DISSOLUTION Flashcards by CHESKA CIANNELLE FRANCISCO

Q

measures the RATE OF RELEASE of active pharmaceutical ingredients into solution from the final pharmaceutical product

A

DISSOLUTION test

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

APPARATUS

for HARD and SOFT gelatin capsules

A

Rotating basket assembly (Apparatus I)

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

process by which a chemical or drug becomes DISSOLVED in a solvent

A

DISSOLUTION

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

the amount of active ingredient in a solid-dosage form DISSOLVED in unit time under standardized conditions of liquid/solid interface, temperature and media compostion

A

DISSOLUTION RATE

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

FACTORS affecting dissolution rate

A

aqueous medium
temperature of the medium
agitation rate

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

IMPORTANCE OF DISSOLUTION TEST

QUALITY CONTROL

A

batch homogeneity
batch to batch conformity
stability
therapeutically optimal dosage forms

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

IMPORTANCE OF DISSOLUTION TEST

RESEARCH & DEVELOPMENT

A

drug release behavior of pre-formulations
in bitro simulation of the GI passage
IVIVC (in vitro in vivo correlation)

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

FACTORS affecting the TEST RELIABILITY

A

proper alignment of the dissolution apparatus
proper conditions during dissolution test
proper validation of analytical method

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

CONDITIONS for DISSOLUTION TEST

A

Temperature
Agitation speed
Sampling
Vibration
Dissolution medium

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

CONDITIONS DURING DISSOLUTION TEST

Temperature

A

37C

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

COMPONENTS OF BASKET APPARATUS

made up of glass or other inert transparent material
CYLINDRICAL with HEMISPHERICAL bottom
1L, 2L, or 4L nominal capacity
PARTIALLY immersed in water bath (37 ∓0.5C)

A

VESSEL

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

COMPONENTS OF BASKET APPARATUS

positioned so that its axis in NMT 2mm from the vertical axis of the vessel
rotates smoothly WITHOUT significant wobble
made of STAINLESS STEEL 316

A

METALLIC SHAFT

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

COMPONENTS OF BASKET APPARATUS

METALLIC SHAFT:
positioned so that its axis in ____ from the vertical axis of the vessel

A

NMT 2mm

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

COMPONENTS OF BASKET APPARATUS

METALLIC SHAFT:
made of ____

A

stainless steel 316

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

COMPONENTS OF BASKET APPARATUS

40 mesh
made of stainless steel 316 (gold plating is allowed)
distance between INSIDE bottom vessel and bottom of basket is maintained at 25 ∓ 2

A

CYLINDRICAL BASKET

How well did you know this?

1

Not at all

2

3

4

5

Perfectly

Q

COMPONENTS OF BASKET APPARATUS

CYLINDRICAL BASKET:
____ mesh

A

40

Q

COMPONENTS OF BASKET APPARATUS

CYLINDRICAL BASKET:
made of ____

A

stainless steel 316

Q

COMPONENTS OF BASKET APPARATUS

CYLINDRICAL BASKET:
DISTANCE between inside bottom of vessel and bottom of basket is maintained at ____

A

25 ∓ 2 mm

Q

COMPONENTS OF BASKET APPARATUS

FITTED COVER to retard evaporation

A

VESSEL EVAPORATION COVER

Q

COMPONENTS OF PADDLE APPARATUS

stirring element

A

paddle

Q

COMPONENTS OF PADDLE APPARATUS

a small, loose piece of non-reactive material, such as not more than a few turns of WIRE HELIX, may be attached to dosage units that would otherwise FLOAT

A

CAPSULE SINKER

Q

ASSAY OF AMOXICILLIN CAPSULES

DISSOLUTION MEDIA

A

900mL of distilled water at 37C

Q

ASSAY OF AMOXICILLIN CAPSULES

OPERATION of the DISSOLUTION APPARATUS

A

50 rpm, 90mins

Q

ASSAY OF ASPIRIN CAPSULES

DISSOLUTION MEDIA

A

900mL of 0.05 M acetate buffer at 37C

# **ASSAY OF ASPIRIN CAPSULES** **pH**: ACETATE BUFFER

4.5

# **USP DISSOLUTION APPARATUS** 1-7

Basket Paddle recip Cylinder Flow-throug cell Paddle over disk rotating cylinder recip Disk

# **USP DISSOLUTION APPARATUS** * **capsules** * **uncoated** tabs * **plain** coated tabs

1 basket 2 paddle

# **USP DISSOLUTION APPARATUS** **ER** dosage forms

3 recip cylinder 4 flow through cell

# **USP DISSOLUTION APPARATUS** **DR** dosage forms, **TDDS**

5 paddle over disk 6 rotating cylinder 7 reciprocaating disk

# **IMPORTANT CONSIDERATIONS** ____ and ____ are **greatly affected** by **MECHANICAL FACTORS**

Apparatus 1 & 2

# **IMPORTANT CONSIDERATIONS** ____ is based on the **principle** of **disintegration tester**, has **HYDRODYNAMIC** features

apparatus 3

# **IMPORTANT CONSIDERATIONS** * **forces** dissolution medium **through cell** * best use for **LOW solubility** drugs such as **implants**, **suppositories**, and **controlled release formulations**

apparatus 4

# **IMPORTANT CONSIDERATIONS** * is also known as **SANDWICH ASSEMBLY** * the dosage form is covered by **screen** (released side up) and commonly used for **TRANSDERMAL patches**

apparatus 5

# **IMPORTANT CONSIDERATIONS** apparatus **5** is also known as

SANDWICH ASSEMBLY

# **IMPORTANT CONSIDERATIONS** * is almost the same with apparatus **1** except to replace the basket with a **STAINLESS STEEL CYLINDER STIRRING ELEMENT** * it usually where we place the dosage form, **release side out**

apparatus 6

# **IMPORTANT CONSIDERATIONS** * described as **FLAT BOTTOMED CYLINDRICAL VESSEL** * medium: **32 ∓ 0.5**

apparatus 7