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Manufacturing > Manufacturing of Liquids > Flashcards

Manufacturing of Liquids Flashcards

1
Q

Equipment used in manufacture of Liquid DF

A
  1. Mixing Tanks
  2. Mixers
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2
Q

Mixing Tanks

A

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

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3
Q

Mixers

A

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

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4
Q

Components of Liquid Dosage Form

A

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

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5
Q

Characteristics of Ideal Preservative

A
  • Effective against a broad spectrum of microorganism
  • Physically, Chemically, & Microbiologically stable
  • Non-toxic, non-sensitizing, soluble, compatible with other components
  • Acceptable taste and color
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6
Q

Antifungal Preservatives

A

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

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7
Q

Concentration of Methyl & Propylparaben

A

01.% - 0.25%

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8
Q

Concentration of Sodium benzoate

A

0.1% - 0.2%

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9
Q

Concentration of Benzoic Acid

A

0.1 - 0.5%

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10
Q

Antimicrobial preservatives

A

Benzyl Alcohol
Benzalkonium chloride
Thimerosal
Chlorobutanol
Phenol

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11
Q

Concentration of Benzyl Alcohol

A

3%

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12
Q

Concentration of Benzalkonium chloride

A

0.002 - 0.02%

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13
Q

Concentration of Thimerosal

A

0.1%

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14
Q

Concentration of Chlorobutanol

A

0.5%

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15
Q

Concentration of Phenol

Oldest & best known pharmaceutical preservative

A

0.1 - 0.5%

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16
Q

Antioxidants

A

True oxidants
Reducing Agents
Antioxidant synergist

17
Q

True antioxidants

A

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

18
Q

Reducing Agents

A

Ascorbic Acid
Sodium sulfite
Sodium metabisulfite

ASS

19
Q

Antioxidant synergists

A

React with heavy metals
EDTA
Citric Acid
Tartaric Acid

20
Q

Steps in Preparation of Solution

A

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

21
Q

Filtration Types

A

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

22
Q

Filter Media

A

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

23
Q

Membrane Filter Size

A

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

24
Q

Filling Methods

A

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

25
Q

General Formulation of Suspension

A

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

26
Q

Dispersed Phase of Solution

A

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

27
Q

Dispersion Medium of Suspension

A

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

28
Q

Suspending Agents in Suspensions

A

Acacia
Tragacanth
Celluloses
Bentonite
Magma
Veegum
Agar
Carrageenan
Gelatin

29
Q

Wetting Agents in Suspensions

A

Surfactants
Spans & Tweens, SLS

Solvent
Alcohol, Glycerol, Glycol

Hydrophilic Colloids

30
Q

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

A

Wetting Agent

31
Q

Flocculated

A

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

32
Q

Deffloculated

A

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

33
Q

Prevent formation of compact sediments/cake

Decrease Zeta Potential

A

Flocculating Agents

34
Q

Flocculating Agents

A

Electrolytes
Monobasic potassium phosphate

Surfactants
Benzalkonium chloride

Polymers
Xanthan Gum
Cellulose Derivatives

35
Q

Method on Suspension Method

A

Precipitation Method – by organic solvent; by changing pH; by double decomposition

Dispersion Methods – suspensoids are wetted first before dispersing into vehicle

Manufacturing (13 decks)

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