Good Drug Manufacturing Practices

Module 5 of Pharmacy Fundamentals

excipient

an excipient is an inactive ingredient used in the manufacture of a dosage form. can be used to improve the form, taste, appearance, stability, etc. of the medication. can also be used to aid in the manufacturing process and to prolong shelf life.

anti adherents

prevent sticking of powder or sticking of tablets

binders

cause powder particles to stick together

diluents

provide bulk

coating agents

used to enhance stability, mask taste or odour, assist release time, and enhance appearance

disintegrant

absorbs water and causes breakdown in the stomach

glidant

improve flow of powder

lubricants

reduce friction during manufacturing

polishing agents

make tablets shiny

colouring agents

give colour

flavour agents

give flavour, masks bad taste

stiffening agents

gives body to ointments

perfumes

gives pleasant scent to topical preparations

sweetening agents

makes preparations sweet

acidifying agent

adds acidity

alkalinizing agent

adds alkalinity

air displacement agent

used in inhalers

anti fungal

prevents fungus growth in aqueous preparations and creams

antioxidant

extend shelf life

buffering agent

maintain pH

emulsifying agent

aid and maintain emulsions

humectants

control moisture

surfactant

control oil

suspending agent

aid in suspensions

ointment base

to provide a base for the drug in an ointment preparation

solvent

a fluid in which the solvent is dissolved

suppository base

provides a base for the drug in suppository preparations

vehicle

base for syrups

levigating agent

liquid used to aid in particle breakdown

drug stability

capability of a particular formulation, stored in specific conditions within a specific container, to remain within acceptable limits, for a defined amount of time

shelf life

how long a drug remains stable

what can effect a drugs shelf life

nature of drug, dosage form, storage conditions

what can happen to a medication after its expiry date

can simply become less effective, or can possible become toxic

hydrolysis

a reaction in which molecules interact with water molecules to cause breakdown. buffers can be added to maintain a non reactive pH.

oxidation

reaction that involves a loss of electrons within an atom or molecule.

microbial growth

can occurr in media such as aqueous liquids and semi solid preparations. anti fungals often added to prevent this.

signs of physical breakdown

cracking emulsions, caking suspensions, broken tablets, soft capsules

signs of chemical breakdown

change in colour, taste, smell, and gas formation

ways to prevent drug stability issues

packaging, storage conditions, use of desiccants, protective coatings, preservatives

glass packaging advantages

protects against air and moisture, can be heat sterilized, allows for visual inspection, low reactivity rate, can be tinted

glass packaging disadvantages

heavy, breakable so there are storage issues, can change pH of aqueous productsp

plastic packaging advantages

weigh less, resist breaking, can be made opaque, designable

plastic packaging disadvantages

heat sensitive, permeable, absorb product, can deform or change shape/texture

effects light can have on medication

can cause a fading of dyes or a yellowing of product

effects heat can have on medication

cause an unwanted softening of medication, evaporation of solvents, seperation of emulsions, sedimentation in suspensions.

what temperature range is considered cold

2-8 C

what temperature range is considered cool

8-15 C

what temperature range is considered room temperature

15-30 C

what temperature range is considered excessive heat

>40 C

what percentage of prescriptions are compounded daily

1%

definition of a compound

a compound is a drug or combination of drugs compounded in a pharmacy, according to a prescription, which does not duplicate the formula of a manufactured product.

NAPRA standards for compounding approved in

March 2018

in what situation is compounding done

when there is a therapeutic need or a lack of product availability.

manufacturing vs compounding

manufacturing - large scale, under federal regulation
compounding - small scale/patient specific, under provincial regulation

compounding level a

a) simple to moderate
require a designated sterile compounding area

compounding level b

b) complex compounds
require specific calculations, stability data not always known. need a designated seperate room.

compounding level c

c) hazardous compounds
require ppe and a separate well ventilated room with air exchange and negative pressure. can include chemotherapy compounds, hazardous hormonal products, and more.

niosh

national institute for occupational safety and health