Ingredient Considerations in Compounding Flashcards by Jamaicah Cueto

DEFINITION

pertains to the preparation of medications and is also included in the dispensing process

extemporaneous compounding

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DEFINITION

practice of preparation of a therapeutic product by mixing and combining pharmaceutical agents for an individual patient in response to the identified need

extemporaneous compounding

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What are the other cases in which extemporaneous compounding is needed?

if px is allergic to a certain excipient
if px has dysphagia (difficulty in swallowing)

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What are the two types of extemporaneous compounding?

simple
complex

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DEFINITION

extemporaneous compounding that requires 1 API

simple

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DEFINITION

extemporaneous compounding that requires 2 or more APIs

complex

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What is the potency to be considered acceptable for USP-NF?

API potency of 80% and above

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FCC stands for?

Food Chemical Codex

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What is the chemical grade with the highest purity?

analytical grade

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T/F: reagent grade can be taken orally or parenterally

F - cannot be taken PO or parenterally

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SOURCES OF INGREDIENTS

What are the recommended or standardized sources of ingredients for compounding all drug preparations?

USP, NF or FCC

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SOURCES OF INGREDIENTS

Alternative high-quality source such as __________________________ or
certified _______________________ grade may be considered applying professional judgement

analytical reagent (AR) or certified American Chemical Society (ACS)

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SOURCES OF INGREDIENTS

T/F: Only manufactured drug products from containers labeled with a batch control number and a future expiration date are acceptable as potential source of active ingredients

True

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SOURCES OF INGREDIENTS

used when receiving raw materials to assure quality of material received for manufacture

certificate of analysis

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SOURCES OF INGREDIENTS

when compounding with ______________________ products, all ingredients present in the drug product must be considered relative to the _______________________ of the compounded preparation

manufacture drug; intended use

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What are the special considerations in compounding?

compounding with…
1. hydrates and solvates
2. inorganic salts
3. organic salts
4. esters
5. aliquots, dilutions, & concentrates
6. potency-designated ingredients
7. complex organic molecules
8. commercial products

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Hours of stability of high-risk compounded products

24 hours

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COMPOUNDING WITH HYDRATES AND SOLVATES

T/F: The more molecules of water present in the molecule, the less of the chemical should be weighed to obtain the actual active drug.

F - more of the chemical should be weighed

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T/F: if water adds to the total weight, it is considered overdosage

F - underdosage

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PACKAGING OF HYDRATES AND SOLVATES

Why must these products be packaged in tight containers?

to prevent the loss or gain of moisture

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STORAGE OF HYDRATES AND SOLVATES

What is the importance of storing these products at the indicated temperatures?

to minimize exposure to high humidity levels

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What is the required %humidity in the compounding area?

less than 60%

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compounds that lose water in their molecules and may become powdery when exposed to air

efflorescent

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compounds that gain water in their molecules or absorb water but remain solid

hygroscopic

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compounds that absorb water and liquefies

deliquescent

COMPOUNDING WITH INORGANIC SALTS What are the characteristics of inorganic salts that affect their physical and chemical properties?

1. particle size 2. tendency to absorb or give off water 3. pH

COMPOUNDING WITH INORGANIC SALTS _______________ properties of the compound should be considered

solubility

COMPOUNDING WITH INORGANIC SALTS Acid salts corresponding to an insoluble salt will be _________________ than the original salt

more water soluble

COMPOUNDING WITH INORGANIC SALTS __________________ are water-insoluble, except for their alkali metal salts

Sulfides

COMPOUNDING WITH INORGANIC SALTS most products are combined with salts to increase _______________ and become readily _____________ by the body (e.g., Losartan mixed with Potassium)

solubility; absorbed

COMPOUNDING WITH INORGANIC SALTS smaller particles have ___________ surface area

higher

examples of inorganic salts

NaCl, KCl, CaCO3

COMPOUNDING WITH ORGANIC SALTS Many drugs are _______, and the dose may be based on the ______________ form or just the ________ form of the drug

salts; total salt form; base form

COMPOUNDING WITH ORGANIC SALTS _______________________, USP, are based on the “albuterol” content (present as sulfate form)

Albuterol Sulfate Tablets

COMPOUNDING WITH ORGANIC SALTS _________________________________, USP, are based on the total molecule

Diphenhydramine Hydrochloride Capsules

COMPOUNDING WITH ORGANIC SALTS Drugs that are either weak acids or weak bases and have limited water solubility are often used as their “salts” form for what purpose?

to increase aqueous solubility

COMPOUNDING WITH ORGANIC SALTS What are the other uses of salt forms?

1. to enhance stability 2. to change other attributes of the drug to aid handling during compounding

COMPOUNDING WITH ORGANIC SALTS acids mixed with bases would yield water and salts that would cause ___________

precipitation

COMPOUNDING WITH ESTERS __________ prepared for solubility and stability purposes, to enhance resistance to degradation after administration and for use as prodrugs

esters

COMPOUNDING WITH ESTERS Drugs that form a precipitate upon injection may cause what?

pain at the site of injection and damage to the surrounding tissue

COMPOUNDING WITH ESTERS pain at the site of injection caused by drug precipitate formation may be overcome by?

preparing a drug with increased solubility

COMPOUNDING WITH ESTERS example of an ester drug preparation

Chloramphenicol succinate

COMPOUNDING WITH ESTERS T/F: Since some drugs may occur in salt forms, ester forms, and/or salt-ester forms, it is important to document what form is used and whether it is a salt, ester, or combination

COMPOUNDING WITH ESTERS examples of salts

Erythromycin estolate & Erythromycin stearate

COMPOUNDING WITH ESTERS example of an ester

Erythromycin ethylsuccinate

Reasons for preparing aliquots, dilutions and concentrates:

summarized answer: 1. quantities required are too small for accurate weighing 2. some are explosive and must be diluted 3. many substances are commercially available in percentage strengths that vary from one acid to another

What is a possible incompatibility when acids and bases are mixed?

precipitation

COMPOUNDING WITH POTENCY-DESIGNATED INGREDIENTS Some antibiotics, endocrine products, biotechnology-derived products, and biologics, have potencies that are based on “__________” and are expressed in terms of “________________”

activity; units of activity

COMPOUNDING WITH POTENCY-DESIGNATED INGREDIENTS T/F: There is a relationship between the units of potency of one drug with another different drug

F - no relationship

COMPOUNDING WITH POTENCY-DESIGNATED INGREDIENTS What is the basis of potency determination?

dried or anhydrous basis

COMPOUNDING WITH POTENCY-DESIGNATED INGREDIENTS Antibiotics potency is expressed as _________________________

mcg of activity per mg of substance

COMPOUNDING WITH POTENCY-DESIGNATED INGREDIENTS in drugs like heparin and insulin, the actual dose may be expressed in ________, instead of mg

units

LABELLING OF POTENCY-DESIGNATED INGREDIENTS Each container must be labeled with the _________________, and this information is to be used in calculations involving dosing prior to compounding

actual potency

COMPOUNDING WITH COMPLEX ORGANIC MOLECULES identified as the most complex molecules and biotechnology products

proteins

COMPOUNDING WITH COMPLEX ORGANIC MOLECULES proteins are inherently _________________ molecules and require special handling, and their ________________ profiles can be quite complex

unstable; degradation

COMPOUNDING WITH COMPLEX ORGANIC MOLECULES pharmacists should be knowledgable on the protein's ________________, _________________, and _______________ to the site of action

stabilization, formulation, and delivery

COMPOUNDING WITH COMPLEX ORGANIC MOLECULES Protein drugs are ________________ and are used in quite _____________________________

very potent; low concentrations

COMPOUNDING WITH COMPLEX ORGANIC MOLECULES T/F: The bulk of compounded protein preparations may be the excipients, including the vehicle, buffers and stabilizers

COMPOUNDING WITH COMPLEX ORGANIC MOLECULES In TPN’s containing Calcium and Phosphate salts can form precipitate with proteins ________________

less than 6%

What are the factors to be considered when compounding with complex organic molecules?

1. pH 2. chelating agents 3. antioxidants 4. preservatives 5. stabilizers and tonicity-adjusting agents

What is the key to formulating a stable preparation?

What are used to obtain optimal pH range?

physiologic buffers

COMPOUNDING WITH COMPLEX ORGANIC MOLECULES T/F: An increase in buffer concentration indicates decrease in pain on injection

F - increase in pain

Purpose of adding chelating agents in preparations

1. to bind trace metals, like copper, iron, calcium and manganese 2. to minimize rates of degradation

Example of chelating agent

EDTA (0.01-0.05%)

incorporated to prevent protein degradation due to oxidation

antioxidants

Examples of antioxidants

ascorbic acid, sodium disulfide, a-tocopherol (0.05-0.1%)

T/F: Preservatives may be required, especially if multiple dose vials are prepared.

phenol, chlorobutanol and benzyl alcohol are examples of

preservatives

Example of stabilizer

polyols at 1-10%

Example of tonicity-adjusting agents

sodium chloride and dextrose

COMPOUNDING WITH COMMERCIAL PRODUCTS commonly used to prepare oral liquids (solutions and suspensions) for pediatric use

oral tablets and capsules

COMPOUNDING WITH COMMERCIAL PRODUCTS used to prepare intravenous admixtures

injectable drugs

T/F: Use of commercial products as source of API usually result in lower prescription cost

F - higher prescription cost

Uncertainties in compounding involve the presence of __________________ and ____________________

excipients and actual assay potency

presence of ____________ in the commercial drug product may influence and dictate the _____ of the final compounded preparation

buffers; pH

This type of dosage form should not be used in compounding unless it has been indicated or documented that they can be used

modified-release dosage forms (e.g., extended-release, delayed-release, repeat-action and targeted release)

Important things to note when using commercial products in compounding

list the... 1. manufacturer 2. lot number 3. expiration date and, 4. assign the BUD based on the product stability and insert

What are the basis of the most appropriate method for medication disposal?

1. government regulations 2. environmental impact 3. type, volume, and toxicity of medication 4. setting and risk of diversion

What is the optimal method of medication disposal?

incineration

What are the types of pharmaceutical waste?

1. hazardous waste 2. regulated medical waste 3. universal waste 4. controlled substance waste 5. non-hazardous medical waste

Types of hazardous wastes

1. ignitable 2. corrosive 3. reactive 4. toxic

DETERMINE WHAT TYPE OF WASTE aqueous drug formulations containing >24% alcohol by volume

hazardous - ignitable waste

DETERMINE WHAT TYPE OF WASTE oxidizers or materials that readily supply oxygen to a reaction in the absence of air (e.g. AgNO3 applicators)

hazardous - ignitable waste

DETERMINE WHAT TYPE OF WASTE flammable aerosol propellants

hazardous - ignitable waste

DETERMINE WHAT TYPE OF WASTE agents with pH <2 or >12.5

hazardous - corrosive waste

DETERMINE WHAT TYPE OF WASTE glacial acetic acid, NaOH

hazardous - corrosive waste

DETERMINE WHAT TYPE OF WASTE heavy metals like barium, selenium and thimerosal

hazardous - toxic waste

DETERMINE WHAT TYPE OF WASTE biohazardous waste or infectious medical waste

regulated medical waste

DETERMINE WHAT TYPE OF WASTE waste contaminated by blood, body fluids, or other potentially infectious material, including sharps

regulated medical waste

DETERMINE WHAT TYPE OF WASTE commonly generated hazardous waste (e.g., batteries, pesticides, mercury-containing products and bulbs/lamps)

universal waste

DISPOSAL OF MEDICATION WASTE ASHP recommends that healthcare facilities have a ____________________ waste management team

multidisciplinary

DISPOSAL OF MEDICATION WASTE _________________ must be incinerated at an EPA-approved facility

Hazardous waste

What does EPA stand for?

Environmental Protection Agency

DISPOSAL OF MEDICATION WASTE ________________________________ should be disposed of in a medical waste or municipal incinerator

nonhazardous pharmaceutical waste

T/F: Do not flush medications unless otherwise stated

T/F: When disposal programs are not available, do not throw away unwanted medications in the trash.

F - throw away unwanted medications in the trash using appropriate safeguards

Topical patches should be folded in _____, _______________, and should remain intact

half, adhesive in

Mix the medications with ___________________, like used coffee grounds, sawdust, or kitty litter to make them less appealing to children and animals

undesirable substance

T/F: Throw away medication container in household trash