Manufacturing of Liquids

Question 1

Equipment used in manufacture of Liquid DF

Answer 1

1. Mixing Tanks
2. Mixers

Question 2

Mixing Tanks

Answer 2

Stainless Steel
* Non-additive
* Non-absorptive
* Non-reactive
* Non-corrosive

Stainless Steel 304 (Surgical Stainless)

Stainless steel 316
* With Molybdenum
* Most widely used in pharm
* Better resistance to saline conditions, sulfuric acid, stress corrosions

Question 3

Mixers

Answer 3

Mechanical Stirrer - Mixers with various impellers mounted on shafts
Homogenizers - Compresses liquid with high pressure by a strong spring mechanism
Ultrasonofiers - User ultrasonic energy to produce emulsion
Colloid Mill - Comminution of solids or dispersion of suspensions

Question 4

Components of Liquid Dosage Form

Answer 4

APIs
Solvent or Vehicle
Co-Solvent
Buffers
Viscosity Enhancer/Modifier
Stability Enhancers
Humectancts
Colorants, Flavors, and Sweeteners, Perfumes

Question 5

Characteristics of Ideal Preservative

Answer 5

• Effective against a broad spectrum of microorganism
• Physically, Chemically, & Microbiologically stable
• Non-toxic, non-sensitizing, soluble, compatible with other components
• Acceptable taste and color

Question 6

Antifungal Preservatives

Answer 6

Methylparaben - Molds
Propylparaben - Yeast
Sodium benzoate - For acidic liquid prep
Benzoic Acid - Effective at low pH

Question 7

Concentration of Methyl & Propylparaben

Answer 7

01.% - 0.25%

Question 8

Concentration of Sodium benzoate

Answer 8

0.1% - 0.2%

Question 9

Concentration of Benzoic Acid

Answer 9

0.1 - 0.5%

Question 10

Antimicrobial preservatives

Answer 10

Benzyl Alcohol
Benzalkonium chloride
Thimerosal
Chlorobutanol
Phenol

Question 11

Concentration of Benzyl Alcohol

Answer 11

3%

Question 12

Concentration of Benzalkonium chloride

Answer 12

0.002 - 0.02%

Question 13

Concentration of Thimerosal

Answer 13

0.1%

Question 14

Concentration of Chlorobutanol

Answer 14

0.5%

Question 15

Concentration of Phenol

Oldest & best known pharmaceutical preservative

Answer 15

0.1 - 0.5%

Question 16

Antioxidants

Answer 16

True oxidants
Reducing Agents
Antioxidant synergist

Question 17

True antioxidants

Answer 17

React with free radicals
Vitamin E
BHA (butylated hydroxyanisole)
BHT (butylated hydroxytoluene)

Question 18

Reducing Agents

Answer 18

Ascorbic Acid
Sodium sulfite
Sodium metabisulfite

ASS

Question 19

Antioxidant synergists

Answer 19

React with heavy metals
EDTA
Citric Acid
Tartaric Acid

Question 20

Steps in Preparation of Solution

Answer 20

Preparation formulation materials and equipment
Compounding - Dissolution of solutes; ↑ solubility = speed of agitation, temperature, particle size, pH, complexation
Storage and Aging - Improves flavor or odor of volatile oils
Filtration

or

Dispensing
Mixing
Storage and aging
Filtration
Filling

Question 21

Filtration Types

Answer 21

Parallel - passes thru and filter medium
Series - 2 or more filter media

Question 22

Filter Media

Answer 22

Felts - Gelatinous solution
Nylon - Most suitable
Terylene - Acid filtration
Membrane Filter Media - For sterile soln; Bubble point test

Question 23

Membrane Filter Size

Answer 23

0.2 micron - All bacteria
0.45 micron -
0.8 micron -
1.2 micron -
4 micron - All significant cells from body fluids

Question 24

Filling Methods

Answer 24

Gravimetric – large containers and high viscosity
Volumetric – constant volume using piston action
Constant-Level – container is used to control fill

Question 25

General Formulation of Suspension

Answer 25

Dispersed Phase Dispersion Medium Suspending Agents Wetting Agents Flocculating Agents Buffer, Sweeteners, Colorant, Flavorant, Preservative

Question 26

Dispersed Phase of Solution

Answer 26

Colloidal Dispersion: 0.1 - 0.2mcm Coarse Dispersion: >0.2mcm

Question 27

Dispersion Medium of Suspension

Answer 27

Aqueous: Deionized H2O Non-Aq: PEG, Propylene glycol

Question 28

Suspending Agents in Suspensions

Answer 28

Acacia Tragacanth Celluloses Bentonite Magma Veegum Agar Carrageenan Gelatin

Question 29

Wetting Agents in Suspensions

Answer 29

**Surfactants** *Spans & Tweens, SLS* **Solvent** *Alcohol, Glycerol, Glycol* **Hydrophilic Colloids**

Question 30

Displace air in the crevice of the particles to allow the penetration of dispersion medium into the powder

Answer 30

Wetting Agent

Question 31

Flocculated

Answer 31

Particle Size: Large Sedimentation rate: Faster Sediment formation: Faster Sediment: Loose Appearance: Not Pharmaceutically Elegant

Question 32

Deffloculated

Answer 32

Particle Size: Small Sedimentation rate: Slower Sediment formation: Slower Sediment: Compact Appearance: Pharmaceutically Elegant

Question 33

Prevent formation of compact sediments/cake | Decrease Zeta Potential

Answer 33

Flocculating Agents

Question 34

Flocculating Agents

Answer 34

**Electrolytes** Monobasic potassium phosphate **Surfactants** Benzalkonium chloride **Polymers** Xanthan Gum Cellulose Derivatives

Question 35

Method on Suspension Method

Answer 35

**Precipitation Method** – by organic solvent; by changing pH; by double decomposition **Dispersion Method**s – suspensoids are wetted first before dispersing into vehicle