SAS 6 Commercial Manufacturing (semi-solids)

Question 1

semisolid preparations for cutaneous application

Answer 1

ointments

Question 2

refer to the therapeutic ointments, creams, sieves, pastes or other forms of viscous consistency
intended for application on the skin.

Answer 2

semisolids

Question 3

soothing or softening effect on surface tissues

Answer 3

emollients

Question 4

is produced in the skin, it is claimed that the fat on the human skin
provides a protective film to prevent this factor from being removed from the skin during
excessive contact with water as a bathing

Answer 4

natural moisturizing
factor

Question 5

The FDA approves chemical substances and states the maximum concentration considered safe
for food and cosmetics are listed in

Answer 5

Federal Register

Question 6

are not generally included in semi-solids formulations because in the past dermatologist
objected to the use due to danger of sensitization

Answer 6

perfumes

Question 7

the widely used substance in semisolids next to
water

Answer 7

Petrolatum and mineral oil

Question 8

a complex mixture of semisolids containing hydrocarbon alipathic, cycle,
saturated, unsaturated branch and unbranched substances in varying proportions.

Answer 8

Petrolatum

Question 9

is obtained also from petroleum acid

Answer 9

Mineral oil

Question 10

These are frequently employed to increase the viscosity of mineral oil to prevent separation
from an ointment

Answer 10

Hydrocarbon waxes

Question 11

mixture of paraffin wax and ozokerite

Answer 11

ceresin wax

Question 12

Vegetable oil such as peanut oil, almond oil, sesame oil and olive oil are glycerides of
mixtures of unsaturated fatty acid

Answer 12

oleaginous substances

Question 13

are used in water removable creams as an emulsifier to develop
a certain consistency in the cream

Answer 13

Stearic acids

Question 14

are used in creams as
auxiliary emulsifiers and emollients. In sufficient quantity, stearyl alcohol produces
a firm cream which maybe softened by cetyl alcohol

Answer 14

Stearyl alcohol and cetyl alcohol (palmityl alcohol)

Question 15

water soluble soaps that were among the first emulsifiers
used for semisolid oil in water emulsions

Answer 15

triethanolamine stearate soap

Question 16

prevents drying up and prevents formation of a crust on top of the
cream

Answer 16

humectants

Question 17

must be uniformly dispersed throughout the vehicle to assure homogeneity
of the product. The solid must be impalpable to the touch otherwise grittiness will result.

Answer 17

Insoluble powders

Question 18

is the most commonly used in ointment vehicles because of its consistent blend
and neutral characteristics and its ability to spread easily on the skin

Answer 18

Petrolatum

Question 18

These vehicles are difficult to wash off and are used as occlusive dressings which produces
sensation of warmth because of the normal evaporation of insensible perspiration is inhibited.

Answer 18

Hydrocarbon bases

Question 19

are hydrophilic mixtures formed by the addition of substances miscible
with hydrocarbons and possessing polar groupings such as SO4, sulfonate, carboxyl hydroxyl or
an ether linage.

Answer 19

Absorption bases

Question 20

added to these bases to reduce tackiness of the base

Answer 20

Mineral oil

Question 21

Oil in water emulsions and we referred to this category because upon application and
rubbing in to the skin, there is little or no visible evidence of its presence.

Answer 21

Water Removable Bases

Question 22

are the representative of O/W emulsions
whereas the absorption base is generally W/O emulsions

Answer 22

vanishing cream type vehicles

Question 23

These are prepared from mixtures of high and low molecular weights polyethylene glycols.

Answer 23

Water Soluble Bases

Question 24

are liquids those with moderately higher molecular are unctuous and the high molecular weight are solids

Answer 24

Low molecular weights

Question 25

maybe applied to moist skin lesions since the O/W vehicle tends to absorb any discharge

Answer 25

Creams

Question 26

No water is required for their preparation

Answer 26

Water Soluble Bases

Question 27

The water soluble bases are also known as

Answer 27

greaseless ointment bases

Question 28

frequently contain of petrolatum, a brand adsorption base or a water soluble base

Answer 28

Semi-solid ophthalmic vehicles

Question 29

All materials used in the ophthalmic ointment should be impalpable to avoid eye discomfort and irritation

Answer 29

Ophthalmic Ointments

Question 30

when used in injured eyes should be sterile

Answer 30

Ophthalmic ointments

Question 31

The chemical preservative or semisolids should be carefully evaluated as to:

Answer 31

1. Stability with regard to other components of the formula 2. Container to be used

Question 32

are added to prevent contamination, deterioration and spoilage by bacteria and molds.

Answer 32

Preservatives

Question 33

are used in combination due to their synergistic action

Answer 33

p-hydroxybenzoate esters (parabens)

Question 34

may be used in ophthalmic preparation against bacterial or fungal contamination

Answer 34

Boric acid

Question 37

should be made on the water supply, raw material, pipelines, filling equipment and containers

Answer 37

Bacterial counts

Question 38

They we added to semi solid whenever oxidative deterioration is anticipated

Answer 38

Antioxidants

Question 39

equipment is essential in developing a manufacturing procedure for a production-size batch

Answer 39

Pilot plants or small sale production

Question 40

are critical in preparation of semi-solids

Answer 40

Mixing and stirring operations

Question 41

should be prevented for stability and consistency in density. This can be done by introducing one phase below the surface of the other liquid or phase and mixing carefully.

Answer 41

Aeration

Question 42

is the study of the deformation and few of the liquid and semi-solid pharmaceuticals.

Answer 42

Rheology

Question 43

homogenization frequently increases the consistency due to increase of the number of emulsified droplets but in some case may decrease the viscosity due to electrolyte effect.

Answer 43

theological changes

Question 44

The characteristic of these preparations is that when subjected to stress line homogenization, they tend to deform in shape and flow

Answer 44

Rheological Changes

Question 45

is also affected by the number of times the preparation is passed through the homogenizer

Answer 45

Consistency

Question 46

are manufactured by the fusion process which is dissolving the active ingredients in the melted fats and waxes or in the vehicle and then mixed with the base

Answer 46

Anhydrous ointments

Question 47

The melted mass must be mixed while cooling to ensure homogenous distribution or the ingredients.

Answer 47

Fusion Method

Question 48

In mixing the oil and aqueous phases, the phases are usually mixed at a temperature of

Answer 48

70-73 degree Celsius

Question 49

use of a proportioning pump and continuous mixer. This is good for continuous large batch operation

Answer 49

Simultaneous blending of the phases

Question 50

useful for emulsion system with a low dispersed phase

Answer 50

Addition of the discontinuous or internal phase to the continuous phase or external

Question 51

useful for many emulsion system since the emulsion undergo inversion of the emulsion type during the addition of the continuous phase which results in a finer dispersed phase volume

Answer 51

Additional of the continuous phase to the discontinuous or dispersed phases

Question 52

In cooling the semi-solid emulsion it is best done at temperature to facilitate dissolution of the perfume oil

Answer 52

40-45 degree Celsius