4 - Liquid Dosage Forms Single Phase Systems - Part 1

Proverbs 16:3

c. Solutions

[Liquid Dosage Forms Single Phase Systems

Liquid preparations containing one or more substances dissolved in a suitable solvent.

a. Suspensions
b. Emulsions
c. Solutions
d. Syrups

• Homogenous

• Immediate availability for absorption

• Flexibility

[Liquid Dosage Forms Single Phase Systems

Advantages of Solutions [3]

• Bulky

• Difficulty to mask unpleasant taste / odor

• Less stable than solid dosage forms

• Interact with other components

[Liquid Dosage Forms Single Phase Systems

Disadvantages [4]

a. Leaching

[Liquid Dosage Forms Single Phase Systems

Container to solution

a. Leaching

b. Sorption

b. Sorption

[Liquid Dosage Forms Single Phase Systems

Solution to container

a. Leaching

b. Sorption

a. Very soluble (VS)

[Parts of Solvent Required for 1 P]

< 1

a. Very soluble (VS)

b. Freely soluble (FS)

c. Soluble

d. Sparingly soluble (SPS)

e. Slightly soluble (SS)

f. Very slightly soluble (VSS)

g. Practically insoluble (PI)

b. Freely soluble (FS)

[Parts of Solvent Required for 1 P]

1 – 10

a. Very soluble (VS)

b. Freely soluble (FS)

c. Soluble

d. Sparingly soluble (SPS)

e. Slightly soluble (SS)

f. Very slightly soluble (VSS)

g. Practically insoluble (PI)

c. Soluble

[Parts of Solvent Required for 1 P]

10 – 30

a. Very soluble (VS)

b. Freely soluble (FS)

c. Soluble

d. Sparingly soluble (SPS)

e. Slightly soluble (SS)

f. Very slightly soluble (VSS)

g. Practically insoluble (PI)

d. Sparingly soluble (SPS)

[Parts of Solvent Required for 1 P]

30 – 100

a. Very soluble (VS)

b. Freely soluble (FS)

c. Soluble

d. Sparingly soluble (SPS)

e. Slightly soluble (SS)

f. Very slightly soluble (VSS)

g. Practically insoluble (PI)

e. Slightly soluble (SS)

[Parts of Solvent Required for 1 P]

100 – 1,000

a. Very soluble (VS)

b. Freely soluble (FS)

c. Soluble

d. Sparingly soluble (SPS)

e. Slightly soluble (SS)

f. Very slightly soluble (VSS)

g. Practically insoluble (PI)

f. Very slightly soluble (VSS)

[Parts of Solvent Required for 1 P]

1,000 – 10,000

a. Very soluble (VS)

b. Freely soluble (FS)

c. Soluble

d. Sparingly soluble (SPS)

e. Slightly soluble (SS)

f. Very slightly soluble (VSS)

g. Practically insoluble (PI)

g. Practically insoluble (PI)

[Parts of Solvent Required for 1 P]

> 10,000

a. Very soluble (VS)

b. Freely soluble (FS)

c. Soluble

d. Sparingly soluble (SPS)

e. Slightly soluble (SS)

f. Very slightly soluble (VSS)

g. Practically insoluble (PI)

c. Water

[Pharmaceutical Solvents / Diluting Agents]

Most common pharmaceutical solvent.

a. Water
b. Alcohol
c. Glycerin

d. Propylene glycol

e. Fixed oils

• Purified Water

• Water for Injection

• Sterile Water for Injection

• Bacteriostatic Water for Injection

• Sterile Water for Inhalation

• Sterile Water for Irrigation

Official Types of Water [6]

c. Purified Water

[Official Types of Water]

Obtained by distillation, ion-exchange, or reverse osmosis.

a. Tap water
b. Mineral water
c. Purified Water
d. Distilled water only

• Distillation

• Ion-exchage

• Reverse Osmosis

[Official Types of Water]

Purified Water is obtained by:

a. Distillation, ion-exchange, or reverse osmosis
b. Filtration, sedimentation, or chlorination
c. Boiling, freezing, or evaporation
d. Precipitation, crystallization, or centrifugation

c. Purified Water

[Official Types of Water]

Used for aqueous dosage forms except parenteral and other sterile solutions

a. Tap water
b. Mineral water
c. Purified Water
d. Distilled water only

b. Water for Injection

[Official Types of Water]

Most commonly used

a. Purified Water
b. Water for Injection
c. Sterile Water for Injection
d. Bacteriostatic Water for Injection

b. Water for Injection

[Official Types of Water]

Pyrogen free water

a. Purified Water
b. Water for Injection
c. Sterile Water for Injection
d. Bacteriostatic Water for Injection

b. Water for Injection

[Official Types of Water]

Obtained by distillation or reverse osmosis

a. Purified Water
b. Water for Injection
c. Sterile Water for Injection
d. Bacteriostatic Water for Injection

• Distillation

• Reverse osmosis

[Official Types of Water]

Water for Injection is obtained by:

a. Distillation or ion-exchange
b. Distillation or reverse osmosis
c. Ion-exchange or reverse osmosis
d. Filtration or sedimentation

c. Sterile Water for Injection

[Official Types of Water]

WFI that is sterilized for single dose preparations not larger than 1L

a. Purified Water
b. Water for Injection
c. Sterile Water for Injection
d. Bacteriostatic Water for Injection

c. Sterile Water for Injection

[Official Types of Water]

Has an endotoxin limit of not more than (NMT) 0.25 USP units / mL

a. Purified Water
b. Water for Injection
c. Sterile Water for Injection
d. Bacteriostatic Water for Injection

a. 0.25 USP units / mL

[Official Types of Water]

The endotoxin limit for Sterile Water for Injection is NMT:

a. 0.25 USP units / mL
b. 0.5 USP units / mL
c. 1.0 USP units / mL
d. 2.0 USP units / mL

Bacteriostatic Water for Injection

[Official Types of Water]

SWFI + antimicrobial agent (Benzyl OH)

a. Purified Water
b. Water for Injection
c. Sterile Water for Injection
d. Bacteriostatic Water for Injection

d. Bacteriostatic Water for Injection

[Official Types of Water]

For multiple dose preparation

a. Purified Water
b. Water for Injection
c. Sterile Water for Injection
d. Bacteriostatic Water for Injection

c. Neonates

• WARNING: NOT for neonates

[Official Types of Water]

Bacteriostatic Water for Injection is NOT for use in:

a. Adults

b. Children

c. Neonates

d. Elderly

c. Benzyl OH

[NOTES]

Undergoes glycine conjugation.

a. Phenol
b. Chlorobutanol
c. Benzyl OH
d. Methylparaben

b. Gasping syndrome

[NOTES]

Benzyl alcohol accumulation leads to:

a. Gray baby syndrome
b. Gasping syndrome
c. Red man syndrome
d. Stevens-Johnson syndrome

c. Sulfation

[NOTES]

Neonates rely on _______

a. Glucuronidation
b. Glycine conjugation
c. Sulfation
d. Acetylation

b. Glycine conjugation

[NOTES]

Neonates lack _________ pathway

a. Glucuronidation

b. Glycine conjugation

c. Sulfation

d. Acetylation

Alcohol

[Pharmaceutical Solvents / Diluting Agents]

Also known as:

• Ethyl Alcohol

• Ethanol (C2H5OH)

a. Water
b. Alcohol
c. Glycerin

d. Propylene glycol

e. Fixed oils

a. Alcohol

[Pharmaceutical Solvents / Diluting Agents]

Can dissolve water-insoluble substances

a. Water
b. Alcohol
c. Glycerin

d. Propylene glycol

e. Fixed oils

a. 0.5%

[Alcohol Content Limit Proposed by FDA to Manufacturers of OTC Oral Products]

<6 yrs old

a. 0.5%

b. 5%

c. 10%

b. 5%

[Alcohol Content Limit Proposed by FDA to Manufacturers of OTC Oral Products]

6 – 12 yrs old

a. 0.5%

b. 5%

c. 10%

c. 10%

[Alcohol Content Limit Proposed by FDA to Manufacturers of OTC Oral Products]

>12 yrs old

a. 0.5%

b. 5%

c. 10%

• Alcohol, USP

• Dehydrated Alcohol

• Rubbing Alcohol

• Isopropyl Rubbing Alcohol

Types of Alcohol [4]

a. Alcohol, USP

[Types of Alcohol]

94.9% to 96% v/v ethanol

a. Alcohol, USP

b. Dehydrated Alcohol

c. Rubbing Alcohol

d. Isopropyl Rubbing Alcohol

b. Dehydrated Alcohol

[Types of Alcohol]

NLT 99.5% v/v ethanol

a. Alcohol, USP

b. Dehydrated Alcohol

c. Rubbing Alcohol

d. Isopropyl Rubbing Alcohol

c. Rubbing Alcohol

[Types of Alcohol]

70% v/v ethanol, the remainder consisting of water and denaturant

a. Alcohol, USP

b. Dehydrated Alcohol

c. Rubbing Alcohol

d. Isopropyl Rubbing Alcohol

• 8 parts acetone

• 1.5 parts methyl isobutyl ketone

• 100 parts ethyl alcohol

The Denaturant in Rubbing Alcohol consists of:

a. 8 parts acetone, 1.5 parts methyl isobutyl ketone, 100 parts ethyl alcohol
b. 10 parts methanol, 5 parts benzene
c. 5 parts acetone, 2 parts methyl alcohol
d. 8 parts isopropyl alcohol, 1.5 parts water

d. Isopropyl Rubbing Alcohol

[Types of Alcohol]

70% v/v isopropyl alcohol, the remainder consisting of water

a. Alcohol, USP

b. Dehydrated Alcohol

c. Rubbing Alcohol

d. Isopropyl Rubbing Alcohol

c. Glycerin

[Pharmaceutical Solvents / Diluting Agents]

Clear, syrupy liquid with a sweet taste

a. Water
b. Alcohol
c. Glycerin

d. Propylene glycol

e. Fixed oils

c. Glycerin

[Pharmaceutical Solvents / Diluting Agents]

Clear, syrupy liquid with a sweet taste

a. Water
b. Alcohol
c. Glycerin

d. Propylene glycol

e. Fixed oils

c. Glycerin

[Pharmaceutical Solvents / Diluting Agents]

Miscible with both water and alcohol

a. Water
b. Alcohol
c. Glycerin

d. Propylene glycol

e. Fixed oils

c. Glycerin

[Pharmaceutical Solvents / Diluting Agents]

Can cause protein denaturation

a. Water
b. Alcohol
c. Glycerin

d. Propylene glycol

e. Fixed oils

• Humectant

• Emollient

• Preservative

[Pharmaceutical Solvents / Diluting Agents]

Glycerin has which of the following qualities?

a. Humectant, emollient, and preservative
b. Antiseptic, disinfectant, and solvent
c. Emulsifier, stabilizer, and thickener
d. Antioxidant, chelator, and buffer

d. Propylene glycol

[Pharmaceutical Solvents / Diluting Agents]

• Viscous liquid

• Miscible with both water and alcohol

a. Water
b. Alcohol
c. Glycerin

d. Propylene glycol

e. Fixed oils

d. Propylene glycol

[Pharmaceutical Solvents / Diluting Agents]

Can be used as substitute for glycerin

a. Water
b. Alcohol
c. Glycerin

d. Propylene glycol

e. Fixed oils

e. Fixed oils

[Pharmaceutical Solvents / Diluting Agents]

Usually of vegetable origin

a. Water
b. Alcohol
c. Glycerin

d. Propylene glycol

e. Fixed oils

e. Fixed oils

[Pharmaceutical Solvents / Diluting Agents]

Can also use mineral oil for stability

a. Water
b. Alcohol
c. Glycerin

d. Propylene glycol

e. Fixed oils

b. Rancidity

[Pharmaceutical Solvents / Diluting Agents]

The main problem associated with fixed oils is:

a. Evaporation
b. Rancidity
c. Solidification
d. Crystallization

• Corn oil

• Cottonseed oil

• Peanut oil

• Sesame oil

Example of Fixed Oils [4]

• Aromatic / Medicated Waters

• Diluted Acids

• Topical Solutions

  • Astringents

  • Anti-infectives

• Douches

• Enemas

  • Evacuation Enema

  • Retention Enema

• Mouthwashes

Classification of Aqueous Solutions [6]

b. Aqueous solutions

Solvent or vehicle is mainly water.

a. Alcoholic solutions
b. Aqueous solutions
c. Glycerin solutions
d. Oily solutions

Aromatic/Medicated Waters

[Classification of Aqueous Solutions]

Clear, saturated aqueous solutions of volatile oils or other aromatic substances

a. Aromatic / Medicated Waters

b. Diluted Acids

c. Topical Solutions

d. Douches

e. Enemas

f. Mouthwashes

a. Aromatic / Medicated Waters

[Classification of Aqueous Solutions]

Used as Flavored or perfumed vehicle for drugs

a. Aromatic / Medicated Waters

b. Diluted Acids

c. Topical Solutions

d. Douches

e. Enemas

f. Mouthwashes

a. Distillation

[Method of Preparing Aromatic / Medicated Water]

Universal but not practical

a. Distillation

b. Simple solution

a. Distillation

[Method of Preparing Aromatic / Medicated Water]

Used for preparing:

• Stronger Rose Water

• Orange Flower Water

a. Distillation

b. Simple solution

b. Simple solution

[Method of Preparing Aromatic / Medicated Water]

More economical and simpler

a. Distillation

b. Simple solution

b. Simple solution

[Method of Preparing Aromatic / Medicated Water]

With or without dispersant (Ex.Talc)

a. Distillation

b. Simple solution

b. Talc

[Method of Preparing Aromatic / Medicated Water]

In the simple solution method, a dispersant such as _______ may be used.

a. Sugar
b. Talc
c. Starch
d. Gelatin

b. Salting out

[Classification of Aqueous Solutions]

Formation of an insoluble layer at the top of aromatic waters.

a. Precipitation
b. Salting out
c. Crystallization
d. Flocculation

Diluted Acids

[Classification of Aqueous Solutions]

Prepared by diluting the corresponding concentrated acids with purified watergs

a. Aromatic / Medicated Waters

b. Diluted Acids

c. Topical Solutions

d. Douches

e. Enemas

f. Mouthwashes

c. % w/v

Diluted acids are expressed on a _______ basis.

a. % w/w
b. % v/v
c. % w/v
d. Molar basis

b. Diluted Acids

[Classification of Aqueous Solutions]

Most have a strength of 10% w/v with exception of diluted acetic acid (6% w/v)

a. Aromatic / Medicated Waters

b. Diluted Acids

c. Topical Solutions

d. Douches

e. Enemas

f. Mouthwashes

c. 6% w/v

[Classification of Aqueous Solutions]

Most diluted acids have a strength of 10% w/v, with the exception of diluted acetic acid which has a strength of _____

a. 2% w/v
b. 4% w/v
c. 6% w/v
d. 8% w/v

b. Diluted HCl, USP

[Classification of Aqueous Solutions]

Used for the treatment of achlorhydria.

a. Diluted Acetic Acid
b. Diluted HCl, USP
c. Diluted Sulfuric Acid
d. Diluted Nitric Acid

b. Diluted HCl, USP

[Classification of Aqueous Solutions]

Should be taken with a straw to avoid enamel damage and oral irritation

a. Diluted Acetic Acid
b. Diluted HCl, USP
c. Diluted Sulfuric Acid
d. Diluted Nitric Acid

• Enamel damage

• Oral irritation

[Classification of Aqueous Solutions]

Diluted HCl, USP should be taken with a straw to avoid:

a. Nausea
b. Enamel damage and oral irritation
c. Stomach upset
d. Tooth discoloration

• Al Acetate (Burrow’s Solution)

• CaOH (Limewater or Liquor calcis)

• Coal tar (Liquor carbonis detergens)

[Topical Solutions - Astringents]

Example of Topical Solution that is ASTRINGENT [3]

a. Al Acetate (Burrow’s Solution)

[Topical Solutions - Astringents]

5% aqueous solution

a. Al Acetate (Burrow’s Solution)

b. CaOH (Limewater or Liquor calcis)

c. Coal tar (Liquor carbonis detergens)

a. Al Acetate (Burrow’s Solution)

[Topical Solutions - Astringents]

Tx for contact dermatitis

a. Al Acetate (Burrow’s Solution)

b. CaOH (Limewater or Liquor calcis)

c. Coal tar (Liquor carbonis detergens)

b. CaOH (Limewater or Liquor calcis)

[Topical Solutions - Astringents]

0.14% aqueous solution
a. Al Acetate (Burrow’s Solution)

b. CaOH (Limewater or Liquor calcis)

c. Coal tar (Liquor carbonis detergens)

b. CaOH (Limewater or Liquor calcis)

[Topical Solutions - Astringents]

More soluble in cold water

a. Al Acetate (Burrow’s Solution)

b. CaOH (Limewater or Liquor calcis)

c. Coal tar (Liquor carbonis detergens)

c. Coal tar (Liquor carbonis detergens)

[Topical Solutions - Astringents]

20% alcoholic solution

a. Al Acetate (Burrow’s Solution)

b. CaOH (Limewater or Liquor calcis)

c. Coal tar (Liquor carbonis detergens)

c. Coal tar (Liquor carbonis detergens)

[Topical Solutions - Astringents]

Black viscous liquid

a. Al Acetate (Burrow’s Solution)

b. CaOH (Limewater or Liquor calcis)

c. Coal tar (Liquor carbonis detergens)

c. Coal tar (Liquor carbonis detergens)

[Topical Solutions - Astringents]

Tx for eczema

a. Al Acetate (Burrow’s Solution)

b. CaOH (Limewater or Liquor calcis)

c. Coal tar (Liquor carbonis detergens)

• Hydrogen Peroxide (Agua oxinada)

• Povidone-Iodine (Betadine)

• Chlorhexidine gluconate

• Thimerosal (Old Merthiolate)

[Topical Solutions - Anti-infectives]

Example of Topical Solution that is ANTI-INFECTIVES [4]

• 10 volumes

• 20 volume

3% Hydrogen Peroxide (Agua oxinada) → _____ volumes

6% Hydrogen Peroxide (Agua oxinada) → _____ volumes

a. 3% (10 volumes) Hydrogen Peroxide

[Topical Solutions - Anti-infectives]

Used as antiseptic / anti-infective

a. 3% (10 volumes) Hydrogen Peroxide

b. 6% (20 volumes) Hydrogen Peroxide

b. 6% (20 volumes) Hydrogen Peroxide

[Topical Solutions - Anti-infectives]

Used as a bleach

a. 3% (10 volumes) Hydrogen Peroxide

b. 6% (20 volumes) Hydrogen Peroxide

b. Povidone-Iodine (Betadine)

[Topical Solutions - Anti-infectives]

Used as surgical scrub / anti-infective

a. Chlorhexidine gluconate 4% aqueous solution

b. Chlorhexidine gluconate 0.12% solution

c. Thimerosal (Old Merthiolate)

b. Chlorhexidine gluconate 0.12% solution

[Topical Solutions - Anti-infectives]

Used as an antiplaque mouthwash

a. Chlorhexidine gluconate 4% aqueous solution

b. Chlorhexidine gluconate 0.12% solution

c. Thimerosal (Old Merthiolate)

b. 0.1%

[Topical Solutions - Anti-infectives]

The concentration of Thimerosal (Old Merthiolate) solution is:

a. 0.01%
b. 0.1%
c. 1%
d. 10%

c. Thimerosal

[Topical Solutions - Anti-infectives]

Old Merthiolate contains which active ingredient?

a. Benzalkonium chloride

b. Povidone-iodine

c. Thimerosal

d. Chlorhexidine

a. Benzalkonium chloride

[Topical Solutions - Anti-infectives]

New Merthiolate contains which active ingredient?

a. Benzalkonium chloride

b. Povidone-iodine

c. Thimerosal

d. Chlorhexidine

a. Douches

[Classification of Aqueous Solutions]

Aqueous solutions directed against a part or into a cavity of the body

a. Douches

b. Enemas

c. Gargles

d. Irrigations

a. Douches

[Classification of Aqueous Solutions]

Used as a cleansing or antiseptic agent.

a. Douches

b. Enemas

c. Gargles

d. Irrigations

• Eye douche

• Pharyngeal douche

• Vaginal douche

[Classification of Aqueous Solutions]

Example of Douches [3]

a. Chlorhexidine gluconate (pH Care)

[Classification of Aqueous Solutions]

Example of a vaginal douche.

a. Chlorhexidine gluconate (pH Care)
b. Povidone-iodine (Betadine)
c. Hydrogen peroxide (Agua oxinada)
d. Benzalkonium chloride (Merthiolate)

c. Chlorhexidine gluconate

[Classification of Aqueous Solutions]

pH Care

a. Povidone-iodine
b. Hydrogen peroxide
c. Chlorhexidine gluconate
d. Benzalkonium chloride

b. Enemas

[Classification of Aqueous Solutions]

Aqueous solutions administered rectally for either local or systemic effect

a. Douches

b. Enemas

c. Gargles

d. Irrigations

• Evacuation Enema

• Retention Enema

[Classification of Aqueous Solutions]

Types of Enema [2]

a. Evacuation Enema

[Types of Enema]

To evacuate the bowel

a. Evacuation Enema

b. Retention Enema

b. Fleet Enema (NaPO₄ Enema; Saline laxative)

[Classification of Aqueous Solutions]

Example of Evacuation Enema

a. Sulfasalazine enema
b. Fleet Enema (NaPO₄ Enema; Saline laxative)
c. Chlorhexidine solution
d. Povidone-iodine solution

a. Sodium phosphate

[Classification of Aqueous Solutions]

Fleet Enema contains ______ as an active ingredient

a. Sodium phosphate

b. Sulfasalazine

c. Glycerin

d. Mineral oil

a. Saline laxative

[Classification of Aqueous Solutions]

Fleet Enema is classified as:

a. Saline laxative

b. Stimulant laxative

c. Bulk-forming laxative

d. Emollient laxative

b. Retention Enema

[Types of Enema]

Retained in the intestine for systemic absorption

a. Evacuation Enema

b. Retention Enema

b. Retention Enema

[Types of Enema]

Used in the tx of local or systemic disease

a. Evacuation Enema

b. Retention Enema