Capsules Flashcards

1
Q

These are solid dosage form in which the drug is enclosed within either hard or soft soluble container or “shell”. They are usually formed from gelatin; however, they also may be made from starch or other suitable substances.

A

Capsules

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2
Q

“Telescoping Capsules” or “Dry Filled Capsules”

A

Hard Gelatin Capsules

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3
Q

A heterogeneous product derived by irreversible hydrolytic extraction of treated animal collagen. Obtained by the partial hydrolysis of collagen obtained from the skin, white connective tissue, and bones of animals.

A

Gelatin Blends

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4
Q

Two (2) Types of Gelatin Blends

A
  1. Type A
  2. Type B
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5
Q

Pork Skins by Acid Hydrolysis

A

Type A

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6
Q

Bone and Animal Skin by Alkaline Hydrolysis

A

Type B

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7
Q

It contributes to the plasticity and clarity to the blend, thereby reducing haze or cloudiness of the tablet finished capsules.

A

Pork Skin Gelatin

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8
Q

It gives tough, firm film; but tends to be hazy and brittle by itself.

A

Calf Bone Gelatin

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9
Q

(T/F): Materials such as methylcellulose, polyvinyl alcohols, and denatured gelatins—modifies the solubility of capsules and produces enteric effect.

A

T

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10
Q

The “Pin Method” of production is adapted, with the use of completely automatic machines.

A

Hard Gelatin Capsules

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11
Q

Four (4) Capsule Filling Equipment

A
  1. Lilly and Parke Davis Machines
  2. MG2 Machine Automatiche
  3. Zanasi
  4. Hofliger and Karg
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12
Q

An equipment where pelletized or granular materials are readily filled by the removal of the auger, to avoid crushing of the pellets or granules.

A

Lilly and Parke Davis Machines

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13
Q

An equipment where each station of the machine is equipped with safety device that automatically stops the machine, at any event of irregularity.

A

MG2 Machine Automatiche

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14
Q

Four (4) Models of MG2 Machine Automatiche

A
  1. Model G36/4
  2. Model G36/2
  3. Model G36
  4. Model G37
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15
Q

150 filled cap / min

A

Model G36/4

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16
Q

300 filled cap / min

A

Model G36/2

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17
Q

600 filled cap / min

A

Model G36

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18
Q

1600 filled cap / min

A

G37

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19
Q

An equipment which is composed of six (6) machine models with the capacity ranging from 60 to 1,000 filled capsules / min.

A

Zanasi

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20
Q

Six (6) Models of Zanasi

A
  1. Model LZ 64
  2. Model RM 63
  3. Model RV 59
  4. Model AZ 30
  5. Model AZ 60
  6. Model BZ 150
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21
Q

60 filled cap / min

A

Model LZ 64

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22
Q

160 filled cap / min

A

Model RM 63

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23
Q

250 filled cap / min

A

Model RV 59

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24
Q

500 filled cap / min

A

Model AZ 30

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25
Q

1,000 filled cap / min

A

Model AZ 60

26
Q

2,500 filled cap / min

A

Model BZ 150

27
Q

All models are completely automatic and require only compressed air and power outlet for operation.

A

Hofliger and Karg

28
Q

Four (4) Models of Hofliger and Karg

A
  1. Model GKF 70
  2. Model GKF 600
  3. Model GKF 1200
  4. Model GKF 2400
29
Q

(T/F): Usually 10-15% or 12-15% under high temperature conditions (100 deg F) should not be prolonged.

A

T

30
Q

Empty Hard Capsules should be handled in an environment within RH range of __________.

A

30% to 45%

31
Q

Four (4) Finishing Filled Hard Gelatin Capsules

A
  1. Salt Polishing
  2. Pan Polishing
  3. Cloth Dusting
  4. Brushing
32
Q

The filled capsules are rotated in polishing pan, along with granular sodium chloride. Following rotations, the capsules are separated from the salt by screening operation.

A

Salt Polishing

33
Q

A polyurethane or cheesecloth is placed in the pan, and the liner is used to tap the removed dust, as well as to impart gloss to the capsules.

A

Pan Polishing

34
Q

The bulk filled capsules are rubbed with cloth (may or may not be impregnated with oil). It imparts an improved gloss to the capsules, as it removes resistant materials.

A

Cloth Dusting

35
Q

The capsules are fed under rotating soft brushes, which remove the dust from the capsule shells. A vacuum for dust removal must accompany this operation.

A

Brushing

36
Q

Four (4) Special Techniques for Hard Gelatin Capsules

A
  1. Imprinting
  2. Sealing / Banding Operations
  3. Locking Capsules
  4. Special Purpose Capsules
37
Q

A convenient method for purpose of product identification and control. This is best performed on empty capsules.

A

Imprinting

38
Q

Provide distinctive appearance to the product. Prevent filled capsules from unjoining. Permit color coding. Provide tamper proof feature to individual capsule.

A

Sealing / Banding Operations

39
Q

Deliberate modification is made on one or more of the normal contours of the capsules so that the body is more tightly held, in relation to the cap after closing.

A

Locking Capsules

40
Q

It refers to special capsules to which special treatment has been given to retard the solubility.

A

Special Purpose Capsules

41
Q

It is also referred to as “Pearls”. It is also made from shells of gelatin except for the addition of glycerin or any polyhydric alcohol (sorbitol), which renders the shells more elastic or plastic like.

A

Soft Gelatin Capsules

42
Q

Three (3) Materials for Soft Gelatin Capsules

A
  1. Gelatin
  2. Plasticizer
  3. Water
43
Q

USP grade with additional specifications required by the capsule manufacturer, such as bloom or gel strength, viscosity and iron content.

A

Gelatin

44
Q

Four (4) Optional Components of Soft Gelatin Capsules

A
  1. Preservatives
  2. Colorants
  3. Opacifying Agents
  4. Flavoring Agents
45
Q

0.2% mixture of 4 parts of methyl paraben and 1 part of propyl paraben.

A

Preservatives

46
Q

FD&C, D&C water soluble dyes, certified lakes, pigments and vegetable colors.

A

Colorants

47
Q

Titanium Dioxide (2-12 g/kg of Gelatin Mass)

A

Opacifying Agents

48
Q

Ethyl Vanillin and Essential Oils; Sugars (For Chewable Properties); Cellulose Acetate Phthalate (Enteric Properties); Fumaric Acid (Solubility of the Gelatin Shell.

A

Flavoring Agents

49
Q

Three (3) Methods of Production of Gelatin Capsules

A
  1. Plate Process
  2. Rotary Die Process
  3. Reciprocating Die Process
50
Q

This is the oldest, commercial method.

A

Plate Process

51
Q

A continuous process of production of soft gelatin capsules, invented by Robert Scherer in 1933.

A

Rotary Die Process

52
Q

A process of application of relatively thin coating to small particles of solids or droplets of liquids and dispersions.

A

Microencapsulation

53
Q

Two (2) Types of Result

A
  1. Single Limit
  2. Double Limit
54
Q

All weight must be within the pair of limits.

A

Single Limit

55
Q

A proportion can be outside an inner limit.

A

Double Limit

56
Q

Unless otherwise stated in the USP, the amount of active ingredient, determined by assay, is within the range of 85% to 115% of the label claim for 9 to 10 dosage units assayed, with no unit outside the range of 70% to 125% of the label claim.

A

Content Uniformity

57
Q

A state in which any residue of the tablet or capsule (except fragments of insoluble tablet coating) remains on the screen, resulting to soft mass without no palpably visible core.

A

Disintegration

58
Q

The capsules are placed in the basket rack assembly, which is immersed 30 times per minute into thermostatically controlled fluid at 37 degree Celsius and observed over the time.

A

Disintegration Test

59
Q

It determines the length of time by which 50% and 90% of the tablet’s active ingredient has dissolved in the media of 0.1 N HCI, or buffer water at 37 degree Celsius.

A

Dissolution Test

60
Q

Separate the capsule from the body of the capsule shell and repeatedly press the open end of the body of the shell downward into the powder bed.

A

Punching Capsules