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Gursharan Khera

on 14 January 2014

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Dissolution and Disintegration
Pharmaceutical Technology
Step 1:
Powder Characterisation
Step 2: Granulation
Step 3: Tabletting
Step 4: Dissolution and Disintegration Testing
Powder Characterisation
How is this practical relevant to industrial pharmacy?
Watch the instructional video for this practical
Portfolio& Review
How is this practical relevant to industrial pharmacy?
Watch the instructional video for this practical
How is this practical relevant to industrial pharmacy?
Watch the instructional video for this practical
How is this practical relevant to industrial pharmacy?
Watch the instructional video for this practical
Portfolio and Industrial Review
What is expected of you?
Industrial Review
What is it?
What is expected of you?
You are expected to compile a portfolio consisting of two elements: three practical reports and one summary statement.

Each report should have the following sections: introduction, materials and methods, results & discussion, conclusions and references.

Powder Characterisation
In the report for this practical include a critical discussion comparing the different techniques you have used to assess particle size and size distribution
and powder flow

*A separate report is not required for this practical, as it is a manufacturing process rather than an experiment. Include details of this practical in the methodology section of the tabletting report.

Include the granulation and compression methodology in addition to your observations on the granules and the results of the tablet quality assurance tests.

Dissolution and Disintegration
Discuss what you can infer from the calibration curve, along with the results of the dissolution and disintegration tests.

Summary Statement
This should be approximately 1000 words long and should act as a stand-alone description of your overall findings from the practicals. Make sure to tie the practicals together by covering how the data sets relate to one another across the different practicals. Furthermore, give your conclusions on the effect of the hydration status of theophylline and include ways in which the study might have been improved.
*The information below is given as a summary - for more specific information (including dates) please refer to the laboratory manual.
Each group will meet in front of a panel to discuss their participation and findings in the practical sessions near the end of the semester.

The panel will consist of one industrial pharmacist and one academic pharmacist.
Every member of the group is expected to speak.

You should be knowledgeable about the aspects of formulation covered in the practicals. Moreover, you should be able to discuss your results in context.

You will NOT be asked to remember specific facts beyond what you have covered in the practical sessions.
Helpful Tips
Designate one or two representatives to answer questions on each subject area (for example those who wrote the tabletting practical will be most knowledgeable about this area so they might be given the task of answer any questions relating to tabletting).

Bring your portfolio in case you need to refer to it (though it will not be looked at or assessed by members of staff at this stage).

Do not bring textbooks.

Take advantage of the practice/review session on offer to each group in the week leading up to the presentation.
Example Questions
How do you think laser particle size analysis compares to sieving in terms of its usefulness?

In light of your experiences how would you change the tablet formulation?

Do you think dissolution testing is useful? why?
In this practical session you will be testing particle size, size distribution and powder flow properties of Theophylline Monohydrate BP and Theophylline Anhydrous BP. You will use the following tests: microscopic examination of the powder samples, particle size analysis by sieving, particle size analysis by laser diffraction, angle of repose and tap density.
The characterisation of the particle size, size distribution and flow properties of a powder are all essential components of developing a viable dosage form.

The particle size of the powder is important in calculating the dissolution rate and bioavailability of a drug. For example, a smaller particle will have a larger surface area: volume ratio and therefore dissolve quicker in the GI tract.

When a tablet is formed, the powder flows through a hopper into punches or capsules. Different sized particles have different flow rates, which affects the volume of powder filling the die or capsule. The higher (or lower) the volume of powder, the higher (or lower) the volume of drug within the tablet or capsule. The particle size of the powder must be known so that the dose within the tablets or capsules is always reproducible.
In this practical you will prepare two batches of granules: one from Theophylline Anhydrous BP and one from Theophylline Monohydrate BP. You will do this using the method of wet granulation.
Revise your lectures on powder properties
In order to make tablets, an API (active pharmaceutical product) must first be combined with excipients to form granules. Numerous granulation methods are used in industrial pharmacy. Wet granulation is often favoured over other granulation techniques for a number of reasons. Not only does it allow the drug to be more evenly distributed throughout the excipients but it also reduces segregation and mixing issues.
Revise your lectures on granulation
In this practical you will make two batches of tablets (Theophylline Anhydrous BP and Theophylline Monohydrate BP) using the granules you prepared during the previous session. After you have made the tablets you will perform the following quality assurance tests on them: tensile strength, uniformity of weight, thickness and friability.
In this practical, the single-station press was used. This apparatus consists of a hopper which feeds the granules into a die and an upper and lower punch which compress the granules into tablets. This is a popular tabletting process in industry due to its simple and cost-effective nature.
Once the tablets have been made they must undergo a number of quality assurance tests to ensure they are suitable for use. Compendial tests, which are outlined in the British and European pharmacopoeias, must be performed by manufacturers before they can release products for sale. These tests include: weight uniformity, content uniformity and disintegration time. Non-compendial tests are not required by law but are carried out by pharmaceutical companies to ensure their tablets are uniform. Examples of these include hardness and thickness testing.
Revise your lectures on tabletting and specifications.
In this practical session you will design a UV assay and perform dissolution and disintegration tests on the two batches of tablets (Theophylline Monohydrate BP and Theophylline Anhydrous BP) that you made in the the last practical.
Disintegrating tablets, such as the ones made in the previous practical, are most common type of tablet. When they are swallowed it is expected that they will release the API in a relatively short amount of time (compared with modified release tablets etc.). As a result, their disintegration, dissolution and absorption times must be fast. In this experiment you will measure exactly how long the tablets take to disintegrate and dissolve and compare the results of your tests to the requirements set out in the British Pharmacopoeia.
Revise your lectures on dissolution testing.
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