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Name:  Example: belladonna tincture

Pharmaceutical Dosage  Maceration


Chapter 13: Solutions  "process M"
Compound Benzoin Tincture
Elixirs  Prepared by maceration in alcohol of 10% benzoin and
 Clear, sweetened hydroalcoholic solutions for oral use lesser amount of aloe, storax, and tolu balsam totaling
 Less viscous since they contain a lower proportion of sugar about 24% of starting material
and consequently less effective than syrups  Used as a protectant to toughen skin in treatment of bed
 Maintain both water soluble and alcohol soluble sores, ulcers cracked nipples and tissues of the lips and
components in solutions than aqueous syrups anus
 Excipients:  Serves as delivery vehicle of podophyllum in treatment of
 Sweetened with sucrose or sucrose syrups, some visceral warts
sorbitol, glycerin or artificial sweeteners Thimerosal Tincture
 High alcoholic content requires artificial  Similar with thimerosal topical solution except that sodium
sweeteners usually saccharin chloride and sodium borate are absent from the tincture and
 Flavorants to increase palatability and coloring the vehicle of the tincture is water, acetone and about 50%
agents to enhance their appearance alcohol
Kinds of Elixirs  Monoethanolamine and ethylenediamine are used as
 Medicated stabilizers
 Elixir with active ingredient  Effective because of its chelating action on metallic
 Example: terpin hydrate elixir impurities that may be present at time of preparation
 Non-medicated Iodine Tincture
 Useful to the pharmacist's in extemporaneous  Sodium iodide reacts with iodine to form sodium triiodide
filling of Rx involving: which prevents formation of ethyl iodide.
 Addition of a therapeutic agent  NaI + I2 --> NaI3
 Dilution of an existing medicated elixir  Ethyl iodide will decrease the anti-microbial property of
 Example: iso-alcoholic elixir tincture
 Advantages of elixirs over the counterpart solid dosage  NaI: solubilizing agent
form:  Prepared by dissolving 2% iodine crystals and 2.4%
 Flexibility and ease of administration sodium iodide
 Disadvantage  Advantage: water solution
 For patients who choose to avoid alcohol  Popular local anti-infective agent
Preparation of Elixirs  Reddish brown stain on the skin
 By simple solution with agitation  Local anti-infective agent: brownish red color stains on the
 Administration of two or more liquid ingredients skin
Kinds of elixirs Topical Solutions and Tinctures
 Antihistamine elixirs  Topical solution
 Useful in the symptomatic relief of certain allergies  Employed as an aqueous vehicle
disorder  Prepared by simple solution dissolving some by
 Other adverse effects include dryness of the nose, chemical reaction and maceration
throat and mouth, dizziness and disturbed  Topical tinctures
concentration  Alcoholic vehicle
 Digoxin elixir Aluminum Acetate Topical Solution
 Contain 4.5 to 5.25mg of digoxin per 100ml of elixir  Colorless and has a faint odor and sweetish, astringent taste
 Oral adult dose as cardiotonic agent: 1.5 mg on initial used in dermatologic lotions, creams and pastes
and 0.5 as maintenance therapy Aluminum Subacetate Topical Solution
 Obtained from leaves of digitalis lanata  Ratio of aluminum oxide to acetic acid
Tinctures  Subacetate solution: 1:2:3:5
 Hydroalcoholic solution prepared from vegetable materials  Acetate solution: 1:3:5:2
or from chemical substances  Subacetate is stronger of the two.
 Have a potency of 10-20%  Used as astringent wash and wet dressing
 Prepared by simple solution Calcium Hydroxide Topical Solution (Lime Water)
 Alcohol content ranging from 15-80%  More soluble in cold water than hot water
 Protects solution from microbial growth  Stored in well-filled tightly stoppered containers to
 Never mixed with liquids because the solute may determine the absorption of carbon monoxide and kept in
precipitate cool places
 Undergo photochemical changes: exposure to light  Only supernatant is dispersed
 Tightly stoppered  Used as astringent
 Stored in a light-resistant containers Sprays
Specific Methods of Preparation of Tincture  Aqueous or oleaginous solutions in the form of coarse
 Simple solution droplets or as finely divided solids applied topically to
 Chemical substances as active ingredient nasopharyngeal tract or to the skin
 Example: iodine tincture, thiomerosal Tincture  Break up a solution into small particles effectively sprayed
 Percolation of to facilitate the spraying of a powder
 "process P"  Advantage over conventional spray
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 Prevents drawback contamination of nasal fluids into  Tablets containing sodium fluoride 1.1 or 2.2 mg
the bottle after administration are chewed or swallowed as required
Vaginal and Rectal Solutions  Sodium fluoride and phosphoric acid gel and sodium
 Vaginal douches fluoride and phosphoric acid topical solution: dental caries
 For irrigation and cleansing of the vagina prophylactic
 Rectal solutions  Gel and solutions applied to teeth
 Retention enemas  Triamcinolone acetonide dental paste: topical anti-
 Corticosteroids or continuous drip as adjunctive inflammatory agent
treatment of some patients with ulcerative colitis  Applied to the oral mucous membranes as a 0.1%
 Evacuation enemas paste
 Used to cleanse the bowel Miscellaneous Solutions
 Agents: solution of sodium phosphate and sodium  Aromatic waters
biphosphate, glycerin and docusate potassium and  Clear, aqueous solution saturated with volatile oil
light mineral oil or other aromatic or volatile substances
Component of Douche Powders  Prepared from a number of volatile substances
 Boric acid or sodium borate including orange flower oil, peppermint oil, rose
 Astringents: (e.g.) potassium, alum, ammonium alum, zinc oil, anise oil, spearmint oil, wintergreen oil,
sulfate camphor and chloroform
 Antimicrobials: (e.g.) oxyquinolone sulfate, povidone  Very low solubility in water
iodine  Used for perfuming and for flavoring
 Quaternary ammonium compounds: (e.g.) benzethonium  Diluted acids
chloride  Aqueous solutions prepared by diluting the
 Detergents: (e.g) sodium lauryl sulfate corresponding concentrated acids with purified
 Oxidizing agents: sodium perborate water
 Salts: (e.g.) sodium citrate, sodium chloride  Concentrated acid expressed in: percent weight to
weight (w/w%): number of grams of solute per
 Aromatics: (e.g.) menthol, thymol, eucalyptol, methyl
100g of solution
salicylate, phenol
Topical Oral (Dental) Solutions  Concentrated HCl
 Not less than 15g and not more than 38g solute
 Benzocaine: topical anesthetic
per 100g of acid (36.5%w/w in strength)
 For temporary relief of pain, soreness, and
irritation in the mouth associated with teeth,  Diluted HCl
orthodontic appliances new or poorly fitting  9.3g and 10.3g solute per 100ml solution
dentures and canker sores (10%w/v in strength)
Spirits
 Camphorated parachlorophenol: dental anti-infective
 Used in dentistry by sterilization of deep root  Alcoholic or hydroalcoholic solutions of volatile substances
canals with or without medicinal substances
 Carbamide peroxide topical solution: dental anti-infective  High alcoholic concentration: over 60%
 Chemo-mechanical cleansing and darkening  Pharmaceutically as flavoring agent for therapeutic value of
agent the aromatic solute
 Cetylpyridinium chloride solution and cetylpyridinium  Prepared by simple solution, solution by maceration or
chloride lozenges: local anti-infective distillation
 A freshening mouth cleanser Methods of Preparations of Spirits
 Have benzyl alcohol as a local anesthetic in  Simple solution
soothing throat irritations  Aromatic ammonia spirit
 Erythrosine sodium topical solution and erythrosine sodium  Maceration
soluble tablets  Peppermint spirit
 Solution applied to teeth to reveal remaining  Chemical reaction
plaque tablet same affect but not swallowed  Ethyl nitrite spirit
 Eugenol: dental analgesic  Distillation
 Applied topically to dental cavities and dental  Brandy: distillation of fermented fruit of grapes
protective  Whisky: distillation of fermented malt cereal
 Pale yellow solution having an aromatic odor of grains
clove and a spicy taste Non-aqueous Solutions
 Lidocaine oral spray: topical dental anesthetic  Liniments
 Nystatin oral suspension: antifungal  Embrocation
 For oral fungal infections by retaining in the  Medicinal substitution intended to be rubbed on
mouth as long as possible before swallowing the skin
 Saliva substitutes: electrolytes in a carboxymethylcellulose  Alcohol as a vehicle: useful when rubefacient,
base counterirritant or penetrating action is desired
 Relief of dry mouth and throat in xerostomia  Oleaginous liniments are less irritating to the skin
than alcoholic liniments
 Sodium fluoride oral solution and tablets: dental caries
 For external use (not to be applied to the broken
prophylactic
skin and open wounds)
 Applied to the teeth or when drinking water that
 Applied with rubbing
does not contain adequate fluoride, a dilute
Types of Liniments
solution may be swallowed
 Alcoholic
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 Faster effect Example Preparations Prepared by Extraction Processes
 Ability to penetrate skin faster  Fluid extract
 To relieve pain  Too potent, too bitter tasting, unpalatable to be
 Example: Efficascent Oil accepted by the patient
 Oily  Modified by flavorants or sweetening agents
 Milder action than alcoholic liniment  Not used in medical practice
 Example: Omega Pain  Liquid preparations of vegetable drugs by
Non-aqueous Solutions percolation
 Collodions  Use: drug source component of other liquid
 A clear or slightly opalescent viscous liquid prepared dosage
by dissolving pyroxylin in a 3:1 solvent mixture of  3 processes:
ether and alcohol with or without added medicinal  Process A
substances  Entails exhaustive percolation with an alcoholic
 For external use: applied to skin with a fine camel’s or hydroalcoholic menstruum
hair brush or glass applicator, the solvent rapidly  Example: senna fluidextract
evaporates, leaving a filmy residue of pyroxylin  Process B or D
 Forms a protectant film on application to the skin and  Used in the preparation of fluidextract with
volatilization of the solvent boiling water as the menstruum and alcohol
 Highly volatile and flammable generally added to the concentrated percolate as
 Useful in holding the edges of an incised wound preservative.
together  A heat resistant or metallic percolator is used.
 Flexible collodion  Example: Aromatic cascara sagrada
 Prepared by adding 2% camphor (makes product  Process C and E
water proof) and 3% castor oil  Intended to facilitate total drug extraction by
 Castor oil is the cause of its flexibility collecting 1000ml of percolate from each 1000g
 Apply the coating over bandages or stitched of drug uses long marrow column of drug and
incisions to make them water proof and to protect percolation under pressure
them from external stress Official Preparation
 Salicylic collodion  Glycyrrhiza fluidextract: Licorice Root
 10% solution of salicylic acid in flexible  Fluidextract: flavoring agent
collodion  Eriodietyon fluidextract : Yerba Santa
 Used for its keratolytic effects, especially in  Fluidextract: cathartic
removal of corns from the toes  Cascara Sagrada Fluidextract: Rhammus Pushiana
 Irritates normal healthy skin Fluidextract
 Pyroxylin  Aromatic Cascara Sagrada Fluidextract
 Soluble gun cotton, collodion cotton  Senna Fluidextract – Fluidextractum Sennae
 Obtained by the action of a mixture of nitric and Example Preparations Prepared by Extraction Processes
sulfuric acids on cotton, consists chiefly of cellulose  Extracts
tetranitrate  Concentrated preparations of vegetable or animal
 1 part soluble in 25 parts of a mixture of 3 volumes of drugs obtained by the removal of the active
ether and 1 volume of alcohol constituents of the respective drugs with suitable
 Also soluble in acetone and glacial acetic acid solvent
 Extraction  Syrupy
 Withdrawal of desired constituents from crude drugs  Add solvent system to drug, either macerate or
through the use of selected solvents in which the percolate
desired selected constituents are soluble  Obtain through evaporation
 Crude drugs: vegetable or animal drugs that have  2 to 6 times more potent than crude drug
undergone no other processes than collodion, cleaning  Extract are made in 3 forms:
and drying  Syrupy semiliquid
 Extractives: product of extraction containing varying o 20 ml of solvent system is remained
numbers of constituents removing all or most of the menstruum
 In drug extraction:  Pilular plastic consistency
 Menstruum: solvent or solvent mixture o Plastic consistency, nearly all solvent
o Hydroalcoholic mixture: inherent protection
has evaporated
against microbial contamination and helps o Preferred in compounding a caustic
prevent separation of extracted material on
dosage form: ointment, paste, or pliable
standing
material facilitates compounding
o Glycerin
 Powdered extract: dry extract by removal of all
 Cosolvent with water or alcoholic menstruum
menstruum and prevent inert materials o Vegetable drug material which are
from precipitating upon standing
starchy
 Prevents separation of lannin and
o Preferred in compounding of powders
tannin oxidation products in extractives
capsules and tablets
 Contributes to the stability of
Extractive
pharmaceutical extractive
 Marc: plant residue exhausted

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 Drug products obtained by extracting animal or vegetable  Percolation: soaking using percolator
drug with suitable solvent system  Infusion: hot or cold water
 Methods of preparation:  Digestion: applying gentle heat
 Maceration: soaking in solvent Nasal Decongestant Solution
 Decoction: boiling for 15 minutes  Treatment of rhinitis of the common cold, for sinusitis

Table 13.8: Examples of Medicated Elixirs by Category


Elixir Commercial Product Comments
Adrenocortical steroid
 Dexamethasone Dexamethasone Elixir Synthethic analogue of hydrocortisone, about 30 times
more potent. Commercial elixir is packaged with a
calibrated dropper for accurate measurement of small
doses; intended primarily for children; also has utility
for adults with trouble swallowing tablets. Used for
many indications: rheumatoid arthritis, skin disease,
allergies, inflammatory conditions. Commercial product
contains 5% alcohol.
Analgesic, antipyretic
 Acetaminophen Children’s Tylenol Elixir Reduction of pain and lowering of fever particularly in
patients sensitive to or unable to take aspirin. Elixir
especially useful for pediatric patients and is alcohol
free.
Anticholinergic,antispasmodic
 Hyoscyamine sulfate Levsin Elixir Used to control gastric secretions, visceral spasm,
hypermotility, abdominal cramps. Commercial product
contains 20%
Antihistamine
 Diphenhydramine HCl Elixir Diphenhydramine HCl Elixir Antihistamines are used for a variety of allergic
reactions e.g. perennial and seasonal allergic rhinitis,
allergic skin manifestations of urticaria. Reactions of
insect bites. Commercial product contains 5.6% alcohol.
Antipsychotic
 Fluphenazine HCl Fluphenazine HCl Elixir Management of psychotic disorders.
Cardiotonic
 Digoxin Lanoxin Pediatric Elixir Among other effects, increase force of myocardial
contraction. Used in congestive heart failure, atrial
fibrillation, other cardiac conditions. Commercial
product contains 10% alcohol.
Sedative, hypnotics
 Butabarbital sodium Butisol sodium Elixir In low dosage, sedatives;in higher dosage,hypnotics.
Butabarbital sodium elixir contains 7% alcohol;
 Phenobarbital Phenobarbital Elixir Phenobarbital elixir contains 14% alcohol.

Table 13.9: Examples of Solutions Applied to Skin


Solution Corresponding Commercial Vehicle Category and Comments
Product
Aluminum acetate - Aqueous Astringent
Aluminum subacetate - Aqueous Astringent
Calcium hydroxide - Aqueous Astringent
(limewater)
Chlorhexidine Gluconate Hibiclens Skin Cleanser Skin wound and general skin cleanser, surgical
(Stuart) scrub, preoperative skin preparation. Effective for
gram-positive and gram-negative bacteria such as
Pseudomonas aeruginosa.
Clindamycin phosphate Cleocin T topical Solution Isopropyl alcohol, water Treatmentof acne vulgaris.
(Pharmacia & Upjohn)
Clotrimazole Lotrimin Solution (Schering) PEG 400 Antifungal
Coal tar (liquor carbonis - Alcohol Antieczematic; antipsoriatic
detergens; LCD)
Erythromycin Erymax Topical Solution Polyethylene glycol/ acetone/ Treatment of acne vulgaris.
(Allergan Helbert) alcohol
Fluocinolone acetonide Synalar Topical Solution Propylene glycol Adrenocortical steroid (topical anti-
(Syntex) inflammatory)
Fluorouracil Efudex Topical Solution Propylene glycol Antineoplastic (actinic keratoses)
(Roche)

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Hydrogen peroxide - Aqueous Topical anti-infective
Hydroquinone Melanex Topical Solution Water, alcohol, propylene temporary bleaching of hyperpigmented skin,
(Neutrogena Dermatologies) glycol e.g., chloasma, melasma
Minoxidil Rogaine Topical Solution Alcohol, water, propylene Long-term topical treatment of male pattern
(Pharmacia & Upjohn) glycol baldness by stimulating hair growth.
Povidone iodine Betadine Solution (Purdue Aqueous Topical anti-infective
Frederick)
Tolnaftate Tinactin Solution (Schering- Polyethylene glycol Topical antifungal
Plough)

Table 13.10: Examples of Tinctures Applied to the Skin


Tincture Vehicle Category and Comments
Green Soap Tincture Alcohol Detergent. Also contains 2% lavender oil as
perfume.
Iodine Tincture Alcohol, water Topical anti-infective
Compound Benzoin Tincture Alcohol Topical protectant. Prepared by maceration in
alcohol.

Pharmaceutical Dosage
Chapter 13 – Quiz: Try it!

Identify:
(1) _______________ Clear, sweetened hydroalcoholic solutions for oral use
(2) _______________ Alcoholic or hydroalcoholic solutions of volatile substances with or without medicinal substances
(3) _______________ Clear, aqueous solution saturated with volatile oil or other aromatic or volatile substances
(4) _______________ Aqueous solutions prepared by diluting the corresponding concentrated acids with purified water
(5) _______________ Drug products obtained by extracting animal or vegetable drug with suitable solvent system
(6) _______________ Concentrated preparations of vegetable or animal drugs obtained by the removal of the active constituents of the
respective drugs with suitable solvent
(7) _______________ Aqueous or oleaginous solutions in the form of coarse droplets or as finely divided solids applied topically to
nasopharyngeal tract or to the skin
(8) _______________ Hydroalcoholic solution prepared from vegetable materials or from chemical substances
(9) _______________ Treatment of rhinitis of the common cold, for sinusitis

Matching Type:
Set 1
(A) Calcium Hydroxide Topical Solution (Lime Water)
(B) Compound Benzoin Tincture
(C) Thimerosal Tincture
(D) Aluminum Acetate Topical Solution
(E) Iodine Tincture
(F) Aluminum Subacetate Topical Solution
(G) Vaginal douches
(H) Evacuation enemas
(I) Rectal solutions

(a) ___ Serves as delivery vehicle of podophyllum in treatment of visceral warts


(b) ___ Used as a protectant to toughen skin in treatment of bed sores, ulcers cracked nipples and tissues of the lips and anus
(c) ___ Stored in well-filled tightly stoppered containers to determine the absorption of carbon monoxide and kept in cool places
(d) ___ For irrigation and cleansing of the vagina
(e) ___ Retention enemas
(f) ___ Popular local anti-infective agent
(g) ___ Colorless and has a faint odor and sweetish, astringent taste used in dermatologic lotions, creams and pastes
(h) ___ Monoethanolamine and ethylenediamine are used as stabilizers
(i) ___ Effective because of its chelating action on metallic impurities that may be present at time of preparation
5
(j) ___ Used as astringent
(k) ___ Used as astringent wash and wet dressing
(l) ___ Used to cleanse the bowel

Set 2
(A) Aromatics
(B) Astringents
(C) Antimicrobials
(D) Quaternary ammonium compounds
(E) Detergents
(F) Oxidizing agents
(G) Salts
(H) Component of douche powders

(a) ___ Oxyquinolone sulfate, povidone iodine


(b) ___ Boric acid or sodium borate
(c) ___ Sodium citrate, sodium chloride
(d) ___ Benzethonium chloride
(e) ___ Sodium perborate
(f) ___ Sodium lauryl sulfate
(g) ___ Menthol, thymol, eucalyptol, methyl salicylate, phenol
(h) ___ Potassium, alum, ammonium alum, zinc sulfate

Set 3
(A) Benzocaine
(B) Camphorated parachlorophenol
(C) Carbamide peroxide topical solution
(D) Cetylpyridinium chloride solution and cetylpyridinium chloride lozenges
(E) Erythrosine sodium topical solution and erythrosine sodium soluble tablets
(F) Eugenol
(G) Lidocaine oral spray
(H) Nystatin oral suspension
(I) Saliva substitutes
(J) Sodium fluoride oral solution and tablets
(K) Triamcinolone acetonide dental paste
(L) Sodium fluoride and phosphoric acid gel and sodium fluoride and phosphoric acid topical solution

(a) ___ Topical anti-inflammatory agent


(b) ___ Topical anesthetic
(c) ___ Electrolytes in a carboxymethylcellulose base
(d) ___ Dental anti-infective
(e) ___ Local anti-infective
(f) ___ Dental caries prophylactic
(g) ___ Dental analgesic
(h) ___ Topical dental anesthetic

Odd Man Out: Put a check that does not belong to the group.
(A) ___ Adrenocortical steroid ___ Children’s Tylenol ___ Elixir ___ Dexamethasone Elixir
(B) ___ Phenobarbital ___ Butisol Sodium Elixir ___ Hypnotics ___ Fluphenazine HCl
(C) ___ Antipsychotic ___ Hyoscyamine sulfate ___ Anticholinergic ___ Levsin Elixir
(D) ___ Anticholinergic ___ Children’s Tylenol Elixir ___ Antipyretic ___ Acetaminophen
(E) ___ Detergent ___ Alcohol, water ___ Green Soap ___ Tincture Alcohol

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