)

000

disadvantages of capsules (3)

• sensitive to heat & humidity (esp softgel)

• not suitable for certain populations like muslims and vegetarians

• more costly than corresponding medication in liquid form

define linctuses (1)

viscous liquids that are usually used for treatment of cough

precaution for patients consuming linctuses (1)

should be sipped slowly without dilution of water

define elixirs (1)

clear, pleasantly flavoured liquids containing syrup, high content of ethanol and other solvents like glycerol

at what concentrations of alcohol do elixir become self-preserving (1)

10-12%

why are elixirs often used for potent and unpleasant tasting drugs (1)

high ethanol and syrup content masks unpleasant drug taste

define mouthwashes (2)

• aq solution in concentrated form, with antiseptic / local analgesic or astringent properties

• used to clean and refresh oral cavity

purpose of gargles (1)

to relieve soreness in mild throat infections by bringing the medicament into contact with mucous surface of throat

gargles vs mouthwash (2)

• both have similar type of ingredients

• gargles tend to contain higher concentration of API

define suspensions (1)

coarse dispersion containing finely divided insoluble material suspended in a liquid medium

characteristics of indiffusible solid suspension (1)

contains drug that settle too rapidly / do not wet enough to produce a uniform smooth suspension

characteristics of diffusible solid suspensions (2)

• readily disperse in aqueous media when suspension is shaken

• solid remains suspended for sufficient time to allow withdrawal of uniform dose

how are indiffusible solids successfully formulated into stable oral suspensions (1)

by incorporating suspending / thickening agents

purpose of suspending / thickening agents (1)

to increase the viscosity of the vehicle

examples of diffusible solid suspension (3)

• light kaolin

• light magnesium carbonate

• magnesium trisilicate

examples of indiffusible solid suspension (4)

• aspirin

• chalk

• barbiturates

• phenacetin

types of suspending agents (4)

• natural polysaccharides (eg tragacanth powder)

• semisynthetic polysaccharides (eg methylcellulose)

• clays (eg bentonite)

• synthetic thickeners (eg carbomer)

define inhalations (2)

• liquid preparations containing volatile substances

• used to reduce inflammation and congestion of respiratory tract

define emulsions (2)

• disperse system consisting of 2 immiscible liquids

• the disperse phase is finely divided and distributed through the continuous phase

emulsions are stabilised by… (1)

emulsifying agent

properties of emulsifying agents (2)

• adsorb at the interface between oily and aq phases

• have hydrophilic and lipophilic groups

examples of fixed oil emulsions & proportions of oil:water:gum (2)

almond oil, arachis oil, castor oil, cod-liver oil

4:2:1

examples of mineral oil emulsions & proportions of oil:water:gum (2)

liquid paraffin

3:2:1

examples of volatile oil emulsions & proportions of oil:water:gum (2)

turpentine, cinnamon oil, peppermint oil

2:2:1

examples of oleo-resin emulsions & proportions of oil:water:gum (2)

male fern extract

1:2:1

ways to categorise dosage forms (4)

• physical state

• route of administration

• site of action

• microbiological quality

key considerations in formulating a drug into a dosage form (4)

• therapeutic

• drug factors

• biopharmaceutical

• regulations & standards

chemical stability of pharmaceutical product (1)

each active ingredient retains its chemical integrity and labeled potency, within the specified limits

physical stability of pharmaceutical product (1)

retention of original physical properties, incl appearance, palatability, uniformity, dissolution, suspendability

microbiological stability of pharmaceutical product (1)

maintenance of sterility and resistance to microbial growth

first-pass effect (3)

• some drug is broken down by enzymes in the gi tract

• liver enzymes break down large portion of active drug into inactive form before it is being circulated around the body

• results in decreased drug absorption