FACULTY OF CHEMICAL AND PROCESS ENGINEERING

TECHNOLOGY

PHARMACEUTICAL FORMULATION METHODS

BTF 2153

LABORATORY MODULE

DISSOLUTION TEST
 BTF2153 PHARMACEUTICAL FORMULATION METHODS 2

1.0 TITLE

Dissolution test for Paracetamol Tablet 500 mg

2.0 OBJECTIVE

To understand the dissolution process for pharmaceutical tablets.

3.0 PRINCIPLE

Dissolution is the process by which a solid solute enters a solution. In the

pharmaceutical industry, it may be defined as the amount of drug substance that goes into
solution per unit time under standardized conditions of liquid/solid interface, temperature,
and solvent composition. In the pharmaceutical industry and research, dissolution testing
is commonly used to provide critical in vitro drug release information for quality control
purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as
tablets, and for drug development, i.e., to predict in vivo drug release profiles.
This test is provided to determine compliance with the dissolution requirements
where stated in Pharmacopeia’s monograph for dosage forms administered orally. The
dissolution can be carried out by apparatus 1 (basket type) or apparatus 2 (paddle type)
based on the need.
To achieve bioavailability the active ingredient from the dosage form has to be
dissolved. Hence solubility and dissolution measurements are requirements to estimate the
bioavailability of the drug. In theory, the intrinsic dissolution rate is proportional to the
solubility of the compound. It also implies that the dissolution rate is proportional to the
solubility (but here the particle size/the surface area of the particles should also be taken
into account). However, in some cases, the liberation of molecules from the surface into
water is not ideal – and the dissolution rate will be lower or higher than theoretically
calculated.
 BTF2153 PHARMACEUTICAL FORMULATION METHODS 3

4.0 MATERIALS & METHODOLOGY

Acceptance Criteria

Not less than 80% (Q) of the labeled amount of paracetamol is dissolved in 30 minutes.

Method : UV Spectrophotometry

Equipment : UV spectrophotometer
: Analytical balance
: Dissolution tester
: Sonicator

Dissolution Condition

Apparatus : Paddle
Medium : pH 5.8 phosphate buffer, 900 mL
Speed : 50 rpm
Run time : 30 minutes

Apparatus Chemical/Reagent Standard and Sample

• Measuring cylinder • Dipotassium hydrogen • Pure Paracetamol
100, 1000 mL phosphate – AR grade • Paracetamol Tablet 500
• Beaker • Potassium dihydrogen mg (1 strip)
1000 mL phosphate – AR grade
• Volumetric flask
50, 200, 250 mL
• Volumetric pipette
2, 3 mL
• Graduated pipette
5 mL
 BTF2153 PHARMACEUTICAL FORMULATION METHODS 4

Medium preparation (Phosphate buffer pH 5.8)

1. Prepare 800 mL of distilled water in a suitable container.

2. Dissolve 81.39 mg of dipotassium hydrogen phosphate in the solution.
3. Dissolve 1.025 g of Potassium dihydrogen Phosphate in the solution.
4. Add distilled water until the volume is 1000 ml.

Standard Solution

1. Prepare in duplicates.
2. Weigh accurately 35 mg of pure paracetamol and transfer it into a 50 mL volumetric flask.
3. Add 20 mL of medium and sonicate for 5 minutes or until a clear solution is obtained.
4. Dilute to volume with the medium and mix well.
5. Pipette 2 mL of the solution and transfer it into a 200 mL volumetric flask.
6. Dilute to volume with the medium and mix well.
7. Filter through 0.45 µm nylon membrane filter.
8. Use the filtrate as Standard Solution. Each mL of Standard Solution contains about 0.007 mg
of paracetamol.

Sample Solution

1. Transfer the tablet individually to six dissolution vessel having 900 mL of medium
equilibrated to 37.0 ± 0.5°C and start the apparatus.
2. At 30 minutes, pipette 3 mL of the test solution and transfer into a 250 mL volumetric flask.
3. Dilute to volume with the medium and mix well.
4. Filter through 0.45 µm nylon membrane filter.
5. Use the filtrate as Sample Solution. Each mL of Test Solution contains about 0.007 mg of
paracetamol.
 BTF2153 PHARMACEUTICAL FORMULATION METHODS 5

Procedure

Measure the absorbance of Standard Solution (mean absorbance) and Sample Solution at 243 nm

using pH 5.8 phosphate buffer as blank with 1 cm pathlength flow cell.

Calculate the percentage dissolve of paracetamol content by the formula:

𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴 𝐴𝐴 2 900 250

𝑥𝑥 𝑥𝑥 𝑥𝑥 𝑥𝑥 𝑥𝑥 𝑃𝑃 = _____%
𝐴𝐴𝐴𝐴𝐴𝐴𝐴𝐴 50 200 500 3

Where,

Aspl = Absorbance of paracetamol obtained from Sample Solution.

Astd = Absorbance of paracetamol obtained from Standard Solution.

A = Weight of pure paracetamol in mg in the Standard Solution.

P = Potency/purity in the percentage of pure paracetamol.

 BTF2153 PHARMACEUTICAL FORMULATION METHODS 6

5.0 RESULTS & DISCUSSIONS

Your result and discussion may include the followings:

1. Result of In-vitro dissolution of Paracetamol Tablet 500 mg

Weight of Standard (Wtstd) mg

Weight of Sample (Ws) mg

Absorbance Standard (Astd)

Absorbance of Sample (Aspl)

Potency/purity

2. Determine the percentage of paracetamol release in 30 min and compliance result

based on USP <711> specification.

3. Recommend the steps that should be done if the paracetamol release percentage does

not meet the acceptance criteria (provide a table if any).

4. Explain the importance of the dissolution test to be included in the evaluation of

tablet formulation.

5. Discuss the factor that affects drug dissolution.