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Medicine Design Manufacture > Parental products > Flashcards

Parental products Flashcards

1
Q

What dosage forms do parental productsa come in?

A

(1) Solution
(2) Emulsion
(3) Suspension
(4) Concentrate
(5) Powder
(6) Gel
(7) Implant

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2
Q

What are parental products administrated via?

A

(1) Injection
(2) Infusion
(3) Implantation

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3
Q

Where in the body are parental products admistrated?

A

(1) Vascular system (Veins)
(2) Soft tissue
(3) Muscle

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4
Q

Under what circumstances are parental products used?

A

(1) When 100% bioavailability is required
(2) Oral route is unavailable
(3) Drug may not be absorbed orally or may be metabolised in GI track/liver
(4) Rapid effect (emergency)
(5) Delayed, prolonged, controlled or localised effect required

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5
Q

What range of volume is considered small volume?

A

SVP Less than or equal to 100ml

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6
Q

What range of colume is considered large volume?

A

LVP 100 - 1000 ml

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7
Q

Routes of delivery - injection

A

(1) Injection
(2) Intramuscular
(3) Intravenous

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8
Q

Dosage forms - Injections

A

(1) Sterile solution
(2) Emulsion
(3) Suspension

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9
Q

Packaging - Injections

A

(1) Ampoules
(2) Viles
(3) Prefilled solution

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10
Q

Are Infusions SVP or LVP

A

LVP >100ml - 1000ml

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11
Q

Administration - Infusions

A

Intravenous

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12
Q

Dosage forms - Infusions

A

(1) Sterile solution
(2) Emulsion

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13
Q

Do infusions contain perservatives?

A

No perservative - single use only

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14
Q

Packaging - Infusions

A

(1) Glass
(2) Plastice bottles
(3) Collapsible plastic bags (additive ports)

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15
Q

When are concentrated solutions used?

A

For injection or Infusion after dilution

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16
Q

What are concentrated solutions diluted with

A

(1) Water for injection
(2) 0.9% w/v sodium chloride

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17
Q

Why are powders used for parental products?

A

When the drug is unstable in aqeous solution, powders are used whch arereconstituted with water for injection prior to administration

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18
Q

Why are powders freeze dried?

A

To remove and water from the final product

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19
Q

Why are gels used?

A

Enhanced viscocity allows a modified-release of the active substance(s) at the site of injection

20
Q

What are implants?

A

Sterile solid preperations containing one or more active ingridient

21
Q

Why are implants used?

A

Provides release of the active ingridient over an extended period of time

22
Q

Manufacturing of implants

A

Manufactured via:
(1) Titanium
(2) Silicone
(3) Polymers

23
Q

Routes of administration - angles and location

A

(1) Intramuscular - 90° - Into muscle
(2) Subcutaneous - 45° - Into subcutaenous tissue
(3) Intravenous - 25° - Into veins
(4) Intradermal - 10° - Into dermis

24
Q

Erros in administration

A

(1) Wrong route - IV instead of IM
(2) Wrong preparation - diluted in wrong solvent
(3) Wrong drug
(4) Wrong dose - decimal point/calculation error
(5) Wrong time
(6) Omission of drug

25
Q

Where are parental porducts manufactured
?

A

Clean room - terminally sterilised or aseptically prepared

26
Q

Why do parental products need to be sterile?

A

Microorganisms and oyrogens may bypass the bodys natural defence system and barriers going directly into blood stream or tissue - patients may be immunocomprimised, require nutrition, age compromised

27
Q

Solutions must be ___ of ____ ____ and ___ number of ___ ___ particles

A

In suspensions particles __ __ __ but not delivered ___

28
Q

What happens if particles are found in parental products?

A

Can lodge capilliries resulting in pulmanory embolism

29
Q

What vehicles are used in parental products?

A

Water for injection
co-solvents (aid solubility in porly soluble drugs)
solubilizing agents (aid dissolution eg. cyclodextrins)
Oil in water (water insoluble drugs)
Oil (intramuscular injections for modified release)

30
Q

purpose of preservatives in parental products

A

To inhibit growth of microorganisms introduced into multi-dose products
co-solvents can also exhibit microbal effects

31
Q

Why are antioxidants involved in parental products?

A

oxidation - displacing oxygen with nitrogen gas
antioxidants - vitamin C and E, sulphate salts
Hydrolysis - removes all water

32
Q

What ranges should the pH be for parental products and why?

A

pH must be between 3.0 - 9.0 so it is not too acidic or basic

33
Q

How is pH maintained in parental products?

A

Buffers are used to maintain pH (eg. citric acid, sodium citrate)
acidifying or alkalizing agents (eg. hydrochloric acid / sodium hydroxide)

34
Q

Purpose of suspending agents in parental products?

A

Ensures drug is readily and uniformly suspended prior to administration
eg. water soluble cellulose derivitives (methylcellulose)

35
Q

Injections and infusions should be made ___ with ___ ___

A

Injections and infusions should be made isotonic with humsn plasma

36
Q

Osmosis:

A

the movement of water from a lower solute concentration to higher solute concentration across a semi-permeable membrane

37
Q

Tonicity adjustment agents

A

Used so injectin/infusion is isotnoic with human plasma
eg. 0.9& sodium chloride solution (osmolarity 286 mmol/L) = Isotonic with human plasma (osmolarity 280-295 mmol / kg)

38
Q

What is meant by hypotonic

A

(1) Lower solute concentration (higher water concentration
(2) Lower osmotic pressure than blood plasma - water driven into cells by osmosis - Cell burst - Pain
(3) counter by adding sodium chloride/dextrose
(4) Restore cell volums by adding Saline`

39
Q

What is meant by isotonic?

A

Same conentration of solute in solution and blood plasma - same osmotic pressure - no osmosis

40
Q

what is meant by hypertonic?

A

(1) Higher solute concentration (lower water concentration)
(2) Higher osmotic pressure than blood plasma - water driven out of cells via osmosis - shrink - pain

41
Q

Packaging of Vials

A

(1) Volume - 5-100ml
(2) Glass with reusable self sealing rubber closure, plastic dust cap
(3) Multiple use - preservative

42
Q

Packagine Ampoules

A

(1) small volume - <1-10ml
(2) Glass or plastic
(3) Single use -unpreserved
(4) Open neck, selaed after filling

43
Q

Packaging Prefilled syringe

A

(1) Small volume - 0.5 - 20ml
(2) Glass or plastic-base prefilled syringe and their corresponding syringe
(3) Convenient, affordable, sterile, safe

44
Q

Packaging Infusion bags/bottles

A

(1) Volume (100-1000ml)
(2) Glass bottles, plastic collapsible bags, semi-ridged plastic bottles
(3) Addititve ports
(4) Single use

45
Q

What are the disadvantages of Parental products?

A

(1) Patient compliance
(2) Painful/stressful (needle phobia)
(3) Expensive
(4) stringent require for manufacture
(5) Professional administration

Medicine Design Manufacture (12 decks)

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