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Compounding > Block 8 > Flashcards

Block 8 Flashcards

1
Q

Define IV incompatibility and interactions.

A
  • an undesirable reaction is one in which a drug or drug mixture fails to combine with another drug or substance in an expected/desired manner
  • an interaction occurs inside the body and cannot be seen
  • an incompatibility occurs in a fluid container or infusion line and is usually visible (color change, hazy appearance, precipitation)
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2
Q

The monobasic form of phosphate (dihydrogen phosphate) forms what combination with calcium?

What is its solubility?

A

Monocalcium phosphate (aka monobasic calcium phosphate aka calcium dihydrogen phosphate)

Soluble up to 18mg/mL

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3
Q

Define bioequivalence.

A

The absence of significant difference in the rate and extent to which the API becomes available at the drug site of action (bioavailability) when administered at the same molar dose under similar conditions

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4
Q

Compare the different types of non-degradable polymeric pumps.

A

Reservoir Type - the drug is surrounded by a rate controlling polymeric membrane

Matrix Type - the drug is embedded within a polymeric matrix

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5
Q

Most proteins can undergo denaturation upon cooling around ____

A

-20 C

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6
Q

Describe adhesive type patches.

A

monolithic system

  • they consist of the backing layer, a release liner, and the adhesive layer that contains the drug
    ex. Daytrana
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7
Q

What is the difference between first and second generation class B recombinant protein drugs?

A

1st = unmodified, native proteins

2nd = engineered proteins and chemically modified proteins

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8
Q

What type of incompatibility produces a visible change?

Provide examples.

A

Physical. Examples:

  • evolution of gas
  • color changes or darkening
  • precipitation (acid-base reactions, salting alt, degree of dilution, change in solvent)
  • drug-IV container incompatibility (adsorption or leaching)
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9
Q

What is found in each of the following chapters:

795

1075

1160

A

795 - Pharmacy Comopunding Non-Sterile Preparations

1075 - Good Compounding Practices

1160 - Pharmaceutical Calculations in Prescription Compounding

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10
Q

What is found in USP <795>?

A

Non-Sterile Compounding Rules

  • rules for extemporaneous compounding
  • defines standards of care
  • provides an enforceable set of standards
  • outlines responsibility of the compounder
  • mandates a compounding record
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11
Q

What are some alternative methods for assessing bioavailability (other than plasma or urine blood concentrations)?

A
  • acute pharmacodynamic effect (max effect, time until max effect, area under effect-time curve, onset time for pharmacodynamic effect)
  • clinical observations
  • in vitro studies
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12
Q

Identify the type of implant and MOA of Viadur.

A
  • leuprolide acetate implant
  • incorporates DUROS implant pump, which is a modified Alzet osmotic pump (it has a piston between the osmotic engine and drug reservoir that controls the flow of drug)
  • leuprolide is a synthetic analog of GnRH (or LHRH)
  • it is indicated in the palliative treatment of advanced prostate cancer (histrelin is used for hormone sensitive prostate cancer treatment)
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13
Q

What are some advantages to using transdermal drug delivery systems?

A
  • non-invasive
  • utilize a large (1-2 meters2) and accessible surface area
  • avoids the stomach
  • avoids the liver (first pass)
  • reduces frequency of administration
  • ideal for drugs with short biological half-lives
  • improves compliance
  • easily removed
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14
Q

Identify some factors that promote aggregation. Why do they have this effect?

A

Temperature

Ionic Strength

Vortexing (mechanical agitation)

Surface/Interface Adsorption

They promote exposure of hydrophobic surface area

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15
Q

Identify some solvents that are used for chemical penetration enhancement in second generation TDDS.

A

Dimethylsulfoxide ethanol (DMSO) and propylene glycol

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16
Q

Drug products are considered to be therapeutic equivalents only if they are __________________.

A

pharmaceutical equivalents for which bioequivalence has been established

meaning, they can be expected to have the same clinical effect and safety profile when administered to patients

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17
Q

What color book contains the lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evalutions?

A

The purple book

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18
Q

Identify the different instability degradiation mechanisms.

A

Physical - when no covalent bonds are being broken or formed (conformation alterations, aggregation, surface adsorption)

Chemical - those in which existing chemical bonds are broken and/or new bonds are formed (hydrolysis, disulfide bond breakage, oxidation)

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19
Q

What factors may impact drug permeability through the skin?

A
  • size (must be small, less than 400 Da)
  • lipophilicity (log P between -1 and 4)
  • potency (effective at low doses)
  • preferably non-irritating and non-sensitizing
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20
Q

When can waivers of in-vivo bioequivalence be given? (biowaivers)

A
  • the process of using in vitro dissolution profile instead of in vivo; it’s done based on the BCS and can be appropriate if used for highly soluble, highly permeable (class 1) drugs, as well as highly soluble and lowly permeable (class 3) drugs in imediate release solid oral dosage forms that exhibit rapid in vitro dissolution

highly soluble = highest dosage strenght is soluble in <250mL of water

highly permeable = extent of absorption is > 90% of the administered dose

rapidly dissolving = > 85% dissolves within 30 minutes

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21
Q

Based on the drug name, identify:

  • biodegradable or non-biodegradable
  • what it is used for
  • where it is placed

Drug name: gliadel wafer (carmustine)

A
  • bioegradable polyanhydride polymers
  • indicated in patients with newly diagnosed malignant glioma as an adjunct to surgery and radiation
  • releases carmustine (chemotherapy agent) over a 2-3 week period
  • wafers are implanted in a cavity after the surgeous removes the brain tumor
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22
Q

Gives somes examples of the various materials that can be used to make biodegradable polymeric implants (including synthetic and natural materials).

A

Synthetic - polyanhydrides, poly(lactic acid) (PLA), poly(lactic-co-glycolic acid) (PLGA) poly ortho esters, polycaprolactones, polyhydroxy-butyrate

Natural - albumin, gelatin, callagin, casein, starch, dextran

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23
Q

When can a prescribed treatment be changed without a physician’s consent?

A
  • interchangeability is one of the criteria that insurers and government programs use when they determine whether a similar medication can be provided instead of the one prescribed by the doctor

–> most generic drugs that are therapeutically equivalent to the brand drug it copied are interchangeable

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24
Q

A drug product is considered a pharmaceutical alternative if it contains the same API but is different in either…

A
  • chemical form (salt, ester, complexes of the moiety)
  • dosage form (tablets vs. capsules)
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25
Q

What are the technical classifications of protein drugs?

A

A - non-recombinant

B - recombinant

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26
Q

Based on the drug name, identify if it is a:

  • biodegradable or non-biodegradable
  • what it is used for
  • where it is placed

Drug: Vitrasert (ganciclovir)

A
  • intravitreal implant
  • non-degradable polymers (PVA [polyvinyl alcohol] and EVA [ethylene co vinyl acetate])
  • delivers ganciclovir locally to the eye for treatment of cytomegalovirus
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27
Q

Between what pH ranges are monobasic forms of calcium phosphate salts capable of forming (in higher quantities)?

Dibasic forms?

A

Mono: 2-7.2

Dibasic: 7.2-12.3

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28
Q

What occurs during leaching incompatibilities? Provide an example.

A
  • there’s migration of chemicals from the container to the solution
    ex. PVC bag and tubing are made from di(2-ethylhexyl) phthalate (DEHP), a potential hepatotoxin and known carcinogen.

It is a plasticizer used to increase pliability and optical clarity. It was found to leach from PVC containers, which can be minimized by using non-DEHP plastics or glass materials.

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29
Q

________ are a type of biological product that are approved by the FDA because they are highly similar to an already approved biological product (biologic)

A

Biosimilar

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30
Q

PSA stands for

A

pressure sensitive adhesive

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31
Q

List and describe different types of chemical incompatibilities.

A

Complexation (ex. combination of calcium and tetracycline leads to formation of a complex that inactivates tetracycline)

Hydrolysis (as in the case of esters, amides, and lactams)

Oxidation/Reduction

Photolysis (chemical decomposition caused by light)

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32
Q

Which layer of skin is the rate-limiting area for TDDS? Why?

A

The stratum corneum

  • it is comprised of about 20 layers of highly cornified (dead) cells that are embedded into a matrix of non-polar lipids
  • this layer is the primary barrier to absorption as it is a unique two-compartment system
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33
Q

When can a pharmacist compound something that’s commercially available?

A

If the prescriber specifically orders the strength or dosage form and specifies why the patient needs the particualr strength and dosage form of the prep

(if the physician requests an alternate product due to hypersensitivity to the excipients or preservatives in the FDA-approved product, or if they request an effective alternative dosage form)

OR

If the drug is not commercially available

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34
Q

Define implants (as drug delivery devices).

A

They are single unit drug delivery systems that are designed to deliver drug (systemically or locally) at a controlled rate over a prolonged period of time from a specific site of the body

35
Q

What are some different ways you can control how a drug is released parenterally?

A
  • prepare a water-insoluble drug derivative
  • use of viscous, water-miscible vehicles (gelatin or polyvinylpyrrolidone)
  • use of water-immiscible vehicles (like vegetable oil)
  • dispersion in biodegradable or non-biodegradable polymeric materials (implants)
36
Q

For a drug to be considered a pharmaceutical equivalent, it must be identical in

A
  • active drug moiety (same salt or ester of the same therapeutic moiety)
  • amount (strenght) of the API
  • dosage form
  • route of administration
37
Q

What are some important variables to consider when preparing mixutres that contain calcium and phosphate?

A
  • concentrations of calcium and phosphate
  • pH (because pH will determine what form phosphate takes, and thus the solubility of any calcium-phosphate precipitates)
  • other drugs and nutrients that may be included in the IV admixture
38
Q

Reservoir and matrix type patches are ______ controlled drug delivery systems.

A

Membrane controlled

39
Q

Conventional topical formulations (ointments, creams, lotions, or gels applied directly on the skin) are ______ generation TDSS.

A

First

40
Q

How does fat (from IV emulsions) affect IV admixtures?

A

raises pH, so it favors precipitation

this is due to the fact that dibasic calcium phosphate has a much lower solubility and forms at higher pH

Fat emulsion pH ranges from 6-9

41
Q

__________ is the availability of the drug from a drug product (test/generic) as compared to the recognized standard (innovator) when the 2 drug products are given by the same route of administration.

A

Relative bioavailability

42
Q

What are some methods used in second generation TDDS?

A

Chemical Penetration (water, solvents, surfactants)

Heat Penetration

43
Q

The dibasic form of phosphate (hydrogen phosphate) forms what combination with calcium?

What is its solubility?

A

Dicalcium phosphate (aka dibasic calcium phosphate, aka calcium mono-hydrogen phosphate)

Poorly soluble (0.3mg/mL), so it will precipitate

44
Q

Hazardous compounds must follow USP <…>

A

800

45
Q

If there is no stability info, what are the maximum BUDs that are to be used for:

  • non-aqueous liquids/solids
  • water containing formulations
  • all other formulations
A
  • nonaqueous liquids and solids = 25% of the time remaining until the products expiration date or 6 months, whichever is earlier
  • water-containing = no longer than 14 days when refrigerated
  • all other = intended duration of therapy or 30 days, whichever is earlier
46
Q

Define “generic drug”.

A

a medication created to have the same active ingredient, strength, dosage form, route of administration, and performance characteristics

it should be a bioequivalent to the brand drug and thus be therapeutically equivalent

47
Q

What components are present on all patches?

A
  • backing layer (impermeable, protects the patch from the outer environment and loss of drug)
  • peel strip (liner; removed prior to application)
  • drug layer (composition and design varies between reservoir/matrix types and adhesive types)
48
Q

Pharmaceutical equivalents may differ in

A
  • shape
  • scoring configuration
  • release mechanisms
  • packaging
  • excipients (including colors, flavors, preservatives)
  • expiration date
  • labeling
49
Q

List some factors by which incompatibilities can be minimized.

A

1 - potassium/sodium phosphate added early & calcium gluconate added last/nearly last

2 - the mixtures should be agitated after each ingredient is added

3 - final [calcium] and [phosphate] should be below the solubility curve

4 - higher amino acid concentrations = less likely to have precipitants

5 - lower final pH = more soluble calcium phosphate

6 - 0.2 micrometer filter for non-fat and 1.2 micrometer filter for fat containing

7 - higher temp favors precipitation!!!

8 - NEVER EVER USE CALCIUM CHLORIDE

50
Q

The timer interval between application of a TDDS and steady state is known as

A

lag time

51
Q

If the unfolded (denatured) state cannot recover to its native state, the denaturation is considered _______ and can lead to ________.

A

irreversible and can lead to loss of activity and aggregation (solution turbidity)

52
Q

During reconstitution, diluent should be added __________.

A

on the side of the vial, rather than directly into the powder.

53
Q

How do amino acids affect IV admixtures?

A

certain amino acids (like aspartate and other negative AAs) can form soluble complexes with calcium ions (causing calcium sequestration), depleting the levels of free calcium that are available for precipitation

(favors solubility)

54
Q

Which book contains info about approved drug products with therapeutic equivalence evaluations?

A

The Orange Book

55
Q

The amount of drug that is able to move through a unit area of skin in time is described by

A

Fick’s Equation

dMv / dt = CvKDS / h

Cv = concentration of drug in the vehicle

K = partition coefficient

D = diffusion coefficient of the stratum corneum

S = surface area of application

h = thickness of the stratum corneum

56
Q

How does dextrose affect IV admixtures containing calcium and phosphate?

A

Dextrose lowers the pH of the IV admixture. This favors solubility because monobasic calcium phosphate is more likely to form and it has a higher solubility than dibasic calcium phosphate.

**USP requirement for the pH of dextrose fluids is 3.5-6.5

57
Q

Which type of pump is intended for zero order or intermittent drug delivery? Give an example.

A

Programmable electronic pumps

SynchroMed II Pump

58
Q

What is the driving force for percutaneous absorption?

A

Solubility of the drug in the vehicle

59
Q

Based on the drug name, identify:

  • biodegradable or non-biodegradable
  • what it is used for
  • where it is placed

Drug name: Vantas and Supprelin LA (histrelin)

A
  • non-degradable, diffusion-controlled reservoir drug delivery system
  • subcutaneous implantation
  • Histrelin acetate is a gonadotropin-releasing hormone agonist (GnRH agonist) used to treat hormone-sensitive cancers of the prostate and uterine fibroids (it’s also been proven highly effective in treating central precocious puberty)
60
Q

_______ is the asociation between 2 or more paritially unfolded protein molecules to form dimers, trimers, and higher molecular weight multimers

A

Aggregation

61
Q

Second generation TDDS techniques are limited to

A

small, lipophilic molecules and stil have little effect on larger hydrophilic molecules

62
Q

The majority of transport across the stratum corneum occurs how?

What are some other methods?

A

Transcellularly is the major pathway

there is insignificant transport intracellular and paracellular

transappendeageal is not significant

Stripping (ablation, abrasion) and microneedles remove the stratum corneum to make micron-scale (or larger) pathways

63
Q

When can pharmacists change the flavor of a medication?

A

They may flavor a prescription at the request of the patient, patient’s agent, or prescriber

They may only flavor an OTC if the patient gets a prescription for the OTC (can’t just pull it off the shelf)

64
Q

Some of the main causes of incompatibilities are…

A
  • incompatible drug combinations
  • non-appropriate diluents
  • incompatible material
65
Q

What are the main components of osmotic pumps?

A
  • semipermeable membrane (serves as the housing for the entire pump and allows water to enter the osmotic compartment)
  • osmotic layer (containing the osmotic agent)
  • reservoir wall (cylindrical cavity that is impermeable to water)
  • drug reservoir (contains the drug solution)
  • flow modulator (stainless steel, open ended tube that serves as the exit route for the drug solution)
66
Q

Describe the process of thermal ablation.

A

aka microporation; it is accomplished by heating the skin to the 100s for a very short period of time (micro to milliseconds), which creates microchannels in the stratum corneum

it can be carried out by using tiny heating electrodes or radio frequency (RF) waves

67
Q

Based on the drug name, identify if it is a:

  • biodegradable or non-biodegradable
  • what it is used for
  • where it is placed

Drug Name: Nexplanon (etonogestrel)

A
  • subdermal implant (upper arm)
  • non-degradable (EVA)
  • is used as birth control for women

**Contains a small amount of barium sulfate so that it can be seen by an xrya

68
Q

CHADD stands for

A

Controlled Heat-Assisted Drug Delivery (system)

69
Q

List some common sites of implantations.

A
  • loose interstitial tissues of the outer surface of the upper arm
  • anterior surface of the thigh
  • lower portion of the abdomen
  • other (eye, ear)
70
Q

A drug product that contains a different API (chemically different) that is indicated for the same therapeutic or clinical objective is known as a

A

therapeutic alternative

71
Q

List possible excipients that may be used in protein formulations, as well as their uses.

A

Amino acids (glycine) - reduces adsorption, inhibits aggregation, stabilizes against heat

Surfactants - preferential adsorption at interphase; prevents aggregation during drying

Polyols - used to stabilize, solubilize, and minimize aggregation by encapsulating hydrophobic chanis

Antioxidants

Chelating Agents

  • *Polymers** - reduce surface adsorption
  • *Sugars** - bulking agents/cryoprotectants (mannitol)
72
Q

___________ TDDS rely on the thermodynamic potential of the drug molecule to drive the compound across the skin. (____ generation)

_____________ TDDS rely on external factors to drive the compounds across the skin ( ______ and ______ generation)

A

Passive TDDS rely on the thermodynamic potential of the drug molecule to drive the compound across the skin. (first generation)

Active TDDS rely on external factors to drive the compounds across the skin (second and third generation)

73
Q

________ uses constant low voltage electric current (applied for minutes to hours from an externally placed electrode) to drive a drug (of the same charge) across the stratum corneum.

What is an advantage of using this system?

Give an example of a drug that uses this system.

A

Iontophoresis (aka electro-repulsion)

the rate of drug delivery is proportional to the electrical current. since the amount of current can be controlled, so can the rate of drug delivery

ex. Ionsys (fentanyl)

74
Q

Describe some advantages and disadvantages associated with implants.

A

Advantages: blood drug levels can be maintained for long periods of time, reduced incidence of infection related complications, improved compliance, controlled release, can be designed for intermittent release, can be designed to allow for bio-responsive release

Disadvantages: invasive, termination somtimes requires surgery, danger of device failure, limited to potent drugs, adverse reactions (due to local concentration buildup), biocompatibility

75
Q

What are some of the core competencies for non-sterile prep training?

A
  • hand hygeine
  • garbing
  • cleaning/sanitizing
  • component selection, handling, and transport
  • calculations
  • measuring and mixing
  • use of equipment
  • documentation
76
Q

List examples of complications associated with parenteral drug delivery.

A

1 - infection 6 - thrombosis

2 - hypothermia 7 - hemolysis

3 - neurotoxicity 8 - pain

4 - phlebitis 9 - air embolism

5 - extravasation 10 - allergic reactions

77
Q

Based on the drug name, identify:

  • biodegradable or non-biodegradable
  • what it is used for
  • where it is placed

Drug name: Compudose (estradiol)

A
  • non-degradable, silicone rubber implant for cattle
  • administered one dose in the ear subcutaneously
  • stimulates the animal’s pituitary gland to produce more growth hormones and gain weight quickly
78
Q

Who does USP <795> pertain to?

A
  • compounding for a patient
  • compounding for office use by the practitioner
  • compounding and distribution of the compounded non-sterile prep by a community pharmacy for use in an institutional pharmacy
  • compounding and delivery of non-sterile preps by an institutional pharmacy to another institutional pharmacy under common ownership
79
Q

What are some important counseling points to remember for transdermal drug delivery systems?

A
  • don’t cut them
  • apply to clean, dry skin
  • read the package insert for specifics (application site, etc.)
  • wet/moist skin and warm skin both accelerate delivery faster than the intended rate
  • press firmly against the skin with the heal of the hand for about 10s
80
Q

For non-sterile solid and liquid dosage forms that are single-unit and unit-dose containers, the BUD shall be _______ from the date packaged or the BUD on the manufacturer’s container, whichever is earlier.

A

1 year

81
Q

Which surfactants are commonly used in second gen TDDS?

A

sodium dodcyl (lauryl) sulfate and glyceryl monooleate

82
Q

Identify the different types of implants.

A

1 - Nondegradable Polymeric implants (reservoir or matrix type)

2 - Biodegradable Polymeric Implants (reservoir or matrix type)

3 - Other (osmotic implants [pumps] and mechanical pumps)

83
Q

Based on the drug name, identify:

  • biodegradable or non-biodegradable
  • what it is used for
  • where it is placed

Drug name: Zoladex (goserelin acetate)

A
  • subcutaneous implant
  • PLA and PLGA biodegradable implant
  • delivers goserelin acetate over 1-3 months; goserelin is a synthetic analog of luteinizing hormone releasing hormone (LHRH; aka GnRH)
  • it’s used to treat endometriosis prior ot surgery for abnormal uterine bleeding

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