packaging and assessment Flashcards
how is pharmaceutical quality measured and what is it affected by?
affected by: - starting materials - manufacturing process - packaging and transport - storaging measured by: - physical and chemical analysis
what does microbiological quality depend on?
- bioburden
- bacterial endotoxins
- pyrogens
- sterility
what is a special/unlicensed medicine?
manufactured for human use and has been specially prepared to meet a prescription ordered for individual patients without need to hold a marketing authorisation for the product
- can be supplied for individual patients need
- need a mnaufacturer’s special license
what is the aim of bioequivalence?
to determine if two pharmaceutical products demonstrate in vivo biological equivalence
- generic medicines must prove bioequivalence
- allows patient compliance and reassure them they have the same product and effect
how can we establish bioequivalence?
use the PK parameters
- plasma conc. vs time curves
- Cmax and Tmax
- look at the ADME phases
- Tmax shouldn’t be first sampling point
take blood samples at specific points and with equal time intervals
need to see if its single dose or multi dose; if multi must add more sampling points
want to see full picture of drug exposure
what is the acceptance range for different AUC and Cmax ratio?
AUC should lie within 90% confidence interval; 0.8-1.25 of the reference value
Cmax ratio should lie within 90% confidence interval; 0.8-1.25 of the reference value
- can be tighter for drugs with narrow therapeutic window
what does it mean by specification and how are these set?
a specification is defined as a list of tests, references to analytical procedures and appropriate acceptance criteria
- set to confirm the quality of a drug product
- focus on making drug effective and safe
- need relevant data
what should development of a pharmaceutical product include?
should include the definition of the quality target product profile
should have identification of the critical quality attributes
a control strategy for insurance and ensure product is fit for use
should have a selection of manufacturing processes
what does quality by design mean, require and ensure?
it means that design a formulation that ensures the product has met the pre-defined standards
requires understanding how formulation and manufacturing process influences product quality
it ensures good quality with a good control strategy
what is a quality target product profile?
it is a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality
must consider
- closures
- dose strength
- drug release and delivery
- intended use, dosage form, route
what is meant by CQA?
critical quality attributes is a physical, chemical or microbiological property that should be within an appropriate limit range or distribution to ensure good product quality
- can be defined for drug substances, drug products and excipients and intermediates
what is a CPP?
Critical Process Parameter is a a parameter whose variability has an effect on CQA and so should be monitored or controlled to ensure good quality
e. g for tablets CPPs could include:
- mixing
- granulation
- drying
- compression
- coating
for a simple immediate release tablet what must the analytical measurements be?
must be
- linear
- accurate
- repeatable
- reproducible
what is the dissolution specification?
75% dissolved in 30 minutes
what is primary packaging?
- direct contact with the product
must be
1. compatible with product
2. have all product info
3. be child resistant but easy to open and re-seal
4. be tamper-resistant or tamper-evident
5. fit for purpose
what is secondary packaging?
- added layer of protection
- information provided
- image of what medication looks like
what is packaging used for and why?
- containment
- shouldnt leak
- no diffusion of product
- be strong during handling - protection
- maintain quality, safety and stability of product through its shelf life - identification, presentation and information
- not direct contact
- essential source of information
what type of bottle packaging can you have?
- Tablet bottles
- made of glass or plastic
- amber coloured
- child resistant cap - medicine bottles
- amber coloured bottle
- fluted amber bottle
- dropper bottle
what are examples of single dose and multi dose containers?
single dose - glass ampoules - infusion bags - single dose syringes - nebuliser ampoules multi dose - multi dose vials or glass bottles - pMDI's - cream jar/bottle/tube - DPI's
what do sealed containers do?t
- prevents product from contaminants such as air or moisture
- a single unit with our preparation
- once opened it is unsealable
what are laminates?
two bits of metal that you put together
paper outside for printing info on
what are blister packs?
- tray with lid used as packaging for tablets and capsules
- provides hermetic seal
- good barrier properties
- tamper-evident
what does strip packaging look like?
the tablets or capsules are heat sealed between two same materials, such as aluminium
protects drug from environment
what are collapsible tubes and ointment jars?
collapsible tubes: - lacquered aluminium and is sealed at both end - can be heat sealed - layer of foil when first opened so needs to be removed for access ointment jars: - wide mouthed - semi solid preparation - risk of contamination by patient
