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Kirstys Flashcards > Parental formulations > Flashcards

Parental formulations Flashcards

1
Q

Define Parental route of administration

A

A sterile preparation intended for administration by injection, infusion or implantation

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2
Q

What tissues can the parental route be given too?

A

Muscle, soft tissue, organ, anatomical space, vascular system

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3
Q

Advantages of Parental route of administration

A
  1. Rapid effect - emergency
  2. Effective, predictable response
  3. Good if oral route unavailable
  4. Drug may not be absorbed orally or is metabolised by GI tract/ liver
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4
Q

Disadvantages of Parental Route

A
  1. Painful
  2. Expensive to manufacture
  3. Patient compliance low—needle phobia
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5
Q

What is the difference between large and small volumes of parental injections?

A

Large: 100—1000ml

Small: < 100ml

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6
Q

Describe parental injections

A
  • · small volumes (<100ml)
  • · Various routes: IV, IM, SC
  • · Drug and excipients in vehicle
  • · Sterile solution or emulsion
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7
Q

Describe parental infusion

A
  • · Large volumes (100– 100ml)
  • · Delivered IV
  • · Sterile solution or emulsion
  • · No preservatives (one usage)
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8
Q

Describe concentrates for injection/ infusion

A
  • · Sterile concentrated solutions that need to be diluted before administration
  • · Patient specific doses
  • · Diluted with water or 0.9% w/v NaCl solution
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9
Q

Describe powders for injection/ infusion

A
  • · Dry, solid sterile powder sealed in final container
  • · Instable in aqueous solution
  • · Diluted before administration
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10
Q

Describe gels for injection

A
  • · Sterile gel
  • · Enhanced viscosity allows for modified release of drug
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11
Q

Describe implant

A
  • · Sterile solid preparation
  • · Allows for release of drug over extended time period
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12
Q

What is a clean room?

A

Manufacturing room where concentration of particles are tightly controlled as well as parameters: temp, humidity

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13
Q

Describe Particulates control

A
  • · Don’t want MCP (carry bacteria) or inert particles (lodge in BVs)
  • · Solutions: No visible particles and low subvisable particles
  • · Suspensions: particles permitted bar IV
  • · Emulsion: droplet size < 3 uM
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14
Q

Describe sterile control

A
  • · No pyrogens/ microorganisms (these by pass defence system and go into blood stream)
  • · Terminally sterilised or anespetically prepared
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15
Q

What excipients are required in parental products?

A
  • · preservative
  • · Antioxidant
  • · Suspending agent
  • · buffer
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16
Q

What is needed in the vehicle?

A

· co– solvent: aids solubility of poorly soluble drugs (ethanol)

· Solubilizing agents: aids dissolution

· Water for injection

· O/W emulsion (for water in sol drugs)

· Oils (intramuscular injections)

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17
Q

Why are preservatives required?

A

To prevent microbial growth. Co-solvents can also be effected

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18
Q

Why are buffers needed and why is PH so important?

A
  • Stability and solubility is pH dependent. Also determines ionisation.
  • Buffers maintain pH
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19
Q

What is plasma pH and what is the pH requirement of a drug?

A

Plasma pH: 7.4

PH needs to be between 3 and 9

(3= pain, 9= necrosis)

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20
Q

Why are suspending agents needed?

A

Ensures drug stays suspended in vehicle and it is uniform/ even so the correct dose is administered

21
Q

What is Tonicity? What is the requirement?

A

The ability of an extracellular solution to make water move in or out or a cell by osmosis.

0.9% saline isotonic with plasma. Osm (280 –295)

22
Q

What is osmosis?

A

The movement of water from an area of low solute concentration to high solute concentration through a semi perm membrane

23
Q

What happens if a hypertonic solution is administered?

A

Solution has higher solute conc and osmotic pressure. Water driven out blood cells causing them to shrink

24
Q

What happens if an isotonic solution is administered?

A

Solute concentration same in blood plasma. Same osmotic Pressure. No net flow of water.

25
Q

What happens if a hypotonic solution is administered?

A

Solute concentration and osmotic pressure lower than blood cells therefore water moves into the cells and cell lysis occurs.

Add dextrose or NaCl

26
Q

Describe Ampoules

A
  • · Small volumes <1—10ml
  • · Glass or plastic
  • · Single use—unpreserved
  • · Open necked, sealed after filling
27
Q

Describe Vials

A
  • · Volume: 5 –100ml
  • · Glass with reusable plastic cap
  • · Multiple use—preservative
28
Q

Describe pre-filled syringes

A

· small volumes: 0.5—20 ml

· Glass or plastic base

· Convenient, affordable, accurate, sterile, safe

29
Q

Describe infusion bags/ bottles

A
  • · volume 100 –1000 ml
  • · Glass bottles, collapsible plastic bags
  • · Single use
30
Q

What tests are carried out for parental products?

A

uniformity of weight, Uniformity of content, Test for pyrogens , Test for sterility - membrane filtration, direct inoculation, Particulate test—light obscuration particle count test, microscopic particle count, LAL test

31
Q

Describe IM injections

A
  • · 90 into muscle
  • · Solution, emulsion, suspension
  • · Rapid absorption
  • · <4 ml
32
Q

Describe SC injections

A
  • · 45 into SC below dermis
  • · Solution, emulstion, suspension
  • · Slower absorption
  • · <1 ml
33
Q

Describe IV injections

A
  • · 25 into vein
  • · Solutions, emulsions
  • · Fastest absorption
  • · <1ml—litres
34
Q

Describe IA parental injections

A
  • · into artery
  • · Immediate effect on peripheral organs
  • When vein isn’t available. Cancer treatments. Causes arterial spasms
35
Q

Describe inradermal

A
  • · 10—15 into skin between dermis and epidermis
  • · 0.1– 0.2 mL
  • · Used for diagnostic testing
36
Q

Describe intrathecal injections

A
  • · Into the spine in the CSF in the subarachnoid space between 2 inner protective membranes
  • · Up to 10 mL
  • · Used to treat bacterial meningitis
37
Q

Describe Intra Cisternal

A
  • · Into the cisterna magna
  • · Antibiotics into CSF
38
Q

Describe Epidural

A
  • · Injections / infusions
  • · Peridural space between the dura and the vertebrae
39
Q

Describe intra-bursal / intraarticular

A
  • · Into the synovial fluid of joint cavities
  • · Aqueous solution/ suspension
  • · Local effect
40
Q

Describe ophthalmic

A

· Around or in eye

· Subjunctaval, intravitreal, intracameral

41
Q

Describe intra cardiac

A

Directly into cardiac muscle/ ventricle. Rapid local effect

42
Q

What controls are involved in parental administration

A

Temperature, pH, mixing, time, light, concentration

43
Q

What are physical complications?

A
  • · Mixing of drugs prior to administration
  • · Insolubility, colour change, precipitation, gas formualtion
44
Q

What are Chemical complications?

A

Oxidation, reduction, hydrolysis, photolysis, increase in toxicity, drug degradation, pH changes, packaging incompatibility

45
Q

What are Error complications?

A
  • · Wrong drug
  • · Wrong route
  • · Wrong dose
  • · Wrong time
46
Q

What are contamination complications?

A
  • Microbial: bacteria, fungi, virus.
  • Source: air, water
  • Particulate: dust, glass, fibres
  • Source: packaging, enviroment
47
Q

What are clinical complications that may occur through parental route of administration

A

Thrombus, Vein irritation, leakage of IV med into extravascular tissue,

Kirstys Flashcards (116 decks)

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