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DDS III Big Quiz 3 > Patenteral DD Lecture > Flashcards

Patenteral DD Lecture Flashcards

1
Q

Parenteral Drug Delivery

A

Medicines administered by means of an injection

IV, SC, IM

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2
Q

Advantages

A

Can’t handle GI
Poorly absorbed drugs (insolubility size, or molecular props)
Uncooperative, unconscious or unable to swallow
Emergency situationts
Localized therapy
- Limits of other: degradation by enzymes and impereable nature of drug for transdermal

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3
Q

Disadvantages

A

Expensive
Have to be sterile
Required skilled person
Difficult to remove if there is an ADR

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4
Q

Challenges

A 
Solubility
Stability
Delivery
Manufacturability
Sterility
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5
Q

Small Volume Parenterals

A 
< 100 mL
Rapidly --> bolus
IV, IM: 4 mL
SQ: 2 mL
Can be added to LVPs
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6
Q

Large Volume Parenterals

A

> _ 100 mL

No bacteriostatic agents or additive/excipients

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7
Q

Types of SVP

A 
Solutions ready for injection
Suspensions ready for injection
Dry soluble produce with no excipients
Dry soluble products with excipients
Dry insoluble and unstable products
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8
Q

Uses of LVP

A 
Entering or recovering from surgery
Unconscious or unable to take fluids
Replenish body fluids and electrolytes
Total parenteral nutrition
Vehicle for administrating other drugs
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9
Q

Examples of LVP

A

Vitamins, electrolytes, antieoplastics
Ringers/Lactated Ringer
Mannitol
Dextrose and sodium chloride

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10
Q

Ready to Use

A 
Get rid of sterile techniques
Premix drug solutions
Can be both SVP and LVP
- Clindamycin
- Ciprofloxacin
- Vancomycin
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11
Q

IV Admixtures

A

IV fluid with one or more added sterile product for administration
Sterile Product
Additive must be compatible with the LVP
Aspetic techniques

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12
Q

Available Dosage Forms

A

Simple solution, suspension, emulsions, liposomes, particulate systems, solid implants

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13
Q

Solution

A 
Most common of all injectable products
Usually aqueous (mixtures of water with alcohols, glycols or other non aqueous solvents)
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14
Q

Suspensions

A

Most difficult parenteral dosage form
Combine sterile vehicle and powder in an aseptic environment or combining sterile solution and allowed to form crystals in situ
- Penicillin G procaine suspension

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15
Q

Emulsions

A

Rarely used
Size of droplets should be less than 1 micrometer
W/O: sustained release of steroids
O/: Injected IV – Fat emulsion
- Liposyn II, Propofol injection (Diprivan)

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16
Q

Dry Powders

A

Unstable in an aqueous medium are formulated as dry powder for injection
Reconstituted by addition of water before administration

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17
Q

Excipients

A

Provide efficacious, safe, elegant dosage forms
Maintain stability, ensure sterility, or aid in parenteral admin
- Need good quality
- One or more suitable substance be added to parenteral products that are packaged in multiple-dose containers

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18
Q

Water for Injection

A

Difficult quality to achieve
May not contain added substances
Made by distillation or reverse osmosis
Can be collect in holding tank for subsequent use < 24 hours or use a temperature too high for microbial growth

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19
Q

Sterile Water for Injection

A

Sterilized and packed in a single dose container of not greater than 1 liter in size

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20
Q

Bacteriostatic Water for Injection

A

Sterile water for injection containing one or more suitable antimicrobial agent

  • Prefilled syringe > 30 mL of water
  • Small volume injections
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21
Q

Non-aqueous vehicle Uses

A

Drug has a very limited solubility in water

Drug is susceptible to hydrolysis

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22
Q

Ideal Non-aqueous solvent

A 
Non-irritating, non-toxic, non-sensitizing
Pharmacologically inert
Stable at various pH inert
Stable at various pH level
Capable of preserving the activity and stability
Adequate viscosity and fluidity
Miscible with body fluids
Stable during sterilization process
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23
Q

Commonly used solvents

A

Fixed veggie oil, glycerin, PEG, proovlene glycol, ethanol

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24
Q

Fixed oils

A

Nonvolatile
Veggie
Oil vehicle = IM
Must remain clear with cooled

25
Q

Water Miscible Non-aqueous solvents

A

Improve drug solubility

- Ethyl alcohol, PEG, PEG 300

26
Q

pH Requirements

A

Formulated with a pH close to physiological, unless stability or solubility consideration preclude this
Often a compromise between the pH of maximum stability, solubility and physiological acceptability
- Wide can be tolerated: 3-9

27
Q

pH greater than 9

A

Tissue necrosis

28
Q

pH Less than 3

A

Pain and phlebitis

29
Q

Extreme pH in IM

A

Dilantin injection - 12

Robinul injection- 2-3

30
Q

Buffers

A

Phosphate, citrate, or acetate

  • Sodium salts of acidic buffers are used
  • Potassium salts occasionaly
  • HCl salts of basic buffers
31
Q

Antioxidants

A

Maintain stability
Salts of sulfur dioxide, including sodium bisulfite, metabisulfite, and sulfite
Ascorbic acid, cysteine
Auto-oxidation prevented by purging N2 and CO2

32
Q

Antimicrobial Agents

A

To inhibit growth of microorganisms accidentally introduced during withdrawal of individual doses
SVP
- Benzalkonium chloride, metacresol, phenol, thiomersal, chlorobutanol

33
Q

Protectants

A

Protect against loss of activity of active ingredients by some stress that introduced by the manufacturing process or to prevent loss of active ingredients by adsorption to process equipment or to primary packaging materials

  • Cyroprotectants (freezing) or lyroprotectants (drying)
  • In Protein and liposomal formulation
  • Albumin used to prevent adsorptive loss of insulin to hydrophobic material
34
Q

Surfactants

A

Solubilizing, wetting and emulsifying agents

35
Q

Chelating agents

A

Enhance stability, preservative efficiency, inactivation of metal ions
- Should NOT be used in metalloprotein formulation

36
Q

Tonicity adjustment agents

A

Osmolarities between 280-290
Essential for LVPs
Hypertonic solution are preferable to hypotonic because of the risk of hemolysis
- Dextrose and sodium chloride

37
Q

Cautions

A
  • Some preservatives cannot be used in pediatric/neonatal formulations
  • Work with SWFI rather than BWFI to avoid use of preservatives
    Agents for coloring effect only are not allowed
38
Q

Requirements for preparation

A

Pyrogen free and sterile everthing
Prepared in environmentally controlled areas
Must meet special purity standards and compendial standards for particulate matter
Filtered air supply

39
Q

Packaging

A

Container components should not react with other ingredients

May dramatically affect product stability, potency, toxicity and safety

40
Q

Single Dose containers

A

A quality of sterile drug intended for parenteral administration as a single dose
Ampoules (glass seals)
- Prefilled syringe
Once opened, cannot be reused

41
Q

Multiple Dose containers

A

Hermetic container that permits withdrawal of successive portions of the contents without changing the strength, quality or purity of the remaining portion
- Closure must reseal

42
Q

Ampules

A

Sealed glass containers with an elongated neck that must be broken off
Liquids only

43
Q

Vials

A

Made of glass or plastic and sealed with a rubber stopper
Need used to remove
Equal volume of air pushed in as what is going to be taken out
Both liquid and dry powder formulation

44
Q

Prefilled syringes

A

Used for single unit liquid formulations
Lyophilized powders also
- Eliminates steps, eliminates dosing errors, reduces drug waste

45
Q

Syringeability

A

Handling characteristics of a suspension while drawing it into and manipulating it in a syringe- Ease of withdrawel, clogging and foaming tendencies, accuracy

46
Q

Injectability

A

Properties of suspension during injection

- Pressure or force required, evenness of flow, aspiration qualities, freedom from clogging

47
Q

Hypodermic needles

A

Hub, shaft, bevel
Gauge: outside diameter of shaft
13 (largest) to 28

48
Q

Bevels

A

Slanted edges to facilitate injection

  • Short: shallow penetration
  • Intradermal: ID injections
  • Regular: SQ and IM
49
Q

Three common types of syringe tips

A

Slip-Tip
Luer-Lok
Eccentric

50
Q

Direct IV Injection

A

SV of drugs are administered into the vein over a short period of time

51
Q

Volume Controlled Method

A

Provides intermittent infusion for drug solution in precise quantities in controlled rates of flow

52
Q

Piggyback method

A

Intermittent IV drip of second solution through venipuncture site of an established primary IV system
- Enters on top of the primary IV

53
Q

Needle Free Injections

A

Applies high pressure to push the medication through the skin to the desired site
Gas powdered or spring powdered

54
Q

Advantages

A

Avoids needles, no sharp box, reduced risk of infection, reduced pain, reduced cost

55
Q

Penjet

A

Single use, disposable jet injector that comes prefilled

- Need free

56
Q

Injex

A

Reusable injection device coupled with a single-use disposable ampule and are best suited for long term or frequent injection
- Need free

57
Q

Bioject

A

Forcing liquid meds at high speed through a tiny orifice that is held against the skin
- Need free

58
Q

Counseling

A

Proper storage and use
Maintain sterility
Program ambulatory pumps and how to deal with emergencies
Correct disposal

DDS III Big Quiz 3 (6 decks)

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