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PHA 332 > injection formulations > Flashcards

injection formulations Flashcards

1
Q

what is parenteral liquid?

A

A sterile preparation of drugs for injection through one

or more layers of the skin or mucous membrane

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2
Q

what volume considerations would there be for IV injections?

A

solution, suspension, emulsion, powder for
reconstitution (POR)
– Max. volume 20 mL, > 5mL considered as “large”
– Bolus (1-2mL), rapid effect

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3
Q

what volume considerations would there be for IV infusions?-sol or emulsions

A

e.g. total parenteral nutrient (TPN), patient controlled analgesia
– Intermittent (25 -100 mL) or continuous (up to 1 L)

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4
Q

what volume considerations would there be for sc injections?

A

max.1 mL

– Injected slowly otherwise painful, e.g. hormones

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5
Q

what volume consideraions would there be for IM injections?

A

• Intramuscular (I.M.): max. 5 mL

– Volume based on muscle mass, e.g. steroids

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6
Q

what volume considerations would there be for ID injections?

A

max 0.2 mL, e.g. immunological tests

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7
Q

what are the bulking agents availibe?

A

water for injection
water miscible organic solvents
oily vehicles
to enhance solubilisation

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8
Q

what are the traits for water for injection?what are the probelms?

A

– Free of microbial, pyrogen and particulate contamination

– Problems with hydrolysis and solubility issues

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9
Q

what are the probelms with water miscible organic solvents?

A

Problems with irritation and toxicity → small volume
– One phase system (co-solvent)
– e.g. alcohol, glycerin, propylene glycol, liquid PEGs

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10
Q

what are the probelms associated with oily vehicles? give an example

A

– Fixed oils e.g. arachis oil, ethyl oleate
– Depot effect and high consistency (warm preparation)
– Slow injection rate otherwise painful

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11
Q

what is the purpose of the bulking agent?

A

to enhance solubilisation
– Surfactants, e.g. Tween 80, Solutol HS15, Cremophor EL
– Buffers → adjust according to pKa of drugs

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12
Q

how does osmotic pressure affect the solution?

A 
• Deviation from isotonicity: 
• Hypotonic solution : (diluted)
– Cell swell and burst → haemolysis
• Hypertonic solution : (concentrated)
– Cell shrink → vein sclerosis
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13
Q

why do we want an isotonic solution?

A 
Isotonic solution: 
– Same osmotic pressure to tissue fluids 
– Freezing point depression (ΔTf)
– ΔTf for blood: (-) 0.52oC
– e.g. 0.9% NaCl
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14
Q

what is the osmotic pressure of an IV injection?

A

• Intravenous:
– Small volume (slightly hypertonic)
– Infusion (isotonic)

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15
Q

what is the osmotic pressure of an intralhecal solution?

A

Intrathecal (I.T.) (isotonic)

→otherwise headache and vomiting

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16
Q

what is the osmotic pressure of an im injection?

A

• Intramuscular (Isotonic or slightly hypertonic)

→local effusion of tissue fluids to enhance absorption

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17
Q

what is the osmotic pressure of an ID injection?

A

Intradermal (I.D.): To prevent skin irritation (isotonic)

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18
Q

what is the osmotic pressure of a subcutaneous injection?

A

– Isotonic less painful, can be mildly hypertonic or hypotonic

19
Q

what are the additives in injection which can affect the osmotic pressure?

A 
Tonicity modifiers (sodium chloride, glucose, dextrose, mannitol); 
other additives (buffers, antioxidant) can affect
20
Q

how does ph affect sterile liquid?

A

problems which cehemical stability
probelm with solubility and physiological activity
affect microbiological stability
affect compliance

21
Q

what is the summary of the formulation components?

A

• Active ingredient
• Vehicle
• Tonicity agent
• Buffering agent or pH modifier
• Preservative (multi-dose)
– e.g. benzyl alcohol, thimerosal, parabens
– Concentration, pH, compatibility issue
• Surfactants – non toxic, non ionic form
• Antioxidant
– Oxygen radical scavengers (alpha tocopherol, BHT)
– Reducing agents (ascorbic acid and sodium bisulphite)
• Chelating agent

22
Q

what affects a parenteral suspension?

A

-nature of drugs
-problem with particle size
prevent needle blockage
promote wettability and dispersion
prevent agglomeration and caking

23
Q

how does the nature of drugs affect parenteral suspensions?

A

poorly solublised and chemically labile drugs

high purity via re-crystallization and associated polymorphic form

24
Q

how does problems with particle size affect a parenteral suspension?

A

ideal drug diameter- 5 -10 m, <100 m)

– Large crystals → longer depot effect but more painful

25
Q

how do you prevent needle blockage in a parenteral suspension?

A

isodiametric shape for drug particles (needle vs spherical shape)

26
Q

what promotes wettability and disperson in parenteral suspensions?

A

non-ionic surfactants

27
Q

how do you prevent agglomeration and caking in parenteral suspensions?

A

– Control flocculation → partially deflocculated (e.g. SAA, electrolyte)
– Adjust sedimentation rate (e.g. viscosity modifier)
– Optimise consistency, e.g. aluminium stearate → thixotrophic

28
Q

when manufacturing a parenteral suspension how does a high purity grade drug affect it?

A

recrystallization occurs

polymorphism affects solubility

29
Q

what do you have to consider when manufacturing parenteral suspensions?

A

high purity grade drug
sterilisation
production of suspension under aseptic condition

30
Q

how do you produce a suspension under an aseptic condition?

A

– Wetting and dispersion of drug powder in vehicle
– Milling of bulk suspension to deagglomerate wetted
powder
– Filling into final containers and closure

31
Q

what size are the droplets in parenteral emulsions? what is the reason for this?

A

• Droplet size (0.5 - 1.0 μm)

– mimic chylomicra, fat transporter; size >3 μm →thrombosis

32
Q

why do parenteral emulsions have problems with stability?

A

Problem with emulsion stability:
– Coalescence on storage → emulsifying agents
– e.g. lecithin, Tween 80 → non toxic

33
Q

what types of containers are there for a small volume?

A 
• Single dose  
– Container not resealable on opening  
– e.g. pre-filled syringe, cartridges, fusion-sealed ampoules 
– No preservative & volume in excess of indicated volume 
• Multi-dose containers/vials 
– Container affixed with rubber closure
– Aluminium sealed and plastic capped 
– Permit needle penetration
– Need preservative
34
Q

what types of containers are there for a large volume?

A

– e.g. glass bottle, PVC collapsible bag and polythene container

35
Q

what are the types of materials that can be used for containers?

A

glass

plastic

36
Q

how is glass used for a container? what are the different types?

A

Heat sealing; packed under vacuum
– Type 1: borasilicate with low leachability
– Type 2: soda- lime & leachable, resistance to acid & water
– Type 3: soda- lime & leachable

37
Q

what are the features of plastic as a container?

A

– Blow- fill- seal procedure; need not packed under vacuum
– e.g. PVC, polyethylene, polyolefin
– Adsorption to container wall
– Leaching of plastizicer into content

38
Q

how do you sterilize drugs and solid additives?

A

– dry heat (DH)

– ethylene oxide (EO) or ionization radiation (IR)

39
Q

how do you steralise vehicles?

A

– Oily
– Aqueous but thermostable
– Aqueous but thermolabile
→ Cellulose nitrate or polycarbonate membrane
→ Cutoff 0.22m for microbial; 5m for particulate

40
Q

during the mixing process what is the diameter of agitator to vessel?

A

1:10 to 1:20

41
Q

during the mixing process what is the speed of the mixing?

A

1-20rps

42
Q

what type of mixing occurs in the manufacturing process?

A

axial=propeller

radial=radial

43
Q

how does clarification occur?

A

by filtration
pressure filters
cartridge filters

44
Q

what are the 3 approaches to prepare isotonic solutions?

A

– Use tabulated ΔTf1% values
– Determine ΔTf of drug or excipient
– Calculate NaCl equivalent (E) using Liso value

PHA 332 (42 decks)

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