DDS LAB - SUPPLEMENTAL NOTES ON SPIRITS, ELIXIRS, AND EXTRACTED PRODUCTS

SPIRITS

• are alcoholic or hydroalcoholic solutions of volatile substances

60%

generally, the alcohol concentration of spirits is rather high, usually over ____________-

Aromatic substances in alcohol

because of the greater solubility of ____________________ than in water, spirits can contain greater concentration of these materials than corresponding aromatic waters

62-68%

lowest percentage is in Aromatic Ammonia Spirit _________________

80-87%

highest percentage is in Camphor Spirit

Milky preparation

spirits when mixed with water or with an aqueous preparation, the volatile substances present in spirits generally separate from the solution and form a ____________________

Distillation

the introduction of spirit into pharmacy and medicine was brought about by the development of ________________ procedures (methods to prepare spirits: simple solution, solution by maceration, distillation, chemical reaction)

Flavoring agents

as _____________________, spirits are used to impart the flavor of their solute to other pharmaceutical preparations

Medicinal purposes

for ____________________, spirits may be taken orally, applied externally, or used by inhalation, depending upon the particular preparation (when taken orally, they are generally mixed with a portion of water to reduce the pungency of the spirit)

AROMATIC AMMONIA SPIRIT, NF

it acts:

• as a carminative due to the volatile oils present

• as an antacid

• as a mild reflex circulatory stimulation due to the liberation of ammonia (NH3) from the ammonium carbonate, which the spirit contains, so it is used of cases of fainting

CAMPHOR SPIRIT, NF

• referred to as Tincture of camphor and also as camphor

• this preparation is a simple solution of 10% camphor in alcohol

• rarely used internally, but its external use is very common: applied to "cold sores" and similar ailments

COMPOUND ORANGE SPIRIT, USP

• it is a blend of several oils and is readily prepared by simple solution

• important ingredient of aromatic elixir

PEPPERMINT SPIRIT, NF

• used as a carminative and flavor

• given orally in small doses, usually 1mL

• effective carminative

ELIXIRS

are clear, sweetened, hydroalcoholic solutions for oral use and are usually flavored to enhance their palatability

4-40%

in the official elixirs, the alcohol content varies from __________ (generally, there is just enough alcohol to keep volatile oil or medicinal substances in solution)

Glycerin and propylene glycol

frequently employed in elixirs as adjuncts solvents

SACCHARIN

elixirs having a high alcohol content usually utilize artificial sweeteners, such as _____________, which is required only in small amounts, rather than sucrose which is only slightly soluble in alcohol and require greater quantities for equivalent sweetness

10-12%

elixirs containing over __________________ of alcohol are usually self-preserving and do not require the addition of an antimicrobial agent for their preservation

Alcohol content

A disadvantage of elixirs for children and for an adult who chooses to avoid alcohol is their ___________________

Tight, light-resistant containers

because of their usual content of volatile oils and alcohol, elixirs should be stored in ________________ and protect from excessive heat

Cloudy

the final mixture of elixirs will not be clear but _____________, due principally to the separation of some of the flavoring oils by the reduced alcoholic concentration

TALC

a frequent filter aid in the preparation of elixirs, has the ability to absorb excessive amounts of oils and therefore assist in their removal from the solution

NON-MEDICATED ELIXIRS

used as vehicles in preparing medicated elixirs either by the addition of a therapeutic agent to a pleasant tasting vehicle and the dilution of an existing medicated elixir

AROMATIC ELIXIR, USP

• is the most widely used elixir

• simple preparation

• difficult to prepare in small quantities

• consists of compound orange spirit, syrup, alcohol, water, and talc

Terpeneless oils (water-soluble)

the use of ______________ to avoid the difficult occurs (cloudiness), which is due to the insolubility in water of the oils present in compound orange spirit

31 percent or less than half that of syrup

the sugar content of aromatic elixir is about __________

21 to 23 percent by volume

the alcohol content is from _______________ by volume

COMPOUND BENZALDEHYDE ELIXIR, NF

it is prepared by simple solution and is used when a bitter almond-like flavor is desired

ISO-ALCOHOLIC ELIXIR, NF

• it is composed of two separate parts, a low alcoholic elixir with an alcohol content of from 8 to 10 percent, and high alcoholic elixir with an alcohol content of from 73-78 percent

• by mixing two solutions, the final product may be obtained which an alcohol content within the ranges has required for elixirs

• if prescribed, the drug could be dispersed in solution by using the right proportion of the low and high alcoholic elixirs

• easy to prepare and both forms are stable

• product is similar in flavor and odor to the aromatic elixir

MEDICATED ELIXIRS

• have therapeutic action are sometimes used as the vehicle for other drugs

• can be described further classifying them according to their therapeutic activity

ANTIHISTAMINE ELIXIRS

• largest group of elixirs having a definite therapeutic action

• useful primarily in the symptomatic relief of certain allergic disorders

• they suppress symptoms caused by histamine, one of the chemical agents released during the antigen-antibody reaction of the allergic response

• Diphenyhydramine HCl elixir; Chlorpheniramine HCl elixir

SEDATIVE AND HYPNOTICS

• second largest group of elixirs

• Phenobarbital elixir, barbiturate

• used in low dosages as sedatives and in higher dosages as hypnotics

• either long-acting sedation, intermediate sedation, or short-acting sedation or duration

PHENOBARBITAL ELIXIR

• used for long-acting sedation

• the active ingredient first is dissolved in alcohol before adding the other liquids

• dissolves readily in alcohol and will remain in solution when the alcohol content is lowered

• mix of alcohol, water, and glycerin is used in this elixir

GLYCERIN (& GLYCERIN WATER)

• presence in phernobarbital prevents it from precipitating

• poor solvents for phenobarbital

• solubility of phenobarbital in alcohol is enhanced by the addition of __________ (solubility of phenobarbital in 10% alcohol solution is 0.19%, while the solubility is increased to 0.5% by using 10% alcohol + 40% _________ -- causes a correlation between the dielectric constant of the mixture with the amount of drug solubilized)

AMOBARBITAL ELIXIR

it is used for intermediate duration (methanamine is used to increase the solubility of ___________)

PENTOBARBITAL ELIXIR

commonly used as a short-acting barbiturate

Diluted hydrochloric acid

the sodium salt of pentobarbital is used in the preparation of elixir, which is readily water-soluble, this compound after being dissolved, is later converted to pentobarbital by adding _________________ (the conversion is necessary because sodium pentobarbital is not stable in solution but decomposed on standing)

EXPECTORANT AND COUGH PREPARATIONS

• Terpin Hydrate Elixir, NF; Terpin hydrate and dextromethorphan Hydrobromide Elixir, NF; Terpin Hydrate and codeine Elixir, NF (latter two are made by dissolving the respective drugs in Terpin Hydrate Elixir -- cannot be diluted with much water because the slightly water-soluble terpin hydrate will precipitate)

• contain the highest percentage of alcohol (39-44%) of all elixirs in order to keep the terpin hydrate in solution

NARCOTIC ELIXIR

terpin hydrate and codein elixir

NON-NARCOTIC ELIXIR

terpin hydrate and dextromethorphan HBr elixir

TERPIN HYDRATE AND CODEINE ELIXIR

• a preparation of the expectorant terpin hydrate, with sweet orange peel tincture, benzaldehyde, glycerin, alcohol, syrup, water, and the antitussive opiate codeine

• terpin hydrate diminishes secretions and promotes healing of the mucous membrane and the codeine depressed the cough center in the medulla oblongata

• prolonged use may lead to addiction

TERPIN HYDRATE

• is prepared by the action of nitric acid on oil of turpentine in the presence of alcohol, the resulting crystals being filtered off and crystallized from alcohol

• the yield of crystallizable material is largely dependent upon the temperature at which the reaction is allowed to proceed (temperature is too high = polymerization of the turpentine takes place; too low = yield is insufficient)

• banned by the US FDA in the 1990s due to a lack of efficacy

DIGOXIN ELIXIR USP

used as a cardiotonic

ACETAMINOPHEN ELIXIR, NF

used as analgesic

DEXAMETHASONE ELIXIR, NF

contains synthetic adrenocorticosteroid and is used in the treatment of rheumatoid arthritis and other conditions for which corticosteroid therapy is indicated