4 - Manufacturing of Liquid Dosage Forms

Proverbs 16:3

• Mixing Tank

• Mix

Equipment for Manufacturing Liquid Dosage Forms [2]

b. Mixing Tank

[Equipment for Manufacturing Liquid Dosage Forms]

Equipment that is jacketed to allow heating or cooling of contents, made of stainless steel
a. Mixer
b. Mixing Tank
c. Colloid Mill
d. Homogenizer

b. SS 304

[Equipment for Manufacturing Liquid Dosage Forms]

Stainless steel grade composed of 18% Cr and 8% Ni
a. SS 316
b. SS 304
c. SS 410
d. SS 430

c. SS 316

[Equipment for Manufacturing Liquid Dosage Forms]

Stainless steel grade composed of 16% Cr, 10% Ni and 2% Mo
a. SS 304
b. SS 410
c. SS 316
d. SS 430

c. SS 316

[Equipment for Manufacturing Liquid Dosage Forms]

Considered as the most inert stainless steel grade

a. SS 304
b. SS 410
c. SS 316
d. SS 430

• Mechanical Stirrer

• Colloid Mill

• Homogenizer

• Ultrasonifier

Type of Mixers [4]

b. Mechanical Stirrer

[Equipment for Manufacturing Liquid Dosage Forms - Type of Mixers]

Type of mixer with various impellers mounted on shafts
a. Colloid Mill
b. Mechanical Stirrer
c. Homogenizer
d. Ultrasonifier

b. Vortex formation

[Equipment for Manufacturing Liquid Dosage Forms - Type of Mixers]

Problem encountered in mechanical stirrer mixers
a. Cavitation
b. Vortex formation
c. Segregation
d. Foaming

• Buffers

• Slanted (45°)

[Equipment for Manufacturing Liquid Dosage Forms - Type of Mixers]

Remedy for vortex formation in mechanical stirrer mixers
a. Increase speed
b. Buffers, slanted (45°)
c. Add surfactant
d. Reduce temperature

c. Colloid Mill

[Equipment for Manufacturing Liquid Dosage Forms - Type of Mixers]

Mixer used for comminution of solids and dispersion of suspensions
a. Mechanical Stirrer
b. Homogenizer
c. Colloid Mill
d. Ultrasonifier

c. Homogenizer

[Equipment for Manufacturing Liquid Dosage Forms - Type of Mixers]

Mixer that compresses liquid with high pressure by a strong spring mechanism

a. Colloid Mill
b. Ultrasonifier
c. Homogenizer
d. Mechanical Stirrer

c. Homogenizer

[Equipment for Manufacturing Liquid Dosage Forms - Type of Mixers]

Mixer used for emulsification
a. Colloid Mill
b. Ultrasonifier
c. Homogenizer
d. Mechanical Stirrer

d. Ultrasonifier

[Equipment for Manufacturing Liquid Dosage Forms - Type of Mixers]

Mixer that uses ultrasonic energy to produce emulsion
a. Homogenizer
b. Colloid Mill
c. Mechanical Stirrer
d. Ultrasonifier

1. APIs

2. Solvent or Vehicle

3. Buffers

4. Viscosity Enhancers

5. Humectants

6. Colorants, Flavors, and Fragrances

7. Stability Enhancers

Components of Liquid Dosage Forms include _____ [7]

• Preservative

• Antioxidants

Stability enhancer include _____ [2]

c. Preservative

[Stability Enhancer]

Stability enhancer that prevents microbial growth, effective at low concentration against all possible microorganisms
a. Buffer
b. Humectant
c. Preservative
d. Viscosity Enhancer

a. True

[Stability Enhancer]

Preservative are , effective at low concentration against all possible microorganisms

a. True

b. False

• Alcohols:

  • Ethanol

  • Propylene glycol

  • Chlorobutanol

  • Phenyl alcohol

• Acids:

  • Benzoic acid

  • Sorbic acid

• Esters:

  • Parabens

• Quaternary Ammonium:

  • Benzalkonium chloride

  • Cetrimide

  • Cetylpyridinium chloride

• Organic Mercurial:

  • Thimerosal

  • Phenylmercuric nitrate

Classification of Preservatives [5]

• Ethanol

• Propylene glycol

• Chlorobutanol

• Phenyl alcohol

[Classification of Preservatives]

Example of Acid Preservative [4]

• Benzoic acid

• Sorbic acid

[Classification of Preservatives]

Example of Acid Preservative [2]

Parabens

[Classification of Preservatives]

Example of Ester Preservative [1]

• Benzalkonium chloride

• Cetrimide

• Cetylpyridinium chloride

[Classification of Preservatives]

Example of Quaternary Ammonium Preservative [3]

• Thimerosal

• Phenylmercuric nitrate

[Classification of Preservatives]

Example of Organic Mercurial preservative [2]

b. Methylparaben

[Classification of Preservatives]

Type of paraben effective against molds

a. Propylparaben
b. Methylparaben
c. Butylparaben
d. Ethylparaben

a. Propylparaben

[Classification of Preservatives]

Type of paraben effective against yeasts and bacteria

a. Propylparaben
b. Methylparaben
c. Butylparaben
d. Ethylparaben

b. Antioxidant

[Stability Enhancer]

Stability enhancer that prevents oxidation of the active components, fats, and oils
a. Preservative
b. Antioxidant
c. Buffer
d. Humectant

• True Antioxidants

• Reducing Agents

• Antioxidant Synergists:

Classification of Antioxidants [3]

c. True Antioxidants

[Classification of Antioxidants]

Classification of antioxidants that react with free radicals
a. Reducing Agents
b. Antioxidant Synergists
c. True Antioxidants
d. Chelating Agents

• Alpha tocopherol (vit. E)

• Butylated Hydroxytoluene (BHT)

• Butylated Hydroxyanisole (BHA)

• Alkyl gallates

[Classification of Antioxidants]

Example of True Antioxidant [4]

• Ascorbic acid (vit. C)

• Sulfites

[Classification of Antioxidants]

Example of Reducing Agent [2]

c. Antioxidant Synergists

[Classification of Antioxidants]

Classification of antioxidants that react with heavy metals
a. True Antioxidants
b. Reducing Agents
c. Antioxidant Synergists
d. Preservatives

• EDTA

• Citric acid

• Tartaric acid

[Classification of Antioxidants]

Example of antioxidant synergists [3]

• Simple Solution

• Solution by Chemical Reaction

• Solution by Extraction

Methods of Manufacturing Solutions [3]

c. Simple Solution

[Methods of Manufacturing Solutions]

Method of solution preparation involving dissolving the solute in most of the solvent, mixing until dissolved, then adding sufficient solvent to bring the solution up to the proper volume
a. Solution by Chemical Reaction
b. Solution by Extraction
c. Simple Solution
d. Solution by Diffusion

c. Calcium Hydroxide Topical Solution, USP

[Methods of Manufacturing Solutions]

Example of Simple Solution
a. Belladonna Extract, USP
b. Aluminum Subacetate Topical Solution, USP
c. Calcium Hydroxide Topical Solution, USP
d. Strong Iodine Solution, USP

c. Solution by Chemical Reaction

[Methods of Manufacturing Solutions]

Method of solution preparation involving reacting 2 or more solutes with each other in a suitable solvent
a. Simple Solution
b. Solution by Extraction
c. Solution by Chemical Reaction
d. Solution by Diffusion

c. Aluminum Subacetate Topical Solution, USP

[Methods of Manufacturing Solutions]

Example of Solution by Chemical Reaction
a. Calcium Hydroxide Topical Solution, USP
b. Belladonna Extract, USP
c. Aluminum Subacetate Topical Solution, USP
d. Lugol's Solution, USP

c. Belladonna Extract, USP

[Methods of Manufacturing Solutions]

Example of Solution by Extraction
a. Calcium Hydroxide Topical Solution, USP
b. Aluminum Subacetate Topical Solution, USP
c. Belladonna Extract, USP
d. Simethicone Emulsion, USP

Dispensing

↓

Mixing

↓

Storage and Aging

↓

Filtration

↓

Filling

Steps for Manufacturing Solutions [5]

c. Dispensing

[Steps for Manufacturing Solutions]

First step in manufacturing solutions, involves weighing and measuring of raw materials
a. Mixing
b. Filtration
c. Dispensing
d. Filling

a. Mixing

[Steps for Manufacturing Solutions]

Step in solution manufacturing involving:

• Dissolution of solute in solvent

• Methods to hasten dissolution involving:

  • Vigorous agitation

  • Application of heat

  • Particle size reduction

  • Use of solubilizer and chelating agents

a. Mixing
b. Filtration
c. Dispensing
d. Filling

b. Filtration

[Steps for Manufacturing Solutions]

Step in solution For solutions with high amounts of volatile oils
a. Mixing
b. Filtration
c. Dispensing
d. Filling

b. Filtration

[Steps for Manufacturing Solutions]

Step in solution manufacturing that enhances odor and flavor

a. Mixing
b. Filtration
c. Dispensing
d. Filling

c. Filtration

[Steps for Manufacturing Solutions]

Process of separating liquids from solids with the use of filter medium
a. Mixing
b. Dispensing
c. Filtration
d. Storage and Aging

a. Filter Medium

[Steps for Manufacturing Solutions]

Resists the flow of solid materials while permitting the passage of liquid
a. Filter Medium
b. Solubilizer
c. Chelating Agent
d. Viscosity Enhancer

• Filter paper

• Membrane Filter

• Cotton Filter

• Glass-wool Filter

• Sintered-glass FIlter

[Steps for Manufacturing Solutions]

FIlter medium used for Manufacturing Solutions include ______ [5]

c. Membrane filter

[Steps for Manufacturing Solutions]

Filter medium used for sterile products

a. Cotton filter
b. Sintered-glass filter
c. Membrane filter
d. Glass-wool filter

b. Bubble Point Test

[Steps for Manufacturing Solutions]

Test used to determine the efficiency of membrane filter
a. Dissolution Test
b. Bubble Point Test
c. Disintegration Test
d. Sterility Test

• Parallel Filtration

• Series Filtration

[Steps for Manufacturing Solutions]

Types of Filtration [2]

b. Parallel Filtration

[Steps for Manufacturing Solutions]

Type of filtration wherein the material passes through filter medium
a. Series Filtration
b. Parallel Filtration
c. Membrane Filtration
d. Vacuum Filtration

c. Series Filtration

[Steps for Manufacturing Solutions]

Type of filtration involving 2 or more filter media
a. Parallel Filtration
b. Membrane Filtration
c. Series Filtration
d. Sintered Filtration

• Gravimeteric

• Volumetric

• Constant-Level

[Steps for Manufacturing Solutions]

Filling Methods [3]

c. Gravimetric

[Steps for Manufacturing Solutions]

Filling method used for large containers and high viscosity products
a. Volumetric
b. Constant-Level
c. Gravimetric
d. Vacuum Filling

b. Volumetric

[Steps for Manufacturing Solutions]

Filling method using constant volume with piston action
a. Gravimetric
b. Volumetric
c. Constant-Level
d. Automatic Filling

c. Constant-Level

[Steps for Manufacturing Solutions]

Filling method wherein the container is used to control fill
a. Volumetric
b. Gravimetric
c. Constant-Level
d. Piston Filling

• Carbohydrate Materials

• Protein substances

• Finely Divided Solids

• HMW Alcohols

• Synthetic Surfactants

  • Anionic

  • Cationic

  • Amphoteric

  • Non-Ionic

[Manufacturing of Emulsions]

Classification of Emulsifying Agents [5]

b. Carbohydrate Materials

Classification of emulsifying agent that includes:

• Tragacanth

• Acacia

• Agar

• Pectin

• Chondrus

• Xanthan

• Carrageenan
  
  

a. Protein Substances
b. Carbohydrate Materials
c. Finely Divided Solids
d. HMW Alcohols

c. Protein Substances

[Classification of Emulsifying Agents]

Classification of emulsifying agent that includes:

• Gelatin

• Egg yolk

• Casein
  
  

a. Carbohydrate Materials
b. Finely Divided Solids
c. Protein Substances
d. HMW Alcohols

a. Finely Divided Solids

[Classification of Emulsifying Agents]

Classification of emulsifying agent that includes

• Colloidal clay

• Bentonite

• Mg(OH)₂, Al(OH)₃
  
  

a. Finely Divided Solids
b. Carbohydrate Materials
c. Protein Substances
d. HMW Alcohols

c. HMW Alcohols

[Classification of Emulsifying Agents]

Classification of emulsifying agent that includes:

• Glyceryl monostearate

• Stearyl alcohol

• Cetyl alcohol

• Cholesterol
  
  

a. Finely Divided Solids
b. Protein Substances
c. HMW Alcohols
d. Carbohydrate Materials

b. Anionic

[Classification of Emulsifying Agents]

Type of synthetic surfactant effective at basic pH
a. Cationic
b. Anionic
c. Amphoteric
d. Non-Ionic

b. Anionic

[Type of Synthetic Surfactant]

Example include:

• Soaps

• Alkyl SO4

• Sarcosinates

a. Cationic
b. Anionic
c. Amphoteric
d. Non-Ionic

a. Cationic

[Type of Synthetic Surfactant]

Type of synthetic surfactant effective at acidic pH

a. Cationic
b. Anionic
c. Amphoteric
d. Non-Ionic

a. Cationic

[Type of Synthetic Surfactant]

Example include:

• Benzalkonium Cl

• Cetypyridinium Cl

a. Cationic
b. Anionic
c. Amphoteric
d. Non-Ionic

c. Amphoteric

[Type of Synthetic Surfactant]

Type of synthetic surfactant effective for both anionic and cationic

a. Cationic
b. Anionic
c. Amphoteric
d. Non-Ionic

c. Amphoteric

[Type of Synthetic Surfactant]

Example include:

• Betaine

• Lecithin

a. Cationic
b. Anionic
c. Amphoteric
d. Non-Ionic

d. Non-Ionic

[Type of Synthetic Surfactant]

Type of synthetic surfactant that is not affected by pH

a. Cationic
b. Anionic
c. Amphoteric
d. Non-Ionic

d. Non-Ionic

[Type of Synthetic Surfactant]

Example include:

• Span® – sorbitan esters → lipophilic

• Tween® – polysorbates → hydrophilic

a. Cationic
b. Anionic
c. Amphoteric
d. Non-Ionic

a. lipophilic

[Type of Synthetic Surfactant]

Span® (sorbitan esters)

a. lipophilic

b. hydrophilic

b. hydrophilic

[Type of Synthetic Surfactant]

Tween® (polysorbates)

a. lipophilic

b. hydrophilic

b. Hydrophilic-Lipophilic Balance

[Manufacturing of Emulsions]

HLB stands for
a. High Lipid Balance
b. Hydrophilic-Lipophilic Balance
c. Heavy Liquid Barrier
d. Hydro-Lipid Bonding

b. HLB System

[Manufacturing of Emulsions]

Used to categorize surfactants based on the substance's polarity
a. pH Scale
b. HLB System
c. Zeta Potential
d. Viscosity Index

b. 1 and 40

[Manufacturing of Emulsions]

Range of values in the HLB system
a. 1 and 20
b. 1 and 40
c. 1 and 100
d. 0 and 10

a. True

[Manufacturing of Emulsions]

In HLB system:

• Materials that are highly polar or hydrophilic have been assigned higher numbers

a. True

b. False

f. Antifoaming

[HLB Value]

1-3

a. Solubilizer

b. Detergent

c. O/W Emulsifier

d. Wetting Agent

e. W/O Emulsifier

f. Antifoaming

e. W/O Emulsifier

[HLB Value]

3-6

a. Solubilizer

b. Detergent

c. O/W Emulsifier

d. Wetting Agent

e. W/O Emulsifier

f. Antifoaming

d. Wetting Agent

[HLB Value]

7-9

a. Solubilizer

b. Detergent

c. O/W Emulsifier

d. Wetting Agent

e. W/O Emulsifier

f. Antifoaming

c. O/W Emulsifier

[HLB Value]

8-18

a. Solubilizer

b. Detergent

c. O/W Emulsifier

d. Wetting Agent

e. W/O Emulsifier

f. Antifoaming

b. Detergent

[HLB Value]

13-16

a. Solubilizer

b. Detergent

c. O/W Emulsifier

d. Wetting Agent

e. W/O Emulsifier

f. Antifoaming

a. Solubilizer

[HLB Value]

15-20

a. Solubilizer

b. Detergent

c. O/W Emulsifier

d. Wetting Agent

e. W/O Emulsifier

f. Antifoaming

b. Creaming

[Instabilities of Emulsion]

The upward movement of dispersed globules (↑ internal phase)

a. Sedimentation
b. Creaming
c. Coalescence
d. Flocculation

c. Sedimentation

[Instabilities of Emulsion]

The downward movement of dispersed globules (↓ internal phase)

a. Creaming
b. Phase Inversion
c. Sedimentation
d. Breaking

b. Phase Inversion

[Instabilities of Emulsion]

An o/w changes to a w/o emulsion or vice versa (w/o ↔ o/w)

a. Coalescence
b. Phase Inversion
c. Flocculation
d. Creaming

b. Flocculation/Aggregation

[Instabilities of Emulsion]

The dispersed globules come together but do not fuse

a. Coalescence
b. Flocculation/Aggregation
c. Breaking/Cracking
d. Creaming

c. Coalescence

[Instabilities of Emulsion]

Complete fusion of droplets

a. Flocculation
b. Sedimentation
c. Coalescence
d. Phase Inversion

d. Breaking/Cracking

[Instabilities of Emulsion]

Complete separation of oil and water

a. Coalescence
b. Creaming
c. Flocculation
d. Breaking/Cracking

• Suspending Agent

• Wetting Agents

• Flocculating Agents

• APIs

• Liquid Vehicle

• Buffers

• Preservatives

• Colorants, Flavors and Fragrances

Components of suspension formulation include ______ [8]

b. Suspending Agents

[Components of Suspension Formulation]

Viscosity-increasing agents used to reduce sedimentation rate of particles in a vehicle
a. Wetting Agents
b. Suspending Agents
c. Flocculating Agents
d. Preservatives

• Tragacanth

• Acacia

• Celluloses

• Bentonite

• Magma

• Veegum

• Agar

• Carrageenan

• Gelatin

• Kaolin

[Components of Suspension Formulation]

Examples of suspending agents
a. Electrolytes, surfactants and polymers
b. Tragacanth, acacia, celluloses, bentonite, magma, veegum, agar, carrageenan, gelatin, kaolin
c. Glycerin, PPG, PEG, syrup
d. NaCl, KCl

b. Wetting Agents

[Components of Suspension Formulation]

Agents that displace air from cervices of hydrophobic solids to allow penetration of water
a. Suspending Agents
b. Wetting Agents
c. Flocculating Agents
d. Preservatives

• Surfactants

• Glycerin

• Polypropylene Glycol (PPG)

• PEG

• Syrup

[Components of Suspension Formulation]

Examples of wetting agents
a. Tragacanth, acacia, celluloses
b. Electrolytes, surfactants and polymers
c. Surfactants, glycerin, PPG, PEG, syrup
d. Bentonite, magma, veegum

d. Flocculating Agents

[Components of Suspension Formulation]

Agents that reduce the electrical barrier between the particles of the suspensoid and forming a bridge so as to link them together
a. Suspending Agents
b. Wetting Agents
c. Preservatives
d. Flocculating Agents

b. Decrease zeta potential

[Components of Suspension Formulation]

Flocculating agents work by causing this effect on zeta potential to avoid formation of cake
a. Increase zeta potential
b. Decrease zeta potential
c. Neutralize zeta potential
d. Reverse zeta potential

• Electrolytes (NaCl, KCl)

• Surfactants

• Polymers

[Components of Suspension Formulation]

Examples of flocculating agents
a. Tragacanth, acacia, celluloses
b. Surfactants, glycerin, PPG, PEG
c. Electrolytes (NaCl, KCl), surfactants and Polymers
d. Bentonite, magma, veegum

• Dispersion

• Precipitation

[Components of Suspension Formulation]

Methods for Manufacturing Suspensions [2]

b. Dispersion

[Methods for Manufacturing Suspensions]

Method of suspension manufacturing wherein finely divided solid drug is wetted first before dispersion in the liquid vehicle
a. Precipitation
b. Dispersion
c. Levigation
d. Trituration

c. Precipitation

[Methods for Manufacturing Suspensions]

Method of suspension manufacturing wherein finely divided solid drug is reacted with another substance
a. Dispersion
b. Levigation
c. Precipitation
d. Trituration

b. Milk of Magnesia

[Methods for Manufacturing Suspensions]

Example of suspension prepared by precipitation method
a. Calcium Hydroxide Topical Solution
b. Milk of Magnesia
c. Belladonna Extract
d. Aluminum Subacetate Topical Solution