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Calibration of Dissolution
Apparatus

Presented by: Submitted to:

Himanshu Shahu Dr. Gaurav Jain

M.Pharm(1st sem) Dept. of Pharmaceutics

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WHAT IS CALIBRATION ?

The activity of checking, by comparison with a standard,
the accuracy of a measuring instrument of any type. It
may also include adjustment of the instrument to bring it
into alignment with the standard.

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WHAT IS DISSOLUTION?

The process by which a solid solute enters in to a solution
i.e. mass transfer from solid surface to liquid phase

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WHY DISSOLUTION STUDY?

Estimation of amount of drug released per unit time.

Batch to batch quality control.

For product development.

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COMMONLY USED DISSOLUTION MEDIUM:

Purified water

Dilute acid (0.001N-0.1N HCL)

Stimulated gastric fluid (pH 1.2)

Stimulated intestinal fluid (pH 6.8)

Surfactants (e.g. Polysorbate, SLS)

Aqueous buffers (pH 5-7)

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Calibration of Dissolution Tester :

 Physical Parameters:

1)Shaft Rotating

2)Speed Wobble

3)Temperature

4)Shaft Alignment

5)Instrument Level

6)Vibration

7)Shaft Centering

 USP Tablet Calibrators
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Dissolution Tablet Calibrators:

Prednisone Tablets

(Disintegrating)

Salicylic Acid Tablets

(Non-disintegrating)

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Item Prednisone Tablets Salicylic acid Tablets

Type Disintegrating Non-disintegrating

Amount 10mg/tab 300mg/tab

Apparatus I and II I and II

RPM 50 100

Dissolution Medium Deaerated Water, 500 ml Deaerated0.05 M

Phosphate Buffer

pH7.4±0.05, 900 ml

Time point 30 minutes 30 minutes 31

 

Item Prednisone Tablets Salicylic acid Tablets

Max. λ(nm) 242 296

Packaging Plastic bottle Blister pack

% alcohol in Std. solution ≤5 % ≤1 %

Acceptance values (%la.)

Apparatus I 51-81 23-30

Apparatus II 26-47 17-25

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Tablet Calibration:

 Study the Certificate of Analysis (COA) of the USP tablet calibrators

 Prepare deaerated dissolution medium

 Setup the dissolution tester

 Pour the dissolution medium into the vessels and equilibrate to 37 °C, use
immediately (Check and record the temperature of each vessels)

 Weigh each tablet calibrators

 Insert the tablet calibrators into the baskets/ Drop the tablet calibrators
into the vessels

 Activate the spindles at the desired speed

 Withdraw the specimens at the stated time and immediately filter

 Recheck and record the temperature of the vessels
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 Measure the absorbance of samples and standard solutions

 

“There are many reasons that a tablet
calibration test may fail. The items in the
checklist may or may not the reason for a failed
test. Deaeration and vibration are two of the
largest contributors to failure.”

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Influence of Release Gases:

The bubbles that appear in media as the equilibrium is disturbed may:

– buoyancy dissolution rate

– available surface area dissolution rate

– associate with aggregate particles random concentrations of the particles in the

solvent stream

-collect at the screen on the basket changing the effective porosity of the mesh

-cling the particle to the apparatus and vessel walls

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-influence on pH of the media

 

Deaeration Methods:

 Helium flushing

 Sonicating + Vacuum

 Automated media degasser (ex. DosaPrep®)

 Warming to 41 °C + filtering + Vacuum

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Maintenance:

 Careful cleaning is required to ensure there is no contamination
between tests.

 Handling the basket and shaft/ paddles with care Visually inspect
the bath water weekly for algae or other foreign material.

 Water in the bath is reasonable clean to ensure that the
circulating pump is also clean.

 Do not allow dissolution media sit on the system.

 Clean up dissolution media whenever it is spilled on the system

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Maintenance Schedule:
Frequency Procedure

After each test Clean up system

Weekly Inspect circulating water pump; bath

water

Monthly Replace bath water

Every 6 months -Check temperature calibration

-Calibration of the system

-Inspect guide rods and spindle bearings

Annually Inspect belts; Idler pulleys

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Every 2 years Replace belts