FACULTY OF CHEMICAL AND PROCESS ENGINEERING TECHNOLOGY

PHARMACEUTICAL FORMULATION METHOD

(BTF2153 )
Semester I 2023/2024
Title of Experiment : Dissolution Test
Date of Experiment : 31 October 2023
Lecturer’s Name : En. Razhan Bin Hassan

Group Number: 6

NO NAME NO. ID

1 NUR IZZAIDAH BINTI ZAIRUL FAMI TJ22054

2 WAN ANIS 'AQILAH BINTI WAN KHAIRULAMIN TJ22044

3 NAZHIRATUL FARHANAH BINTI RUSDI TJ22045

4 ZULAIKA BINTI ZAINAL ABIDIN TJ22046

5 MUHAMMAD NAQIUDDIN BIN KHAMISAN TJ22047

6 NURUL AIN NABILA BINTI MOHD JIDI TJ22048

MARKS
TABLE OF CONTENTS

ABSTRACT 2

INTRODUCTION 3-4

EXPERIMENTAL PROCEDURES 5-7

RESULT 8

DISCUSSION 9

CONCLUSION 10

REFERENCES 11

APPENDICES 12

1
ABSTRACT

Dissolution is defined as the quantity of drug material dissolved in a unit of time at

standard temperature, solvent composition, and liquid/solid interface conditions. This test is
offered to ascertain whether oral dosage forms are being administered in accordance with the
dissolution requirements specified in the Pharmacopeia monograph. To perform this
experiment, firstly, dipotassium hydrogen phosphate and Potassium dihydrogen Phosphate
were dissolved in distilled water to produce a buffer solution. After that, the buffer solution
was transferred into six dissolution vessels containing 500 mL for each vessel. Secondly, in
order to make a sample solution, the tablet was individually transferred to the six dissolution
vessels having a buffer medium to dissolve it in desired minutes. Then, a little amount of test
solution was drawn from the dissolution vessel. The test solution was diluted and mixed well
with the buffer solution. Then, the test solution was filtered before transferring it to the
cuvette. Lastly, the standard solution was prepared by dissolving the pure paracetamol in the
buffer medium. After that, the solution was sonicated until a clear solution was obtained. A
little amount of solution was drawn to dilute and mix it well with the buffer solution. Then,
the solution was filtered before transferring it to the cuvette. Based on the results obtained,
the percentage of paracetamol dissolved in a certain time for all samples was below 80% of
the acceptance criteria. To sum up, the dissolution rate of the paracetamol tablet obtained
from this experiment did not comply with the standard requirement due to several factors.

2
INTRODUCTION

In the pharmaceutical industry, drug dissolution testing is routinely used to provide

critical in vitro drug release.Dissolution is the process in which a substance forms a solution.
Dissolution testing is an essential analytical procedure that’s required as part of the final
release investigation for solid oral dosage forms to control product quality, stability, and
batch-to-batch consistency (Meike Eckert,2019). Currently, there are seven different types of
dissolution apparatus defined in the United States Pharmacopeia (USP)-basket type, paddle
type, reciprocating cylinder, flow through cell, paddle over disc, rotating cylinder, and
reciprocating disc. Of the seven apparatus, basket type (apparatus 1) and paddle type
(apparatus 2) are most commonly used for oral solid dosage forms.

USP Apparatus 1 (basket) and 2 (paddle) were introduced in the 1970s for the purpose
of providing a platform to evaluate the in vitro performance of dosage forms using
standardised conditions. The dissolution test in a USP monograph solely provides conditions
that facilitate discrimination among variations in critical quality attributes for the article. No
claim has been made that the design of the apparatus is specifically linked to, or mimics, in
vivo dissolution conditions of medium volume or agitation. However, since those early
years, these apparatus and associated procedures have become widely used and accepted.

This test is offered to determine whether oral dosage forms are being supplied
according to the dissolving requirements specified in the Pharmacopoeia monograph. Both
equipment 1 (basket type) and apparatus 2 (paddle type) can be used to carry out the
dissolution according to the requirement.

The active ingredient in the dosage form needs to dissolve in order to achieve
bioavailability. Therefore, measures of solubility and dissolution are necessary to determine
the drug's bioavailability. The intrinsic dissolution rate is, in principle, inversely related to the
compound's solubility. Additionally, it suggests that the solubility and the dissolving rate are
proportionate, but in this case, it's also important to consider the particle size and surface
area. But occasionally, the release of molecules from the surface into water is not perfect,
therefore the theoretically predicted dissolving rate may be higher or lower computed.

3
EXPERIMENTAL PROCEDURES

1. Medium Preparation (Phosphate buffer pH 5.8)

800mL of distilled water was prepared in a suitable container

↓
81.39mg of dipotassium hydrogen phosphate was dissolve in the solution

↓
1,025g of Potassium Dihydrogen was dissolved in the solution

↓
Distilled water was added until the volume is 1000ml

2. Standard Solution

Solution is prepared

↓
35mg of pure paracetamol was weighed accurately and was transferred into a 50mL
volumetric flask

↓
20mL of the solution was pipetted and was transferred into a 200mL volumetric
flask.

↓
The solution was diluted to volume with the medium and was mixed well.

4
 The solution was filtered through 0.45µ𝑚 nylon membrane filter

↓
The filtrate was used as a standard solution. Each mL of it contains about 0.007mg
of Paracetamol

3. Sample Solution

The tablet is transferred individually to six dissolution vessel having 900mL of

medium equilibrated to 37.0 +/- 0.5C and the apparatus is started.

↓
At 30 mins, 3mL of the test solution is pipetted and transferred into 250mL
volumetric flask

↓
It is diluted to volume with the medium and mixed well, It is the filtered through
0.45µ𝑚 nylon membrane filter.

↓
The filtered is used as a sample solution. About 0.007mg of paracetamol contained
in each ml of test solution

↓
Each sample are transferred into a cuvette

5
4. Procedure

6
 RESULT

Solution Blank Standard Sample

1 2 3 4 5 6 Average

Absorbance(Abs) 0.946 0.946 0.873 0.839 0.849 0.834 0.836 0.851 0.847

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

Weight of Standard (Wtstd) 35 mg

Weight of Sample (Ws) 500 mg

Absorbance Standard (Astd) 0.946

Absorbance of Sample (Aspl) 0.847

Potency/purity 99% - 101%

Percentage dissolve of paracetamol content:

Standard sample

0.946 35 1 500 100

0.946
× 50
× 100
× 500
× 1
× 99% = 70. 00%

0.873 35 1 500 100

Sample 1: 0.946
× 50
× 100
× 500
× 1
× 100% = 64. 60%

0.839 35 1 500 100

Sample 2: 0.946
× 50
× 100
× 500
× 1
× 100% = 62. 08%

0.849 35 1 500 100

Sample 3: 0.946
× 50
× 100
× 500
× 1
× 100% = 62. 82%

0.834 35 1 500 100

Sample 4: 0.946
× 50
× 100
× 500
× 1
× 100% = 61. 72%

0.836 35 1 500 100

Sample 5: 0.946
× 50
× 100
× 500
× 1
× 100% = 61. 86%

0.851 35 1 500 100

Sample 6: 0.946
× 50
× 100
× 500
× 1
× 100% = 62. 97%

7
DISCUSSION

The results obtained in this experiment reveal that each sample 1,2,3,4,5,and 6 has the
percentage of paracetamol release in 30 minutes which is 70.00%, 64.60%, 62.08%, 62.82%,
61.72%, 61.86%, and 62.97% respectively. From the result it can be conclude that the sample
is not accepted based on the compliance result based on USP specification which stated that
the percentage must be not less than 80% (Q) of the labelled amount of paracetamol is
dissolved in 30 minutes.The absorbance of sample(Aspl) is 0.847 and the purity falls
between 99% - 101%.

To enhance the precision of future experiments, it is recommended that when the

paracetamol release percentage does not meet the acceptance criteria it is highly suggested to
conduct a retesting using the same or modified conditions if there are doubts about the
accuracy of the initial test. This may involve adjusting parameters such as dissolution
medium, pH, or agitation speed.Secondly, if formulation issues are identified, consider
optimizing the formulation to enhance dissolution. This might involve adjusting excipient
ratios, particle size, or other formulation parameters.

There are several importance of the dissolution test to be included in the evaluation of
tablet formulation,one of it is that the dissolution test helps to predict the rate and extent to
which a drug substance will be released from a tablet and become available for absorption in
the bloodstream which is crucial for understanding the bioavailability of the drug.Not just
that but also a proper dissolution is directly linked to the therapeutic effectiveness of tablets.
Tablets that fail to dissolve adequately may result in insufficient drug levels in the
bloodstream, compromising the efficacy of the treatment.Next, serving as a crucial quality
control measure, the dissolution test ensures that different batches of the same tablet
formulation consistently adhere to specified standards. This consistency is vital for
maintaining the effectiveness and safety of the medication.

8
 There are various factors that affects the drug dissolution which is the size of drug
particles is a significant determinant. Smaller particles generally offer a larger surface area,
facilitating faster dissolution.Secondly, is the pH of the dissolution medium affects the
ionization state of the drug. Adjusting the pH can influence solubility and dissolution,
particularly for drugs with ionizable functional groups.Temperature also impacts the drug
solubility, with higher temperatures generally promoting faster dissolution. However, extreme
temperatures may also affect drug stability.The last but not least is the agitation or stirring
enhances mass transfer, aiding drug dissolution. The speed and intensity of agitation play a
role in influencing dissolution rates.

9
CONCLUSION

Based on the experiment, the objective was to investigate the disintegration process
for paracetamol tablets, and was effectively achieved. Dissolution is the process in which a
substance forms a solution. Basically, the factors that affect the dissolution of a drug product
include the intrinsic properties of the API (e.g., solubility, wettability, particle size, surface
area, morphology, polymorphs), the formulation composition and characteristics (e.g.,
excipients, hardness, manufacturing process), and the dissolution method used for its
assessment (e.g., apparatus, medium, test conditions, sampling, and sample analysis). These
factors were the reasons that affected the dissolution rate of the paracetamol tablets. The
dissolution of a drug is important for its bioavailability and therapeutic effectiveness. The
percentage that the paracetamol content has dissolved is approximately 70.00%, 64.60%,
62.08%, 62.82%, 61.72%, 61.86%, and 62.97% by using the formula that has been given.
The percentage that obtained is less than 80% (Q) of the acceptance criteria. Suggesting to
enhance the smooth flow of the experiment is ensuring the volumetric flask is shaken
carefully to dilute the solution approximately. Furthermore, carry the cuvette carefully and
make sure to not touch the clear part on it to prevent any fingerprint stick on it that can cause
the non penetrating light through it. Next, ensuring that the dissolution medium maintains
sink conditions throughout the experiment. This ensures that the drug concentration in the
medium remains low relative to its solubility.

10
REFERENCES

1. USP. (n.d.). Dissolution Testing and Drug Release Tests | USP. Www.usp.org.

https://www.usp.org/small-molecules/dissolution

2. Siew, A. (2016, November 2). Dissolution Testing. PharmTech.

https://www.pharmtech.com/view/dissolution-testing-3

3. Dr. JIGAR N. SHAH. (n.d.). FACTORS AFFECTING DISSOLUTION RATE.

Institute of Pharmacy, Nirma University.
https://jigarshahblog.files.wordpress.com/2015/07/dissolutionfactors.pdf

4. In-vitro evaluations of quality control parameters of paracetamol tablets marketed in

Gondar city, northwest Ethiopia. (2020, December 21). PubMed Central (PMC).
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7762764/

5. Vivian A. Gray, & Thomas W. Rosanske. (2020). Dissolution. ScienceDirect.

https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-s
cience/dissolution#:~:text=For%20quality%20control%20purposes%2C%20dissoluti
on,or%20storage%20of%20a%20product

11
APPENDICES

Figure 1 Figure 2

Figure 3

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