DISP 2 LAB: Extemporaneous Compounding PT 2

longer BUD (10 days in a refrigerator)

BUD for sterile preparations | category 2 - aseptically processed, no sterility, only sterile compounds: shorter/longer BUD?

shorter BUD (4 days in a refrigerator)

BUD for sterile preparations | category 2 - aseptically processed, no sterility, one or more non sterile starting components: shorter/longer BUD?

• ≤ 12

• ≤ 24

BUD for sterile preparations | category 1

• _ _ hours at CRT

• _ _ hours in a refrigerator

1. active ingredient

2. routes of administration patient

3. disease

4. comfort

5. ease or convenice

factors to consider in selecting the dosage form:

1. physicochemical characteristics of the _ _

2. possible _ _ _ that will produce the desired therapeutic effect

3. _ characteristics

4. specific characteristics of the _ being treated

5. _ for the patient

6. _ of administration

pharmaceutical (usp/nf)

grade required by FDA for compounding

food

pharmaceutical grade > _ grade

technical

least pure grade; not used in compounding

greater

more molecules of water that are present in a molecule of the substance, the _ is the amount of chemical that must be weighed to obtain the actual active drug

analytical

pharmaceutical grade > food grade > _ grade

tight containers

hydrates and solvates - must be packaged in _ containers to prevent the loss or gain of moisture

weighing

hydrates and solvates - when working with hygroscopic, deliquescent, and efflorescent powders, extra care should be observed

• _ should be done quickly after opening the bulk chemical containers, and the containers should then be resealed

hygroscopic powders

those that will tend to absorb moisture from the air

deliquescent powders

those that will absorb moisture from the air and even liquefy

efflorescent powders

those that may give up their water of crystallization and may even become damp and pasty

• weak acids or weak bases

• water

most drugs are ? acids or ? bases and have limited _ solubility

• solubility

• stability

• ease

advantages of salt form:

• enhance _ of the drug

• enhance drug _

• may change other attributes for _ of manufacturing

1. weak acid + strong base

2. weak base + strong acid

3. weak acid + weak base

salt may be prepared as follows (neutralization reaction):

1. WA + SB

2. WB + SA

3. WA + WB

weak acid + strong base

salicylic acid + sodium hydroxide = sodium salicylate is a combination of (weak/strong acid/base + weak/strong acid/base)

weak base + strong acid

ephedrine + HCl = ephedrine HCl is a combination of (weak/strong acid/base + weak/strong acid/base)

weak acid + weak base

phosphoric acid + codeine = codeine phosphate is a combination of (weak/strong acid/base + weak/strong acid/base)

ester

formed through the dehydration of a molecule of an alcohol and a molecule of an organic acid

• solubility

• stability

• delivery

• resustance

• prodrug

reasons for preparing esters:

• s___

• s___

• improvement of drug _

• _ to degradation after administration

• use as _

ester

chloramphenicol succinate is an example of _ drug

ester

_ drugs can help reduce pain when injecting the medicine

• particle size

• water

• pH

• hygroscopic

• deliquescent

• efflorescent

• eutectic

characteristics of inorganic salts that can affect their physical and chemical

properties:

• PS

• tendency to absorb or give off _

• p_

• special considerations:

• _ powders

• _ powders

• _ powders

• _ mixtures

eutectic mixture

mixtures that when you mix together, the melting point changes

• easily

• water soluble

solubility of inorganic salts - if both the cation and the anion of an ionic compound are monovalent, the solute–solute attractive forces are usually _ overcome; therefore, these compounds are generally water _

• easily

• water soluble

solubility of inorganic salts - if only one of the two ions in an ionic compound is monovalent, the solute-solute interactions also are usually _ overcome, and the compounds are water _

• too great

• poor

• ZnSO4

• FeSO4

solubility of inorganic salts

• if both the cation and the anion are multivalent, the solute–solute interaction may be _ _ to be overcome by the solute–solvent interaction, and the compound may have _ water solubility

• exceptions: _ & _

• water soluble

• Li2CO3

solubility of inorganic salts

• common salts of alkali metals are usually water _

• exception: _

soluble

solubility of inorganic salts - ammonium and quaternary ammonium salts are water _

• water soluble

• silver

• mercurous acetate

solubility of inorganic salts

• nitrates, nitrites, acetates, chlorates, and lactates generally are water _

• exceptions: _ & _

• water soluble

• calcium

• barium salts

solubility of inorganic salts

• sulfates, sulfites, and thiosulfates generally are water _

• exceptions: _ and _ _

• water soluble

• silver and mercurous ions

solubility of inorganic salts

• chlorides, bromides, and iodides are water _

• exceptions: salts of _ and _ _

• acid

• insoluble

solubility of inorganic salts - _ salts corresponding to an _ salt will be more water soluble than the original salt

alkali metal cations

ammonium ion

solubility of inorganic salts - hydroxides and oxides of compounds other than _ _ _ and the _ _ generally are water insoluble

alkali metal salts

solubility of inorganic salts - sulfides are water insoluble except for their _ _ _

• insoluble

• alkali metal

• ammonium

solubility of inorganic salts - phosphates, carbonates, silicates, borates, and hypochlorites are water _ except for their _ _ salts and _ salts

potency

determinations of _ are done on a “dried or anhydrous” basis

mcg of activity per mg of substance

potency of antibiotics is commonly expressed as _____

heparin and insulin

potency-designated ingredients: in some drugs, the actual dose may be expressed in units, instead of mg, such as h___ and i___

proteins

inherently unstable molecules and require special handling, and their degradation profiles can be quite complex

higher

use of commercial products as source of API usually result in lower/higher prescription cost

buffers

presence of _ in the commercial drug product may influence and dictate the pH of the final compounded preparation.

should not be used

modified-release dosage forms, including ER, DR, repeat-action and targeted release, should be/not be used in compounding unless it has been indicated or documented that they can be used.

• manufacturer

• lot number

• expiration date

when using commercial products in compounding, it is important to list the m___, LN, and ED of the product used.

units of activity

some antibiotics, endocrine products, biotechnology-derived products, and biologics, have potencies that are based on “activity” and are expressed in terms of ___ ___ ___

no relationship

there is a/no relationship between the units of potency of one drug with another different drug