Université Ferhat Abbas Sétif 1 1ère Année Master

Faculté de Technologie M. Génie

pharmaceutique
Département : Génie des procédés Année unv : 2022/2023

Compte rendu du 1ère Tp

Drug analysis and control:
Dissolution test of solid forms:
Dissolutest

Instructor: Conducted by:

Pr. Baitich Hamza Fatima Zahra
Dr. Ameur Khadraoui Riheb
Groupe :
2-1

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I- Theoretical reminder :
I.1- Introduction :
Dissolution testing is an essential tool in the pharmaceutical
industry to assess the speed of dissolution of solid forms of
drugs. It ensures that drugs dissolve properly, ensuring their
effectiveness and bioavailability. Dissolution tests are
standardized to ensure the reliability of the results and are
regulated by national and international bodies.

The Dissolu test principle is crucial in the pharmaceutical industry for the following
reasons:
• Quality Assurance: It guarantees the rapid and homogeneous dissolubility of
drugs, thus ensuring the quality of the final product.
• Bioavailability assessment: It provides information on the speed and extent of the
release of active ingredients, allowing to estimate their availability and therapeutic
efficacy.
• Formulation optimization: It helps improve the solubility and release of active
ingredients, leading to more effective formulations and faster-acting drugs.
• Regulatory Compliance: It demonstrates compliance with regulatory standards,
thereby promoting approval of pharmaceuticals.
• Patient Safety: Ensures controlled release of active ingredients, minimizing risks
associated with inappropriate dosing.

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II- Manipulation:
II.1- Equipment :
The Dissolutest is a collection of dissolve testing equipment used to conduct tests on
solid solids. The Dissolutest device's key characteristics are:

• Dissolution baths: Throughout the test, materials

are kept in separate baths that maintain a consistent
temperature.
• dissolving baskets: Special baskets are used to hold
the samples and distribute the dissolving media
evenly.
• Agitation device: The dissolving baths have an
agitation mechanism to keep the dissolution media
moving continuously.
• System for collecting samples: The Dissolutest
enables the measurement of the concentration of the
active component by taking samples from the
dissolving media at predetermined time intervals.
• Temperature control: For repeatable test conditions, the gadget keeps the
dissolving baths' temperature constant.
• Software for data monitoring and analysis: Some Dissolutest models include
software for managing the dissolving process and analyzing the outcomes.

II.2- Procedure :
The operating conditions in the dissolution test:
When conducting the dissolution test, the main points to consider are:
1. Use an appropriate dissolution device according to regulatory standards.
2. Prepare a compliant dissolution medium in 900ml volume.
3. Check and maintain a constant temperature of the dissolution medium (water bath
with thermostat (37 0.5°C)).
4. Use an appropriate agitation rate to ensure homogeneous distribution.
5. Plan sample collection times in 45min.
6. Perform manual or automatic debits.
7. Dilute samples, using erlenmayer capacity 100 mL .
8. Prepare standard solutions of known concentration for calibration.
9. Verify and document the stability of the dissolution solutions and samples
collected.
It is essential to refer to regulatory protocols and standards to follow specific
operating conditions during dissolution testing.

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III- Les réponses :
1- To calculate the mass of paracetamol in a tablet, you need the following
information:
ü Concentration of each drugs
ü mass of paracetamol in a tablet
ü Percentage by mass of drugs

1- First step : Calculation of sample concentrations :

we have Beer-Lambert's law :
𝐴 =ℰ×ℓ×𝒸
as :
A : Absorbance
ℰ :The molar absorption coefficient in L.mol-1.cm-1
ℓ : The width in cm
𝒸 : Concentrations of each drugs in g/L
And from :
!
𝒸 = ℰ×ℓ
v drugs 1 :
!.!"!
𝒸 = !".!"# ×100

𝒸 = 0.377 g/L

drugs number 1 2 3 4 5 6
A 0.303 0.351 0.334 0.285 0.279 0.392
𝒸 (g/L) 0.377 0.437 0.416 0.355 0.348 0.489

2- Second step : Calculation The mass of paracetamol :

we have :
v drugs 1 :
0.377g/L → 1000 mL
x → 900 mL
And from :
0.377×900
𝑥=
1000
𝑥 = 0.339 g/L
⇒ 𝑥 = 339 mg/L

drugs number 1 2 3 4 5 6
Mass of drugs 339 393 374 320 313 440
in device
(mg/L)

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3- Third step : Calculation Percentage by mass of drugs :
we have :
v drugs 1 :
500 mg → 100%
339 mg → y%

And from :
339×100
𝑦=
500
⇒ 𝑦 = 67.8 %
drugs number 1 2 3 4 5 6
Percentage by 67.8 78.6 74.8 64 62.6 88
mass of
drugs (%)

2-
Paracetamol is frequently sold in combinations with other drugs to boost their
therapeutic benefits or target certain symptoms. Instances of paracetamol taken
together often include:
Ø Commonly seen in over-the-counter pain medications is the combination of
caffeine and paracetamol. With the addition of caffeine, paracetamol's
analgesic and moderate stimulating properties are improved.
Ø In order to treat moderate to severe pain, paracetamol and codeine are
combined. In order to deliver more potent pain relief, codeine, an opioid
analgesic, works in concert with paracetamol.
Ø Anti-cold and anti-flu drugs typically contain the combination of
pseudoephedrine and paracetamol. While paracetamol relieves pain and
fever, pseudoephedrine, a decongestant, helps clear up nasal congestion.
Ø Some allergy medicines contain the combination of paracetamol and
chlorpheniramine. Paracetamol relieves the discomfort and fever that come
with allergies, while chlorpheniramine, an antihistamine, helps to reduce allergy
symptoms like sneezing and itching.

There are a number of analytical techniques that may be used to determine the
quantity of paracetamol in these combination formulations. The most popular
techniques include:
Ø Spectrophotometry: The absorption of paracetamol at a certain wavelength
may be determined using UV-visible spectrophotometry. To determine the
quantity of paracetamol present, a calibration curve is created using standard
solutions with known paracetamol concentrations. The absorbance of the
sample is then compared to the curve.

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 Ø High-Performance Liquid Chromatography (HPLC) is a method that is
frequently used to measure paracetamol in complicated matrices. It entails
utilizing a particular column and mobile phase to separate the paracetamol from
other substances, followed by measurement of the paracetamol peak area or
peak height in the chromatogram. Comparing the concentration of paracetamol
to the calibration curve produced using standard solutions allows for the
determination of its concentration.
These techniques make it possible to precisely measure paracetamol in combination
products, enabling quality control and guaranteeing the right quantity of the active
component.

3- Yes, paracetamol is available in syrup form, which is a liquid formulation

containing the active ingredient dissolved in a solvent or suspension medium. It is
commonly used for pediatric patients or individuals who have difficulty swallowing
tablets or capsules. The syrup form offers convenient administration and precise
dosing, particularly for smaller doses required by children. It is often formulated with
pleasant flavors to improve taste and acceptance. Paracetamol syrup is absorbed in
the gastrointestinal tract after ingestion, providing its analgesic and antipyretic effects.

4- there are several pharmaceutical companies in Algeria that may produce

paracetamol or paracetamol-containing products. Some well-known pharmaceutical
companies in Algeria include:
• Saidal Group.
• Biopharm.
• Sanofi Algeria.
• Fidia Pharma Algeria.
• Laboratoires Hasnaoui.
• Dar El Dawa.
• Pharmalliance.

IIII- Conclusion :
Dissolutest is a dissolution test used to evaluate the rate of dissolution of active
ingredients in solid forms. It allows to measure the release of the active principles of
the galenical forms in the digestive tract. The operating conditions, analytical methods
such as UV spectrophotometry and HPLC, as well as the various forms of paracetamol
available were discussed.
The Dissolutest is an essential tool to ensure the quality and effectiveness of
immediate and delayed release drugs. Analytical methods make it possible to
accurately quantify active ingredients such as paracetamol in different pharmaceutical
products.
In short, Dissolutest and the associated analytical methods play an important role in
the quality control of drugs and the quantification of active ingredients. The proper
use of these tests and knowledge of local pharmaceutical companies ensures the safety
and efficacy of pharmaceutical products containing paracetamol in Algeria.

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